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The SimpleStitch Suturing System is intended for endoscopic placement of suture(s) and approximation of soft tissue (e.g., closure and healing of ESD/EMR sites, and closing of fistula, perforation or leaks).

The SimpleStitch Suturing System ("SimpleStitch SS") is a sterile, single patient-use device that enables endoscopic placement of sutures and approximation of soft tissue within the gastrointestinal tract using a flexible endoscope. The system includes the following components: SimpleStitch Suture Device, SimpleStitch Suture Cartridge, and SimpleStitch Suture Cinch. The SimpleStitch SS is designed for compatibility with single-channel endoscopes (gastroscopes and colonoscopes) with a minimum working channel inner diameter of 2.8mm. During use, the suturing device/suture cartridge is mounted to the endoscope's exterior; the cinching device goes through the endoscope's working channel. The SimpleStitch SS is available with a USP 2-0 and USP 0 nonabsorbable polyester suture. Tissue is secured using a cinch anchor once tissue approximation is complete.

This FDA 510(k) clearance letter and summary is for a physical medical device (SimpleStitch Suturing System), not an AI/Software as a Medical Device (SaMD). Therefore, the information typically requested for AI/SaMD performance studies (such as acceptance criteria for algorithm performance, sample size for test sets with ground truth, number of experts for ground truth, MRMC studies, standalone performance, training set details, etc.) is not applicable here.

The document focuses on demonstrating substantial equivalence to a predicate device (OverStitch Endoscopic Suturing System) through:

• Comparison of Technological Characteristics: Showing similarities in intended use, indications for use, principle of operation, materials, and design.
• Performance Data: Primarily bench testing (dimensional verification, functionality, destructive testing, side-by-side comparison with predicate, usability, packaging, shelf-life), biocompatibility, MRI safety, and an animal (swine) survival study.

There is no mention of an algorithm or AI model, nor any associated acceptance criteria, ground truth establishment, or statistical performance metrics typically associated with AI/SaMD.

Therefore, I cannot provide the requested information regarding acceptance criteria and study proof in the context of an AI/SaMD for this document.

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The SimpleSnip Suture Cutter is intended to cut sutures during all flexible endoscopic procedures.

The SimpleSnip Endoscopic Suture Cutter is sterile, single patient-use device intended to cut sutures during flexible endoscopic procedures. The cutting device goes through the working channel of the endoscope and is compatible with flexible endoscopes with a minimum channel diameter of 2.8mm. The device is available in two working lengths: 160cm working length for gastroscopes and 230 cm working length for colonoscopes. The device consists principally of a proximal handle assembly, a catheter with core wire, and a blade to cut the suture. Once the SimpleSnip device is inserted in the working channel of the endoscope, the blade is advanced from the catheter, the suture is captured within the blade such that when the blade is pulled back toward the catheter the suture is cut. The blade is rotatable to allow easy suture capturing and cutting.

I am sorry, but the provided text does not contain information about acceptance criteria and a study proving a device meets these criteria. The document is an FDA 510(k) clearance letter for the SimpleSnip Endoscopic Suture Cutter, detailing its substantial equivalence to a predicate device. It includes information about the device description, indications for use, comparison with a predicate device, and performance/biocompatibility/sterilization testing conducted.

Specifically, it states:

• "No clinical studies were deemed necessary to demonstrate the safety and effectiveness of the subject device." This means there isn't a clinical study with acceptance criteria and reported performance in the context of human data.
• The performance data mentioned is primarily bench testing and functional testing, as well as comparative testing against the predicate device for certain mechanical aspects (rotation, actuation, bending stiffness). These tests are designed to verify specifications and show equivalence, not necessarily to meet pre-defined clinical performance acceptance criteria against human outcomes.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for a test set or data provenance for a clinical study.
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone algorithm performance.
7. Type of ground truth for a clinical study.
8. Sample size for a training set.
9. How ground truth for the training set was established.

This document focuses on demonstrating substantial equivalence through non-clinical data and comparison to a predicate device, which is common for 510(k) submissions where clinical studies are not deemed necessary.

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The Simplexa C. auris Direct is a real-time polymerase chain reaction (RT-PCR) assay intended for use on the LIAISON MDX instrument for the direct in vitro qualitative detection of Candida auris DNA from a composite swab of bilateral axilla/groin from patients suspected of C. auris colonization.

The test is intended to aid in the prevention and control of C. auris infection in healthcare settings by detecting C. auris from colonized patients.

Positive results indicate that the patient is colonized with C. auris. A positive result cannot rule out co-colonization with other pathogens. A negative result does not preclude C. auris colonization or infection and should not be used as the sole basis for treatment or other patient management decisions. Results are meant to be used in conjunction with other clinical, epidemiologic, and laboratory information available to the clinician evaluating the patient. The test is not intended to diagnose or monitor treatment for C. auris infection. Concomitant cultures are necessary to recover organisms for epidemiological typing or for antimicrobial susceptibility testing.

The Simplexa C. auris RT-PCR system is intended for the amplification and qualitative detection of nucleic acid from Candida auris in composite bilateral axilla/groin swab specimens and consists of the following:

1. The Simplexa C. auris Direct is the RT-PCR assay kit that contains all the reagents for the amplification reaction, including the primers and fluorescent probes for the detection of nucleic acid from Candida auris. The primers and fluorescent probes amplifies the C. auris DNA and Internal Control DNA. In addition, the kit comes with a barcode card, which contains assay specific parameters and lot information.
2. The Simplexa C. auris Positive Control Pack is the separately packaged external positive quality control kit for use with the Simplexa C. auris Direct assay.
3. The Simplexa C. auris Sample Prep Kit is the enzymatic buffer solution to receive the sample solution (bilateral axilla/groin swab in Amies transport media) from the patient.

The Simplexa C. auris RT-PCR system is for use with the LIAISON MDX instrument (with LIAISON MDX Studio Software), the RT-PCR thermocycler that amplifies the nucleic acid from biological specimens and uses real-time fluorescence detection to identify targets, and the Direct Amplification Disc (DAD), which is the accessory containing the input sample wells for use on the LIAISON MDX. The instrument and accessory were previously cleared under K102314 and K120413. The instrument is controlled by an external laptop running the software. The DAD consumable is compartmentalized into eight (8) separate wedges and can process up to eight (8) separate specimens or controls on each disc. Each wedge contains sample and reagent input wells, microfluidic channels and laser activated valves to control the fluid flow as well as a reaction/detection chamber.

The provided document describes the analytical and clinical performance of the Simplexa C. auris Direct RT-PCR system. However, it does not explicitly state pre-defined acceptance criteria in a table format that the device needed to meet. Instead, it presents the results of various studies (precision, analytical specificity, limit of detection, inclusivity, clinical performance) and then often concludes whether these results are "acceptable."

For example, for precision, it states: "For the multisite study, the test device showed ≥ 98.9% agreement of the qualitative result and ≤ 8.2% CV for each of the variance components, which is acceptable." This implies that ≥ 98.9% agreement and ≤ 8.2% CV were the internal acceptance criteria for precision.

Similarly, for the clinical performance, the reported Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) values are presented as the device's performance, but explicit pre-defined minimum thresholds for PPA and NPA as acceptance criteria are not given. They are implied by the fact that the De Novo request was granted.

Given this, I will infer the acceptance criteria from the reported "acceptable" results where possible and present the device performance based on the clinical study results.

Here's the information requested based on the provided text:

1. Table of Acceptance Criteria (Inferred) and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

Test Set (Clinical Study):

• Total Evaluable Clinical Specimens (Combined Cohort): 2,020 specimens.
  • Prospective Cohort: 1,930 evaluable specimens.
  • Retrospective/Enriched Cohort: 90 evaluable specimens (11 retrospective pre-selected C. auris positive + 202 enriched specimens, of which 90 were evaluable).
• Data Provenance:
  • Geographic Locations: Six study sites across four geographically diverse locations within the United States and one in Italy.
  • Type of Data:
    • Prospective: Prospectively collected specimens (axilla/groin swabs) from patients suspected of C. auris colonization. Tested either fresh or frozen. Collected from April to July 2023.
    • Retrospective/Enriched: Leftover, de-identified composite bilateral axilla/groin swabs. Included 11 pre-selected C. auris positive retrospective specimens and 202 enriched specimens (identified as positive by a laboratory-verified RT-PCR test, then blinded and tested).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document states that the ground truth for the clinical study was established by a reference method consisting of "standard of care (SOC) culture followed by matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS) for identification." These are laboratory methods, not human expert interpretation of images or other subjective data.

For discordant analysis, "Bi-directional sequencing (BDS) assays were performed when the candidate assay results differed from the comparator method." Again, this is a laboratory method.

The document does not specify human experts or their qualifications for establishing the ground truth for the test set.

4. Adjudication Method for the Test Set

The primary ground truth was established by the reference method (SOC culture + MALDI-TOF MS). For discordant results between the candidate assay and the reference method, Bi-directional Sequencing (BDS) was performed. However, "The results from discordant analysis were not used to alter the original performance but are provided in footnotes to the performance tables."

Therefore, there wasn't a human-based adjudication method in the traditional sense (e.g., 2+1 or 3+1 radiologists making a consensus decision). The reference method and supplemental BDS purely relied on objective laboratory techniques.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, this document describes a diagnostic device (RT-PCR assay) for detecting nucleic acids of Candida auris. It is not an AI-assisted diagnostic imaging device for which an MRMC study comparing human readers with and without AI assistance would be relevant. The study focuses solely on the direct performance of the molecular diagnostic test against a laboratory reference method.

6. If a Standalone (i.e. Algorithm only without human-in-the-loop performance) was Done

Yes, the entire clinical evaluation (Sections VI.C) and analytical performance studies (Sections VI.A) describe the standalone performance of the Simplexa C. auris Direct RT-PCR system. This device is an automated molecular diagnostic test and does not involve human interpretation in a loop, except for the user performing the test steps according to the instructions. The results (Ct values, positive/negative calls) are generated directly by the instrument platform (LIAISON MDX).

7. The Type of Ground Truth Used

The primary ground truth used for the clinical study was Standard of Care (SOC) culture followed by Matrix-Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry (MALDI-TOF MS) for identification. For discordant results, Bi-directional Sequencing (BDS) was used as a supplemental ground truth, though these results did not alter the original performance metrics. This is a form of laboratory reference standard.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of an AI/ML algorithm that would undergo a distinct training phase. This document describes a molecular diagnostic assay, not a machine learning model. The development of such assays involves establishing parameters (like fluorescence and Ct thresholds) using initial data, which could be considered an internal "calibration" or "development" process rather than a "training set" in the AI sense.

It states: "The fluorescence and Ct thresholds for C. auris and Internal Control were established using 717 sample runs of No Template Control (NTC), Limit of Detection (LoD), Microbial Inhibition, Interference and Limiting Dilution samples. The established thresholds were then confirmed using an independent data set comprising 2,924 sample runs..." These 717 runs could be considered the data used for establishing (or "training") the assay's interpretive parameters.

9. How the Ground Truth for the Training Set Was Established

Given that this is a molecular diagnostic assay and not an AI/ML system, the concept of "ground truth for a training set" as it pertains to labeled examples for model learning is not directly applicable.

Instead, the "establishment" of the assay's operating parameters (like Ct thresholds) was based on experimental data where the expected outcome (presence/absence of C. auris, inhibition, etc.) was known by design:

• No Template Control (NTC): Expected negative.
• Limit of Detection (LoD): Contrived samples with known concentrations of C. auris.
• Microbial Inhibition/Interference: Samples with C. auris at known concentrations (e.g., 3x LoD) spiked with other substances/organisms.
• Limiting Dilution: Samples serially diluted to determine the lowest detectable concentration.

These experiments provide the "ground truth" for setting the assay's interpretive parameters and analytical performance characteristics. The known concentrations, presence/absence of target nucleic acids, and presence/absence of interfering substances served as the factual basis for defining how the device should interpret its signals (e.g., Ct value thresholds for positivity).

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The SimpleSense Platform is intended for use at home, a healthcare facility, or medical research organization under the direction of a licensed medical professional to record, display, and store the following physiological data: a) 2 leads of Electrocardiogram; b) Respiration rate measured through thoracic impedance; c) Heart Sounds; d) Activity including posture; e) Systolic and Diastolic Blood Pressure and f) other validated data sources. The SimpleSense Platform is intended for use when the licensed medical professional decides to evaluate the physiologic signals of adult patients as an aid to diagnosis and treatment. The SimpleSense Platform is intended to be used by patients at rest with a stationary torso. ECG recordings are indicated for the manual assessment of cardiac rhythm disturbances.

The SimpleSense Platform does not produce alarms and is not intended for active patient monitoring. The SimpleSense Platform is not intended for use as life supporting equipment on high-risk patients such as critical care patients. The SimpleSense Platform is not intended for use in the presence of a pacemaker.

The SimpleSense-BP software application is intended to estimate, display and store blood pressure data on adult patients who are twenty two (22) years and older. The SimpleSense-BP can be used after a clinician determines the user's hypertension classification via an auscultatory blood pressure cuff measurement. The Blood Pressure algorithm uses patient specific information (age, gender, height and weight) and the blood pressure measurement as inputs. SimpleSense-BP is used to provide blood pressure estimations derived from physiological sensors to qualified medical personnel as a complimentary physiological feature for the purposes of assessing a patient's cardiac health and variance.

The SimpleSense-BP Software Application accesses the physiological parameters like ECG, heart sounds, and thoracic impedance captured by the SimpleSense Device for processing into the vital sign outputs of the product which includes estimation of Systolic and Diastolic blood pressure. The software uses recorded data from the SimpleSense electronics module as inputs into a validated computational model for estimating blood pressure over the period of wear. The system samples blood pressure while the user is at rest. In addition, SimpleSense-BP Software utilizes inputs such as demographic information (age, weight, height, and gender) and a blood pressure measurement for clinical stratification to the algorithm. The blood pressure outputs are returned to the SimpleSense Mobile Application and/or SimpleSense webserver for display, review and interpretation by a physician.

The Nanowear SimpleSense system is a non-invasive, wearable, and portable medical device for the evaluation and monitoring of patients. It utilizes physiologic and biometric sensors embedded in a garment and an electronics module to gather the heart health data. The specific physiological parameters recorded by the device include: two vectors of Electrocardiogram (ECG), respiratory rate though thoracic impedance, heart sounds, and activity including posture. The signals are recorded by the electronics module on a removable data storage card and are periodically transferred to a smartphone mobile application that connects to the electronics module over a wireless Bluetooth connection. The mobile application provides the functionality of transferring the data collected by the electronics module then relaying the data to the Nanowear web server for display of the data by a physician.

The provided text describes the acceptance criteria and study proving the performance of the SimpleSense-BP software application for blood pressure estimation.

Here's an organized breakdown of the requested information:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the SimpleSense-BP algorithm are based on the ISO 81060-2 standard for non-invasive sphygmomanometers. The reported performance refers to the accuracy of the device's blood pressure estimations compared to reference measurements.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Induced Change Test: 149 subjects in total were identified, with 147 subjects having usable data. The study ensured at least 10 subjects had a change in BP of at least 15 mmHg systolic or 10 mmHg diastolic for each of the 4 models used by the device.
• Sample Size for Accuracy over Calibration Period Test: 91 subjects. The study enrolled subjects until at least 85 subjects were included and at least 21 subjects in each clinical stratification (Normal, Prehypertension, Stage 1 hypertension, and Stage 2 hypertension) were represented.
• Data Provenance: The document does not explicitly state the country of origin. It indicates that blood pressure variations were induced using physical activity and thermal stimuli, and auscultatory reference measurements were used for validation, suggesting a prospective study design.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document states that "auscultatory reference measurements were used to validate the SimpleSense-BP algorithm." This implies a clinical setting where blood pressure is manually measured by trained personnel, typically healthcare professionals, using a cuff. However, the exact number of experts, their specific qualifications (e.g., "radiologist with 10 years of experience"), or the method of their involvement (e.g., individual readings, consensus) are not specified in the provided text.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1, none) for the test set. The ground truth was established by "auscultatory reference measurements," which usually implies direct clinical measurement rather than adjudicated review of digital data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The provided text describes a standalone performance study comparing the device's output to a gold standard (auscultatory measurements), not a comparative effectiveness study involving human readers with and without AI assistance. Therefore, there is no mention of an effect size for human reader improvement with AI assistance.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes. The entire performance testing section (Section 11) is dedicated to evaluating the "SimpleSense-BP algorithm" against auscultatory reference measurements. This represents a standalone (algorithm only) performance evaluation.

7. The Type of Ground Truth Used

The type of ground truth used is auscultatory blood pressure cuff measurements, which is considered the gold standard for non-invasive blood pressure measurement.

8. The Sample Size for the Training Set

The sample size for the training set is not specified. The document explicitly states, "There was no overlap of subjects between the training and test data sets i.e., none of the measurements from subjects in the training data set were included in the test data set and vice versa," confirming that a training set was used but not detailing its size.

9. How the Ground Truth for the Training Set Was Established

The document does not explicitly state how the ground truth for the training set was established. However, given that the validation uses "auscultatory reference measurements" as the gold standard, it is highly probable that the training data's ground truth was established using the same (or a similar and equally robust) method of auscultatory blood pressure measurements.

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The Simple 2 Test is intended for in vitro detection and identification of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) in home-collected specimens which are shipped to a clinical laboratory for testing using the Aptima Combo 2 Assay on the Panther System. This product is available over-the-counter (OTC) to consumers 18 years of age and older.

The Simple 2 Test contains all the necessary components to collect urine from male patients (Simple 2 Urine Home Collection Kit (Penile)) or vaginal swabs from female patients (Simple 2 Swab Home Collection Kit (Vaginal)) in their home, or in similar environments, without supervision from a healthcare provider.

The Simple 2 Test Collection Kits may also be used to self-collect specimens in a clinic.

The testing is performed, as determined to be appropriate, based on the results of LetsGetChecked Suitability Questionnaire.

This test system is not a substitute for visits to a healthcare provider. The information provided by this product should not be used to start, stop, or change any course of treatment unless advised by your healthcare provider.

Testing is limited to the manufacturer, Priva Path laboratories (d.b.a. LetsGetChecked. Inc.).

The LetsGetChecked Simple 2 Test is composed of the Simple 2 Urine Home Collection Kit (Penile) and the Simple 2 Swab Home Collection Kit (Vaginal) and the samples are shipped to LetsGetChecked's Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory for processing using the Aptima Combo 2 Assay on the Panther System. The Aptima Combo 2 Assay was previously cleared for the qualitative in vitro detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) when used with male urine and self-collected vaginal swabs collected in clinical settings.

The home collection kits are intended to be distributed for purchase online without the need for prescription from a physician or healthcare professional (over-the-counter use). After purchase, the user activates the kit on LetsGetChecked's website and is requested to fill out the Suitability Questionnaire to determine whether this test is appropriate for this individual. The user follows detailed directions for self-collecting a urogenital specimen (male urine or female vaginal swab, as applicable), packaging and shipping it to the LetsGetChecked CLIA certified laboratory for testing (PrivaPath lab). The test results are delivered to the individual via LetsGetChecked online portal. Positive and invalid/inconclusive results are followed up with a call from the LetsGetChecked Care Team. If the patient received a positive chlamydia result, treatment options are discussed. Patients receiving a positive gonorrhea test result, will be advised to contact their healthcare provider to receive appropriate treatment. The LetsGetChecked Care Team will also contact all patients who test negative for chlamydia and gonorrhea, but do report symptoms, or concerns, or where further investigation is indicated. These patients are internally flagged for follow-up.

The provided text describes the evaluation of the Simple 2 Test, a device for the in vitro detection and identification of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) in home-collected specimens. The device is intended for over-the-counter use by consumers 18 years of age and older.

The acceptance criteria for the device are focused on usability and comprehension by lay users and the analytical performance of the collection kits under various challenging conditions (flex studies, interfering substances, shipping stability), ensuring that the home collection process does not compromise the accuracy of the downstream testing performed by the Aptima Combo 2 Assay on the Panther System.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a single table outlining predefined "acceptance criteria" alongside specific performance metrics the device must meet. Instead, it describes various studies and their outcomes, implicitly demonstrating the device's acceptable performance. The "Success Rate" shown in Tables 3, 4, 7, and 8 for usability/comprehension, and the "Agreement with expected result" in Tables 9, 10, 11, 12, 13, 14, 16, 18, 19, and 20 for analytical performance, serve as the evidence of meeting the unstated acceptance goals.

Based on the summaries of the studies, the implicit acceptance criterion for usability and comprehension appears to be a high success rate (generally aiming for 100% in critical steps or demonstrating that modifications resolve issues) for proper specimen collection, packaging, and comprehension of instructions and results. For analytical performance, the criterion is largely 100% agreement with expected results under various challenging conditions, or demonstration that the test robustly performs within acceptable limits despite certain challenging conditions, with any identified limitations clearly called out in labeling.

Implicit Acceptance Criteria and Reported Performance (Selected examples from the document):

2. Sample Size Used for the Test Set and Data Provenance

The test sets are primarily derived from usability and analytical performance studies.

• Usability Studies (Test Set):

  • Simple 2 Urine Home Collection Kit (Penile):
    • Initial study: 89 male participants.
    • Final usability study: 32 male participants.
  • Simple 2 Swab Home Collection Kit (Vaginal):
    • Initial study: 85 female participants.
    • Final usability study: 34 participants (33 female, 1 transgender male).
  • Data Provenance: The studies were conducted remotely from lay users' homes via online video conferencing. No specific country of origin is mentioned beyond being a US FDA submission, implying the studies were conducted in the US or for the US market. The studies appear to be prospective in nature, as they involve participants actively performing tasks following instructions and providing feedback/data.

• Analytical Performance Studies (Flex, Interfering Substances, Shipping Stability - Test Set):

  • These studies involved specific numbers of replicates for each condition (e.g., [b-4] positive and [b-4] negative replicates for flex studies on urine volume). The exact total sample sizes for these analytical tests are scattered across tables with redacted information (e.g., "[b-4] positives/[b-4] tested").
  • Data Provenance: These are laboratory-based analytical studies, not human clinical trials. The data provenance is internal to the manufacturer's testing or a clinical laboratory. No specific country of origin is stated, but given the FDA submission, the data is expected to be relevant to US regulatory standards. These are experimental evaluations, likely prospective in nature within a controlled lab setting, designed to mimic real-world conditions.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Usability Studies: Ground truth for these studies was generally based on the objective observation of successful completion of tasks (e.g., transferring correct urine volume, proper packaging) and comprehension of instructions/information as assessed by study staff questions. The document does not specify the number or qualifications of experts involved in observing or assessing these lay user interactions directly. However, the design of the modifications and the evaluation criteria would have been informed by regulatory requirements and potentially human factors experts.
• Analytical Performance Studies: For these studies, the ground truth is the expected presence or absence of CT/GC in the spiked or unspiked samples. This is a scientific, laboratory-defined ground truth, established by the precise spiking of organisms at known concentrations into negative matrices or using truly negative samples. The "experts" in this context are the laboratory scientists and technicians conducting the assays and preparing the samples, presumed to be qualified in molecular diagnostics. No specific number or external qualifications are mentioned for establishing this analytical ground truth, as it's inherent to the experimental design (e.g., "spiked with CT or GC organisms at the target concentration of LoD").

4. Adjudication Method for the Test Set

• Usability Studies: The success/failure of user actions and comprehension was likely determined by the study staff observing and questioning participants. The document doesn't detail a formal "adjudication" process akin to expert reader consensus, but rather a direct assessment of task completion and questionnaire responses. Issues identified (e.g., difficulty transferring urine) led to design modifications, implying an iterative evaluation process rather than a strict adjudication of initial failures.
• Analytical Performance Studies: The results (e.g., #positives/#tested, agreement with expected result) are quantitative outcomes of the biochemical assay. There is no mention of an "adjudication method" in the sense of multiple human experts reviewing results. The expectation is that the laboratory results directly represent the device's performance under the tested conditions.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention (and no indication) of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study involving human readers with and without AI assistance. This device is not an AI-assisted diagnostic. It is a home collection kit for a laboratory test, wherein the "device" is the collection system and the final analysis is done by an established IVD system (Aptima Combo 2 Assay on the Panther System). The studies focus on the usability and analytical integrity of the home-collected samples, not on AI-assisted interpretation of diagnostic images or data.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This question is Not Applicable in the context of this device. The Simple 2 Test is a collection kit, not a standalone algorithm. The "algorithm" (nucleic acid amplification assay) is the Aptima Combo 2 Assay on the Panther System, which is a pre-existing cleared/approved device. The performance data presented relates to the integrity and suitability of the home-collected samples for use with that established assay, not a novel standalone algorithm.

7. Type of Ground Truth Used

• Usability Studies: The ground truth for these studies was the observed proper execution of instructed tasks and comprehension of information by lay users, assessed against predefined criteria for successful use of the collection kit and understanding of the accompanying materials.
• Analytical Performance Studies: The ground truth was analytically established through precise spiking of known concentrations of CT and GC organisms into negative matrices, or the use of confirmed negative samples. This constitutes a laboratory-defined ground truth (e.g., "spiked with GC or CT at 3x LoD").

8. Sample Size for the Training Set

The document describes two phases of usability/comprehension studies (initial and final) for both the urine and vaginal swab kits. The initial studies for both kits served a similar function to a training set or preliminary evaluation, leading to modifications in the kit and instructions.

• Simple 2 Urine Home Collection Kit (Penile): 89 male participants in the initial study.
• Simple 2 Swab Home Collection Kit (Vaginal): 85 female participants in the initial study.
  These initial studies acted as "training" or optimization phases by identifying deficiencies that informed product improvements.

For the analytical "flex studies, interfering substances, and shipping stability" tests, the concept of a "training set" is not applicable in the typical machine learning sense. These are experimental validations. The initial LoD (Limit of Detection) establishment, mentioned briefly, might involve some preliminary testing that could be seen as "training" for setting analytical parameters, but no specific sample size for such an activity is provided.

9. How the Ground Truth for the Training Set Was Established

For the usability studies, the ground truth for the initial "training" phase was based on direct observation of user performance and comprehension assessments, identifying areas where users struggled or misunderstood. For example, the 9% of users having difficulty transferring urine volume in the initial penile kit usability study highlighted a deficiency that needed to be addressed. This identified "ground truth" (i.e., areas of user error) then informed the modifications.

For the analytical studies, as noted in point 7, ground truth is laboratory-defined by precise manipulation of samples (e.g., spiking with known concentrations, ensuring negative samples are truly negative). This analytical ground truth would be established through standard laboratory and molecular biology techniques.

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The DiaSorin Molecular Simplexa™ COVID-19 & Flu A/B Direct is a real-time RT-PCR assay intended for use on the LIAISON® MDX instrument for the in vitro qualitative detection and differentiation of nucleic acid from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza B virus in nasopharyngeal swabs (NPS) from individuals with signs and symptoms of respiratory tract infection.

The Simplexa™ COVID-19 & Flu A/B Direct assay is intended for use as an aid in the differential diagnosis of SARS-CoV-2, influenza A and influenza B infection.

Negative results do not preclude SARS-CoV-2, influenza B infection and should not be used as the sole basis for patient management decisions. Positive results do not rule out coinfection with other organisms. Results should be combined with clinical observations, patient history, and epidemiological information.

The Simplexa™ COVID-19 & Flu A/B Direct assay is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.

The Simplexa™ COVID-19 & Flu A/B Direct assay system is a real-time RT-PCR system that enables the direct amplification, detection and differentiation of SARS-CoV-2 RNA, human influenza A (Flu A) virus RNA and human influenza B (Flu B) virus RNA from unprocessed nasopharyngeal swabs (NPS) that have not undergone nucleic acid extraction. The system consists of the Simplexa™ COVID-19 & Flu A/B Direct assay, the LIAISON® MDX (with LIAISON® MDX Studio Software), the Direct Amplification Disc and associated accessories.

In the Simplexa™ COVID-19 & Flu A/B Direct assay, fluorescent probes are used together with corresponding forward and reverse primers to amplify SARS-CoV-2, Flu A, Flu B and internal control RNA targets. For COVID-19 detection, the assay targets two different regions specific to the SARS-CoV-2 genome; the S gene which encodes the spike glycoprotein and the ORF1ab region which encodes wellconserved non-structural proteins and therefore is less susceptible to recombination. For Flu detection the assay targets conserved regions of influenza A viruses (matrix gene) and influenza B viruses (matrix gene). The assay provides three results; COVID-19 (ORF1ab and/or S gene detection), influenza A viruses (matrix gene detection) and influenza B viruses (matrix gene detection). An RNA internal control is used to detect RT-PCR failure and/or inhibition.

This document describes the analytical and clinical performance studies for the DiaSorin Molecular Simplexa™ COVID-19 & Flu A/B Direct assay.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the clinical performance are generally indicated by the Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) with their corresponding 95% Confidence Intervals (CI).

2. Sample Size Used for the Test Set and Data Provenance

• Prospective Samples: Over 1400 total specimens (nasopharyngeal swabs (NPS)) were collected between August 2021 and March 2022 from six geographically diverse clinical sites within the United States. The exact number of prospective samples used for each target in the agreement analysis can be inferred from the TP/(TP+FN) and TN/(TN+FP) values in Table 2:
  • Influenza A: 1168 (62 positive, 1106 negative, plus 5 and 2 discrepant)
  • Influenza B: 1165 (all negative)
  • SARS-CoV-2: 496 (68 positive, 428 negative, plus 1 and 11 discrepant)
• Retrospective Samples: 82 positive influenza B specimens and 62 negative specimens were used. These were blinded and randomized for the study. The exact number of retrospective samples used for each target in the agreement analysis can be inferred from the TP/(TP+FN) and TN/(TN+FP) values in Table 3:
  • Influenza A: 258 (82 positive, 176 negative)
  • Influenza B: 258 (114 positive, 144 negative)
  • SARS-CoV-2: 252 (all negative)

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not explicitly state the number of experts or their specific qualifications (e.g., radiologist with 10 years of experience) used to establish the ground truth for the test set.

4. Adjudication Method for the Test Set

• SARS-CoV-2: For SARS-CoV-2, a composite reference method (CRM) was used. This involved three COVID-19 Emergency Use Authorized (EUA) NAAT assays. The adjudication method was:
  • "Detected" CRM if two out of three EUA assays were positive.
  • "Not Detected" CRM if two out of three EUA assays were negative.
• Influenza A and B: For influenza A and B, the comparator was an FDA-cleared NAAT. There is no mention of a multi-assay composite reference method, suggesting a single FDA-cleared NAAT was used as the ground truth. Discrepancy analysis involved additional FDA cleared NAATs and PCR followed by BDS.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study focuses on the standalone performance of the diagnostic assay rather than human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, a standalone performance study was done. The entire clinical performance section evaluates the Simplexa™ COVID-19 & Flu A/B Direct assay's ability to detect and differentiate nucleic acids directly, without human interpretation in the results reporting, other than laboratory personnel operating the instrument. The results are presented as the assay's agreement with reference methods.

7. The Type of Ground Truth Used

• SARS-CoV-2: Composite reference method (CRM) based on the consensus of three COVID-19 Emergency Use Authorized (EUA) NAAT assays.
• Influenza A and B: An FDA-cleared NAAT was used as the primary comparator. In cases of discrepancy, additional FDA-cleared NAATs and PCR followed by Bidirectional Sequencing (BDS) were used for confirmation.

8. The Sample Size for the Training Set

The document describes the clinical performance (test set) and analytical studies. It does not explicitly mention a "training set" in the context of machine learning. The assay is a real-time RT-PCR assay, which typically relies on pre-defined primer and probe sequences rather than a machine learning model that requires a distinct training set in the conventional sense. The development and optimization of the primer/probe sets (e.g., analytical reactivity, inclusivity) can be considered analogous to a "training" or development phase, but no specific dataset labeled as such is provided.

9. How the Ground Truth for the Training Set Was Established

As noted in point 8, a traditional "training set" with ground truth establishment in the context of machine learning is not applicable to this RT-PCR assay. The analytical studies (Limit of Detection, Analytical Reactivity/Inclusivity, Cross-Reactivity, Interfering Substances, Competitive Interference, Microbial Interference) use quantitated viral stocks, cultured isolates, purified nucleic acids, or in silico analysis against public strain databases (e.g., GISAID) to demonstrate the assay's analytical performance across a wide range of relevant targets and conditions. This ensures the assay's biochemical design (primers, probes) is sound and effective.

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The DiaSorin Molecular Simplexa™ Congenital CMV Direct is a real-time PCR assay intended for use on the LIAISON® MDX instrument for the in vitro qualitative detection of cytomegalovirus (CMV) from saliva swabs and urine from infants less than 21 days of age. Positive results from saliva are presumptive and should be confirmed with urine. The results of the Simplexa™ Congenital CMV Direct assay should be used in conjunction with the results of other clinical findings as an aid in the diagnosis of congenital CMV infection.

This test has not been cleared for screening of blood products for the presence of CMV or for use with samples other than urine and saliva swabs.

DiaSorin Molecular's Simplexa™ Congenital CMV Positive Control Pack is intended to be used as a control with the Simplexa Congenital CMV Direct kit for use on the LIAISON MDX instrument. This control is not intended for use with other assays or systems.

The Simplexa™ Congenital CMV Direct assay is a real-time PCR system that enables the direct amplification and detection of CMV DNA from either saliva swab or urine specimens without nucleic acid extraction. The system consists of the Simplexa™ Congenital CMV Direct Reaction Mix, the LIAISON® MDX (with LIAISON® MDX Studio Software), the Direct Amplification Disc (DAD) and associated accessories.

In the Simplexa™ Congenital CMV Direct assay, bi-functional fluorescent probe-primers are used together with corresponding reverse primers to amplify CMV DNA. A well-conserved region of the CMV UL83 gene is targeted to identify CMV DNA. An internal control is used to detect PCR failure and/or inhibition.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a dedicated table format. However, the reported performance metrics imply the criteria for acceptance. For the purpose of this response, I'll infer the implicit acceptance criteria based on the demonstrated performance, generally implying "high agreement" for positive and negative cases.

2. Sample Size and Data Provenance

• Retrospective Study:

  • Saliva Swab: 173 total specimens (3 removed due to indeterminate CRM result, 170 analyzed)
  • Urine: 173 total specimens
  • Provenance: "collected during the clinical study", "stored at a central site", then distributed to three (3) laboratories. The document doesn't explicitly state the country of origin for these retrospective samples, though the testing sites were in the USA. These were pre-selected positive and negative samples based on routine laboratory results.

• Prospective Study:

  • Saliva Swab: 1,859 initially collected, 6 deemed ineligible, resulting in 1,853 analyzed specimens.
  • Urine: 1,656 initially collected, 32 deemed ineligible, resulting in 1,624 analyzed specimens.
  • Provenance: Prospectively collected (frozen and/or fresh) from ten (10) collection sites across the USA and two (2) collection sites outside the USA. Testing was performed at six (6) testing sites located in the USA.

3. Number of Experts and Qualifications

The document states that a "Composite Reference Method (CRM)" was used, which involved "two (2) validated PCR followed by bi-directional sequencing assays." One (1) central laboratory performed these comparator assays.

• The document does not specify the number of experts used to establish the ground truth or their specific qualifications (e.g., radiologist with 10 years of experience). It relies on the validation of the PCR and bi-directional sequencing assays as the basis for ground truth, implying that these are established and reliable laboratory methods.

4. Adjudication Method

The ground truth for the clinical agreement studies (both retrospective and prospective) was established via a "Composite Reference Method (CRM)".
This CRM "utilized two (2) validated PCR followed by bi-directional sequencing assays. A sample had a final sequencing result of 'Detected' if one or both sequencing results were 'Detected'. Conversely a sample had a final sequencing result of 'Not Detected' if both results were 'Not Detected'." This implies a form of 2+0 or 1+1 adjudication model where if either reference method detects CMV, the sample is considered positive, and both must be negative for the sample to be considered negative.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This study focuses on the diagnostic performance of the device itself against a laboratory-based reference method, not on how human readers/clinicians improve with AI assistance.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance evaluation was done. The Simplexa™ Congenital CMV Direct assay is a real-time PCR assay and its performance was evaluated directly against the Composite Reference Method (CRM) without human-in-the-loop assistance. The reported PPA and NPA values represent the algorithm's standalone performance.

7. Type of Ground Truth Used

The ground truth used was expert consensus on laboratory results, specifically based on a "Composite Reference Method (CRM) utilized two (2) validated PCR followed by bi-directional sequencing assays." This is a highly robust and objective form of ground truth for nucleic acid detection devices, often considered a gold standard in molecular diagnostics.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set. This is typical for submissions of this nature, where the focus is on the validation of the final device/algorithm using a separate, independent test set, rather than details of the developmental (training) phase.

9. How the Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for the training set was established, as details about the training phase are not included in this summary.

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The DiaSorin Molecular Simplexa™ COVID-19 Direct is real-time RT-PCR assay intended for use on the LIAISON® MDX instrument for the in vitro qualitative detection of nucleic acid from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in nasopharyngeal swabs (NPS) and nasal swabs (NS) from symptomatic individuals suspected of COVID 19 by their healthcare provider. The Simplexa™ COVID-19 Direct assay is an aid in the diagnosis of SARS-CoV-2 infection.

Positive results are indicative of the presence of SARS-CoV-2 RNA. Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out co-infection with other pathogens. Negative results do not preclude SARS-CoV-2 infection and should not be used as tor patient management decisions.

Results are meant to be used in conjunction with other clinical, epidemiologic, and laboratory data, in accordance with the guidelines provided by the relevant public health authorities.

The Simplexa COVID-19 Direct is a real-time RT-PCR (rRT-PCR) system that enables the direct amplification and detection of SARS-CoV-2 (COVID-19) RNA from nasopharyngeal swab or nasal swab that has not undergone nucleic acid extraction. The system consists of the Simplexa COVID-19 Direct reaction mix, the LIAISON MDX (with LIAISON MDX Studio Software), the Direct Amplification Disc and associated accessories. The assay uses forward and reverse primers and associated fluorescent probe(s) included in the reaction mix to amplify SARS-CoV-2 cDNA reverse transcribed from RNA. The primers and probe sets are designed to detect SARS-CoV-2 ORF 1ab and S gene from the viral RNA in nasopharyngeal swab or nasal swab. An RNA internal control, with associated primers and a fluorescent probe, is included in the reaction mix to detect RT-PCR failure and/or inhibition.

Here's a breakdown of the acceptance criteria and study proving the device meets them, based on the provided text:

Device: Simplexa™ COVID-19 Direct

1. Table of Acceptance Criteria and Reported Device Performance

For the Simplexa™ COVID-19 Direct assay, the primary acceptance criteria revolve around its accuracy in detecting SARS-CoV-2 (COVID-19) RNA in patient samples, as well as its reproducibility, analytical sensitivity (Limit of Detection), analytical reactivity (ability to detect various strains), and specificity (cross-reactivity and interference).

2. Sample Size Used for the Test Set and Data Provenance

• Clinical Agreement Test Set:

  • Total Samples: 1,150 prospective (fresh and/or frozen) samples collected.
  • Samples analyzed: 1,011 samples (114 excluded due to insufficient evidence for media types, 24 invalid results, 1 indeterminate CRM result).
  • Breakdown: 299 Nasopharyngeal Swabs (NPS) and 712 Nasal Swabs (NS).
  • Provenance: Collected from four (4) geographically diverse collection sites, one of which was outside the United States (OUS). Samples were prospective (fresh and/or frozen).
  • Timeframe: October 2020 to April 2021.

• Reproducibility Test Set:

  • Total replicates: 90 replicates per panel member (4 panel members), totaling 360 individual tests.
  • Panel members: 2 contrived low positive (LP), 2 contrived moderate positive (MP), 1 positive control, 1 negative (UTM).
  • Provenance: Tested at two (2) external clinical sites and one (1) internal site.
  • Study Design: Each panel member tested in triplicate per run, for 2 runs per day, for 5 non-consecutive testing days. Each site had two operators.

• Analytical Sensitivity (LoD) Test Set:

  • NPS: 40 replicates for confirmation.
  • NS: 20 replicates for confirmation.
  • WHO International Standard: 40 replicates for confirmation.

• Analytical Reactivity (Wet testing) Test Set:

  • 3 replicates per strain for 5 SARS-CoV-2 strains.

• Cross-Reactivity Test Set:

  • 3 replicates per organism for 47 different viruses, bacteria, and fungi (some 6 replicates for Leptospira interrogans).

• Potential Interfering Substances Test Set:

  • 3 replicates per substance (some 6 replicates for saliva and Zanamivir).

• Interference by Other Microorganisms Test Set:

  • 3 replicates per organism (some 6 replicates for Lactobacillus plantarum 17-5).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The ground truth for the clinical agreement test set was established using a "Composite Reference Method (CRM)" based on three (3) COVID-19 EUA approved NAAT assays. The rule for CRM agreement was: "Two out of three positive results determined 'Detected' CRM and two out of three negative results determined 'Not Detected' CRM."

The document does not specify the number or qualifications of experts (e.g., medical technologists, clinical lab scientists, or physicians) who performed these NAAT assays or interpreted their results for the CRM. It's implied that these were standard laboratory personnel qualified to run EUA-approved molecular diagnostic tests.

For analytical studies (LoD, reproducibility, reactivity, cross-reactivity, interference), the ground truth was based on the known composition and concentration of the samples (e.g., spiked RNA, cultured organisms, negative matrix). No external experts beyond the study design team would have been needed for this type of ground truth establishment.

4. Adjudication Method for the Test Set

For the clinical agreement test set, the adjudication method for the ground truth (CRM) was clearly defined: "Two out of three positive results determined 'Detected' CRM and two out of three negative results determined 'Not Detected' CRM." This is a form of consensus-based adjudication, specifically a majority rule.

For other analytical studies, adjudication was not described as it involved pre-defined positive/negative samples rather than interpretive human judgment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study focuses on the in vitro diagnostic performance of a molecular assay (RT-PCR) in a laboratory setting, not on the interpretative performance of human readers (e.g., radiologists) with or without AI assistance. Therefore, there is no discussion of human readers or an effect size of AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Yes, the primary clinical performance and analytical studies are standalone (algorithm only) performance. The Simplexa™ COVID-19 Direct is an RT-PCR assay. Its "performance" refers to its ability to detect SARS-CoV-2 RNA based on its set algorithms for signal detection (Ct values for S gene and ORF1ab targets) and interpretation. The results (detected/not detected) are determined directly by the instrument and its software, not by a human interpreting images or complex patterns. The human involvement is in sample preparation and loading, and reviewing the qualitative output from the instrument.

7. The Type of Ground Truth Used

• Clinical Agreement Test Set: Composite Reference Method (CRM) using results from three (3) COVID-19 EUA approved NAAT assays, with a "two out of three" majority rule for determining "Detected" or "Not Detected." This is a form of expert consensus based on other validated diagnostic tests.
• Analytical Studies (Reproducibility, LoD, Reactivity, Cross-Reactivity, Interference): Known analytical truth established by spiking known concentrations of inactivated viral particles or other organisms into negative matrices. This is a laboratory-controlled ground truth.

8. The Sample Size for the Training Set

The provided document describes a premarket notification (510(k)) for an in vitro diagnostic device. For such devices, particularly RT-PCR assays, the "training set" typically refers to internal development and optimization data, rather than a distinct, formally defined "training set" for machine learning algorithms that would be tested on a separate "test set."

The document does not specify a numerical sample size for a training set. The assay's design (primers, probes, conditions) would have been developed and optimized internally by DiaSorin Molecular using various samples and experiments, but these are not enumerated as a specific "training set" in this regulatory submission. The "in silico inclusivity analysis" section points to the use of GISAID databases (millions of sequences) which could be considered a form of "training data" for validating the generalizability of the primer/probe design, but not as a conventional, labeled "training set" in a machine learning context.

9. How the Ground Truth for the Training Set Was Established

Since a formal "training set" with established ground truth is not explicitly detailed in the way a machine learning model's training data would be, we can infer the following:

• Assay Development & Optimization: The ground truth for the development phase would have been based on known positive and negative samples, viral loads, and various SARS-CoV-2 strains or synthetic genetic material. This involves standard molecular biology techniques where the presence or absence of the target nucleic acid, and its concentration, are experimentally determined and controlled.
• In Silico Inclusivity: For the evaluation of primer/probe design against genetic variants, the "ground truth" is the published, annotated SARS-CoV-2 genome sequences available in the GISAID database. This involves bioinformatic analysis to determine sequence homology and potential binding efficacy.

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The SimpleSENSE Platform is intended for use at home, or at a healthcare facility, under the direction of a licensed medical professional, to record, display and store the following physiological data: a) 2 leads of Electrocardiogram; b) Respiration rate measured through thoracic impedance; c) Heart Sounds; d) Activity including posture; and e) other validated data sources. The SimpleSENSE Platform is intended for use when the licensed medical professional decides to evaluate the physiologic signals of adult patients as an aid to diagnosis and treatment. The SimpleSENSE Platform is intended to be used by patients at rest and not performing any activities or movements. ECG recordings are indicated for the manual assessment of cardiac rhythm disturbances. The SimpleSENSE Platform does not produce alarms and is not intended for active patient monitoring (real-time). The SimpleSENSE Platform is not intended for use as life supporting equipment on high-risk patients such as critical care patients. The SimpleSENSE Platform is not intended for use in the presence of a pacemaker.

The Nanowear SimpleSENSE Platform is the next generation diagnostic monitoring technology that captures electrocardiographic (ECG) signals, respiration rate though thoracic impedance, heart sounds, activity including posture and movement with sensors embedded on a wearable textile garment. The signals are stored and wirelessly transmitted to a smartphone, which is then forwarded to a medical professional for review. The garment is designed to be unobtrusive to everyday activity and provide an easier and more efficient means of capturing ECG data from patients. The device consists of a combination of: The SimpleSENSE Garment: an integrated network of nanosensor electrodes for measuring ECG and respiratory rate from thoracic impedance. A MEMS microphone for measuring heart sounds. The SimpleSENSE Signal Acquisition Unit (SAU): data acquisition, storage, and transmission to a phone running iOS or Android. An accelerometer to measure activity. The SimpleSENSE Mobile Application: mobile application to start/stop a recording, logging symptoms, and data transmission. SimpleSENSE Web Server: allows initiation of a test, storage, and review of prescribed test data by a medical professional.

The provided text describes Nanowear Inc.'s K212160 submission for the SimpleSENSE Platform, an upgraded version of their previously cleared SimpleSENSE System (K201669). The submission is a Special 510(k), which means it primarily focuses on changes to an already cleared device, and thus omits much of the original performance data. Therefore, the information regarding acceptance criteria and performance testing is limited to what was specifically re-evaluated or added for the new device.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of acceptance criteria and reported device performance in the format requested. As this is a Special 510(k), the focus is on demonstrating that changes made to the device do not negatively affect safety or efficacy. The "Performance Testing" section (Section 11) lists the tests conducted for the new SimpleSENSE Platform.

However, based on the type of tests performed, we can infer general acceptance criteria for the new or modified components.

Note: The document explicitly states that performance data and verification/validation activities for aspects not affected by product changes were omitted from this Special 510(k). These include core functionalities like multiparametric data capture, ECG sensor performance, electrical current requirements for thoracic impedance, MEMS microphone testing, etc. For those, it relies on the predicate device's clearance (K201669).

2. Sample size used for the test set and the data provenance

The document does not specify a sample size for the test set used for the software and firmware verification activities. It also does not specify the data provenance (e.g., country of origin, retrospective/prospective) for these tests. This information would typically be found in detailed test reports, which are not included in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not provide any information about the number or qualifications of experts used to establish ground truth for the test set, as the performance testing primarily focuses on software and firmware verification rather than clinical outcomes or diagnostic accuracy requiring expert interpretation.

4. Adjudication method for the test set

The document does not describe any adjudication method for the test set. Given the nature of the tests (software and firmware verification), a formal adjudication process involving multiple experts is unlikely to have been part of these specific engineering tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The SimpleSENSE Platform's indications for use state that "ECG recordings are indicated for the manual assessment of cardiac rhythm disturbances" and that the device "does not produce alarms and is not intended for active patient monitoring (real-time)." There is no indication that AI or automated interpretation is part of the device's functionality that would necessitate such a study. The device provides raw physiological data for a medical professional to review.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document does not describe any standalone (algorithm-only) performance testing. The device is intended to record and transfer physiological data for medical professionals to review; it does not explicitly claim automated diagnostic algorithms that would undergo standalone performance evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the software and firmware verification tests, the "ground truth" would be the expected functional behavior of the software and firmware as per design specifications and requirements. This is not medical ground truth (like pathology or expert consensus) but rather engineering ground truth.

8. The sample size for the training set

The document does not mention a training set sample size. Since the described performance testing is for software/firmware verification and not for machine learning model development, a training set as typically understood in AI/ML contexts would not be relevant here.

9. How the ground truth for the training set was established

Not applicable, as no training set for a machine learning model is mentioned or implied by the described performance testing.

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Simpleware ScanlP Medical is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. It is also intended as pre-operative software for diagnostic and surgical planning.

For these purposes, output files can also be used for the fabrication of physical replicas using traditive manufacturing methods. The physical replicas can be used for diagnostic purposes in the field of orthopedic, maxillofacial and cardiovascular applications.

The software is intended to be used in conjunction with other diagnostic tools and expert clinical judgment.

Simpleware ScanIP Medical is image processing software that enables users to import, visualize, and segment medical images, and export digital 3D models. These models can be used in the software for pre-surgical tasks, and can also be used to produce output files suitable for additive manufacturing (3D printing). Simpleware ScanIP Medical also has functionality for transferring from and to third-party software packages.

Simpleware ScanIP Medical is a modular product, including the following functionalities:

• Import of medical images in various formats
• Transferring files from and to computer-aided design (CAD) software packages
• Image filtering and segmentation tools
• 2D and 3D visualization of image data and CAD drawings
• Analysis, measurements, and statistics from 3D image data and CAD drawings
• Generating and exporting meshes to Finite Element (FE) packages.
• Generating and exporting models to CAD software
• Support for scripting in a number of programming languages

The provided text is a 510(k) summary for the device "Simpleware ScanIP Medical". It describes the device, its intended use, and compares it to a predicate device. However, it does not contain specific acceptance criteria, detailed study designs with sample sizes for test sets, expert qualifications, or adjudication methods for establishing ground truth. It states that "Validation was carried out for the workflow of going from 3D image to printed model, demonstrating that the anatomical models for cardiovascular, orthopedic, and maxillofacial applications can be printed accurately when using compatible 3D printers." but does not provide the specifics of this validation study in the format you requested.

The document focuses on demonstrating substantial equivalence to a predicate device (Simpleware ScanIP, K142779) through non-clinical bench testing and technological comparisons, rather than providing detailed performance studies with acceptance criteria for a new clinical efficacy claim.

Therefore, many of your requested items cannot be extracted from this document.

Here's an attempt to answer what can be gathered:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the document in a quantifiable format with specific acceptance criteria and reported performance metrics. The document broadly states: "Validation of the subject device shows it to be equivalent in performance to the predicate device" and "Non-clinical bench-testing results demonstrate that the subject device is as safe, effective, and functional as the predicate device." It also mentions "demonstrating that the anatomical models for cardiovascular, orthopedic, and maxillofacial applications can be printed accurately when using compatible 3D printers." without providing specific accuracy metrics or thresholds.

2. Sample size used for the test set and the data provenance

The document mentions "Validation was carried out for the workflow of going from 3D image to printed model, demonstrating that the anatomical models for cardiovascular, orthopedic, and maxillofacial applications can be printed accurately when using compatible 3D printers." However, it does not specify the sample size for this validation. The provenance of the data (e.g., country of origin, retrospective/prospective) is also not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The document describes non-clinical bench testing, not studies involving expert interpretation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical tests were conducted to determine substantial equivalence." The device is intended as a software interface and image segmentation system, and pre-operative software, not as an AI-powered diagnostic aid that improves human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document describes "bench-testing" and "validation for the workflow of going from 3D image to printed model". This implies a standalone assessment of the software's ability to produce accurate models from images. However, it does not provide specific metrics or a detailed study design for this standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the "validation for the workflow of going from 3D image to printed model," the ground truth likely refers to the "accurate" measurements or representations in the physical replicas compared to the original imaging data. The method for establishing this "accuracy" (e.g., precise measurements of physical models, comparison to established standards) is not detailed but it's reasonable to infer a comparison against the input image data or engineering specifications, rather than clinical ground truth like pathology.

8. The sample size for the training set

This document describes a medical device software (Simpleware ScanIP Medical) which is a tool for image processing and segmentation, not a machine learning or AI model that typically requires a "training set" in the context of deep learning. Therefore, the concept of a training set for this type of device is not applicable and is not mentioned in the document.

9. How the ground truth for the training set was established

As the device described is not an AI/ML model with a typical "training set," this question is not applicable.

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