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The Simplexa COVID-19 / Flu A/B & RSV Direct is a real-time RT-PCR assay intended for use on the LIAISON MDX instrument for the simultaneous in vitro qualitative detection and differentiation of nucleic acid from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A (Flu A) virus, influenza B (Flu B) virus and respiratory syncytial virus (RSV) in nasopharyngeal swab and anterior nasal swab specimens from individuals with signs and symptoms of respiratory tract infection. Clinical signs and symptoms of respiratory tract infection due to SARS-CoV-2, influenza A, influenza B, and RSV can be similar.

The Simplexa COVID-19 / Flu A/B & RSV Direct assay is intended for use as an aid in the differential diagnosis of SARS-CoV-2, influenza A, influenza B and RSV infections if used in conjunction with other clinical and epidemiological information, and laboratory findings. SARS-CoV-2, influenza A, influenza B, and RSV viral RNA are generally detectable in nasopharyngeal swab and anterior nasal swab specimens during the acute phase of infection. This test is not intended to detect influenza C virus infections.

Positive results are indicative of the presence of the identified virus, but do not rule out bacterial infection or co-infection with other pathogens not detected by the test. The agent(s) detected by the Simplexa COVID-19 / Flu A/B & RSV Direct real-time RT-PCR assay may not be the definite cause of the disease. Negative results do not preclude SARS-CoV-2, influenza A, influenza B, or RSV infection and should not be used as the sole basis for patient management decisions.

The Simplexa™ COVID-19 & Flu A/B & RSV Direct assay is a qualitative, multiplex real-time reverse transcription polymerase chain reaction (RT-PCR) test intended for the simultaneous detection and differentiation of RNA from SARS-CoV-2, Influenza A, Influenza B, and Respiratory Syncytial Virus (RSV) in nasopharyngeal swabs (NPS) and anterior nasal swabs (NS) in UTM/UVT and M4RT specimen transport media. The assay is performed on the LIAISON® MDX Instrument using a Direct Amplification Disc (DAD) format, enabling sample-to-answer processing without separate nucleic acid extraction.

The LIAISON® MDX Instrument is a benchtop real-time PCR thermocycler that utilizes a self-contained, single-use direct amplification disc (DAD) to process samples. It performs thermal cycling and real-time fluorescence detection using optical detection modules, each with specific excitation and emission wavelengths. The instrument includes a laser enclosed in a laser product housing, with integrated hardware and software interlocks to ensure user safety. It is operated via a USB connection to a dedicated computer running the LIAISON® MDX Studio software.

The LIAISON® MDX Studio software controls the instrument and provides a user interface for assay setup, execution, and result analysis. The software automatically interprets results for in vitro diagnostic (IVD) assays using pre-defined assay definitions encoded in barcode inserts included with the assay kits. It performs spectral compensation, verifies internal control amplification, and checks for sufficient sample volume prior to amplification. The software also includes user authentication, audit logging, laboratory information system (LIS) connectivity, and cybersecurity features.

The assay kit includes single-use reaction mix vials, a positive control pack with inactivated viral particles in transport media, and the Direct Amplification Disc consumable, which supports up to eight simultaneous reactions.

The assay format is designed for direct amplification, with 24 single-use reaction mix vials per kit. The required sample volume input is 50 µL. The reaction mix is provided in single-use vials and includes DNA polymerase, reverse transcriptase, RNase inhibitor, primers, probes, and encapsulated RNA templates. The buffer component in the reaction mix maintains optimal pH and ionic strength to support enzyme activity and amplification efficiency throughout the RT-PCR process.

The assay includes an encapsulated RNA internal control (RNA IC) in each reaction to monitor for potential RT-PCR inhibition or process failure. The RNA IC is derived from bacteriophage MS2. This non-target RNA is co-amplified with the assay's viral targets and detected independently using post-amplification melting curve analysis. The presence of the RNA IC in a negative specimen confirms that the amplification process functioned as expected, while its absence—along with no target detection—results in an invalid outcome. Detection of the RNA IC is not required in the Positive Control but is expected in the No Template Control (NTC) to verify assay validity.

N/A

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The SImmetry+ System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The SImmetry+ System consists of sterile packaged fully threaded titanium Implants designed to transfix the sacrum and ilium, providing stability for bony fusion. The surgical implants are available in various sizes to accommodate patient anatomy. Implants have major diameters ranging from 9.5mm-14.5mm, in 1mm increments. Implant lengths in 5mm increments range from 30mm to 110mm. All devices are additively manufactured from Titanium Alloy (Ti-6Al4V ELI).

This 510(k) clearance letter pertains to the SImmetry+ System, a device for sacroiliac joint fusion (a metallic bone fixation fastener). Unlike a clearance for a software device or AI/ML system, this document focuses on the physical and mechanical performance of the implantable device.

Therefore, the requested information regarding acceptance criteria and study that proves the device meets the acceptance criteria specifically in the context of AI/ML performance metrics (like sensitivity, specificity, MRMC studies, expert consensus on images, etc.) is not applicable to this type of medical device clearance.

The provided document describes:

• Device Type: A physical, implantable device (fully threaded titanium implants for sacroiliac joint fusion).
• Acceptance Criteria (Implicitly): Demonstrated through non-clinical performance testing against specific ASTM standards. These standards define the expected mechanical properties (e.g., static and dynamic cantilever testing, axial pullout, torsional properties, driving torque).
• Study Proving Acceptance: "Non-clinical testing data" was submitted, including:
  • Static and dynamic cantilever testing per ASTM F2193
  • Axial pullout testing per ASTM F543
  • Torsional properties testing per ASTM F543
  • Driving torque testing per ASTM F543
  • Additive manufacturing characterization

Summary of Requested Information based on the provided document:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Mechanical performance standards defined by ASTM F2193 and ASTM F543, and additive manufacturing characterization. (Specific numerical thresholds are not provided in this public clearance letter, but would have been part of the confidential submission.)
   • Reported Device Performance: The document states that SiVantage completed non-clinical testing and the data demonstrates substantial equivalence. This implies the device met the performance criteria outlined in the standards.

2. Sample sizes used for the test set and the data provenance: Not applicable. The "test set" here refers to physical implants subjected to mechanical testing, not a dataset of patient information for AI/ML evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical implant is established by engineering measurements against defined material and mechanical standards.

4. Adjudication method for the test set: Not applicable. Mechanical testing results are objective measurements.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating human interpretation of medical images, often with AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI/ML algorithm performance.

7. The type of ground truth used:

   • For the physical device: Engineering specifications, material properties, and mechanical performance standards (ASTM F2193, ASTM F543).

8. The sample size for the training set: Not applicable. The "training set" concept applies to AI/ML model development. For a physical device, manufacturing processes are refined, but there isn't a "training set" in the AI sense.

9. How the ground truth for the training set was established: Not applicable for a physical device.

In conclusion, this FDA 510(k) clearance is for a conventional mechanical implant, not an AI/ML powered device. Therefore, many of the questions asked, which are highly relevant for AI/ML device clearances, do not apply to the details provided in this document. The "proof" of meeting acceptance criteria for this device rests on its physical and mechanical characteristics meeting established engineering standards and showing substantial equivalence to existing predicate devices based on those characteristics.

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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 simpli-COLLECT STI Test is a test system intended for in vitro detection and identification of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG) in home-collected specimens. The specimens are shipped to a clinical laboratory for testing using the Alinity m STI Assay with the automated Alinity m System for the direct, qualitative detection and differentiation of ribosomal RNA from CT, DNA from NG, ribosomal RNA from TV, and ribosomal RNA from MG, to aid in the diagnosis of disease(s) caused by infection from these organisms. The assay may be used to test the following self-collected specimens from symptomatic and asymptomatic individuals for the following analytes:

• · CT: vaginal swabs, female urine and male urine .
• NG: vaginal swabs, female urine, and male urine .
• . · TV: vaginal swabs, female urine and male urine
• . • MG: vaginal swabs and male urine

The simpli-COLLECT STI Test contains all the necessary components for the selfcollection and transport of urine from male and female patients (simpli-COLLECT Urine Collection Kit) or vaginal swabs from female patients (simpli-COLLECT Swab Collection Kit) in their home, or in similar environments. The simpli-COLLECT Collection Kits may also be used to self-collect specimens in a clinic.

The simpli-COLLECT STI Test is a test system intended for in vitro detection and identification of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG) in home-collected specimens (simpli-COLLECT Urine Collection Kit [09N93001] and the simpli-COLLECT Swab Collection Kit [09R02-001]).

This test system uses the Alinity m STI Assay (cleared under K202977 and K222379) for real time RT-PCR to amplify and detect Chlamydia trachomatis (CT) ribosomal RNA sequences, Neisseria gonorrhoeae (NG) genomic DNA sequences, Trichomonas vaginalis (TV) ribosomal RNA sequences, Mycoplasma genitalium (MG) ribosomal RNA sequences, and human genomic DNA sequences that have been extracted from vaginal swab specimens or male and female urine specimens.

The Alinity m STI assay requires two separate assay-specific kits as follows:

• . Alinity m STI AMP Kit (09N17-095), which consists of multi-well amplification plates containing lyophilized, unit-dose RT-PCR amplification/detection reagents, and multi-well activator plates containing liquid, unit-dose activation reagents (MgC12. TMAC, and KC1). The intended storage condition for the Alinity m STI AMP Kit is 2°C to 8°C.
• . Alinity m STI CTRL Kit (09N17-085), which consists of negative controls and positive controls, each supplied as liquid in single-use tubes. The intended storage condition for the Alinity m STI Control Kit is -15°C to -25°C.

The steps of the Alinity m STI assay consist of sample preparation. RT-PCR assembly, amplification/detection, and result calculation and reporting. All stages of the Alinity m STI assay procedure are executed automatically by the Alinity m System. No intermediate processing or transfer steps are performed by the user. The Alinity m System is designed to be a random-access analyzer that can perform the Alinity m STI assay in parallel with other Alinity m assays on the same instrument.

Nucleic acids from specimens are extracted automatically on-board the Alinity m System using the Alinity m Sample Prep Kit 1, Alinity m Lysis Solution, Alinity m Ethanol Solution or Alinity m Bottle for Ethanol Use filled with Ethanol supplied by customers, and Alinity m Diluent Solution. The Alinity m System employs magnetic microparticle technology to facilitate nucleic acid capture, wash, and elution. The resulting purified nucleic acids are then combined with the liquid unit dose activator reagent, lyophilized unit-dose Alinity m STI amplification reagents, and Alinity m Vapor Barrier Solution, and transferred by the instrument to an amplification/detection module for reverse transcription, PCR amplification, and real-time fluorescence detection.

Assay controls are tested at or above an established minimum frequency to help ensure that instrument and reagent performance remain satisfactory. During each control event, a negative control and a positive control are processed through sample preparation and RT-PCR procedures that are identical to those used for specimens. Assay controls are used to demonstrate proper sample processing and assay validity. The CTRL kit configuration includes 12 vials at 0.47 mL of both the Alinity m STI Negative CTRL and Alinity m STI Positive CTRL.

The Alinity m STI amplification reagents include primers and probes that amplify and detect the single copy human gene, ß-globin. Amplification and detection of the ß-globin gene demonstrates proper sample processing and adequate sample input. In addition, an exogenous internal control (containing an armored RNA sequence) is included in the lyophilized Alinity m STI amplification reagents and is used to confirm that no PCR inhibitors are present in the sample. The ß-globin control and internal control are both used to demonstrate assay validity. The AMP kit configuration includes 4 trays (96 tests per tray) of both an AMP TRAY 1 and ACT TRAY 2. The AMP Kit provides sufficient reagents for 384 tests.

The simpli-COLLECT Urine Collection Kit is used to collect, stabilize, and transport male urine specimens for the detection of Chlamydia trachomatis, Neisseria gonorrhoeae. Trichomonas vaginalis, and Mycoplasma genitalium, and female urine specimens for the detection of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. Each kit can be used to collect 1 urine specimen. The collected specimens are intended for testing with the Alinity m STI assay. The simpli-COLLECT Urine Collection Kit contains the following components: 1 Abbott Sample Collection pack, which contains 1 Alinity m Sample Tube with Liguid Buffer and 1 Transfer Pipette, 1 Tube and Bag Label Sheet, 1 Urine Cup/Urine Collection Cup, 1 simpli-COLLECT Urine Collection Kit Patient Instructions For Use, 1 Biohazard Bag with Absorbent Pad, 1 Tube and Cap Holder, and 1 simpli-COLLECT Urine Collection Kit Box.

The simpli-COLLECT Swab Collection Kit is used to collect, stabilize, and transport vaginal swab specimens for the detection of Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium. Each kit can be used to collect 1 vaginal swab specimen. The collected specimens are intended for testing with the Alinity m STI assay. The simpli-COLLECT Swab Collection Kit contains the following components: 1 Abbott Swab Collection pack, which contains 1 Alinity m Sample Tube with Liguid Buffer and 1 Specimen Collection Swab, 1 Tube and Bag Label Sheet, 1 Biohazard Bag with Absorbent Pad, 1 Tube and Cap Holder, 1 simpli-COLLECT Swab Collection Kit Patient Instructions For Use, and 1 simpli-COLLECT Swab Collection Kit Box.

Here's a breakdown of the acceptance criteria and study information for the simpli-COLLECT STI Test, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details the performance in terms of usability and absence of interference, rather than specific quantitative diagnostic accuracy metrics (like sensitivity/specificity) for the simpli-COLLECT STI Test itself. The diagnostic accuracy is implicitly covered by the reference to the cleared Alinity m STI Assay (K202977 and K222379).

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

• Human Factors Study:

  • Sample Size: 223 participants.
  • Data Provenance: Prospective, simulated home environment study conducted in the United States.

• Interference Study:

  • Sample Size: Not explicitly stated as a number of "samples" but involved testing 11 potential hand contaminants diluted into negative or positive swab and urine matrices. The number of replicates for each condition is not specified in this summary.
  • Data Provenance: Laboratory study, likely conducted internally by Abbott Molecular.

• Clinical Performance (Reference to K202977 & K222379):

  • The document states that "Performance characteristics of the Alinity m STI assay with swab and urine specimens were established in a multicenter clinical study conducted in the United States to support the clearance of K202977 and K222379." The sample sizes for these previous clearances are not detailed in the provided K243410 summary.

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

This information is not directly stated for the specific studies presented in this document (Human Factors and Interference).

• For the Human Factors study, "ground truth" was evaluated by observing participants' actions and evaluating packaged samples for errors based on laboratory accessioning criteria. This doesn't involve medical experts establishing diagnostic ground truth.
• For the Interference study, "ground truth" refers to the known positive or negative status of the spiked matrices, against which assay performance (presence/absence of interference) was assessed. This is laboratory-controlled.
• For the underlying Alinity m STI assay (K202977 and K222379), clinical studies would have involved a gold standard for establishing ground truth, likely including culture, other cleared NAATs, and/or clinical diagnosis, but the details are not available in this summary.

4. Adjudication Method for the Test Set

This information is not explicitly provided for the studies in this summary.

• For the Human Factors study, "difficulties were noted" and "packaged samples were then evaluated for errors according to the laboratory accessioning criteria." This suggests an objective assessment based on predefined criteria rather than a multi-expert adjudication of clinical diagnoses.
• For the Interference study, it's a technical and controlled laboratory experiment, not requiring adjudication in the clinical sense.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Improvement with AI vs. without AI Assistance

This is not applicable as the simpli-COLLECT STI Test is a molecular diagnostic test system for in vitro detection, not an AI-assisted diagnostic imaging or interpretation device. Therefore, no MRMC study or AI assistance effect size is mentioned or relevant.

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

This is not applicable in the context of an "algorithm only" performance. The simpli-COLLECT STI Test is a collection and transport system intended to be used with the Alinity m STI Assay, which performs the actual detection. The Alinity m STI Assay operates automatically on the Alinity m System (an automated instrument), so its "standalone" performance would be its analytical and clinical performance as an automated assay, which was established in K202977 and K222379. The current submission focuses on the collection and transport component for home use.

7. The Type of Ground Truth Used

• Human Factors Study: Ground truth was based on pre-defined protocol steps for correct specimen collection and packaging, and laboratory accessioning criteria for evaluating collected samples.
• Interference Study: Ground truth was established by preparing matrices with known positive (spiked with target organisms) or negative status, and then adding interfering substances at defined concentrations.
• For the Alinity m STI Assay (from referenced K202977 and K222379): Likely clinical diagnosis, culture, and/or comparison to other legally marketed nucleic acid amplification tests (NAATs). The specific details are not in this summary.

8. The Sample Size for the Training Set

• Human Factors Study: 223 participants used as the test set. There isn't a separate "training set" mentioned for this usability evaluation. The design presumably refined the kit instructions prior to this summative study, but specific training set details are not provided.
• Interference Study: No explicit "training set" concept applies here; it's a validation experiment.
• For the Alinity m STI Assay (from referenced K202977 and K222379): Not detailed in this summary.

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

Not applicable, as there's no explicitly defined "training set" for the type of studies presented here for the simpli-COLLECT STI Test. For the underlying Alinity m STI Assay, the ground truth for its training and validation would have been established through methods applicable to clinical diagnostic assays, as mentioned in point 7.

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The SIMEOX 200 airway clearance device is intended to promote airway clearance and to improve bronchial drainage by enhancing mobilization of bronchial secretions via high frequency oscillatory vibrations and intermittent negative pressure to the airway during exhalation. The device is intended to be prescribed for use in patients capable of independently generating cough.

SIMEOX 200 is intended for use in the home, hospital, and other healthcare institutions by individuals weighing at least 23 Kg.

The SIMEOX 200 Airway Clearance Device consists of a portable generator and a single patient use expiratory kit. The patient inhales from the ambient environment, naturally and independent of the device, and then exhales into the device mouthpiece. During the patient's exhalation, the SIMEOX 200 generates a pneumatic vibration throughout the airway. This vibration, applied at 6 Hz or 12 Hz via negative pressure pulses, disseminates throughout the bronchial tree in order to decrease mucus viscosity and increase secretion mobility. During or after therapy, the patient can clear the secretions by coughing independently.

This document describes the FDA's 510(k) clearance for the SIMEOX 200 Airway Clearance Device. It primarily focuses on demonstrating substantial equivalence to predicate devices through technical specifications and non-clinical performance testing.

The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of human-in-the-loop performance, AI assistance, or expert-based ground truth establishment for diagnostic purposes.

The document states:

• "Performance verification testing was conducted on the bench with the SIMEOX 200 Airway Clearance Device to demonstrate the subject device performs to its pre-specified requirement specifications, which align with those of the predicate devices."
• "The SIMEOX 200 device also went through comprehensive software verification and validation testing to confirm the device operates within specification."
• "Testing demonstrated the SIMEOX 200 performed as intended and was safe and effective."
• "A human factors validation study was conducted with simulated first-time use of the product in adult users and dyads of children with caregivers. The study concluded that the device is safe for its intended users."

This indicates that the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and safety performance specifications, rather than clinical performance metrics typically associated with AI/diagnostic devices (like sensitivity, specificity, or reader improvement).

Therefore, I cannot populate the requested table and study details as they are not present in the provided text. The document describes a medical device (Airway Clearance Device), not an AI or diagnostic device that would typically involve the type of acceptance criteria and studies you've outlined.

The acceptance criteria implied are the device's ability to meet its pre-specified parameters (e.g., pressure range, oscillation frequencies) and demonstration of safety and effectiveness through bench testing, software validation, and human factors validation.

Here's a summary of the information that is available, reframing it in the context of device performance rather than AI/diagnostic performance:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the other requested information, it is largely not applicable or not provided for this type of device and submission:

2. Sample size used for the test set and the data provenance:
* Test Set: Not explicitly stated in terms of a "test set" for performance metrics like sensitivity/specificity. Performance testing was "on the bench" and included software V&V and human factors simulation.
* Data Provenance: Not applicable for this type of technical/safety validation. The human factors study involved "simulated first-time use," but details about participant numbers or demographic provenance are not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* This is not relevant for this device's 510(k) submission, as it's not a diagnostic device requiring expert interpretation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not applicable.

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:
* Not applicable, as this is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable, as this is not an AI/algorithm-driven device in the sense of image analysis or diagnostic prediction. Its "performance" is based on its physical and software operation parameters.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* "Ground truth" in this context refers to the pre-defined engineering specifications and safety standards (e.g., pressure measurements, frequency measurements against a calibrated standard, successful execution of software functions, successful completion of simulated tasks in human factors). It's not a clinical or diagnostic ground truth.

8. The sample size for the training set:
* Not applicable. This device does not use machine learning that requires a "training set."

9. How the ground truth for the training set was established:
* Not applicable.

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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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Sim&Size enables visualization of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery. Sim&Size also allows for the ability to computationally model the placement of neurointerventional devices.

General functionalities are provided such as:

• Segmentation of neurovascular structures
• Automatic centerline detection
• Visualization of X-ray based images for 2D review and 3D reconstruction
• Placing and sizing tools
• Reporting tools

Information provided by the software is not intended in any way to eliminate, replace or substitute for, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition.

Sim&Size is a Software as a Medical Device (SaMD) for simulating neurovascular implantable medical devices. The product enables visualization of cerebral blood vessels for preoperational planning for neurovascular interventions and surgery. It uses an image of the patient produced by 3D rotational angiography. It offers clinicians the possibility of simulating neurovascular implantable medical devices in the artery or in the aneurysm to be treated through endovascular surgery and provides support in the treatment for the sizing and positioning of implantable medical devices.

Each type of implant device is simulated in a simulation module of Sim&Size:

• FDsize, a module that allows pre-operationally planning Flow-Diverter (FD) devices.
• IDsize, a module that allows pre-operationally planning Intrasaccular (ID) devices.
• STsize, a module that allows pre-operationally planning Stent (ST) devices.
• FCsize, a module that allows pre-operationally planning First and filling coils (FC) devices.

Associated with these four modules, a common module is intended to import DICOM and to provide a 3D reconstruction of the vascular tree in the surgical area.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for Sim&Size:

Acceptance Criteria and Device Performance

The provided document highlights performance testing without explicitly stating quantitative acceptance criteria. However, the nature of the tests implies the device must accurately "predictive behavior of the implantable medical device with its theoretical behavior," accurately "compare the device placement in a silicone phantom model with the device simulation," and accurately "compare the in vitro retrospective cases with the device simulation."

Given the context of a 510(k) submission, the implicit acceptance criterion is that the device's performance is substantially equivalent to the predicate device and that the new features do not raise new questions of safety and effectiveness.

Here's a table based on the types of performance tests conducted:

Study Details:

Based on the provided document, here's what can be inferred about the studies conducted:

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated in the document.
   • Data Provenance:
     • "Retrospective in vivo testing" suggests real-world patient data, but the phrase "in vitro retrospective cases" implies these were lab-based re-creations or analyses of that data. The specific country of origin is not mentioned, but given the company's address (Montpellier, France), it's plausible the data could originate from Europe, although this is not confirmed.
     • "Bench testing" uses a "silicone phantom model," which is an experimental setup, not clinical data provenance.
     • "Verification testing" involves comparing theoretical behavior, which doesn't involve a dataset in the same way clinical or phantom models do.

2. 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 refers to "theoretical behavior," "silicone phantom model," and "in vitro retrospective cases" as benchmarks, but it doesn't detail how the ground truth for "in vitro retrospective cases" was established or if experts were involved in defining the "theoretical behavior" or validating the phantom results.

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

   • This information is not provided in the document.

4. 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 MRMC study is explicitly mentioned. The device "enables visualization of cerebral blood vessels" and "allows for the ability to computationally model the placement of neurointerventional devices," but it's stated that "Information provided by the software is not intended in any way to eliminate, replace or substitute for, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition." This indicates it's a tool for assistance, but the document does not detail studies on human reader performance improvement with this AI.

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

   • The "Verification testing," "Bench testing," and "Retrospective in vivo testing" (comparing simulations to "in vitro retrospective cases") all describe methods that would assess the algorithm's standalone performance without a human in the loop for the actual comparison/measurement, although human input (e.g., in segmentation, placing/sizing tools) is part of the device's intended use. The wording "compares the predictive behavior... with its theoretical behavior" and "compares the device placement... with the device simulation" explicitly refers to the device's performance, implying a standalone assessment of the algorithmic component.

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

   • Theoretical Behavior: Used for "Verification testing" (e.g., physical laws, engineering models of device deployment).
   • Physical Phantom Model: Used for "Bench testing" (measurements from a physical silicone model).
   • "In vitro retrospective cases": Used for "Retrospective in vivo testing." This implies a ground truth derived from actual patient data, analyzed or re-created in a laboratory (in vitro). It's not explicitly stated if this ground truth was pathology or outcomes data, but rather a representation of the in vivo reality.

7. The sample size for the training set:

   • This information is not provided in the document. This section focuses on validation testing, not the training of any underlying models.

8. How the ground truth for the training set was established:

   • This information is not provided as the document does not detail the training process.

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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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