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The DASH® SARS-CoV-2 & Flu A/B Test is a rapid reverse transcription polymerase chain reaction (RT-PCR) assay performed on the DASH Rapid PCR Instrument and is intended for the simultaneous in vitro qualitative detection and differentiation of SARS-CoV-2, influenza A and influenza B virus ribonucleic acid (RNA) in anterior nasal swab specimens from patients with signs and symptoms of respiratory tract infection. The test is intended to aid in the differential diagnosis of SARS-CoV-2, influenza B in humans in conjunction with other clinical, epidemiologic and laboratory findings.

Positive results of a specific target are indicative of that viral RNA and may not be the definite cause of disease. Positive results do not rule out co-infection with other pathogens. Negative results do not preclude SARS-COV-2, influenza A or influenza B infection and should not be used as the sole basis for patient management decisions.

The DASH® SARS-CoV-2 & Flu A/B Test is a rapid, polymerase chain reaction (PCR) assay performed on the DASH Rapid PCR Instrument (DASH Instrument) with the DASH External Controls. The external control materials and DASH Instrument are sold and distributed separately from the DASH SARS-CoV-2 & Flu A/B Test. The DASH SARS-CoV-2 & Flu A/B Test (for use with the DASH Rapid PCR System components) uses reverse transcription polymerase chain reaction (RT-PCR) for rapid qualitative detection and differentiation of SARS-CoV-2, Flu A and Flu B from nasal swabs.

The test combines the technologies of sequence specific capture sample preparation and RT-PCR amplification. The DASH SARS-CoV-2 & Flu A/B Test cartridge contains all reagents necessary to perform the test. An anterior nares nasal swab with a 30-mm breakpoint is used to collect a specimen. The nasal swab specimen is added directly to the DASH SARS-CoV-2 & Fly A/B Test cartridge sample chamber. The cartridge is capped and inserted into the DASH Rapid PCR Instrument to initiate the test, and all subsequent test steps are performed automatically by the DASH Instrument.

The provided text describes the performance of the DASH® SARS-CoV-2 & Flu A/B Test, a rapid RT-PCR assay. The information focuses on analytical and clinical performance studies to demonstrate its substantial equivalence to a predicate device for FDA clearance.

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 acceptance criteria for a diagnostic test like this are typically related to:

• Analytical Sensitivity (Limit of Detection - LoD): The lowest concentration of the analyte that can be reliably detected.
• Precision/Reproducibility: The consistency of results when the test is run multiple times under varying conditions (different operators, days, sites, lots).
• Analytical Specificity (Cross-Reactivity & Microbial Interference): The ability of the test to exclusively detect the target analyte without reacting to other related or unrelated microorganisms and to perform accurately in the presence of other common substances.
• Clinical Performance (Agreement with a Comparator Method): How well the device's results align with a well-established (FDA cleared) method when tested on clinical samples. This is typically measured by Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA).

Acceptance Criteria (Implied) and Reported Device Performance for DASH® SARS-CoV-2 & Flu A/B Test

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

• Analytical Test Sets:
  • LoD: 5 viral strains (SARS-CoV-2, Flu A x2, Flu B x2) evaluated, with "replicates" (number not explicitly stated per strain, but implies multiple).
  • Within-Laboratory Precision: 96 replicates per concentration (2X LoD, 5X LoD, and negative) for each of the triple positive samples (SARS-CoV-2, Flu A, Flu B). Total of 288 samples for positive and 96 for negative for each target (total 384 for each target or more generally 96 of each concentration for the multiplex test).
  • Reproducibility (Multi-Site): Over 810 samples tested (270 replicates per panel member across 3 sites, 5 days, 2 runs/day, 3 replicates/panel member). Panel members: true negative, low positive (2X LoD), moderate positive (5X LoD).
  • Analytical Specificity (Cross-Reactivity & Microbial Interference): 50 different viruses, bacteria, and fungi (for wet testing of cross-reactivity and interference). Each tested with three (3) replicates.
  • Inclusivity (Wet Testing): 7 strains of SARS-CoV-2, 21 strains of Flu A, and 10 strains of Flu B. Three (3) replicates evaluated per strain.
• Clinical Test Set:
  • Evaluated Subjects: 795 subjects evaluable for at least one analyte/target.
  • SARS-CoV-2: 795 evaluable subjects (168 positive by comparator, 627 negative).
  • Flu A & Flu B: 792 evaluable subjects (Flu A: 53 positive by comparator, 739 negative; Flu B: 37 positive by comparator, 755 negative).
• Data Provenance:
  • Clinical Study: Prospective collection of specimens within the United States (7 geographical locations). Specimens collected from January to March 2024.
  • Analytical Studies: Lab-based studies using contrived samples/strains. The text does not specify the country of origin for these analytical labs, but given the FDA submission, it's likely US or accredited international labs.

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

• For analytical studies (LoD, precision, specificity, inclusivity), the "ground truth" is established by the known concentration of the spiked viral strains or the defined presence/absence of organisms/substances. This does not involve human expert consensus.
• For the clinical study, the ground truth was established by comparison with an FDA cleared RT-PCR test.
  • SARS-CoV-2: Comparison with an FDA cleared RT-PCR test for SARS-CoV-2.
  • Flu A & Flu B: Comparison with a second FDA cleared test for Flu A and Flu B.
  • Discordant Results: Discordant results were investigated using a "third highly sensitive FDA cleared test."
• The text does not specify the number of experts or their qualifications for establishing the ground truth (i.e., for interpreting the results of the FDA-cleared comparator tests). This is typical for such submissions; the "expert" is implied to be the validated and regulated comparator device.

4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set

• For the clinical study, an adjudication method was used for discordant results. The method was: "All discordant results between the DASH® SARS-CoV-2 & Flu A/B Test and the comparator were investigated using a third highly sensitive FDA cleared test." This acts as a reference standard to resolve discrepancies. It loosely resembles a "2+1" or "tie-breaker" approach where the third test breaks the tie between the investigational device and the initial comparator.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging devices or AI algorithms where human readers interpret images. The DASH® SARS-CoV-2 & Flu A/B Test is a molecular diagnostic (RT-PCR) test; its output is qualitative (positive/negative) and determined by an automated instrument/software algorithm without human visual interpretation of the test result. Therefore, human reader improvement with AI assistance is not applicable to this device.

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

• Yes, a standalone performance was done for the device. The device is an automated RT-PCR system.
  • "The cartridge is capped and inserted into the DASH Rapid PCR Instrument to initiate the test, and all subsequent test steps are performed automatically by the DASH Instrument."
  • "A software algorithm determines whether any of the targets are positive."
  • The analytical and clinical performance data (LoD, precision, specificity, inclusivity, PPA/NPA) all represent the "algorithm only without human-in-the-loop performance" in terms of result generation. The human role is in specimen collection, loading the cartridge, and interpreting the final positive/negative result displayed by the instrument. The operators were "untrained" in the clinical study, further indicating the device's standalone nature in generating results.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Analytical Studies: The ground truth was established using known quantities and defined characteristics of viral strains, bacteria, fungi, and chemical substances spiked into matrices (pooled nasal matrix, simulated clinical nasal matrix). This is a form of defined experimental truth.
• Clinical Study: The ground truth was established by comparison to results from one or more FDA cleared RT-PCR tests. This can be considered a reference standard ground truth based on established diagnostic methods. For discordant results, a "third highly sensitive FDA cleared test" served as the tie-breaker/confirmatory ground truth.

8. The Sample Size for the Training Set

• The document describes a 510(k) submission for a diagnostic test, not an AI/ML device where a distinct "training set" would be explicitly mentioned for model development. The text focuses on the validation of the device rather than its development. Therefore, a specific "training set sample size" for the algorithm itself is not provided in this document. The development of the assay (primers, probes, algorithm thresholds) would involve internal R&D, but the data presented here is for the regulatory submission's performance evaluation.

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

• As noted in point 8, a "training set" in the context of an AI/ML model for image or signal interpretation is not explicitly discussed. The "training" for this type of RT-PCR device involves the development and optimization of the assay's chemical reagents (primers, probes) and the instrument's detection algorithm. The ground truth for such development would involve:
  • Known concentrations of target nucleic acids: To establish reaction efficiency and sensitivity.
  • Characterized positive and negative clinical samples or controls: To optimize thresholds and ensure correct classification.
  • Various interfering substances/microorganisms: To ensure specificity.
• This ground truth is established through standard molecular biology and analytical chemistry practices, using highly characterized reagents and samples, and often iterative testing during the R&D phase prior to formal validation studies. The document does not detail this prior developmental process.

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The DASH 6® NRFit Lock syringe and DASH® NRFit Slip Syringe are intended to be used with ISO 80369-6 NRFit neuraxial compliant devices for administration of neuraxial medication.

The DASH 6® NRFit Plastic LOR Device is intended to be used with ISO 80369-6 NRFit neuraxial compliant epidural needle for locating the epidural space.

Accessories:

DASH 6® Introducer Needle is intended to be used with ISO 80369-6 NRFit neuraxial compliant spinal needle for guiding the placement of the spinal needle into the arachnoid/epidural space.

DASH 6@ NRFit Syringe Cap is intended to be used with ISO 80369-6 NRFit neuraxial syringes for sealing the tip of the syringe.

DASH 6® NRFit Drawing Up Filter Straw are intended to be used with ISO 80369-6 NRFit neuraxial syringe for the drawing up of neuraxial medication and anesthetic.

DASH 6@ NRFit Blunt Drawing Up Needle (with and without filter) is intended to be used with ISO 80369-6 NRFit neuraxial syringe for the drawing up of neuraxial medication and anesthetic.

DASH 6® NRFit Bacterial Disc Filter is intended to be used with ISO 80369-6 NRFit neuraxial compliant devices to ensure aseptic administration of neuraxial medication and anesthetic.

DASH 6® NRFit Epidural Flat Filter is intended to be used with ISO 80369-6 NRFit neuraxial compliant devices to ensure aseptic administration of neuraxial medication and anesthetic.

DASH 6® NRFit Tuohy-Borst Adapter is intended to be used with a epidural catheter to provide an ISO 80369-6 NRFit compliant connection.

DASH 6® NRFit Syringe to Syringe Adapter is intended to be used with ISO 80369-6 NRFit neuraxial syringe to allow for mixing/transfering medication between two syringes.

DASH 6® NRFit Needle Hub Cap is intended for sealing the hub of an NRFit compliant needle.

DASH 6@ NRFit Epidural Catheter Feeder is intended to be used with ISO 80369-6 NRFit neuraxial compliant devices to assist the insertion of an epidural needle into the epidural space.

The DASH 6® NRFit Syringes (Lock and Slip Syringes) are Single Use, in-hospital devices. They are provided in sizes ranging from 1 mL to 60 mL. The devices incorporate a male NRFit connector for connection to a female NRFit port. The syringes are designed according to ISO 7886-1 & ISO 80369-6 standard. The syringes are used for neuraxial purposes (ISO 80369-6 NRFit connection) and functions exactly the same as any hypodermic syringes that are on the market (ISO 7886-1).

The syringes will be supplied as individually packed (sterile) and the bulk packed (Nonsterile). The Sterile packed items will be supplied directly to the user and the bulk packed will be supplied to Anesthetic Conduction Kit manufacturers to be packaged into kit.

The syringe packaging will indicate the volume/size, the connector type (Lock or Slip variants) that the syringe contains and the sterility/sterilization method the syringe have been processed.

The DASH 6 ° Plastic LOR devices are Single Use, in-hospital devices. It is provided with a 10 mL size/volume and incorporates a male ISO 80369-6 NRFit slip connector to connect to a female ISO 80369-6 NRFit Port.

The Plastic LOR devices are designed according to ISO 80369-6 standard. The syringes are used for neuraxial purposes (ISO 80369-6 NRFit connection) and functions exactly the same as the LOR devices on the market.

The device will be supplied as individually packed (sterile) and the bulk packed (Nonsterile). The Sterile packed items will be supplied directly to the user and the bulk packed will be supplied to Anesthetic Conduction Kit manufacturers to be packaged into kit.

The devices packaging will indicate the volume/size, the connector type (Slip) that the device contains and the sterility/sterilization method the device have been processed.

Accessories:
DASH 6® NRFit Syringe Caps: Single Use, in-hospital devices with a female ISO 80369-6 NRFit connector.
DASH 6® NRFit Drawing up Filter Straw: Single Use, in-hospital devices with a female ISO 80369-6 NRFit connector and filter.
DASH 6 ° NRFit Blunt Drawing up Needle (with and without filter): Single Use, in-hospital devices with a female ISO 80369-6 NRFit connector and blunt needle (with or without filter).
DASH 6® NRFit Bacterial Disc Filter: Single Use, in-hospital devices with male & female ISO 80369-6 NRFit connectors and a 0.22µm filter.
DASH 6® NRFit Epidural Flat Filter: Single Use, in-hospital devices with male & female ISO 80369-6 NRFit connectors and a 0.22um filter.
DASH 6 ° NRFit Tuohy Borst Adapter: Single Use, in-hospital devices with a female ISO 80369-6 NRFit connector and open catheter port.
DASH 6® NRFit Needle Hub Caps: Single Use, in-hospital devices with a Male ISO 80369-6 NRFit connector.
DASH 6® Epidural Catheter Feeder: Single Use, in-hospital devices with a compatible male ISO 80369-6 NRFit connector.

The provided text is a 510(k) Premarket Notification for the DASH 6® NRFit System, which includes syringes and various accessories. This document primarily focuses on demonstrating substantial equivalence to predicate devices through design verification and compliance with specific ISO standards. It does not describe an AI medical device or a study involving human readers or AI assistance. Therefore, I cannot provide information on acceptance criteria and a study that proves the device meets those criteria in the context of AI performance, MRMC studies, standalone algorithm performance, number of experts, or ground truth for AI model development.

However, I can extract the acceptance criteria and the type of study conducted to demonstrate the device's technical specifications and substantial equivalence, as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the DASH 6® NRFit System are primarily defined by compliance with several ISO standards. The studies conducted were design verification tests demonstrating compliance with these standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes bench testing for physical characteristics, dimensional verification, and biocompatibility, not a clinical study with a "test set" in the context of AI or diagnostic performance. Therefore, typical sample size or data provenance details for medical image analysis are not applicable. The testing was conducted to verify compliance with engineering standards (ISO standards). The document does not specify the exact number of units tested for each specific test, but mentions "All necessary bench testing was conducted."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the device is a physical medical device (syringes, needles, etc.) and its performance is evaluated against engineering and biological standards, not diagnostic interpretations from experts. Ground truth is established by objective measurements against specified engineering and material science criteria.

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

Not applicable. This device is not an AI diagnostic tool and does not involve human adjudication of results in the traditional sense of a clinical study or image interpretation.

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. The DASH 6® NRFit System is a medical device (syringes, needles, etc.) and not an AI-powered diagnostic or assistive tool.

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

Not applicable. This device is not an algorithm or AI system. Its performance is evaluated intrinsically based on its physical properties and adherence to manufacturing and safety standards.

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

The "ground truth" for this device's evaluation is primarily the specifications and requirements defined by international standards (e.g., ISO 80369-6, ISO 7886-1, ISO 10993 series) and the manufacturer's own design specifications. It is based on objective, quantifiable physical and chemical measurements (e.g., fluid leakage, dimensions, material compatibility).

8. The sample size for the training set

Not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.

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

Not applicable.

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The DASH 3TM ENFit Syringe is a sugle use syninge indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids or nututional formula into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral synnges are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to clinicians, in all age groups.

The DASH 3TM Eccentric ENFit Syringe is a single use syringe indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids or nutritional formula into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral syninges are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to clinicians, in all age groups.

The DASH 3TM Low Volume Tip ENFit Syringe is a sungle use syringe indicated for use as a dispenser, a measuning device, and a fluid transfer device. It is used to deliver fluids or nutritional formula into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral syninges are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinicians, in all age groups.

The DASH 3M ENFit Syringe Cap allows the advance preparation and secure storage and transport of medication fluids or mutritional formula. The synnge cap will fit any size of the Single Use Synnges (DASH 3TM)

The DASH 3™ ENFit Syringe device family is a Single Use, in-hospital and home care (DASH 3TM ENFit Syringe, DASH 3TM Eccentric ENFit Syringe, DASH 3TM ENFit Low Dose Tip Syringe) device.

It is provided in sizes from 1 mL to 100 mL. The device incorporates a female ENFit connector for connection to an enteral access device with a male ENFit port specified in ISO 80369-3. The Low Dose Tip contains the low dose design feature specified in (Draft) ISO 20695.

The DASH 3TM ENFit accessories are designed to be compatible with ENFit connector devices. The DASH 3TM ENFit Syringe Caps fit any size of the Single Use ENFit Syringes (DASH 3™), which allows the advance preparation and secure storage and transport of medication/fluids or nutritional formula.

The provided text describes a medical device, the DASH 3™ ENFit Syringe family and its accessories, and outlines the testing conducted to demonstrate its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of diagnostic performance. Therefore, I cannot extract information related to sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as these are not relevant to this type of device submission.

However, I can provide the acceptance criteria and confirmed performance based on the engineering and functional testing described in the document.

Acceptance Criteria and Reported Device Performance

The device performance is demonstrated through various tests designed to confirm compliance with ISO standards and other design specifications. The document states that the DASH 3™ Syringe device family and its accessories "met all acceptance criteria, as described in Section 17." The table below summarizes the listed tests, which serve as the acceptance criteria, and the reported outcome.

Details of the Study:

The studies conducted are primarily engineering and functional bench tests, and risk assessments.

• Sample sized used for the test set and the data provenance: The document does not specify exact sample sizes for each test. The data provenance is implied to be from internal testing conducted by the manufacturer, Intervene Group Limited, likely in the UK, given the address. The studies are prospective in the sense that they were conducted for the purpose of this 510(k) submission.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these types of engineering tests is typically defined by adherence to published international standards (e.g., ISO) and the device's design specifications, not by expert consensus on observational data.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Performance is measured against predefined objective standards and specifications.
• 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. This is not an AI/diagnostic device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/diagnostic device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for these tests is the adherence to the requirements outlined in the cited ISO standards (ISO 80369-3, ISO 80369-20, ISO 7886-1, Draft ISO 20695) and the internal design specifications of the device.
• The sample size for the training set: Not applicable. This is not a machine learning device; therefore, there is no "training set."
• How the ground truth for the training set was established: Not applicable.

In conclusion, the study supporting the device's substantial equivalence consists of a series of bench tests and assessments confirming that the DASH 3™ ENFit Syringe family and its accessories meet established engineering and performance standards, thereby demonstrating that they perform as intended and do not raise new questions of safety or effectiveness compared to predicate devices.

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Under the supervision of a healthcare professional, Dash-Topic Plus Cream is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. Dash-Topic Plus Cream also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

Dash-Topic Plus Cream is a non-sterile, off-white, low odor, fragrance free, topical product. Dash-Topic Plus Cream forms a physical barrier that helps to maintain a moist wound and skin environment. Dash-Topic Plus Cream is a prescription device.

The provided document is a 510(k) summary for the medical device "Dash-Topic Plus Cream." It is a regulatory submission for premarket notification, aiming to demonstrate substantial equivalence to a legally marketed predicate device. This type of document focuses on comparing the new device to an existing one, rather than presenting a study of its independent effectiveness against clinical outcomes or a rigorous clinical trial. Therefore, the document does not contain the information required to answer your specific questions about acceptance criteria, detailed study designs, sample sizes, expert ground truth, or comparative effectiveness with human readers.

The document discusses "Performance Data" but this refers to non-clinical testing (biocompatibility, stability, etc.) to ensure safety and functionality, not clinical performance in terms of diagnostic accuracy or impact on human readers.

Here's a breakdown of what can be extracted and why the other information is missing:

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

• Missing from document: The document does not provide a table of acceptance criteria in terms of clinical efficacy or diagnostic performance. The "performance data" section (Section VIII) lists non-clinical tests (biocompatibility, stability) and states the results (e.g., "non-cytotoxic, a negligible irritant and non-sensitizing"), but it doesn't define acceptance criteria for these tests within the narrative. Their acceptance is implied by the "Conclusion" that the device is substantially equivalent.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Missing from document: There is no clinical test set described in the sense of a patient cohort or diagnostic images. The "tests" mentioned are laboratory-based assays (e.g., Agar Diffusion Cytotoxicity). Sample sizes for these types of tests typically refer to the number of samples or replicates tested in the lab, not patient populations. No data provenance in terms of country of origin or retrospective/prospective nature is applicable as no clinical study is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Missing from document: Not applicable. No clinical ground truth or expert review is mentioned because no clinical study or diagnostic AI algorithm testing is described.

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

• Missing from document: Not applicable. No clinical adjudication method is mentioned as there is no clinical test set to adjudicate.

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

• Missing from document: Not applicable. This document pertains to a topical cream, not an AI-powered diagnostic device, and therefore no MRMC study was performed or described.

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

• Missing from document: Not applicable. This device is a topical cream, not an algorithm.

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

• Missing from document: Not applicable for clinical ground truth. For the non-clinical tests, the "ground truth" would be the established scientific standards and methods for assessing cytotoxicity, irritation, sensitization, and stability (e.g., ISO standards, USP monographs).

8. The sample size for the training set

• Missing from document: Not applicable. This document is for a medical device (topical cream), not an AI algorithm that requires a training set.

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

• Missing from document: Not applicable. As above, there is no AI algorithm or training set.

Summary of what the document does provide regarding "performance":

The "Performance Data" (Section VIII) describes non-clinical testing to confirm the safety and effective performance in terms of the cream's physical and biological interaction with the body (biocompatibility) and its stability.

• Tests Conducted:

  • Agar Diffusion Cytotoxicity (ISO 10993-5: 2009)
  • Direct Primary Skin Irritation (ISO 10993-10:2010)
  • Kligman Maximization Sensitization (ISO 10993-10:2010)
  • Bench performance testing for release and shelf life stability (monitored parameters: Appearance, pH, preservative content, viscosity and package integrity)
  • Preservative Effectiveness Testing as per USP<51> (Antimicrobial Effectiveness Testing)
  • USP<61> <62> (Microbial Enumeration Tests and Tests for Specified Microorganisms)
  • In-use stability testing for opened 450g container (monitored parameters: Appearance, pH, preservative content, viscosity, package integrity, USP<51> and USP<61> <62>)

• Reported Results (Performance):

  • Dash-Topic Plus Cream is non-cytotoxic.
  • Dash-Topic Plus Cream is a negligible irritant.
  • Dash-Topic Plus Cream is non-sensitizing.
  • The bench performance data confirmed the physical characteristics, stability, and shelf-life.

The acceptance criteria for these tests are implicitly that the device passes specific thresholds or shows no adverse effects according to the referenced ISO and USP standards. However, the exact numerical acceptance criteria are not explicitly stated in this summary.

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DASH hip is intended to be an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface.

The system is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure, such as a long bone, can be identified relative to the anatomy. The system aids the surgeon in controlling leg length and offset discrepancies.

Example orthopedic surgical procedures include but are not limited to:

Total Hip Replacement (THR) Revision surgery of THR Minimally Invasive THR Surgery

DASH hip is intended to enable operational navigation in minimally invasive orthopedic surgery. It links a surgical instrument, tracked by passive markers to virtual computer image space on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks.on the bone surface. DASH hip uses the registered landmarks to determine postoperative changes in leg length and offset,

DASH hip software intraoperatively registers the patient data needed for navigating the surgery. No preoperative CT-scanning is necessary.

Here's an analysis of the acceptance criteria and study information for the BrainLAB DASH hip, based on the provided text:

BrainLAB DASH hip: Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list quantitative acceptance criteria in a table format. However, it states the overall performance goal and the conclusion of the pivotal study.

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

• Sample Size for Test Set: 43 consecutive Total Hip Replacement (THR) surgeries.
• Data Provenance: The study was a "prospective clinical study," implying the data was collected specifically for this purpose in a real-world clinical setting. No specific country of origin is mentioned for the clinical study data.

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

The document does not provide details on the number of experts or their qualifications for establishing ground truth within the clinical study. It states that the study evaluated "navigation accuracy," implying a comparison to some established measurement standard, but doesn't specify who performed or validated these standards. Given the context of surgical navigation, it's highly probable that orthopedic surgeons were involved in the procedures and likely in assessing outcomes, but this is not explicitly stated as "ground truth establishment" by independent experts.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical study data.

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

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed based on the provided text. The study compared the navigation accuracy of the DASH hip (which aids the surgeon) to a previously used predicate device's technique, not the improvement of human readers with AI vs. without AI assistance.

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

The document describes "verification of the software algorithm itself" as part of the design verification activities. This suggests a standalone evaluation of the algorithm's performance prior to integration with instrumentation and human interaction. However, detailed results of this standalone testing are not provided, only that it was "successfully verified." The primary clinical study focuses on the system's navigation accuracy, which inherently includes human interaction in using the system to measure.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the prospective clinical study, the ground truth for "leg length and offset measurements" would likely be derived from:

• Intraoperative measurements: Taken by the surgeon using conventional or established methods, possibly compared against pre-operative plans or fluoroscopic images.
• Radiographic measurements: Post-operative X-rays interpreted to determine actual leg length and offset changes.

The document states the study showed "the accuracy relating purely to the navigation measurements... is comparable to the previously used leg length and offset technique from the predicate device." This implies the "ground truth" was a reliable, established method of measuring these parameters, against which the DASH hip's measurements were compared.

8. The Sample Size for the Training Set

The document does not mention a specific "training set" or sample size for training. The DASH hip is a navigation system that uses landmarks acquired intraoperatively to generate a patient-specific 3D model. It does not appear to be a machine learning or AI system that requires a distinct "training set" in the conventional sense for image analysis or diagnostic tasks. Its core algorithm, though, would have been developed and refined using various data, potentially from predicate devices or simulated scenarios, but this is not described as a "training set."

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

As noted above, a "training set" in the traditional machine learning sense is not explicitly described. The development and verification process included:

• Design verification: Covered instrument and system accuracy during registration, post-operative point acquisition, and analysis by comparing values to "externally-measured reference values." This implicitly establishes ground truth for verification tasks.
• Non-clinical validation: Performed with plastic bone models (sawbones) in "Usability Workshops (use labs)." Ground truth here would be the known anatomical dimensions of the models and the physical measurements taken.
• Pre-clinical validation: Performed in a "cadaver lab." Ground truth here would again be actual anatomical measurements and established surgical reference points.

These pre-clinical and verification steps provided data and a basis for establishing the correctness and accuracy of the device's measurements, which could be considered akin to establishing "ground truth" for development and early testing, distinct from a statistical "training set" for AI model development.

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DASH knee is intended to be an intraoperative image guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to the anatomy. The system aids the surgeon to accurately navigate a knee prosthesis to the intraoperatively planned position. Ligament balancing and measurements of bone alignment are provided by DASH knee.

Example orthopedic surgical procedures include but are not limited to:

• · Total Knee Replacement
• Ligament Balancing

Dash is an image guided surgery system for total knee replacement surgery based on landmark based visualization of the femur and tibia. It is intended to enable operational navigation in orthopedic surgery. It links a surgical instrument, tracked by passive markers to virtual computer image space on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. DASH knee uses the registered landmarks to navigate the femoral and tibial cutting guides to the optimally position.

DASH knee software registers the patient data needed for navigating the surgery intraoperatively. No preoperative CT-scanning is necessary.

The provided text describes the K102251 510(k) Summary for the BrainLAB DASH knee system. This document outlines the device, its intended use, comparisons to predicate devices, and verification/validation activities. However, it does not contain specific acceptance criteria, reported device performance metrics in a quantitative manner, or detailed study results that would typically be presented in a table format with numerical values.

Therefore, I cannot directly extract and fill the table for acceptance criteria and reported device performance, nor can I provide answers for all the requested study design details as the information is not present in the given text.

Here's what can be inferred or stated based on the provided text, along with the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: The document implies that the system must function correctly according to its specifications and ensure safety. It mentions "correct system functionality as it has been specified" and "correct behavior of the system for all possible procedures," but no specific numerical targets or thresholds are given.
• Reported Device Performance: The document states that "All tests have been successfully completed" and that the device was found "substantially equivalent" to predicate devices. This indicates that the device met its internal performance benchmarks, but these benchmarks or the numerical results are not disclosed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified. The document mentions "usability workshops (use labs)" with "plastic bones (sawbones)" and "cadaver lab" testing, but no specific number of instruments, tests, or cadavers is provided.
• Data Provenance: Not explicitly stated. The testing appears to be primarily in a lab setting ("usability workshops," "cadaver lab") and therefore would be considered prospective in nature, generating new simulated or ex vivo data. There is no mention of patient data or country of origin for the data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of Experts & Qualifications: Not specified. The document mentions "testing persons went through same procedure like for the non clinical use lab sessions" during cadaver testing, implying the involvement of individuals simulating surgical procedures. However, their qualification, number, or their role in establishing a formal "ground truth" (beyond following specified procedures) is not detailed.

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

• Adjudication Method: Not specified. The document describes a series of verification and validation steps, including comparing "registration values... to external measured reference values" and testing for "correct behavior." This implies a comparison to a predefined standard or ideal outcome, but no formal adjudication process for discrepancies is mentioned.

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 MRMC comparative effectiveness study involving human readers and AI assistance is described. The DASH knee is an image-guided surgery system, not an AI diagnostic tool that assists human readers in interpreting images. Its purpose is to guide surgical instruments, not to enhance human interpretation of images.

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

• Yes, a form of standalone testing was performed for the software algorithms. The document states: "After the verification of the instruments in combination with the software the verification of the software algorithms itself has been performed." This implies that the core algorithms were tested independently of full human interaction, likely against defined computational outputs or expected results.

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

• The ground truth appears to be based on external measured reference values for registration accuracy and predefined specifications/expected behavior for software functionality and workflow correctness. In the cadaver and sawbone labs, the ground truth would likely be the anatomically correct positions or optimal surgical trajectories as determined by established surgical principles and perhaps simulated by experienced users. It is not expert consensus from reviewing patient data, nor is it pathology or long-term outcomes data as these are pre-market non-clinical validations.

8. The sample size for the training set

• Not applicable as this is not an AI/machine learning device in the contemporary sense that requires a "training set" for model development. The system uses "landmark based visualization" and "acquiring multiple landmarks on the bone surface" to generate a 3D model. Its functionality is based on established algorithms in image guidance and tracking, not on learning from a large dataset.

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

• Not applicable, for the same reason as point 8.

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The Dash 2500 Patient Monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of this device is a portable (intrahospital) multiparameter unit designed for monitoring adult, pediatric, and neonate patient vital signs in a hospital subacute care environments, such as same-day surgery, emergency rooms, recovery/PACU, progressive care, interventional radiology, special care units, and GI/endoscopy.

The Dash 2500 Patient Monitors and displays oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), heart/pulse rate, respiration rate, ECG, temperature with an reusable electronic thermometer (predictive mode for oral and rectal temperature measurement, monitor mode for axillary temperature measurement), and functional oxygen saturation (SpO2) and pulse rate via spot checking and continuous monitoring, including monitoring during conditions of clinical patient motion or low perfusion.

The Dash 2500 also detects alarm limit conditions and is capable of recording up to two waveforms. Using this monitor a clinician can view, record and recall clinical data derived from each parameter.

The Dash 2500 Patient Monitor is a portable (intra-hospital) multi-parameter monitor designed for monitoring adult, pediatric, and neonate patient vital signs.
The Dash 2500 Patient Monitor is self-contained and can be powered by batteries or AC. The Monitor has a carrying handle and can be operated on a shelf or table. It can also be mounted in a variety of ways (e.g., wall, pole, bed rail, or head/foot board) using a mounting plate located on the bottom of the Monitor. The Monitor can be used as a stand-alone monitor with the capability to interface to a central station, a server or any other device capable of receiving data using the host communications protocol.

The provided text does not contain specific acceptance criteria or a study detailing device performance against those criteria. Instead, it is a 510(k) summary for the GE Dash 2500 Patient Monitor, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance metrics from a specific study with defined acceptance criteria.

The document mentions:

• Voluntary standards compliance: "The Dash 2500 complies with the voluntary standards as detailed in Section 9 of this submission." However, Section 9 is not provided in the input, so the specific standards and their associated performance criteria are unknown.
• Quality assurance measures: A list of measures applied during development (Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level, Integration testing, Final acceptance testing, Performance testing, Safety testing, Environmental testing).
• Conclusion: "The results of these measurements demonstrated that the Dash 2500 is as safe, as effective, and performs as well as the predicate device." This is a general statement of equivalence, not a report of specific numerical performance against acceptance criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set information, as this data is not present in the provided submission. The submission confirms a 510(k) clearance based on substantial equivalence, not a detailed performance study against explicit acceptance criteria.

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The DASH™ is a deformable shape memory padded retractor, which is intended to retain or hold back organs and tissue in the course of surgical procedure. At the same time it serves as means of cushioning and absorption to the surgical area.

The DASH™ is a deformable shape memory padded retractor

The provided text is a 510(k) clearance letter from the FDA for a manual surgical instrument named DASH™. It states that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information regarding acceptance criteria, study data, sample sizes, expert qualifications, or ground truth establishment for device performance. It is a regulatory clearance document, not a clinical or performance study report.

Therefore, I cannot provide the requested information based on the input text.

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The Dash 3000/4000 Patient Monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash is designed as a bedside, portable, and transport monitor that can operate in all professional medical facilities and medical transport modes including but not limited to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, freestanding surgical centers, and other alternate care facilities, intra-hospital patient transport, inter-hospital patient transport via ground vehicles (i.e., ambulance, etc.) and fixed and rotary winged aircraft, and pre-hospital emergency response.

Physiologic data includes but is not restricted to: electrocardiogram, invasive blood pressure, noninvasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, carbon dioxide, oxygen, and anesthetic agents as summarized in the operator's manual.

The Dash 3000/4000 Patient Monitor is also intended to provide physiologic data over the Unity network to clinical information systems and allow the user to access hospital data at the point-of-care.

This information can be displayed, trended, stored, and printed.

The Dash 3000/4000 Patient Monitor was developed to interface with non-proprietary third party peripheral devices that support serial data outputs.

The Dash 3000/4000 Patient Monitor is a device that is designed to be used to monitor, display, and print a patient's basic physiological parameters including: electrocardiography (ECG), invasive blood pressure, non-invasive blood pressure, oxygen saturation, temperature, impedance respiration, end-tidal carbon dioxide, oxygen, nitrous oxide and anesthetic agents. Other features include arrhythmia, cardiac output, cardiac and pulmonary calculations, dose calculations, PA wedge, ST analysis, and interpretive 12 lead ECG analysis (12SL). Additionally, the network interface allows for the display and transfer of network available patient data.

The provided document refers to the K020290 submission for the GE Medical Systems Information Technologies Dash 3000/4000 Patient Monitor. This submission is a 510(k) premarket notification, which means the device is seeking substantial equivalence to a predicate device rather than presenting novel acceptance criteria or a detailed clinical study for efficacy.

Therefore, the document does NOT contain the specific information requested in the prompt regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number of experts, adjudication methods, or ground truth details for a test set.
• Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
• Details of a standalone algorithm performance study.
• Sample size and ground truth establishment for a training set.

Instead, the document focuses on the regulatory aspects of a 510(k) submission, confirming the device's intended use, classification, and that it "employs the same functional scientific technology as its predicate devices."

The "Test Summary" section lists quality assurance measures applied to the development, which are general engineering and quality management practices, not specific clinical performance studies with acceptance criteria as typically understood for AI/ML devices. These measures include:

• Risk Analysis
• Requirements Reviews
• Design Reviews
• Testing on unit level (Module verification)
• Integration testing (System verification)
• Final acceptance testing (Validation)
• Performance testing
• Safety testing
• Environmental testing

The conclusion states: "The results of these measurements demonstrated that the Dash 3000/4000 Patient Monitor are as safe, as effective, and perform as well as the predicate device." This is a statement of substantial equivalence, not a report of meeting specific numerical performance criteria from a clinical study.

In summary, the provided document does not contain the detailed study results and acceptance criteria as requested because it is a 510(k) summary for a patient monitor, which relies on demonstrating substantial equivalence to a predicate device rather than presenting novel clinical performance data against predefined acceptance criteria in the manner expected for an AI/ML device.

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