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The A-TAP is intended for use by healthcare professionals for general purpose fluid aspiration/injection.

The A-TAP device is a fluid switching medical device consisting of a clear plastic barrel body, a sliding rod, two 6% female Luer lock connections, and one 6% male Luer lock connection. The internal surface of the device barrel body is lubricated with polydimethylsiloxane (silicone). The A-TAP is a single-use only, disposable, non-pyrogenic and sterilized by Gamma irradiation.

The provided text is a 510(k) summary for the A-TAP device, which is a fluid switching medical device. The submission is a Special 510(k) due to modifications made to the previously cleared Arthrotap device (K201816) by Elcam Medical.

The acceptance criteria and study proving the device meets these criteria concern the physical and biological characteristics of the device, not an AI/ML-driven diagnostic or prognostic tool. Therefore, the questions related to AI/ML performance metrics, sample sizes for training/test sets for AI, expert adjudication of ground truth, and MRMC studies are not applicable in this context.

This document details the tests performed to demonstrate that the modified A-TAP device is substantially equivalent to its predicate.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance tests conducted to demonstrate substantial equivalence, implying that passing these tests served as the acceptance criteria. The "Reported Device Performance" is stated by the successful completion of all listed tests.

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

The document concerns a physical medical device and its components, not a data-driven AI/ML model for which test sets from patients are required. Therefore, typical "sample sizes" in the context of clinical data for AI are not applicable. The tests performed are laboratory-based, often involving a certain number of device units or material samples as specified by the respective ISO/ASTM standards. The data provenance is laboratory testing conducted by or for Elcam Medical. The document does not specify country of origin for the testing itself, nor if it was retrospective or prospective in the clinical sense, as it refers to engineering verification and validation testing.

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

Not applicable. Ground truth for a physical device's performance (e.g., material compatibility, structural integrity, sterility) is established by adherence to recognized international and national standards (ISO, ASTM, USP) and the results of the specified tests, rather than expert consensus on clinical data.

4. Adjudication Method for the Test Set:

Not applicable for a physical device. Performance is determined by meeting the pass/fail criteria defined within the referenced standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

Not applicable. This type of study is relevant for diagnostic imaging AI, not for a fluid switching device.

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

Not applicable for a physical medical device without AI components.

7. The Type of Ground Truth Used:

The ground truth used for proving the device meets acceptance criteria is based on standardized test methods and their defined performance criteria. For example, biocompatibility is evaluated against specific biological responses according to ISO standards, and mechanical integrity is evaluated against criteria set by ISO or ASTM standards. This is not derived from expert consensus, pathology, or outcomes data in the typical clinical sense, but from engineering and material science principles.

8. The Sample Size for the Training Set:

Not applicable. This device does not involve an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for an AI/ML algorithm.

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The ARTHROTAP is intended for use by healthcare professionals for general purpose fluid aspiration.

The ARTHROTAP is a fluid switching medical device consisting of a clear plastic barrel body, a sliding rod, two 6% female Luer lock connections, and one 6% male Luer lock connection. The internal surface of the ARTHROTAP device barrel body is lubricated with polydimethylsiloxane (silicone). The ARTHROTAP is single-use only, non-pyrogenic, and sterilized by electron beam irradiation.

The medical device in question, ARTHROTAP, is a fluid switching medical device intended for general purpose fluid aspiration/injection. The document describes its substantial equivalence to a predicate device, the ANUTRA Feedback Aspiration Syringe (K143757), based on a comparison of technological characteristics and performance testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by meeting relevant ISO and ASTM standards. The reported device performance indicates that ARTHROTAP successfully passed these tests.

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

The document does not specify the exact sample sizes used for each individual test. It states that "Performance testing of ARTHROTAP was conducted and evaluated in accordance with [various ISO and ASTM standards]".

The data provenance is from non-clinical testing conducted by the manufacturer, Accuro Technologies Inc., to demonstrate substantial equivalence to a legally marketed predicate device. This is typically laboratory-based testing, not human patient data. The country of origin of the data is not explicitly stated, but the manufacturer is based in Canada.

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

This information is not applicable to this type of device and study. The "ground truth" for the performance tests outlined (e.g., leakage, material strength, biocompatibility) is determined by meeting the quantitative and qualitative requirements of the respective international standards (ISO, ASTM). This is not typically established by human expert consensus or qualifications in the same way clinical imaging or diagnostic device studies do.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are usually relevant for expert consensus on clinical findings, particularly in studies involving interpretation of medical images or symptoms. The described tests for ARTHROTAP are objective performance and safety evaluations against established technical standards.

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

There is no mention of an MRMC comparative effectiveness study, AI assistance, or human readers. This device is a fluid switching component, not a diagnostic imaging or AI-powered device.

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

There is no mention of any algorithm-only or AI-related performance testing. The ARTHROTAP is a physical medical device, not a software algorithm.

7. The type of ground truth used

The "ground truth" for this device's evaluation is based on established objective technical standards (ISO and ASTM) and biocompatibility guidelines. For example:

• Performance: Meeting specified limits for leakage, operating force, dimensional requirements, etc., as defined by the international standards.
• Biocompatibility: Absence of cytotoxicity, sensitization, irritation, systemic toxicity, hemolysis, particulate matter, and detection of pyrogens/endotoxins, as per ISO 10993 and USP standards.
• Sterilization: Demonstration of sterility assurance level (SAL) according to ISO standards.

8. The sample size for the training set

This information is not applicable. The ARTHROTAP is a physical medical device, not a machine learning model, so there is no concept of a "training set."

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

This information is not applicable, as there is no training set for this device.

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