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WasherCap™ Fixation System is intended for fixation of soft tissue grafts, including tendons and ligaments, during surqical procedures such as in Anterior Cruciate Ligament (ACL) reconstruction of the knee.

The WasherCap™ Fixation System is an implantable non-active device consisting of three components: the washer, the cap, and the screw. All components building the WasherCap™ Fixation System are made of high-quality biocompatible materials, with a long-existence use in terms of human safety and patient's clinical performance.

The Washer and the Cap are made from non-degradable organic thermoplastic polymer biomaterial, so-called Polietheretherketone (PEEK by Invibio™ Biomaterial Solutions in accordance with ASTM 2026) and the Screw is made from implantable degree Titanium Alloy (Ti-6Al- 4V ELI) in accordance with ISO 5832-3 and ASTM F136 standards.

To achieve correct implantation and use of the device requires specific accessories: WasherCap™ Instrument Set. The required accessories are product- specific reusable surgical instruments that have been designed for the implantation of the WasherCap™ Fixation System. Use of the WasherCap™ Instrument Set will ensure the surgical procedure, and the use of the WasherCap™ Fixation System are carried out in an appropriate manner.

The provided text describes a 510(k) premarket notification for a medical device called the WasherCap™ Fixation System. This submission argues for the substantial equivalence of the subject device to a previously cleared predicate device (K212197).

Based on the provided document, the WasherCap™ Fixation System is a mechanical device (an implantable non-active device for fixing soft tissue grafts to bone) and not an AI/software-driven device. Therefore, the questions related to AI/software performance criteria (such as MRMC studies, standalone algorithm performance, training set size, ground truth establishment for training data, expert consensus, and adjudication methods for medical image analysis) are not applicable.

The document explicitly states:

• "Software Verification and Validation: The device does not contain software/firmware."

Therefore, a detailed breakdown of acceptance criteria and a study proving an AI device meets those criteria, as requested in the prompt, cannot be fully provided based on this document.

However, I can extract information related to the performance testing done for this mechanical device to prove substantial equivalence, which is the analogous process for a physical medical device.

Acceptance Criteria and Study for WasherCap™ Fixation System (Mechanical Device)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact sample sizes (number of devices tested) for the mechanical testing. It states that "Mechanical testing verifications were performed on the proposed WasherCap™ Fixation System 11mm implant." Standard engineering practice for medical device testing typically involves statistically relevant sample sizes to ensure robust results, but specific numbers are not disclosed in this summary.
• Data Provenance: The data comes from bench testing performed by the manufacturer, Abanza Tecnomed, S.L., located in Spain ("Multiva, ES, 31192, Spain"). The testing is prospective in the sense that it was conducted specifically for this 510(k) submission to demonstrate equivalence for the new 11mm size.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

• Not Applicable. This is a mechanical device, not an AI/software device requiring human expert consensus for ground truth on medical images. The "ground truth" here is compliance with established mechanical and material standards and performance equivalent to the predicate device.

4. Adjudication Method for the Test Set

• Not Applicable. As a mechanical device, there is no "adjudication" of expert interpretations. Device performance is measured against objective engineering parameters and standards.

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

• No, Not Applicable. This type of study is relevant for AI/software in medical image analysis. No human readers or AI assistance are involved in the function or evaluation of this mechanical fixation system.

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

• No, Not Applicable. The device does not contain an algorithm or software. It is a physical implant.

7. The Type of Ground Truth Used

• The "ground truth" for this mechanical device's evaluation is primarily engineering specifications, material standards (e.g., ISO, ASTM), and the performance characteristics established by the predicate device (K212197). The new 11mm implant needed to demonstrate that its mechanical performance was equivalent to that of the predicate, and that the material and manufacturing processes remained unchanged.

8. The Sample Size for the Training Set

• Not Applicable. This concept applies to AI/machine learning models that are "trained" on data. This device is not software.

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

• Not Applicable. As the device does not contain software/firmware and is not an AI product, there is no "training set" or establishment of ground truth for such a set.

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