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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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WasherCap™ Mini Fixation System is intended for fixation of suture/tape (soft tissue) to bone in the shoulder, knee and hand/wrist, in skeletally mature pediatric and adult patients for the following procedures:

• Knee:

• Meniscal root repair: using non-absorbable UHMWPE USP 2-0 sutures or non-absorbable UHMWPE 1.4-2.2mm tapes.

• Meniscal transplant: using non-absorbable UHMWPE USP 2-0 sutures or non-absorbable UHMWPE 1.4-2.2mm tapes.

• ACL/PCL Repair: using non-absorbable UHMWPE USP 2-0 sutures or non-absorbable UHMWPE 1.4-2.2mm tapes.

• ACL Reconstruction: only with WasherCap™ Mini Fixation System 4.5mm size and using 2 nonabsorbable UHMWPE 1.4mm tapes or 1 non-absorbable UHMWPE 2.2mm tape.

• Shoulder:

• Rotator Cuff Repair: using non-absorbable UHMWPE USP 2-0 sutures or non-absorbable UHMWPE 1.4-2.2mm tapes.

• Hand/Wrist:

• Triangular fibrocartilage complex (TFCC): only with WasherCap™ Mini Fixation System 3.5mm size and using non-absorbable UHMWPE USP 2-0 sutures or non-absorbable UHMWPE 1.4-2.2mm tapes.

The WasherCap™ Mini Fixation System consists of an implantable device, a handled inserter, a handled screwdriver, a drill guide, a drill bit and a suture threader. The WasherCap™ Mini implantable device is pre-loaded on the handled inserter with the suture threader.

The drill guide and the drill bit should be used to perform a drilling guided specifically to the angulation necessary to create the bone socket where the screw of the implant should be located. The suture/tape is passed through the cap with the suture threader and the screw is threaded with the handled screwdriver, setting the tension of the suture/tape.

The WasherCap™ Mini Fixation System is provided sterile and individually packaged. All components are for single use only.

The WasherCap™ Mini Fixation System is available in different sizes and should be implanted following the corresponding surgical procedure.

This document describes the premarket notification for the WasherCap™ Mini Fixation System and does not contain the detailed information about the acceptance criteria and study proving the device meets those criteria for software-based medical devices or AI/ML components.

The provided text pertains to a physical medical device (a bone fixation system) and its substantial equivalence to a predicate device. The performance data mentioned refers to bench testing of mechanical properties, not the performance of an AI/ML algorithm.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and reported device performance for an AI/ML device.
2. Sample size and data provenance for a test set in the context of an AI/ML study.
3. Number and qualifications of experts for ground truth establishment for an AI/ML study.
4. Adjudication method for an AI/ML test set.
5. MRMC comparative effectiveness study results for AI assistance.
6. Standalone performance of an AI algorithm.
7. Type of ground truth used for AI/ML.
8. Sample size for the training set of an AI/ML model.
9. How ground truth for the training set was established for an AI/ML model.

The document explicitly states:

• "This submission does not include any animal performance testing. It was determined that no such testing is required to demonstrate substantial equivalence." (page 8)
• "This submission does not include any clinical performance testing. It was determined that no such testing is required to demonstrate substantial equivalence." (page 9)

Instead, the performance data section (page 8) focuses on:

• "Bench testing was performed on the subject device to evaluate cyclic loading and elongation, insertion, interconnection, and bone anchor pullout force."
• "Bench testing was performed on the subject device and compared to the predicate device: cyclic loading and elongation, and bone anchor pullout force."
• "The results of the testing met the defined acceptance criteria and were assessed against the results obtained with the predicate devices to determine substantial equivalence for design and performance."
• "Final devices were subjected to Bacterial endotoxin testing per EP 2.6.14/USP to demonstrate that the device meets pyrogen limit specifications."

This indicates that the "acceptance criteria" and "study" refer to mechanical and biocompatibility testing for a physical implant, not an AI/ML component.

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