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The 2.3mm ROC EZ Suture Bone Fasteners are intended for the reattachment of soft tissue to bone for the following indications: ANKLE Lateral instability Medial instability Achilles tendon reconstruction and repair Mid-foot reconstructions HAND Ulnar or lateral collateral ligament reconstruction WRIST Scapholunate ligament reconstruction FOOT Hallux valgus reconstruction ELBOW Tennis elbow repair Biceps tendon reattachment Medial and lateral repairs

The ROC EZ suture bone fastener implant tip portion consists of a shear pin, expander and sleeve. The expander and sleeve is fitted onto the shear pin component such that the expander component is located below the sleeve on the shear pin. As the shear pin is pulled up during the device deployment, the expander engages the sleeve. The expander is tapered such that it will fit into the sleeve component as the deployment action progresses. As the expander is drawn into the sleeve, the sleeve expands to make contact with the surrounding bone. This expanding sleeve results in the final fixation properties of the device. Once the expander is completely seated inside the sleeve, the shearing pin shears from the fastener assembly resulting in the device being fixated into the bone hole. In addition to the Fastener, a stainless steel drill and drill guide is available to establish the proper hole in the bone for the Fastener along with an obturator, deployment handle and hole finder. All of the instrumentation except the Fastener will be offered as reusable devices and can be autoclaved in the sterilization tray provided for this purpose. The Fastener will be available as a sterile, single use device in both an open and arthroscopic version. Both sutured and sutureless versions will be marketed.

The provided text describes a 510(k) submission for the Innovasive 2.3mm ROC EZ Suture Bone Fastener. It establishes substantial equivalence to predicate devices based on certain performance criteria.

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

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission does not explicitly define quantitative acceptance criteria (e.g., "holding strength must be X Newtons"). Instead, the acceptance criterion for the new device is demonstrating equivalence to its predicate devices in terms of ultimate holding strength.

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

The document does not specify the sample size used for the bone model or cadaver testing.

The document does not specify the data provenance (e.g., country of origin) or whether the studies were retrospective or prospective.

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

This type of study does not involve expert adjudication of images or diagnoses. Instead, the "ground truth" or reference standard for performance is the mechanical holding strength measurements themselves. Therefore, information about experts establishing ground truth in this context is not applicable.

4. Adjudication Method for the Test Set

Not applicable, as this is a mechanical performance study, not an imaging or diagnostic interpretation study.

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

No, an MRMC comparative effectiveness study was not conducted. This is a mechanical performance study of a medical device, not a study involving human readers interpreting diagnostics.

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

This question is not applicable. The device is a surgical fastener, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this study was the measured ultimate holding strength of the devices. This is an objective, quantitative measurement of mechanical performance, not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. This is a mechanical device, not an AI or machine learning model 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 this type of device.

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