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The Osteo-cable Sleeve is indicated for general orthopedic repairs, such as:

• Femur And Tibial Fractures .
• Prophylactic Banding .
• Trochanteric Reattachment .
• Olecranon Fractures ●
• Patella Fractures ●
• Ankle Fractures ●
• Fixation Of Spiral Fractures In Conjunction With I/M Nailing And Screwing Techniques .
• Sternum Fixation After Open Heart Surgery ●
• Stabilization Of Cortical Onlay Strut Graft .

The device modified is the cable sleeve used in the Biomet's BMP™ Cable System (K982545), P/Ns 350805 and 350813/21. No other parts of this system are being modified. The device is machined from a single piece of 316 LVM stainless steel, eliminating assembly of any components. The device profile is in the shape of a wedge with two longitudinal holes that run the length of the part. The holes allow for cables to be passed through during surgery. The narrow end of the wedge has a thin plate to increase surface area. There are small spikes on the bottom of the plate to help eliminate migration of the plate.

The provided document describes a medical device called the "Osteo-cable Sleeve" and its regulatory submission (K024022). It is a 510(k) premarket notification, which establishes substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials as an FDA approval (PMA) would require.

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

Note: The document doesn't explicitly state numerical acceptance criteria (e.g., minimum tensile strength, fatigue life). Instead, it states that the modified device met the performance of the predicate, which serves as the de facto acceptance criterion for a 510(k) notification.

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

• Sample Size for Test Set: Not applicable. The document states "Non-Clinical Testing: Mechanical testing..." but does not specify the number of devices tested or the sample size.
• Data Provenance: The document does not provide details on the provenance (e.g., country of origin, retrospective or prospective) of the data from the mechanical testing. These tests would typically be conducted in a laboratory setting.

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

• Number of Experts: Not applicable. This device's evaluation relied on mechanical testing, not a ground truth established by medical experts for a test set.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Mechanical testing does not involve adjudication by experts as clinical studies or imaging studies would.

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

• MRMC Study: No. The document explicitly states: "Clinical Testing: Clinical testing was not used to establish substantial equivalence." Therefore, no MRMC study with human readers was performed.

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

• Standalone Performance: Not applicable. This is a physical medical device (Osteo-cable Sleeve), not a software algorithm or AI-powered device. Therefore, the concept of "standalone performance" for an algorithm is not relevant.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the purpose of establishing substantial equivalence in this 510(k) submission, the "ground truth" was the mechanical performance of the legally marketed predicate device (Biomet's BMP™ Cable System, K982545). The performance of the modified device was compared against this established performance standard.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is a physical medical device, not a software algorithm or AI, so there is no concept of a "training set" in the context of machine learning.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this type of device.

Summary of the Study:

The document describes a non-clinical study involving mechanical testing. The purpose was to demonstrate that a modified medical device, the Osteo-cable Sleeve, performed "as well as or better than" a previously marketed, legally equivalent predicate device (Biomet's BMP™ Cable System). This type of testing is common for 510(k) submissions where the new device is substantially equivalent to an existing one and does not raise new questions of safety or effectiveness that would necessitate clinical trials. The specific methodology, sample sizes for mechanical tests, and detailed results are not provided in this summary. The FDA determined that, based on this non-clinical testing and comparison to the predicate, the device was substantially equivalent.

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