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Indications:

1. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
2. Tumor resections.
3. Revision of previously failed total joint arthroplasty.
4. Trauma.
   The Compress® Segmental Femoral Replacement System (Short Spindle and Anchor Plug) components are intended for uncemented use only.

The Compress® Seqmental Femoral Replacement System (Short Spindle and Anchor Plug) utilizes a spring-enhanced and stress-sharing design; to generate stress on the host bone which helps prevent bone atrophy and promotes bone growth. It is intended to be used in conjunction with a knee or hip implant. The device consists of the three main components, the Anchor Plug, Spindle, and the Taper Adapter.

This document is a 510(k) summary for the Compress® Segmental Femoral Replacement System (Short Spindle and Anchor Plug) by Biomet Manufacturing Corp. It is for a medical device, which typically relies on demonstrating substantial equivalence to a predicate device rather than on performance criteria established through clinical studies for new indications.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: This submission relies on demonstrating substantial equivalence to a predicate device (Compress® Segmental Femoral Replacement System - K043547). The acceptance criteria are largely based on matching the design, materials, and mechanical performance of the predicate device. There are no specific quantifiable clinical performance metrics or acceptance thresholds provided beyond "successful mechanical testing" and "substantially equivalent."

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

• Sample Size for Test Set: Not applicable in the context of clinical testing for this 510(k). The evaluation was primarily based on non-clinical (mechanical) testing and a comparison to a predicate device.
• Data Provenance: The document explicitly states "Non-Clinical Testing: Successful mechanical testing on Compress® Segmental Femoral Replacement System (Short Spindle and Anchor Plug)..." This indicates laboratory-based testing rather than patient data. No country of origin is specified for this mechanical testing, and it is by nature retrospective (testing a finished product).

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

• Not applicable. As no clinical data was used to establish performance against a "ground truth" for the test set, no experts were needed for this purpose. The substantial equivalence was evaluated by the FDA based on the provided technical documentation and comparison to the predicate.

4. Adjudication Method for the Test Set

• Not applicable. There was no clinical test set requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." Therefore, no MRMC study was conducted or reported.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable. This is a physical orthopedic implant, not an algorithm or AI-driven device.

7. Type of Ground Truth Used

• Mechanical Performance and Design Equivalence: For the non-clinical testing, the "ground truth" would be the established performance characteristics and design specifications of the predicate device (K043547) and relevant industry standards for orthopedic implants. The new device's mechanical test results were compared against these.

8. Sample Size for the Training Set

• Not applicable. This is a physical orthopedic implant; there is no "training set" in the context of machine learning or algorithms. Its design and manufacturing are based on established engineering principles and the predicate device's specifications.

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

• Not applicable. As there is no training set, there is no ground truth to establish for it. The design and performance are validated against engineering principles and comparison to the existing predicate device.

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Indications:

1. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
2. Tumor resections.
3. Revision of previously failed total joint arthroplasty
4. Trauma
   The Compress Segmental Femoral Replacement System components are intended for uncemented use only.

The ComPreSs® Segmental Femoral Replacement System consists of three main components, the anchor plug, the spindle assembly, and the intercalary segment. The Anchor Plug is embedded within the medullary canal, the Spindle Assembly attaches to the Anchor Plug and is compressed against the bone / implant interface at the osteotomy site. The Intercalary Segment attaches to the Spindle Assembly, and completes the Femoral Stem Component.
This system is intended for use in both the proximal and distal femur.

This document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. Instead, it is a 510(k) summary for a medical device (ComPreSs® Segmental Femoral Replacement System) seeking substantial equivalence to legally marketed predicate devices.

The key points from the provided text are:

• Device: ComPreSs® Segmental Femoral Replacement System
• Applicant: Biomet Manufacturing Corp.
• Date: August 5, 2005 (with a correction letter dated April 23, 2009)
• Purpose of Submission: To demonstrate substantial equivalence to predicate devices, not to prove specific performance against acceptance criteria in a new study.
• Basis for Equivalence: The submission states that "All components of this system are identical in material, processing, function, and design to their respective predicate components."
• Non-clinical Testing: "The engineering rationale with the attached literature and mechanical test reports support the claim for substantial equivalence to the predicate devices." (No specific acceptance criteria or performance numbers are given here).
• Clinical Testing: "Clinical testing in support of the predicate Compress® Distal Femoral Replacement System is sufficient to ensure safety and efficacy. No further clinical testing is necessary to support the claim for substantial equivalence to the predicate devices." This explicitly states that no new clinical study was performed for this specific device to establish novel acceptance criteria.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, adjudication methods, or MRMC studies is not present in the provided text. The document focuses on demonstrating equivalence through comparison to existing, approved devices and their past testing, rather than presenting new performance data for the subject device against defined acceptance metrics.

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