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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.

1. Correction or 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 Humeral Replacement System components are intended use.

The Compress and Mini Compress Anti-Rotation Spindles are components of the Compress Segmental Femoral Replacement System and Compress Segmental Humeral Replacement System. The Anti-Rotation Spindles attach to an anchor plug and a proximal/distal femoral/humeral component to serve as a method of fixing a segmental joint replacement to a patient's host bone. The Anti-Rotation Spindles contain several conical washers which allow a compressive load to be applied at the prosthetic implant-bone interface at the time of device insertion. The Anti-Rotation Spindles also include a series of holes around the spindle collar to allow placement of pins to prevent rotation of the component. The purpose of this submission is the update of the surgical techniques associated with the Compress and Mini Compress Anti-Rotation Spindles to revise the recommended pin selection range for use with the Anti-Rotation Spindles.

This FDA 510(k) premarket notification for the "Compress and Mini Compress Anti-Rotation Spindles" describes a device that is essentially an updated component of existing segmental replacement systems. The submission centers around an update to surgical techniques and therefore does not rely on extensive clinical or performance studies in the way a novel device might.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this submission is for an update to surgical techniques for components of an existing device, and not for a new device itself, the typical "acceptance criteria" related to diagnostic performance metrics (like sensitivity, specificity, accuracy) are not applicable. Instead, the acceptance is based on demonstrating that the updated surgical technique does not adversely affect the device or its intended use, and that the devices remain substantially equivalent to predicates.

The "acceptance criteria" here implicitly relate to ensuring functional compatibility and non-inferiority in terms of mechanical properties and surgical application.

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

• Sample Size: Not applicable in the context of typical performance testing. The "test set" in this case appears to be a geometric evaluation of the components in relation to the revised surgical technique.
• Data Provenance: Not explicitly stated as retrospective or prospective clinical data. The geometric evaluation would be internal to the manufacturer (Biomet Inc.).

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

• Not applicable as this was a geometric evaluation, not a clinical study requiring expert ground truth for interpretation. The "ground truth" would be the engineering specifications and physical properties of the device components.

4. Adjudication Method for the Test Set

• Not applicable. There was no clinical study with a test set requiring adjudication in the traditional sense.

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

• No, a MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data was not provided for the subject devices." This type of study investigates human reader performance, which is not relevant for this engineering-focused submission about surgical technique updates.
• Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as no AI component or human-in-the-loop study was involved.

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

• No, a standalone (algorithm only) performance study was not done. This device is a mechanical implant, not an algorithm or software.

7. Type of Ground Truth Used

• The implicit "ground truth" for this submission is engineering specifications and verification/validation data related to the geometric fit and function of the Anti-Rotation Spindles with the revised surgical technique, as determined by the "geometric evaluation." There is no clinical or pathology-based ground truth mentioned.

8. Sample Size for the Training Set

• Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The design and manufacturing of the device components would follow standard engineering and quality control processes.

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

• Not applicable, as there was no training set in this context.

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Indications For Use:

The Comprehensive Segmental Revision System is intended for use in cases of:

• 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• 2. Rheumatoid arthritis.
• 3. Revision where other devices or treatments have failed.
• 4. Correction of functional deformity.
• 5. Oncology applications including bone loss due to tumor resection.

When used in a proximal or total humeral replacement, the Comprehensive Segmental Revision System is also intended for: Treatment of acute or chronic fractures with humeral head (shoulder) involvement, which are unmanageable using other treatment methods.

When used as a distal or total humeral replacement, the Comprehensive Segmental Revision System is also intended for: Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement, which are unmanageable using other treatment methods.

Biomet Comprehensive Segmental Revision System is indicated for use in a reverse application in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically suited to receive the implants and a functional deltoid muscle is necessary. Reverse application is limited to proximal humeral replacement in the United States.

The Comprehensive Segmental Revision System is intended for use with or without bone cement in the proximal shoulder.

The Comprehensive Segmental Revision System is intended for use with bone cement in distal humeral applications.

Tissue Attachment Augments provide the option for tissue stabilization and attachment.

The Comprehensive Segmental Revision System (SRS) is a multi-piece orthopedic implant designed to replace the shoulder joint. The device is designed specifically for use in cases where there is extensive bone loss requiring extramedullay replacement of bone. The components of the Comprehensive SRS system have previously been cleared for use in hemi and anatomic total shoulder replacement. The current submission is to expand the indications to include reverse shoulder applications. All components have been previously cleared.

I am sorry, but based on the provided text, I cannot provide the detailed information you requested about acceptance criteria and the study proving the device meets them.

The document is a 510(k) premarket notification letter from the FDA to Biomet Manufacturing Corp. It determines substantial equivalence for the Comprehensive Segmental Revision System (SRS) to legally marketed predicate devices.

Here's why I cannot fulfill your request based on this document:

• No specific acceptance criteria or performance metrics are listed for the device itself. The document only details the "Indications for Use" for the device, which are the medical conditions or purposes for which it is intended.
• The document states "No new testing provided" under "Non-Clinical Tests" and "None provided" under "Clinical Tests" for the current submission (K173411). This means the FDA's substantial equivalence determination for this specific submission was based on existing data from previous clearances (K111746) and comparison to the predicate device, not on new studies conducted for this K173411.
• The details about sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment for either training or test sets are not present in this regulatory letter. These types of details would typically be found in the comprehensive testing reports that accompany a 510(k) submission, not in the FDA's determination letter itself.

In summary, the provided text confirms the FDA's decision regarding substantial equivalence but does not contain the specific performance data, acceptance criteria, or study details you are asking for.

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