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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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The Compress® Segmental Femoral Replacement System is indicated for:

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.

The Compress® Seqmental Anti-Rotation Spindles are not joint replacements but rather a method of fixing a segmental joint replacement to the patient's host bone. It utilizes the same spring-enhanced, stress-sharing design as the predicate Compress® Segmental Femoral Replacement System 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 complete device consists of an anchor plug, a spindle and either a proximal or distal femoral component. This 510(k) addresses modifications to the spindles. Holes are being added to the collar of the spindles to allow placement of pins to prevent rotation of the initial weeks following implantation. Additional sizes of spindles are also being added to the line.

The provided text describes modifications to an existing medical device, the Compress® Segmental Anti-Rotation Spindles, and its substantial equivalence to predicate devices. It does not contain information about a study proving the device meets acceptance criteria against specific performance metrics involving human readers or a standalone algorithm. The device, which is a method of fixing a segmental joint replacement, underwent non-clinical testing.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance
The document states "Non-Clinical Testing: Mechanical testing (resistance to rotational torque) and engineering analyses (greater wall thickness, smaller pin holes) of the Compress® Segmental Anti-Rotation Spindles demonstrated that the device will functional within its intended use compared to the predicate device."

• Test Set Sample Size: Not specified. The testing was mechanical and engineering analysis, not involving a population sample in the typical sense.
• Data Provenance: Not specified, but given it's mechanical and engineering testing, it would be laboratory-generated data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The testing was non-clinical, mechanical, and engineering analysis. Ground truth for such tests is typically established by engineering specifications and physical measurements, not expert consensus in the medical image interpretation context.

4. Adjudication Method for the Test Set
Not applicable. There was no human interpretation or ground truth establishment based on expert consensus for this non-clinical testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
"Clinical Testing: None provided as a basis for substantial equivalence."
Therefore, no MRMC comparative effectiveness study was done.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical medical implant, not a software algorithm.

7. Type of Ground Truth Used
For the non-clinical testing, the "ground truth" was based on engineering specifications and physical testing results (e.g., measurements of rotational torque, wall thickness, pin hole size) compared to the predicate device's performance and design.

8. Sample Size for the Training Set
Not applicable. This device is a physical medical implant, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical device.

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