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The indications for the use of the Osteonics® Primary Secur-Fit™ Plus Hip Stems , in keeping with those of other legally marketed Osteonics femoral components, are as follows:

For Use as a Bipolar Hip Replacement:

• Femoral head/neck fractures or non-unions.
• Aseptic necrosis of the femoral head.
• Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.

Other Considerations:

• Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
• Salvage of failed total hip arthroplasty.

For Use as a Total Hip Replacement:

• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

The Osteonics® Primary Secur-Fit™ Plus Hip Stems are currently marketed devices that are being modified. The modification involves the addition of two smaller sizes, 5 and 6, and elimination of the distal tri-slot on stems with a 9mm or 10mm distal diameter. All other aspects of the Osteonics® Primary Secur-Fit™ Plus Hip Stems will remain unchanged.

The provided document is a 510(k) summary for a medical device modification, specifically for the Osteonics® Primary Secur-Fit™ Plus Hip Stems. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than establishing new safety and effectiveness claims. As such, the concept of "acceptance criteria" and a "study proving the device meets acceptance criteria" as it would apply to a novel AI/software medical device is not directly applicable here.

However, I can interpret the request in the context of this 510(k) submission, focusing on how the manufacturer demonstrated equivalence and what evidence was presented.

Here's an analysis based on the provided text, addressing the points you raised, with explanations for why some are not applicable to this type of submission:

Acceptance Criteria and Study for Osteonics® Primary Secur-Fit™ Plus Hip Stems (Modified)

The core "acceptance criteria" for this 510(k) submission are that the modified device remains substantially equivalent in terms of safety and effectiveness to the predicate device, despite the modifications. The study performed aims to demonstrate this equivalence, particularly regarding mechanical performance.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in the document. For mechanical testing of implantable devices like hip stems, "sample size" typically refers to the number of individual stems tested for each configuration (e.g., each size, with/without tri-slot). This exact number is not provided.
• Data Provenance: The document does not specify the country of origin for the mechanical testing data. It's implicitly (and standardly) generated by the manufacturer (Osteonics Corporation, based in Allendale, NJ, USA). The testing would be prospective in nature, as it involves newly manufactured devices being subjected to controlled mechanical loads.

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

This concept is not applicable to this 510(k) submission. "Ground truth" and "expert evaluation" are typically relevant for diagnostic or AI-driven devices where human experts establish the true condition (e.g., presence of disease in an image). For mechanical testing of a hip stem, the "ground truth" is established by the physical testing itself, measuring properties like fatigue strength against established engineering standards (e.g., ASTM standards).

4. Adjudication Method for the Test Set

This is not applicable for the same reasons as #3. Adjudication methods (like 2+1 or 3+1) are used to resolve disagreements among human experts when establishing ground truth. Mechanical testing involves repeatable measurements against objective standards, not subjective expert interpretation.

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

• No, an MRMC study was NOT done. This type of study assesses how human performance (e.g., diagnostic accuracy) changes with or without AI assistance. This submission is for a mechanical orthopedic implant, not a diagnostic or AI-powered device.

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

• Not applicable in the context of typical AI/algorithm standalone studies. This device is a passive mechanical implant. The "standalone" performance here refers to the device's inherent mechanical properties (fatigue strength) as measured in a lab setting, without human interaction beyond the setup and execution of the tests. This is what the "Mechanical testing has been performed" statement refers to.

7. The Type of Ground Truth Used

• Engineering/Mechanical Standards and Benchmarking against Predicate: The "ground truth" for this submission would be adherence to relevant ASTM (American Society for Testing and Materials) standards for orthopedic implants (e.g., for fatigue testing of metallic hip prostheses) and, crucially, demonstrating that the modified design performs equivalently to the previously cleared predicate device in those mechanical tests. It's based on quantitative physical measurements against established criteria.

8. The Sample Size for the Training Set

• Not applicable. This submission is for a physical medical device (hip stem), not for an AI model that requires a "training set."

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

• Not applicable. As there is no AI model or training set, this question is not relevant.

Summary in the Context of a 510(k):

The manufacturer demonstrated substantial equivalence by:

• Clearly defining the modifications (smaller sizes, removal of distal tri-slot).
• Stating that all other aspects remained unchanged (material, overall design principles).
• Asserting that mechanical testing was performed to prove equivalent fatigue strength between the modified design(s) and the predicate device.
• Confirming the intended use remains the same.

The FDA reviewed this information and concurred that the device is substantially equivalent, but placed specific labeling limitations related to "biological attachment" or "enhanced fixation" claims, indicating that equivalence was shown only for a "conventional press-fit hip prosthesis (i.e., mechanical interlock, only)."

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The indications for the use of the Osteonics® C-Tapered Titanium Stems , in keeping with those of other legally marketed Osteonics femoral components, are as follows:

For Use as a Bipolar Hip Replacement:

• Femoral head/neck fractures or non-unions. .
• Aseptic necrosis of the femoral head.
• Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular ● involvement or distortion.

Other Considerations:

• Pathological conditions or age considerations which indicate a more conservative acetabular ● procedure and an avoidance of the use of bone cement in the acetabulum.
• . Salvage of failed total hip arthroplasty.

For Use as a Total Hip Replacement:

• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

The Osteonics® C-Tapered Titanium Stems (Osteonics® Omnifit HA Hip Stem Series, Osteonics® Secur-Fit Hip Stem Series, Osteonics® Primary Secur-Fit Plus HipStem Series) are currently marketed devices that are being modification involves shortening the trunnion and reducing the diameter of the stem neck. All other aspects of the Osteonics® C-Tapered Titanium Stems will remain unchanged.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Osteonics® C-Tapered Titanium Stems:

Analysis of Acceptance Criteria and Performance Study for Osteonics® C-Tapered Titanium Stems

The provided document is a 510(k) submission for a device modification, not a comprehensive clinical study report for a new device. Therefore, the information typically associated with detailed acceptance criteria, test sets, ground truth establishment, and multi-reader studies for AI/ML devices is not present. This submission focuses on demonstrating substantial equivalence of a modified hip stem design to its predicate devices through mechanical testing.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Criteria:
The core acceptance criterion for this 510(k) submission is that the modified device maintains substantial equivalence to its predicate devices, particularly concerning its fatigue strength. This is crucial because it indicates that the design changes (shortened trunnion, reduced neck diameter) do not negatively impact the mechanical integrity and longevity of the hip stem, which is a critical safety and effectiveness aspect for orthopedic implants.

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

• Sample Size: Not explicitly stated as a number of devices or "test set" in the context of a clinical trial. The testing appears to be mechanical in nature.
• Data Provenance: The nature of mechanical testing usually involves engineered samples or actual device prototypes. No mention of human patient data, retrospective, or prospective studies in this context.

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

• Not applicable. Ground truth in this context is the outcome of mechanical fatigue testing, which is determined by engineering standards and measurements, not expert human interpretation of data.

4. Adjudication Method for the Test Set

• Not applicable. As mechanical tests are objective measurements, there's no "adjudication" between multiple interpretations.

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

• No Multi-Reader Multi-Case (MRMC) study was performed. This document pertains to a physical medical device (hip stem) and its mechanical performance, not a diagnostic or AI-assisted interpretation device that would involve human readers.

6. Standalone Performance Study (Algorithm Only)

• No standalone (algorithm only) performance study was performed. This is not an AI/ML device. The "device" is a physical hip stem.

7. Type of Ground Truth Used

• Mechanical Test Results (Fatigue Strength): The "ground truth" here is derived from standardized mechanical fatigue testing methods, typically aligned with ASTM (American Society for Testing and Materials) standards relevant to orthopedic implants (e.g., ASTM F-620 for titanium alloys, potentially other standards for fatigue testing of hip prostheses).

8. Sample Size for the Training Set

• Not applicable. This is not an AI/ML device and therefore does not involve a "training set" in that sense. The design process for such a device involves engineering principles and potentially iterative physical prototyping and testing.

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

• Not applicable. There is no concept of a "training set" or "ground truth" establishment for training in the context of this device type and submission. The design of the hip stem is based on established biomechanical principles and material science.

Summary:

This 510(k) submission for the Osteonics® C-Tapered Titanium Stems is a regulatory filing for a device modification. The "acceptance criteria" and "study" described are focused on mechanical testing to demonstrate substantial equivalence in fatigue strength to previously cleared predicate devices. It is crucial to understand that the concepts of "test set," "ground truth," "experts," and "multi-reader studies" are primarily relevant to diagnostic devices, AI/ML algorithms, or clinical effectiveness studies in a way that doesn't directly apply to this type of device modification submission. The FDA's clearance is based on the finding of substantial equivalence through these engineering tests, implying that the modified design does not introduce new questions of safety or effectiveness compared to the predicate devices.

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