(62 days)
The Osteonics +10 UniPolar Adaptor Sleeve is a single-use device and may be used with all appropriately selected, legally marketed Osteonics C-Taper Femoral Stems and with any size Osteonics legally marketed +0 mm Unipolar Endo Heads (Single-Piece Unipolar Design).
For Use as a Hemi-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 in avoidance of the use of bone cement in the acetabulum.
- Salvage of failed total hip arthroplasty.
Osteonics +10 UniPolar Adaptor Sleeve is composed of cobalt chromium alloy and is designed to function with any size Osteonics +0 Unipolar Endo Head (Single-Piece Unipolar Design) and any Osteonics C-Taper Femoral Stem. The Osteonics +10 UniPolar Adaptor Sleeve is designed with both a male and a female C-taper. The female end receives the femoral stem and the male end engages the Endo Head.
The Osteonics +10 UniPolar Adaptor Sleeve is characterized by the following features:
- A basic taper design.
- A smooth exterior finish.
- Constructed of material that has a long history of orthopedic use.
This document is a 510(k) summary for a medical device (Osteonics® +10 UniPolar Adaptor Sleeve) and focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and providing a study that proves the device meets those criteria in the way a clinical performance study would for a diagnostic or AI-driven device.
Therefore, the requested information elements (acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not applicable or available within this type of regulatory submission.
Here's why and what information is provided:
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A table of acceptance criteria and the reported device performance:
- Not Applicable. This document is not a performance study report for a diagnostic or AI device. It's a regulatory submission for a mechanical implant. Performance is assessed through mechanical testing and comparison to predicate devices, not clinical metrics like sensitivity or specificity.
- The "performance" described relates to the design and material characteristics being consistent with existing, legally marketed devices.
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Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. There is no "test set" in the context of clinical data for this type of device. The evaluation is based on mechanical testing and material compatibility. The document refers to "pre-clinical data incorporated by reference to prior submissions," which would involve mechanical testing on the device itself, not human subjects or biological samples.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. Ground truth, in the sense of expert consensus on diagnostic labels, is not relevant for this device. The "ground truth" for a mechanical implant is its physical and mechanical properties matching design specifications and established safety profiles.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No clinical or diagnostic adjudication methods are relevant here.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is a mechanical implant, not an AI-driven diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a mechanical implant, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable in the diagnostic sense. The "ground truth" for this device's safety and effectiveness relies on:
- Material compatibility: Cobalt chromium alloy has a "long history of orthopedic use."
- Design consistency: Basic taper design, smooth exterior finish, and dimensional specifications designed to accommodate other legally marketed components.
- Comparison to predicate devices: The "substantial equivalence" framework relies on the new device sharing the same intended use, materials, and similar design features to devices already on the market. The "ground truth" is that these predicate devices are safe and effective.
- Not Applicable in the diagnostic sense. The "ground truth" for this device's safety and effectiveness relies on:
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The sample size for the training set:
- Not Applicable. No training set exists as this is not an AI/ML device.
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How the ground truth for the training set was established:
- Not Applicable. No training set exists.
Summary of what is described (substitute for the requested table):
This 510(k) summary establishes the device's substantial equivalence through comparison to legally marketed predicate devices, focusing on:
| Criteria Category | Description / Performance |
|---|---|
| Intended Use | Acceptance Criteria: Same as legally marketed predicate devices (Hemi-Hip Replacement). |
| Reported Performance: "The Osteonics, +10 UniPolar Adaptor Sleeve, like the predicate devices cited above, is intended for use with appropriately selected, legally marketed components for Hemi-Hip replacement." | |
| Materials | Acceptance Criteria: Manufactured from materials with a long history of safe orthopedic use, identical to predicate devices. |
| Reported Performance: "Manufactured from the same material - cobalt chromium alloy. The materials used... are not new and have been used for orthopedic applications... for many years." | |
| Design Features | Acceptance Criteria: Consistent with predicate devices, with differences not raising new safety/effectiveness questions. |
| Reported Performance: "A basic taper design," "a smooth exterior finish." Differences in size (one size vs. multiple for predicates) and specific dimensional specifications are acknowledged but deemed not to "raise any new questions of safety or effectiveness." | |
| Mechanical Testing | Acceptance Criteria: (Implicit) Device meets performance standards comparable to predicate devices for mechanical integrity. |
| Reported Performance: "the supporting testing summary, the pre-clinical data incorporated by reference to prior submissions..." (Specific test results are not detailed in this summary document but were part of the full submission). | |
| Sterilization/Packaging | Acceptance Criteria: Standard, accepted methods. |
| Reported Performance: Device "employs standard sterilization and packaging methods." |
Conclusion:
This 510(k) submission successfully argues for substantial equivalence to existing devices on the market, implying that because the predicate devices are considered safe and effective, and the new device shares fundamental characteristics, it is also safe and effective. It explicitly states that "None of these design differences raises any new questions of safety or effectiveness." The "study" proving this device meets (implicit) acceptance criteria is the overall 510(k) submission itself, which relies on comparative analysis and references to pre-clinical data.
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.