(89 days)
The Osteonics® Anteverted Neck HA Hip Stems are intended for single use in patients requiring either bipolar, hemior total hip replacement. The Osteonics® Anteverted Neck HA Hip Stems are intended to be implanted in a cementless application. These devices feature an Osteonics® C-Taper trunnion, and are therefore compatible with any Osteonics® component which features the mating Osteonics® C-Taper geometry. The Osteonics® Anteverted Neck HA Hip Stems, when used with any commercially available Osteonics® C-Taper femoral bearing head, may be used with any commercially available Osteonics® acetabular component. The use of the Osteonics® Anteverted Neck HA Hip Stems, in keeping with those of other legally marketed Class II hip stems, are as follows:
For use as a Bipolar/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 an avoidance of the use of bone cement in the acetabulum.
- 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® Anteverted Neck HA Hip Stems are fabricated from forged Titanium 6AI-4V ELI alloy and have a surface coating of arc deposited commercially pure (CP) Titanium on the proximal third of the femoral stem, and an HA coating on the full length of the stem. The basic design characteristics of the Osteonics® Anteverted Neck HA Hip Stems include proportional stem sizes, maximized projected proximal area, proximal anterior and posterior normalizations, Osteonics® C-Taper trunnion, reduced anterior/posterior collar, rounded configuration for the length of the stem's lateral aspect, cylindrical distal cross-section, left and right configurations, and 15° anteverted neck angle.
The provided text is a 510(k) Premarket Notification Summary for a medical device (Osteonics® Anteverted Neck HA Hip Stems), not a study report detailing acceptance criteria and performance data. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness is largely absent or not directly applicable in the format requested.
The document primarily focuses on establishing substantial equivalence to predicate devices for regulatory approval. It does not contain a study design, performance metrics, or statistical analysis typically found in a clinical or validation study.
However, based on the information provided, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance:
This document does not present a formal table of acceptance criteria with corresponding device performance data as would be found in a study report. The "acceptance criteria" for this regulatory submission are implicitly based on demonstrating substantial equivalence to predicate devices, which means sharing similar materials, indications, intended use, surgical techniques, basic design features, and manufacturing methods.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied from Substantial Equivalence Claim) |
|---|---|
| Material Equivalence: Fabricated from same/equivalent materials as predicate devices. | "The Osteonics® Anteverted Neck HA Hip Stems share the same materials... of their predicate devices." (Forged Titanium 6AI-4V ELI alloy with CP Titanium and HA coating.) |
| Indications for Use Equivalence: Same indications as predicate devices. | "The Osteonics® Anteverted Neck HA Hip Stems... share the same... indications and intended use... of their predicate devices." (For bipolar, hemi-, or total hip replacement, specifically for femoral head/neck fractures, aseptic necrosis, arthritis, or revision procedures.) |
| Intended Use Equivalence: Same intended use (cementless application). | "The Osteonics® Anteverted Neck HA Hip Stems... share the same... intended use... of their predicate devices." (Intended for cementless application.) |
| Design Feature Equivalence: Similar basic design features to predicate devices. | "The Osteonics® Anteverted Neck HA Hip Stems... share the same... basic design features... and basic manufacturing methods of their predicate devices." (Includes proportional stem sizes, maximized proximal area, normalizations, C-Taper trunnion, reduced collar, etc.) |
| Manufacturing Method Equivalence: Similar manufacturing methods to predicate devices. | "The Osteonics® Anteverted Neck HA Hip Stems... share the same... basic manufacturing methods of their predicate devices." |
| Performance Equivalence: Applicable performance testing demonstrates no significant difference from predicate devices. | "Applicable performance testing demonstrates that no significant difference exists between these components and their predicate designs." (Specific test data not provided in this summary.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document does not provide information on a specific test set sample size or data provenance because it is a regulatory submission for substantial equivalence rather than a report of a clinical trial or performance study. The "performance testing" mentioned is likely mechanical or in-vitro testing to support the equivalence claim, not a human clinical trial with patient data.
3. 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)
This information is not applicable and not present in the document. The device is a hip implant, and its "ground truth" for regulatory approval is based on its physical and mechanical properties, as well as its similarity to previously approved devices, rather than expert interpretation of medical images or outcomes in a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not present. "Adjudication method" is typically relevant for studies involving human interpretation or subjective endpoints, which is not the primary focus of this regulatory submission.
5. 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
This information is not applicable and not present. This submission is for a hip implant, not an AI-assisted diagnostic or interpretative device. Therefore, MRMC studies and AI-related effect sizes are irrelevant to this document.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and not present. As stated above, this is not an AI-driven device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device, in the context of a 510(k) submission, is based on:
- Engineering specifications and material science: Verification of material composition and mechanical properties.
- Design similarities: Comparison of basic design features with predicate devices.
- Performance testing (likely mechanical/in-vitro): Demonstrating that physical performance (e.g., strength, fatigue) is equivalent to predicate devices.
- Established clinical use of predicate devices: The safety and effectiveness of the type of device (hip stem) and its predicate versions are already well-established.
8. The sample size for the training set
This information is not applicable and not present. This document pertains to a physical medical device, not a machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable and not present.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.