(83 days)
The Osteonics® Anteverted Neck Hip Stems are intented for single use in patients requiring either a bipolar hip replacement or a total hip replacement. The Osteonics® Anteverted Neck Hip Stems are intended 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 geomerry. The Osteonics® Anteverted Neck 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 indications for the use of the Osteonics® Anteverted Neck Hip Stems, in keeping with those of other legally marketed Class II hip stems, 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.
- 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 wascular 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 Hip Stems are fabricated from forged ASTM F-620 Titanium 6AI-4V ELI alloy, employ a standard satin finish, and have a surface coating of arc deposited commercially pure (CP) Titanium (per ASTM F-67) on the proximal third of the femoral stem. The basic design characteristics of the Osteonics® Anteverted Neck Hip Stems include proportional stem sizes, maximized projected proximal anterior and posterior normalizations, and an Osteonics® C-Taper trunnion. A reduced anterior/posterior collar is present to resist potential subsidence of the stem. The Osteonics® Anteverted Neck Hip Stems feature a rounded configuration for the length of the stem's lateral aspect and a cylindrical distal cross-section, thereby providing physiological fit in the distal as well as proximal regions of the femur. The subject hip stems are available in three proportional sizes, with distal diameters and stem lengths proportionate to the stem's size, and are available in both left and right configurations. Each hip stem features a 15° anteverted neck angle to satisfy anatomic considerations and physician need.
This document describes a 510(k) premarket notification for a medical device, the Osteonics® Anteverted Neck Hip Stem. 510(k) applications are used to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. They typically do not involve the kind of rigorous clinical studies with specific acceptance criteria and detailed performance reporting that would be present for novel devices or those undergoing PMA (Premarket Approval). The information provided in this 510(k) focuses on demonstrating equivalence through design, materials, and technological comparison.
Therefore, many of the requested categories related to clinical study performance, acceptance criteria, expert ground truth, and statistical analysis for AI devices are not applicable to this 510(k) submission. This submission is for a medical implant (hip stem), not an AI/software device, and precedes modern regulatory requirements for AI performance evaluation.
Here's a breakdown of the applicable information based on the provided text, with clarifications where categories are not relevant:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Demonstrated Equivalence Basis) | Reported Device Performance (Claimed Equivalence) |
|---|---|
| Materials: ASTM F-620 Titanium 6AI-4V ELI alloy, CP Titanium coating (ASTM F-67) | Device fabricated from specified materials. |
| Indications & Intended Use: Consistent with predicate devices. | Device listed the same indications as predicate devices for bipolar and total hip replacement. |
| Surgical Techniques: Compatible with standard surgical techniques. | Implied to be consistent with predicate devices. |
| Basic Design Features: Proportional stem sizes, maximized proximal anterior/posterior normalizations, C-Taper trunnion, reduced A/P collar, rounded configuration for lateral aspect, cylindrical distal cross-section, 15° anteverted neck angle. | Device incorporates these specific design features mentioned. |
| Basic Manufacturing Methods: Consistent with predicate devices. | Implied to be consistent with predicate devices. |
| Performance Testing (Mechanical): Demonstrate no significant difference between components and predicate designs. | "Applicable performance testing demonstrates that no significant difference exists between these components and their predicate designs." (Specific test results or criteria are not detailed in this summary, which is typical for a 510(k) summary). |
Explanation: In a 510(k), "acceptance criteria" for the device itself are more about demonstrating substantial equivalence to a predicate device rather than achieving specific quantitative performance metrics in a clinical trial. The "reported device performance" is the assertion of that equivalence based on the provided comparisons and "applicable performance testing" which were likely mechanical or bench testing.
2. Sample sized used for the test set and the data provenance
- Sample Size: Not applicable. This 510(k) for a hip stem does not describe a clinical "test set" or human subject data in the way an AI study would. The equivalence is based on engineering, materials, and design specifications, likely supported by mechanical testing rather than a patient-based test set for performance evaluation in a clinical context within this summary.
- Data Provenance: Not applicable. If any mechanical testing data was used, it would originate from engineering labs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There was no "test set" for which ground truth was established by medical experts for performance evaluation in the context of this 510(k) summary. The ground truth for device design and safety would be based on engineering standards and regulatory requirements.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set requiring expert adjudication is described in this 510(k) summary.
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
- Not applicable. This device is a passive medical implant (hip stem), not an AI system. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a passive medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable for clinical performance. The "ground truth" in the context of this 510(k) is the established safety and effectiveness of the predicate devices, as well as adherence to relevant material standards (e.g., ASTM F-620, ASTM F-67) and engineering principles for mechanical integrity.
8. The sample size for the training set
- Not applicable. This 510(k) is for a medical implant, not an AI system. There is no "training set" in this context.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, there is no ground truth establishment for one.
§ 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.