(30 days)
The indications for the use of the Osteonics® Restoration HA 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.
Additional Indication for Osteonics Head/Neck Stems:
- Clinical circumstances which require an altered femoral resection level due to a proximal . fracture, bone loss or calcar lysis.
The Osteonics® Restoration HA Hip Stems are currently marketed devices that are being modified. The modification involves shortening the trunnion and reducing the diameter of the stem neck. Additionally, the neck length of each stem will be reduced by 5mm to better accommodate patient physiology. All other aspects of the Osteonics® Restoration HA Hip Stems will remain unchanged, with the exception of one feature on the longest stem (255mm). This stem currently features a distal tri-slot, which will be eliminated on the new version of the stem.
This document is a 510(k) premarket notification for a modified medical device, the Osteonics® Restoration HA Hip Stems. It primarily addresses the substantial equivalence of the modified device to a previously cleared predicate device, rather than presenting a detailed study proving the device meets specific acceptance criteria in the typical sense of a clinical trial or performance study against pre-defined metrics.
Therefore, many of the requested items (e.g., sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, specific ground truth types) are not applicable or cannot be extracted from this type of regulatory submission. The document focuses on mechanical testing to establish substantial equivalence based on engineering properties.
Here's an analysis of what information can be gleaned from the document regarding acceptance criteria and performance, as well as the limitations:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Equivalence: Fatigue strength equivalent to predicate hip stems. | "Mechanical testing has been performed to demonstrate the substantial equivalence of this Osteonics stem design to predicate stem designs in terms of its fatigue strength." |
| Indications for Use Equivalence: Maintain existing approved indications. | The modified device's intended use and indications are listed and are consistent with legally marketed Osteonics femoral components. |
| Material Equivalence: Made from specified titanium alloy. | "The Osteonics® Restoration HA Hip Stems are manufactured from titanium alloy (ASTM F-620-96)." |
Limitations to Acceptance Criteria:
The document does not explicitly state quantitative "acceptance criteria" (e.g., "fatigue life must exceed X cycles at Y load with a 95% confidence interval"). Rather, it states the goal of the mechanical testing was to demonstrate "substantial equivalence" in fatigue strength. The specific numerical thresholds or comparative data from the mechanical testing are not provided in this summary.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: Not specified. The document refers to "mechanical testing," which typically involves a small number of physical samples for engineering tests. It is not a clinical study involving patients.
- Data Provenance: Not applicable in the sense of patient data. The "data" refers to results from laboratory-based mechanical tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not applicable. Ground truth, in this context, would be the precisely measured mechanical properties. These are determined by engineering testing processes, not typically by expert consensus in the way clinical images or diagnoses are.
4. Adjudication Method for the Test Set
- Not applicable. Mechanical test results are objective measurements based on standardized testing protocols, not subjective assessments requiring adjudication.
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
- No. This is a submission for a mechanical implant device, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical implant, not a software algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- For the mechanical testing: The "ground truth" would be the actual mechanical properties (e.g., ultimate tensile strength, yield strength, fatigue life) determined through standardized laboratory testing methods. These are objective engineering measurements.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of an engineering test for a physical implant.
9. How the Ground Truth for the Training Set was Established
- Not applicable.
Summary of the Study Discussed (Mechanical Testing for Substantial Equivalence):
The document describes a special 510(k) submission for modifications to an existing hip stem. The primary "study" mentioned is mechanical testing to demonstrate substantial equivalence in fatigue strength between the modified device and its predicate.
- Purpose: To demonstrate that minor design modifications (shortened trunnion, reduced neck diameter, reduced neck length, removal of a distal tri-slot on one specific stem) do not adversely affect the mechanical performance, specifically fatigue strength, compared to the previously cleared predicate device.
- Methodology: "Mechanical testing has been performed." The specific tests, number of samples, or detailed results are not included in this summary. These details would be contained in the full 510(k) submission but are not publicly detailed in this letter or summary.
- Conclusion: The testing led to a determination of substantial equivalence, allowing the device to be marketed under the same indications, with the critical limitation that no new biological attachment or enhanced performance claims can be made beyond mechanical interlock.
This document is a regulatory communication, not a research paper, and therefore provides only a high-level summary of the safety and effectiveness information.
§ 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.