(77 days)
The Osteonics® HA Generation II Acetabular Components are single-use devices. The shells are intended for cementless fixation within the prepared acetabulum. The Osteonics® HA Generation II Acetabular Component System is compatible with any appropriately selected Osteonics hip stem/femoral head combination.
Indications:
- 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.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
The Osteonics® HA Generation II Acetabular Component System consists of single-use devices. Each Osteonics® HA Generation II Acetabular Component consists of two pieces: an Osteonics® HA Generation II Acetabular Shell and an Osteonics® Generation II Cup Insert. The metal shell is intended for cementless fixation within the prepared acetabulum.
The Osteonics® HA Generation II Acetabular Shells are characterized by the following features:
- A basic dual radius (Secur-Fit option) or hemispherical (Threaded option) design
- The predicate interior geometry which allows a mating polyethylene insert size to be used with more than one shell size.
- A variety of screw hole patterns, including dome hole and peripheral screw holes.
- A dome hole which is compatible with the optional, currently marketed Osteonics® Acetabular Dome Hole Plugs.
- Circumferential normalizations (Secur-Fit option) or Circumferential threads (Threaded option)
- A wide range of sizes.
- Osteonics' AD-HA coating (Secur-Fit option) or HA coating (Threaded option)
- Compatibility with the Generation II Cup Insert
The Osteonics® Generation II Cup Inserts are characterized by the following features:
- A wireless locking mechanism which utilizes a continuous ridge which locks into a groove on the interior of the mating shell.
- A hemispherical geometry which is designed to maximize liner conformity to mating shell.
- Increased indexability through mating of barbs on shell with scalloped areas on insert.
The provided text is a 510(k) summary for the Osteonics® HA Generation II Acetabular Component System. It describes the device, intended use, indications, and how it is substantially equivalent to predicate devices. However, it does not contain information about specific acceptance criteria or a study proving the device meets those criteria with numerical performance data.
The "Performance Data" section (page 3) states: "The performance characteristics of the 'AD-HA' and 'HA' coatings have been presented in predicate 510(k) submissions. Mechanical testing of the subject shell/insert locking mechanism and fatigue performance is provided in this submission and demonstrate substantial equivalence to the predicate devices."
This indicates that mechanical testing was performed, and the results demonstrated substantial equivalence to predicate devices. However, the summary does not provide the acceptance criteria values or the reported performance values from these tests. Without access to the Appendix C mentioned ("supporting testing reproduced in Appendix C"), it's impossible to extract the specific numerical data requested.
Therefore, I cannot fully complete the requested table and answer all questions. I can only provide what is explicitly stated or can be inferred from the provided text.
Here's a breakdown of what can and cannot be answered from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Testing: Specific criteria related to the shell/insert locking mechanism and fatigue performance (Not explicitly stated, assumed to be equivalent or superior to predicate device performance as per substantial equivalence requirements) | Substantial equivalence to predicate devices in shell/insert locking mechanism strength and fatigue performance (No specific numerical values 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)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. It's internal testing for a premarket notification in the US, so likely conducted by the manufacturer, Osteonics Corporation (based in Allendale, NJ, USA).
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 is not applicable as the "ground truth" concept is usually relevant for diagnostic devices or AI algorithms evaluating images/data against expert consensus. This submission is for a medical device (hip implant) where "ground truth" would relate to mechanical properties, biocompatibility, or clinical outcomes, typically evaluated through engineering tests, material science, and clinical studies (though no new clinical studies are mentioned for this 510(k)).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this type of device and testing (mechanical performance).
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 is not an AI/imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/imaging device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical testing, the "ground truth" would be the measured physical properties (e.g., strength, fatigue life) determined by standardized engineering tests. The comparison is against the "performance characteristics" of predicate devices, implying that the established performance of those existing devices serves as a benchmark for equivalence.
8. The sample size for the training set
Not applicable. This is not a machine learning/AI device.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning/AI device.
§ 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.