(27 days)
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis.
- Correction of functional deformity.
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
- Revision of previously failed total hip arthroplasty.
Cemented and Uncemented Applications (as based on mating shell)
Biomet Manufacturing Corp. is adding new +3 MaxRom™ and +3 Hi-Wall profiles to allow the surgeon an option for achieving more range of motion and joint stability in smaller patients.
The provided text is a 510(k) summary for a medical device (Biomet's 100 kGy E-Poly™ Acetabular Liners- Additional Profiles), not a study demonstrating device performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and ground truth cannot be extracted directly from this document.
The document states:
- "Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use."
- "Clinical Testing: None provided as a basis for substantial equivalence."
This indicates that the device's substantial equivalence was based solely on non-clinical testing, comparing it to predicate devices (K070399). Clinical performance criteria and studies as typically described for software or diagnostic devices are not applicable here.
Here's a breakdown of what can be inferred or stated based on the provided text, and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Substantial Equivalence to predicate devices (K070399) based on non-clinical testing. | Non-clinical laboratory testing results indicated the device was functional within its intended use and met the criteria for substantial equivalence to the predicate. |
- Note: The specific, quantifiable acceptance criteria for "functional within its intended use" for the non-clinical testing are not detailed in this summary. These would typically involve mechanical, material, or biocompatibility testing data, but the summary only provides a general statement of compliance.
2. Sample size used for the test set and the data provenance:
- Not applicable / Not provided. No clinical "test set" in the context of human studies for AI performance, for example, was used or described. The non-clinical testing samples (e.g., number of liners tested for mechanical properties) are not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. No human expert ground truth was established as this was a non-clinical submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not provided.
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 a hardware medical device (hip implant component), not an AI or diagnostic imaging device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware medical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not applicable / Not provided in detail. For a non-clinical submission, "ground truth" would refer to established engineering standards, material specifications, or performance benchmarks related to mechanical properties, wear, biocompatibility, etc., when compared to the predicate device. The document only states "The components for cross-linked polyethylene in acetabular applications are adequately supported by biomechanical, materials data, and testing results provided within this Premarket Notification."
8. The sample size for the training set:
- Not applicable / Not provided. There is no "training set" in the context of an algorithm or AI.
9. How the ground truth for the training set was established:
- Not applicable / Not provided.
Summary of Device Performance Study (as per the document):
The device gained 510(k) clearance based on non-clinical laboratory testing that demonstrated substantial equivalence to existing predicate devices (specifically K070399). No clinical studies were conducted or provided as part of this submission for substantial equivalence. The non-clinical testing results "indicated that the device was functional within its intended use." The basis for substantial equivalence was also supported by the "intended use, indications and materials" being similar to the predicate, with the exception of added profiles (+3 MaxRom™ and +3 Hi-Wall).
§ 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.