(196 days)
Total hip replacement for patients with:
- Noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, . osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
- . Femoral neck fractures.
- . Failed previous surgery where pain, deformity, or dysfunction persists.
- Revision of previously failed hip arthroplasty. .
Hemi-hip replacement for patients with:
- Femoral neck fractures. .
This femoral stem is for cementless use only.
The CLS Brevius Stem with Kinectiv Technology is a modular, titanium alloy femoral stem designed to replace the proximal femur in total or hemi-hip arthroplasty. It is a wedge-shaped, collarless design with a proximal-to-distal taper and a trapezoidal cross-section. The proximal portion of the stem contains a tapered female junction to allow for attachment to Kinectiv Technology modular necks and features for attachment of insertion/extraction instrumentation.
The provided text is a 510(k) Summary for a medical device (CLS® Brevius™ Stem with Kinectiv® Technology) seeking clearance from the FDA. This type of document is used to demonstrate substantial equivalence to a legally marketed predicate device, rather than to prove a device meets specific acceptance criteria through a study as would be described for a diagnostic AI/ML device.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable in this context. The document focuses on non-clinical (lab) performance testing and does not describe a clinical study of the type that would involve a test set, ground truth experts, or AI/ML performance metrics.
Here's a breakdown based on the information provided in the document and why certain sections are not applicable:
1. Table of acceptance criteria and the reported device performance
The document does not present acceptance criteria in a quantitative table format that measures diagnostic performance (e.g., sensitivity, specificity, AUC). Instead, it lists performance tests and concludes that the device is "safe and effective and substantially equivalent to the predicate devices."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness | Demonstrated through non-clinical (lab) performance testing. |
| Substantial Equivalence | Shown to be similar or identical in intended use, materials, sterility, and performance characteristics to predicate devices (K042249, K081007, K071856, K063251). |
| Mechanical Performance | Passed: Proximal Stem Fatigue Test (including FEA), Distal Stem Fatigue Evaluation, Primary Stability Test, Influence of Version Analysis, Accelerated Corrosion Fatigue Test, Distraction Test, and MR Evaluation. |
2. Sample size used for the test set and the data provenance
- Not Applicable. This document describes non-clinical (lab) performance testing of a physical medical device (femoral stem prosthesis), not a diagnostic AI/ML system. There is no "test set" of patient data in the context of diagnostic performance. The tests performed are engineering/mechanical tests on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. See point 2. Ground truth in the context of diagnostic AI/ML is not relevant here. The "ground truth" for non-clinical testing refers to established engineering standards and validated testing methodologies.
4. Adjudication method for the test set
- Not Applicable. See point 2.
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 physical implant device, not an AI/ML diagnostic algorithm. Therefore, no MRMC study or AI assistance comparison was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. See point 5.
7. The type of ground truth used
- For the non-clinical performance testing, the "ground truth" implicitly refers to the established engineering and biomechanical standards and validated test methods against which the device's performance (e.g., fatigue strength, stability) is evaluated. There is no "expert consensus," "pathology," or "outcomes data" ground truth in the AI/ML sense in this document.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device. There is no "training set" of data.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.