(36 days)
The CPT® 12/14 Hip Prostheses are indicated for use with patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur and in the presence of proximal femoral bone defects; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the affected extremity; and patients with acute femoral neck fractures.
The CPT® 12/14, like its predicate, is a one-piece straight, collarless and highly polished femoral stem that is intended to be used for cemented fixation into the intramedullary canal for pathological or degenerative conditions involving the femur and/or acetabulum
The provided document is a 510(k) summary for a medical device, the CPT® 12/14 Hip Prostheses. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria for device performance in the way an AI/ML device submission would.
Therefore, many of the requested elements for an AI/ML device study are not applicable to this document. The document describes a traditional medical device (hip prosthesis) and its regulatory clearance process, which relies on demonstrating equivalence to an already marketed device rather than a de novo performance study against specific acceptance criteria for an AI algorithm.
Here's a breakdown of what can be extracted and what is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device itself (e.g., accuracy, sensitivity, specificity). The acceptance criterion for regulatory clearance is "substantial equivalence" to the predicate device.
- Reported Device Performance:
"Non-clinical performance testing demonstrated that the modified devices are equivalent to the predicate."
This statement is the core "performance" reported, indicating that the new device performs comparably to the previously cleared predicate device in non-clinical settings.
| Acceptance Criteria (Implied for 510(k)) | Reported Device Performance (Non-clinical) |
|---|---|
| Substantial equivalence to predicate device Collarless Polished Taper and Collarless Polished Taper LS Hip Prostheses (K960658) in non-clinical performance. | "Non-clinical performance testing demonstrated that the modified devices are equivalent to the predicate." |
2. Sample size used for the test set and the data provenance
- Not Applicable. This document describes non-clinical performance testing, which often involves bench testing (e.g., mechanical tests, fatigue tests) rather than a "test set" of patient data as understood in AI/ML studies. The data provenance would typically refer to the testing conditions and methodologies.
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 the context of a hip prosthesis typically refers to its mechanical properties, biocompatibility, and surgical outcomes, not to an expert-labeled dataset for an AI algorithm.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are relevant for expert consensus on AI ground truth, which is not part of this submission.
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 medical device, not an AI/ML diagnostic tool, so MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- Not Applicable. There is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for a hip prosthesis involves demonstrating that its materials, design, and manufacturing meet established standards for safety and effectiveness, typically through bench testing and material characterization to verify mechanical strength, fatigue life, wear resistance, and biocompatibility. Clinical outcomes data or expert consensus for diagnosis are not the primary ground truth for this device type in a 510(k) submission.
8. The sample size for the training set
- Not Applicable. There is no training set for an AI model.
9. How the ground truth for the training set was established
- Not Applicable. There is no training set for an AI model.
Summary of the Study (as described in the document):
The "study" described in this document is a non-clinical performance testing to demonstrate the substantial equivalence of the CPT® 12/14 Hip Prostheses to its predicate device, the Collarless Polished Taper and Collarless Polished Taper LS Hip Prostheses (K960658).
- Objective of the study: To show that modifications to the predicate device do not change its intended use or fundamental scientific technology and that its performance is equivalent.
- Methodology: "Non-clinical performance testing" was performed. While the details of these tests are not provided in this summary, they would typically include:
- Mechanical testing (e.g., fatigue strength, static strength)
- Material characterization
- Biocompatibility assessments
- Design comparison to the predicate
- Conclusion: The non-clinical performance testing "demonstrated that the modified devices are equivalent to the predicate." This established the basis for the FDA's "substantial equivalence" determination, allowing the device to be marketed.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a 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 have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.