(217 days)
The Klassic HD® Hip System is intended for prosthetic replacement without bone cement in treatment of the following:
- Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular . necrosis, osteoarthritis, ankylosis, protrusio acetabuli and painful hip dysplasia.
- Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis.
- Those patients with failed previous surgery where pain, deformity, or dysfunction persists. ●
- Revision of a previously failed hip arthroplasty. ●
- Patients who require a total hip replacement. ●
The Klassic HD Hip System employs prostheses designed to help surgeons restore hip joint biomechanics. The purpose of this 510(k) is to add the Platform Acetabular System consisting of the Platform Acetabular Shell with Ti-Coat and Platform Acetabular Inserts with E-Link (Neutral and Hooded) to the Klassic HD Hip System. The Platform Acetabular Shells are fabricated from Ti6Al4V per ASTM F136 and the Platform Acetabular Inserts with E-Link are made from Vitamin E. UHMWPE material. The subject acetabular components are available in various sizes ranging in outer diameters of 44mm to 64mm to match patient anatomy and are compatible with 28mm, 32mm, and 36mm heads. The subject components are provided sterile, for single use, by prescription only.
The provided document is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) for the Platform® Acetabular System. This document does not describe a study involving an AI/Machine Learning device, nor does it present acceptance criteria and performance data for such a device in the manner requested.
Instead, this document pertains to a hip joint prosthesis, specifically acetabular components (shells and inserts). The "performance data" discussed relates to mechanical and material testing of these implantable devices, not to an AI's diagnostic or predictive capabilities.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving the device (AI/ML) meets these criteria, as the provided text describes a medical implant. The information in the prompt about "AI vs without AI assistance," "standalone algorithm performance," "number of experts," and "ground truth" is not applicable to the content of this FDA clearance letter.
To answer your request, I would need a document describing the testing and validation of an AI/Machine Learning device.
However, I can extract the information relevant to the mechanical device described in this document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a table with explicit "acceptance criteria" and "reported device performance" in the typical AI/ML context (e.g., sensitivity, specificity, AUC). Instead, it lists the types of non-clinical tests performed to demonstrate substantial equivalence to predicate devices. The implicit "acceptance criterion" for these tests is that the subject device's performance must be comparable to or better than the predicate devices and meet relevant ASTM/ISO standards to ensure safety and effectiveness.
| Test Performed | Implied Acceptance Criterion (from a regulatory perspective) | Reported Device Performance Summary (from document) |
|---|---|---|
| Push out testing (ASTM F1820-13) | Performance comparable to predicate devices and within standard limits for secure fixation. | "Testing and engineering analyses demonstrated that the subject acetabular components perform as safe and effective compared to the predicate components and are substantially equivalent to the predicate." |
| Lever out testing (ASTM F1820-13) | Performance comparable to predicate devices and within standard limits. | "Testing and engineering analyses demonstrated that the subject acetabular components perform as safe and effective compared to the predicate components and are substantially equivalent to the predicate." |
| Axial Torque Disassembly Testing (ASTM F1820-13) | Performance comparable to predicate devices and within standard limits for construct stability. | "Testing and engineering analyses demonstrated that the subject acetabular components perform as safe and effective compared to the predicate components and are substantially equivalent to the predicate." |
| Impingement Testing (ASTM F2582-20) | Performance comparable to predicate devices and within standard limits for range of motion and impingement resistance. | "Testing and engineering analyses demonstrated that the subject acetabular components perform as safe and effective compared to the predicate components and are substantially equivalent to the predicate." |
| Acetabular Shell Fatigue Testing (ASTM F3090-20) | Resistance to fatigue comparable to predicate devices and meeting standard requirements for expected service life. | "Testing and engineering analyses demonstrated that the subject acetabular components perform as safe and effective compared to the predicate components and are substantially equivalent to the predicate." |
| Deformation Testing (ISO 7206-12) | Deformation properties comparable to predicate devices and within standard limits. | "Testing and engineering analyses demonstrated that the subject acetabular components perform as safe and effective compared to the predicate components and are substantially equivalent to the predicate." |
| Material wear (engineering analysis) | Wear characteristics comparable to predicate devices, demonstrating acceptable long-term performance. | "Testing and engineering analyses demonstrated that the subject acetabular components perform as safe and effective compared to the predicate components and are substantially equivalent to the predicate." |
| Range of motion (engineering analysis) | Range of motion comparable to predicate devices, supporting intended function. | "Testing and engineering analyses demonstrated that the subject acetabular components perform as safe and effective compared to the predicate components and are substantially equivalent to the predicate." |
| LAL testing requirements | Compliance with LAL (Limulus Amebocyte Lysate) testing for endotoxin levels to ensure sterility/safety. | "Additionally, the Klassic HD® Hip System is in compliance with LAL testing requirements for orthopedic implants." |
2. Sample size used for the test set and data provenance:
This document describes physical and engineering tests on manufactured components (hip implants), not data analysis on a medical image dataset. Thus, "sample size for the test set" would refer to the number of physical components tested for each mechanical property, which is not specified in detail (e.g., "N=X components"). The "data provenance" is derived from these physical tests conducted by the manufacturer as part of their submission to the FDA. The tests are "non-clinical" (i.e., not involving human subjects).
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. "Ground truth" in this context refers to established engineering and material science standards (ASTM, ISO). Expert mechanical engineers and material scientists would design and interpret these tests, but it's not analogous to clinical expert consensus for image labeling.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not a clinical study involving human readers or interpretation.
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 document is not about an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This document is not about an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the material and mechanical properties of the device is established by ASTM and ISO international standards for orthopedic implants, and the comparative performance to legally marketed predicate devices.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML 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.