(137 days)
The Durasul Bipolar is intended for non-cemented use in a hip hemi-arthroplasty in which it assumes the function of the natural femoral head in conjunction with a prosthetic femoral head component. Specific diagnostic indications for use of a bipolar include displaced femoral neck fractures, avascular necrosis of the femoral head, and non-union of femoral neck fractures.
The Durasul Bipolar consists of a polyethylene insert/liner and an outer CoCr shell. In vivo, the CoCr shell articulates directly with well-preserved articular cartilage while the Durasul insert articulates directly with a 22 or 26mm femoral head. The Durasul Bipolar components are available in a variety of sizes to allow the surgeon to replicate the natural anatomy of the hip joint as closely as possible when performing a hip hemi-arthroplasty.
This document describes the Durasul® Bipolar hemi-hip prosthesis and its regulatory clearance. It does not contain information about acceptance criteria and a study proving a device meets acceptance criteria in the way you've defined, which typically applies to AI/ML software or diagnostic devices with quantifiable performance metrics (e.g., sensitivity, specificity, AUC).
Instead, this document is a 510(k) summary for a traditional medical device (a prosthetic hip component). The "acceptance criteria" here are related to proving substantial equivalence to predicate devices, focusing on design, materials, and intended use, rather than specific performance metrics from a clinical study as you might expect for an AI/ML product.
Therefore, I cannot fill out your requested table and information points as they pertain to AI/ML or diagnostic device performance studies. The document states:
"Performance tests, design comparisons, and functional analyses conducted on the Durasul Bipolar demonstrate that this device is substantially equivalent to the predicate devices."
This broadly refers to engineering and material testing, and potentially comparison to the existing clinical history of the predicate devices. It does not describe a clinical study with a test set, ground truth established by experts, or statistical performance metrics.
To directly answer your request based on the provided text:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Substantial equivalence to predicate devices (Centerpulse Orthopedics, Inc. Bipolar (K873815) and Exactech's AcuMatch L-Series Bipolar (K013211)). This means demonstrating similar design, materials, manufacturing processes, and intended use, and not raising new questions of safety or effectiveness.
- Reported Device Performance: The document states, "Performance tests, design comparisons, and functional analyses conducted on the Durasul Bipolar demonstrate that this device is substantially equivalent to the predicate devices." This indicates the device passed the necessary tests to be deemed substantially equivalent, but no specific quantitative performance metrics (like sensitivity, specificity, accuracy) are reported for clinical use in this document.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable/Not mentioned. This is a traditional device submission, not an AI/ML software submission that would typically involve a "test set" in this context. The "performance tests" would likely refer to bench testing (e.g., wear testing, fatigue testing) rather than a clinical dataset.
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):
- Not applicable/Not mentioned. Ground truth as understood for AI/ML models is not described here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned.
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/Not mentioned. This is not an AI/ML diagnostic assistance device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not mentioned. This is a physical prosthetic device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable/Not mentioned. The "ground truth" here is the established safety and effectiveness of the predicate devices based on their history and testing.
8. The sample size for the training set:
- Not applicable/Not mentioned. This device does not use a "training set" in the AI/ML sense.
9. How the ground truth for the training set was established:
- Not applicable/Not mentioned.
In summary, this 510(k) pertains to a traditional orthopedic implant, and the regulatory process for such devices focuses on demonstrating substantial equivalence to already-approved predicate devices through engineering tests and regulatory comparisons, not on clinical performance metrics from a "study" with test sets and ground truth in the context of AI/ML or diagnostic accuracy.
§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.