(176 days)
The Zimmer Biomet™ Select Ceranic Heads are indicated for the following conditions: (1) a severely painful and/or disabled hip joint as a result of osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia, (2) avascular necrosis of the femoral head, (3) acute traumatic fracture of the femoral head or neck, (4) failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement, (5) certain cases of ankylosis, (6) nonunions, correction of functional deformity, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
When used with constrained acetabular liners, the Zimmer Biomet™ Select Ceramic Heads are intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.
The Zimmer Biomet™ Select™ Ceramic Heads are modular ceramic heads with a Type 1, 12/14 or 6 Degree adapter sleeve. They are offered in a variety of head diameters and neck configurations. They are intended for mating with a variety of Titanium Alloy and Cobalt-Chromium Alloy, as well as Stainless Steel, femoral stems equipped with tapered necks.
This document is a 510(k) Premarket Notification from the FDA for the Zimmer Biomet™ Select™ Ceramic Heads. Since this is a submission for a medical device that does not involve artificial intelligence or machine learning, the concepts of acceptance criteria for algorithm performance, sample sizes for training/test sets, expert ground truth, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance are not applicable.
Instead, the document focuses on demonstrating substantial equivalence to legally marketed predicate devices based on:
- Intended Use and Indications for Use: The subject device has the same intended use and similar indications for use as the predicate devices.
- Materials: The subject device uses similar ceramic materials that meet ISO 6472-2 standards, identical to a reference device (ICONACY™ I-Hip™ Ceramic Heads).
- Design Features: Both the subject and predicate devices mate with various femoral stems with tapered necks. The subject device offers a larger range of tapers and offsets.
- Sterilization: Identical to predicates.
The study that proves the device meets the acceptance criteria is a non-clinical performance study focusing on the mechanical and material characteristics of the implant. The "acceptance criteria" here are defined by the performance standards expected of such medical devices and comparison to predicate devices, rather than algorithm metrics.
Here's a breakdown of the requested information based on the provided document, acknowledging the non-AI context:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test/Characteristic | Reported Device Performance (Summary) |
|---|---|---|
| Intended Use | Identical to predicate | Same intended use as predicate devices. |
| Indications for Use | Similar to predicate | Similar indications for use as predicate devices. |
| Materials | Meets ISO 6472-2, Ceramic Composition | Made from alumina matrix composite. Meets ISO 6472-2. Identical to ICONACY™ I-Hip™ Ceramic Heads (a reference device). |
| Design Features | Mating with femoral stems, range of tapers/offsets | Mates with various Titanium Alloy, Cobalt-Chromium Alloy, and Stainless Steel femoral stems with tapered necks. Offers a larger range of tapers and offsets compared to predicates. |
| Sterilization | Method | Identical to predicates. |
| Mechanical Performance | Static Compression | Non-clinical tests were conducted. |
| Axial Fatigue and Post-Fatigue Compression | Non-clinical tests were conducted. | |
| Axial Pull-Off | Non-clinical tests were conducted. | |
| On-axis and Off-axis Impaction and Compression | Non-clinical tests were conducted. | |
| Resistance to Wear and Head Retention | Considered in non-clinical tests. | |
| Range of Motion | Non-clinical tests were conducted. | |
| Safety and Effectiveness | No new questions raised compared to predicates | Performance data and analyses demonstrate that differences do not raise new questions of safety and effectiveness, and the device is at least as safe and effective as legally marketed predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable in the context of this 510(k) for a physical medical device. There are no "test sets" of data in the AI/ML sense. The "testing" refers to mechanical and material characterization of the device components. The document does not specify the number of individual units tested for each mechanical test, nor does it specify a "country of origin for data" or whether the mechanical tests were "retrospective or prospective."
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)
This is not applicable. "Ground truth" in the AI/ML sense (e.g., expert-labeled images) is not relevant for this medical device submission. The "ground truth" for mechanical properties is established through standardized engineering tests and material specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are used for resolving disagreements in expert labeling of data, which is not part of this device 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
This is not applicable. MRMC studies are specific to evaluating the impact of AI on human performance (e.g., radiologists interpreting images), which is outside the scope of this mechanical implant device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As explained above, "ground truth" in the AI/ML context is not applicable. For this device, the "ground truth" is defined by:
- Standardized Material Specifications: e.g., ISO 6472-2 for ceramic materials.
- Engineering Mechanical Test Results: Bench testing of materials and device components for properties like compression, fatigue, pull-off, wear, and range of motion.
- Comparison to Predicate Devices: Demonstrating that the device's characteristics are similar or equivalent to those of previously cleared devices.
8. The sample size for the training set
This is not applicable. There is no "training set" in the AI/ML sense for this device.
9. How the ground truth for the training set was established
This is not applicable. There is no "training set" or corresponding "ground truth" establishment in the AI/ML sense for this 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.