Search Results

The Zimmer Biomet™ Ceramic 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, internal fixation, 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™ 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.

This traditional 510(k) premarket notification is being submitted to obtain clearance for the Zimmer Biomet™ Ceramic Heads. The heads are made from an alumina matrix composite. The Zimmer Biomet Ceramic Heads are supplied with a 12/14 bore or Type 1 bore and 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 femoral stems equipped with tapered necks.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) premarket notification for Zimmer Biomet Ceramic Heads, which details the device's classification, indications for use, and a summary of its technological characteristics and non-clinical and clinical tests. However, it does not specify acceptance criteria for performance or a study's results against those criteria.

Ask a specific question about this device

MicroPort total hip systems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli. and painful hip dysplasia;

2. inflammatory degenerative joint disease such as rheumatoid arthritis;

3. correction of functional deformity; and,

4. revision procedures where other treatments or devices have failed.

The BIOLOX® delta Option and Extra-long Heads include femoral heads and neck sleeves. The design features are summarized below:

• Femoral Heads
  • BIOLOX® delta Option:
    • Manufactured from alumina matrix composite
    • Head sizes: 28mm, 32mm, 36mm, 40mm, 44mm
    • Conical Bore: 16/18 Taper
  • BIOLOX® delta Extra-long:
    • Manufactured from alumina matrix composite
    • Head Sizes: 32mm, 36mm, 40mm
    • Conical Bore: 12/14 Taper
• Neck Sleeves
  • BIOLOX® delta Option:
    • Manufactured from titanium alloy
    • Neck Sleeve sizes: Short, Medium, Long, and Extra-long
    • Conical Bore: 16/18 External Taper, 12/14 Internal Taper

The provided document describes a 510(k) premarket notification for the BIOLOX® delta Option and Extra-long Heads, which are components of total hip arthroplasty systems. Per the document, the device did not undergo clinical testing, and therefore, no acceptance criteria based on clinical performance metrics are provided. The clearance is based on substantial equivalence to predicate devices and non-clinical testing.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) submission based on substantial equivalence and non-clinical testing, specific acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy, or reduction in error rate) are not stated in the document. The non-clinical tests assess the physical and mechanical properties of the device. The document states that the safety and effectiveness are "adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification." The reported "performance" for these non-clinical tests would typically be within the expected range for such devices and comparable to predicate devices, but the specific numerical results or acceptance thresholds are not detailed in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily discusses non-clinical testing. For these mechanical tests, the sample sizes are not specified, nor is the country of origin of the data mentioned. The data provenance is non-clinical (laboratory testing). No human test set data is presented.

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. The document describes non-clinical testing of a hip implant device, not a diagnostic or AI-based device requiring expert ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study requiring adjudication of expert interpretations.

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 pertains to the mechanical and biological safety of an orthopedic implant, not an AI-assisted diagnostic tool. No MRMC study was conducted or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests, the "ground truth" is based on established engineering principles and material science standards for evaluating the performance and safety of medical devices. For instance, burst strength tests have defined failure points based on material properties and structural integrity. For biocompatibility, the ground truth is established through validated testing methods outlined in international standards (e.g., ISO 10993) or by referencing previously cleared devices with known biological responses.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not applicable. As above, this is a physical medical device, not an AI model.

Ask a specific question about this device