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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.

The Zimmer Biomet Ceramic Heads are made from a composite ceramic containing approximately 75% alumina (Al2O3) and 25% zirconia (ZrO2) (percentage by weight). They are supplied with a 12/14 bore or a Type 1 bore. The scope of the subject submission is limited to the 22.2mm head diameter with multiple neck configurations.
The subject ceramic heads are intended for mating with Ti-6Al-4V alloy, Ti-6Al-7Nb alloy stems with tapered necks. They may only be used in combination with highly crosslinked or conventional polyethylene (PE) or metal-back polyethylene liners.

This document is a 510(k) clearance letter for a medical device: "Zimmer Biomet Ceramic Heads (22.2mm diameter)". It describes the device, its intended use, and states that no non-clinical or clinical tests were submitted to determine substantial equivalence.

Therefore,Based on the provided FDA 510(k) clearance letter for the "Zimmer Biomet Ceramic Heads (22.2mm diameter)", it is explicitly stated that no non-clinical and/or clinical tests were submitted to determine the substantial equivalence of the subject device with the predicate.

This means that the information requested regarding acceptance criteria and the study proving the device meets these criteria cannot be provided from this document. The clearance was based on:

• Technological Comparison: The only difference between the subject device and the predicate device (K181171, K200823) is the addition of a contraindication for the use of 22.2mm ceramic heads with stainless steel femoral stems. All other technological characteristics are identical.
• Indications for Use Comparison: The indications for use and intended use are identical to the predicate device.

Since no testing was performed or reported in this submission for device performance, the following information cannot be extracted:

1. A table of acceptance criteria and the reported device performance: No performance data was submitted.
2. Sample sizes used for the test set and the data provenance: No test set was used.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable as no test set was evaluated.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, as per the text "No Non-Clinical and/or Clinical Tests were submitted".
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device (hip prosthesis component), not an AI/software algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable as no training set (for an algorithm) was used.
9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) clearance relied on substantial equivalence to a predicate device based on identical technology and indications for use, with the only change being an additional contraindication. It did not involve new performance studies.

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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.

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