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• The Zimmer Biomet 12/14 CoCr Femoral Heads are intended for use in total and hemi arthroplasty* in primary and revision patients. Refer to the acetabular system and femoral stem package inserts for the full description of indications for the construct.

Hemi-Arthroplasty indication is for use with Bipolar Systems only.
• The Zimmer Biomet 12/14 CoCr Freedom® 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. Refer to the acetabular system and femoral stem package inserts for the full description of indications for the construct.

Device Description

This traditional 510(k) premarket notification is being submitted to obtain clearance for the Zimmer Biomet 12/14 CoCr Femoral Head and Freedom® Heads. The heads are made from Freedom® Heads cobalt-chromiummolybdenum alloy (CoCrMo) to ISO 5832-12:2007 and ASTM F1537-11.

AI/ML Overview

This document describes the 510(k) premarket notification for the Zimmer Biomet 12/14 CoCr Femoral Head and Freedom® Heads. It outlines the device's characteristics, intended use, indications for use, and a summary of performance data to support its substantial equivalence to predicate devices.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

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

The document does not present explicit acceptance criteria in a formal table format with numerical targets that the device performance must meet. Instead, the "Substantial Equivalence Conclusion" section functions as a high-level summary of how the device meets the criteria for 510(k) clearance, which is demonstrating substantial equivalence to legally marketed predicate devices.

Acceptance Criteria (Implied by 510(k) Requirements):

Criteria Category	Implied Acceptance	Reported Device Performance
Intended Use	Must be equivalent to predicate(s).	"Equivalent to predicate(s)."
Indications for Use	Must be identical to predicate(s).	"Identical to predicate(s)."
Materials	Must be identical or equivalent to predicate(s), posing no new safety or effectiveness concerns.	"Identical to predicate(s)." Specifically, "cobalt-chromium-molybdenum alloy (CoCrMo) to ISO 5832-12:2007 and ASTM F1537-11," which is the same as the primary predicate.
Design Features	Must be equivalent to predicate(s), or any differences must not raise new questions of safety and effectiveness. This often involves demonstrating comparable functional performance and safety.	"Both the subject and predicate devices mate with a variety of femoral stems equipped with tapered necks. The variety of head diameters and neck configurations is equivalent although the subject device is available in a larger range of sizes." The implication is that larger size range does not pose new safety/effectiveness issues.
Sterilization	Must be identical or equivalent to predicate(s), ensuring comparable sterility assurance levels.	"Identical to predicate."
Performance Data (Non-Clinical)	Must demonstrate that the device performs as safely and effectively as the predicate device(s) and that any differences do not raise new questions of safety and effectiveness. This typically involves specific mechanical and material testing relevant to the device's function.	Summarized as: "Pull Off Testing," "Accelerated Corrosion Fatigue," "Head Fatigue," and "Resistance to Wear and Head Retention were considered." The conclusion states these analyses demonstrate that "any differences do not raise new questions of safety and effectiveness; and the proposed device is at least as safe and effective as the legally marketed predicate devices."
Clinical Tests	For this type of device and submission, often not required if substantial equivalence can be demonstrated through non-clinical data and comparison to predicates.	"N/A" (Not Applicable)

2. Sample sizes used for the test set and the data provenance

The document does not specify sample sizes for the non-clinical tests (e.g., how many heads were subjected to pull-off testing). It only lists the types of non-clinical tests performed.

Regarding data provenance:

Country of Origin: The manufacturer is listed as Zimmer, Inc., Warsaw, IN, USA, with a contact person in the UK (Zimmer Biomet UK, Bridgend). The specific location where the non-clinical tests were conducted is not detailed.
Retrospective or Prospective: The non-clinical tests described are by nature prospective tests performed specifically for this submission to demonstrate substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable. The device is a mechanical implant (femoral head for hip arthroplasty), and its performance is evaluated through engineering and material science testing (non-clinical tests), not through analysis of medical images or patient data that would require expert human interpretation and "ground truth" establishment in the way an AI diagnostic device would.

4. Adjudication method for the test set

This is not applicable as the study involves non-clinical mechanical and material testing, not human-read test sets requiring adjudication.

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. The device is a hip implant component, not an AI-assisted diagnostic tool. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance was performed.

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

This is not applicable. The device is a physical implant, not an algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" would be established by the engineering standards and test methodologies (e.g., ISO, ASTM standards, internal validated test protocols) and the resulting objective measurements (e.g., force, cycles to failure, corrosion rates). There isn't a "ground truth" in the sense of expert consensus, pathology, or outcomes data, as these tests are simulating mechanical and material performance rather than diagnosing a condition.

8. The sample size for the training set

This is not applicable. The device is a mechanical implant. There is no concept of a "training set" for an algorithm in this context. The manufacturing process and materials used are based on established engineering principles and prior validated designs.

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

This is not applicable. As there is no training set for an algorithm, there is no ground truth to be established in that context.

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