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The subject humeral stems (MRS Humeral Stems without porous coating) are intended for use with the components of the Modular Replacement System Humeral System. This device is intended for use in patients requiring reconstruction of the proximal humerus due to extensive bone loss as a result of tumor resection secondary to primary or metastatic skeletal lesions. This device is intended for use with bone cement. This is the same intended use as the predicate device in premarket notification K954559 and K032264.

Premarket notification K954559 described the Modular Replacement system (MRS) Porous Coated Humeral Stem system. Special premarket notification K032264 expanded this product line to include non-porous coated humeral stems. Both of these stems are fabricated from cobaltchromium alloy that conforms to ASTM F-1537. It is the intention of Howmedica Osteonics Corp. to fabricate the non-porous coated humeral stems in the MRS system from a slightly different type of cobalt-chromium - this material also conforms to ASTM F-1537, but has slightly different metallurgical properties.

This document is a Special 510(k) Premarket Notification for a medical device, specifically Modular Replacement System (MRS) Humeral Stems. It describes an alternate material for an existing device.

Here's an analysis based on your request:

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

The provided document does not explicitly state acceptance criteria or device performance in measurable terms for this specific Special 510(k). This type of submission, a Special 510(k), is typically used for modifications to a previously cleared device where the change does not significantly alter the device's fundamental technology or safety/effectiveness.

In this case, the change is to an "alternate material" for existing non-porous coated humeral stems. The core of the submission focuses on demonstrating that the new material has similar properties and does not negatively impact the intended use or performance compared to the predicate device's material.

The document states:

• "It is the intention of Howmedica Osteonics Corp. to fabricate the non-porous coated humeral stems in the MRS system from a slightly different type of cobalt-chromium - this material also conforms to ASTM F-1537, but has slightly different metallurgical properties."
• "The intended usc of the subject device is not changed by this material change."

Therefore, the "acceptance criteria" here are implicitly tied to demonstrating that the new material meets the same ASTM F-1537 standard as the original material and that any "slightly different metallurgical properties" do not compromise the device's original performance characteristics (e.g., mechanical strength, biocompatibility, durability).

Acceptance Criteria (Inferred from context):

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

This document does not describe a clinical study with a "test set" in the sense of patient data. Special 510(k)s for material changes typically rely on bench testing and material characterization studies, not clinical trials with human subjects.

Therefore, "sample size used for the test set" would refer to the number of material samples tested or the devices subjected to mechanical testing. This information is not provided in the document.

Data provenance (country of origin, retrospective/prospective) is also not applicable as there is no human subject data referenced.

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 information is not applicable as there is no "ground truth" derived from expert consensus on clinical data. The "ground truth" in this context would be the objective physical and chemical properties of the material, assessed through laboratory testing by material scientists and engineers. Their specific number and qualifications are not mentioned.

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

This information is not applicable as there is no expert review or adjudication of clinical cases or images.

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 document is for a physical orthopedic implant (humeral stem), not a diagnostic imaging device utilizing AI. Therefore, an MRMC study and AI assistance are not applicable.

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

This concept is not applicable to this device.

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

The "ground truth" (or basis for claiming safety and effectiveness for this type of submission) comes from:

• Material Standards Conformance: The new material's compliance with ASTM F-1537.
• Substantial Equivalence: Comparison to the known performance and safety profile of the legally marketed predicate device, as confirmed through the existing regulatory clearances (K954559 and K032264).
• Bench Testing Data: Although not detailed in this summary, a Special 510(k) for a material change would be supported by in-vitro material characterization and mechanical testing to demonstrate that the new material performs equivalently to the predicate's material.

8. The sample size for the training set

This concept is not applicable as there is no machine learning component or "training set" for this device.

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

This concept is not applicable as there is no training set for this device.

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