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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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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.

The predicate MRS Humeral Stems had a porous coated body (or seat) segment. The subject MRS Humeral Stems do not have a porous coated body segment. The subject stems are offered in the same diameters, and the same lengths as the previously released porous coated humeral stems.

This 510(k) summary (K032264) describes a line extension of an existing device, the Modular Replacement System (MRS) Humeral Stems. It's important to understand that a line extension typically focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive new clinical studies to establish performance against pre-defined acceptance criteria as would be the case for a novel device.

The provided document does not contain information on acceptance criteria, a study that proves the device meets specific performance criteria in the way a clinical trial would, or any of the detailed aspects typically required for AI/ML device evaluations. This submission is for a modification to a mechanical orthopedic implant, not a software-driven diagnostic or treatment device.

However, based on the information provided, here's a breakdown of what can be inferred or what is explicitly stated, with a clear indication of what is not present:

This submission (K032264) is a Special 510(k) Premarket Notification for a line extension of the Modular Replacement System (MRS) Humeral Stems. The primary change is the absence of a porous coated body segment on the subject stems, which were present on the predicate MRS Humeral Stems. The subject stems maintain the same diameters and lengths as the previously released porous-coated humeral stems.

Due to the nature of this submission as a line extension for a mechanical implant and the provided document content, the information typically requested for AI/ML device evaluations (e.g., acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert ground truth, MRMC studies) is not applicable or not present in these documents. The focus here is on demonstrating substantial equivalence in terms of material, mechanical properties, and intended use to a legally marketed predicate device.

Here's a breakdown of the requested information, indicating where information is missing or not applicable in this context:

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

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

• Not Applicable/Not Provided. This submission is for a mechanical orthopedic implant. There is no "test set" in the context of diagnostic data or images. The evaluation would typically involve engineering tests (e.g., mechanical strength, fatigue properties) rather than a dataset of patient information. The document does not specify any testing protocols or data from such tests.

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/Not Provided. As there is no "test set" for diagnostic performance, there's no mention of experts establishing ground truth in this context. The substantial equivalence argument for mechanical implants is typically supported by engineering analyses and comparisons.

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

• Not Applicable/Not Provided. No test set or adjudication method applicable to AI/ML diagnostic performance is mentioned.

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/Not Provided. This device is a mechanical implant with no AI/ML component. Therefore, MRMC studies are irrelevant.

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

• Not Applicable/Not Provided. This device is a mechanical implant with no AI/ML component. Therefore, standalone algorithm performance is irrelevant.

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

• Not Applicable/Not Provided. Given this is a mechanical implant, the concept of "ground truth" as applied to diagnostic or AI/ML devices is not relevant. Substantial equivalence for such devices typically relies on engineering principles, materials science data, and comparison to the predicate's established safety and effectiveness profile.

8. The sample size for the training set

• Not Applicable/Not Provided. There is no "training set" as this is not an AI/ML device.

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

• Not Applicable/Not Provided. There is no "training set" or need for "ground truth" establishment in the AI/ML sense for this device.

Study Description (Implied for Substantial Equivalence):

The "study" that proves the device meets acceptance criteria (in this case, substantial equivalence to the predicate) is an engineering and materials comparison rather than a clinical trial or diagnostic performance study.

• Device Under Review: Modular Replacement System (MRS) Humeral Stems without porous coating.
• Predicate Device: MRS Humeral Stems (with porous coated body segment), cleared under K954559.
• Basis for Equivalence: The submission asserts substantial equivalence based on:
  • Same Intended Use: "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." (from K032264, Page 4 and Page 1)
  • Similar Design and Materials: The subject stems are explicitly stated to be "offered in the same diameters, and the same lengths as the previously released porous coated humeral stems." (K032264, page 1). The only structural difference noted is the absence of the porous coated body segment. This implies the core material and mechanical design of the stem itself remain consistent with the predicate.
  • Regulatory Classification: Both the subject device and the predicate are Class II devices, product code 87 HSD, regulated under 21 CFR §888.3690 (Prosthesis, shoulder, hemi-, humeral, metallic uncemented).
  • Lack of New Safety/Effectiveness Questions: By removing the porous coating and maintaining other parameters, the submission likely argued that no new questions of safety or effectiveness are raised compared to the predicate device, especially since the device is intended for use with bone cement, which would mitigate the primary role of a porous coating for bone ingrowth.

In essence, the "study" for this type of submission is a detailed technical comparison demonstrating that the modified device is as safe and effective as the predicate, despite the minor design change. The detailed mechanical testing data and rationale for substantial equivalence would typically be in the main body of the 510(k) submission, not summarized in this public document.

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