(16 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided. This type of pre-defined performance acceptance criteria (e.g., sensitivity, specificity, accuracy) is not typically required or presented for a Class II mechanical implant line extension focused on structural changes. The demonstration relies on substantial equivalence to a predicate. | Not provided. No specific performance metrics (e.g., mechanical load bearing, longevity data specific to this modification) are detailed in this summary for the subject device against explicit acceptance criteria. The claim is substantial equivalence based on material and design characteristics remaining within safe limits compared to the predicate. |
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.
§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.