(63 days)
The PROFEMUR® Preserve Classic Stems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
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non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
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inflammatory degenerative joint disease such as rheumatoid arthritis;
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correction of functional deformity; and,
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revision procedures where other treatments or devices have failed.
The PROFEMUR® Preserve Classic Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of uncemented total hip arthroplasty.
The PROFEMUR® Preserve Classic Stems are monolithic femoral components manufactured from a forged titanium alloy (ASTM F620). The hip stems are designed for use in cementless total hip arthroplasty and possess identical indications for use to the predicates (K112080). The design features of the PROFEMUR® Preserve Classic Stems are summarized below:
- . Stems are forged from Ti6Al4V alloy conforming to ASTM F620
- Stems possess unalloyed titanium plasma coating manufactured from powder ● conforming to ASTM F1580
- . Neck offsets are offered in Straight and Varus 8 options
- Stems are offered in twelve sizes for both neck offsets ●
The provided document is a 510(k) premarket notification for a medical device called the PROFEMUR® Preserve Classic Stem, which is a hip joint prosthesis. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria in terms of performance in patients.
Therefore, many of the requested categories (such as sample size for test/training sets, involvement of experts for ground truth, adjudication methods, MRMC studies, or standalone performance) are not applicable or cannot be extracted from this type of regulatory submission. This document describes mechanical testing and material equivalence, not clinical performance metrics.
Here's a breakdown of what can be inferred or directly stated from the provided text based on your request:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission, the "acceptance criteria" are primarily related to demonstrating substantial equivalence through mechanical testing, material specifications, and design features that are comparable to a predicate device. There are no explicit clinical performance "acceptance criteria" stated in terms of patient outcomes or diagnostic accuracy, as is common for AI/diagnostic device studies.
| Acceptance Criteria (Inferred from testing) | Reported Device Performance |
|---|---|
| Range of motion in accordance with ISO 21535 | Evaluated in accordance with ISO 21535. (Implied successful evaluation, as no adverse findings are noted, and substantial equivalence is claimed). |
| Proximal fatigue testing according to ISO 7206-6 | Successfully evaluated by proximal fatigue testing according to ISO 7206-6. |
| Distal fatigue testing (applicability to ISO 7206-4 for similar geometry) | Verified to be applicable to ISO 7206-4 distal fatigue testing that was performed on a modular stem possessing a similar geometry. (Implied successful performance by comparison to a validated model and similar device, supporting substantial equivalence). |
| Materials compliance (Ti6Al4V alloy) | Stems are forged from Ti6Al4V alloy conforming to ASTM F620. Subject devices are made from an identical titanium alloy (ASTM F620) to the predicate devices. |
| Coating material compliance (unalloyed titanium plasma coating) | Stems possess unalloyed titanium plasma coating manufactured from powder conforming to ASTM F1580. Possess an identical titanium plasma spray coating design specification and material (ASTM F1580 powder) to the predicate device. Coating process and vendor information are identical to those provided for reference device K123688. |
| Design features (e.g., neck offsets, sizes) | Neck offsets are offered in Straight and Varus 8 options. Stems are offered in twelve sizes for both neck offsets. Designed to provide geometric sizing options that resemble a subset of those available with the predicate device. |
| Functional Performance (Implication from mechanical testing) | Successful results of testing support the expectation that the device will perform as intended under normal physiological loading conditions. |
| Substantial Equivalence to Predicate Device (K112080) for intended use and indications | Intended use and indications for use are identical to predicate devices (K112080). Materials and fundamental scientific technology are identical to predicate. Safety and effectiveness are adequately supported by substantial equivalence information. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not applicable. The "test set" here refers to mechanical samples of the device, not patient data. The document does not specify the number of hip stems tested for fatigue or range of motion, but refers to "stems" (plural).
- Data Provenance: Not applicable in the context of clinical data. The testing described is mechanical, under laboratory conditions, using prototypes or production samples of the device.
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. "Ground truth" in this context would typically refer to clinical diagnoses or outcomes. This submission focuses on engineering and material specifications, with testing against international standards (ISO, ASTM). The "ground truth" for mechanical testing is established by these standards themselves and the measured physical properties of the device components.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for clinical studies where expert consensus is needed to establish ground truth from patient data. For mechanical testing, results are typically determined by measurement against predefined specifications in a standard.
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. This device is a hip implant, not an AI-powered diagnostic or decision support tool. Therefore, MRMC studies and AI assistance metrics are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this submission is based on:
- International Standards: e.g., ISO 21535 (range of motion), ISO 7206-6 (proximal fatigue), ISO 7206-4 (distal fatigue), ASTM F620 (titanium alloy), ASTM F1580 (titanium powder).
- Material Specifications: Chemical composition and mechanical properties of the raw materials and finished components.
- FEA Models: Finite Element Analysis models that were previously validated in another submission (K141235) were used for comparison.
8. The sample size for the training set
Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth for a training set to be established.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.