(122 days)
The PROFEMUR® Renaissance® Classic Long Neck Hip 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;
- inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
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- correction of functional deformity; and,
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- revision procedures where other treatments or devices have failed.
The PROFEMUR® Renaissance® Classic Long Neck Hip 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® Renaissance® Classic Long Neck Hip Stems are monolithic stems manufactured from a forged titanium alloy (ASTM F620) and designed for use in uncemented total hip arthroplasty. The PROFEMUR® Renaissance® Classic Long Neck Hip Stems are available in 32 configurations and are coated with titanium plasma spray conforming to ASTM F1580. The 32 configurations consist of standard and reduced flare components (14 sizes reduced and 18 sizes standard). The reduced and standard flares refer to the amount of material in the proximal-medial region. Each flare configuration is available in two neck offset options, Straight (standard) and Varus 8° (extended). The geometry, distal-from-resection, is identical to those available with the predicate device.
The provided document is a 510(k) Premarket Notification for a medical device called "PROFEMUR® Renaissance® Classic Long Neck Hip Stems". This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, not for establishing novel acceptance criteria or performing extensive studies proving a device meets specific performance criteria in the same way, for example, a new drug might.
Therefore, the information regarding acceptance criteria and studies (especially clinical ones) will be limited to what is relevant for a 510(k) submission, primarily focusing on proving similarity to a predicate device and non-clinical performance.
Here's an analysis based on the provided text, addressing your points:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Non-Clinical) | Reported Device Performance |
|---|---|
| Proximal fatigue test (ISO 7206-4) | "satisfied the acceptance criteria" |
| Distal fatigue test (ISO 7206-6) | "satisfied the acceptance criteria" |
| Range of Motion (ISO 21535) | "were deemed acceptable" |
2. Sample sizes used for the test set and the data provenance
The document does not specify the sample sizes (number of devices tested) for the non-clinical tests (fatigue and range of motion). The data provenance is non-clinical/laboratory testing, not human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as the "ground truth" for non-clinical engineering tests (fatigue, range of motion) is based on established ISO standards. There are no "experts" establishing unique ground truth in the sense of clinical interpretation.
4. Adjudication method for the test set
This question is not applicable. Adjudication methods are relevant for human-interpreted data, often in clinical studies. Non-clinical tests follow standardized protocols.
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
No MRMC study was done. This is a hip stem (implantable medical device), not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as this is not an AI algorithm. The device is a physical hip stem.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the "ground truth" is adherence to the specified ISO standards (ISO 7206-4, ISO 7206-6, and ISO 21535). These standards define the test methods and acceptance limits.
8. The sample size for the training set
This question is not applicable as this is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
This question is not applicable as this is not an AI/machine learning device and therefore has no "training set" or corresponding ground truth.
Summary based on the document:
The PROFEMUR® Renaissance® Classic Long Neck Hip Stems are a line extension of an existing predicate device (PROFEMUR® Renaissance® Classic Hip Stem, K130984). The substantial equivalence claim is primarily based on:
- Identical Indications for Use to the predicate device.
- Identical Material (forged titanium alloy, ASTM F620, with titanium plasma spray coating, ASTM F1580) to the predicate device.
- Identical Geometry (distal-from-resection) to the predicate, with the exception of neck length, which is the defining characteristic of the "long neck" extension.
- Non-clinical testing to demonstrate performance in fatigue and range of motion, adhering to ISO standards.
The document explicitly states: "Clinical data was not provided for the subject devices." This is typical for a 510(k) submission for a device modification or line extension where substantial equivalence can be demonstrated through non-clinical data and comparison to a predicate.
§ 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.