(28 days)
The PROFEMUR® RENAISSANCE™ Hip Stem is 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:
- 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;
- correction of functional deformity; and,
- revision procedures where other treatments or devices have failed
The design features of the PROFEMUR® RENAISSANCE™ Hip Stem are summarized below:
- Manufactured from titanium alloy (Ti6A14V) .
- Offered in two medial flare options
- 1mm increments from size 10-18
- Tri-planar proximal geometry with plasma sprayed surface or plasma sprayed surface with HA coating
- Cylindrical, splined, and slotted distal stem with glassbead surface
- Threaded hole with slot impaction mechanism .
- Polished distal tip and collar
The provided text is a 510(k) summary for the PROFEMUR® RENAISSANCE™ Hip Stem. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in performance studies for AI/ML devices.
This document is a regulatory submission for a physical medical device (a hip stem), not a software or AI/ML device. Therefore, the questions related to AI/ML device performance, such as test sets, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance, are not applicable to this document.
The "study" mentioned in this type of 510(k) is usually a demonstration of substantial equivalence, which primarily relies on comparing the new device's design, materials, and intended use to legally marketed predicate devices, along with materials information and analysis data (e.g., mechanical testing, biocompatibility).
Here's what can be extracted from the document in relation to your request, with the understanding that the core elements of your request (AI/ML performance validation) are not present:
Acceptance Criteria and Device Performance (Not Applicable - This is a physical device submission)
- The document describes the device and its intended use, but does not present a table of specific acceptance criteria or quantitative performance metrics for those criteria, as would be expected for an AI/ML device. The "performance" in this context refers to its intended function and safety based on its design and materials.
1. Table of Acceptance Criteria and Reported Device Performance:
| Criteria Type (Inferred for a physical implant) | Acceptance Criteria (Not explicitly stated or quantitative in this document) | Reported Device Performance (Inferred from substantial equivalence) |
|---|---|---|
| Material Composition | Device is made from biocompatible and structurally sound materials used in predicate devices (e.g., Ti6A14V). | Manufactured from titanium alloy (Ti6A14V). |
| Design Features | Similar design features (e.g., geometry, surface treatments, fixation mechanisms) to predicate devices to achieve intended biomechanical function. | Offered in two medial flare options, 1mm increments from size 10-18. Tri-planar proximal geometry with plasma sprayed surface or plasma sprayed surface with HA coating. Cylindrical, splined, and slotted distal stem with glassbead surface. Threaded hole with slot impaction mechanism. Polished distal tip and collar. |
| Intended Use Safety & Effectiveness | Device is safe and effective for its stated indications for use, comparable to predicate devices. | Indicated for total hip arthroplasty for reduction/relief of pain and/or improved hip function in skeletally mature patients with specified conditions (non-inflammatory/inflammatory degenerative joint disease, functional deformity, revision procedures). |
| Substantial Equivalence | The indications for use, materials, and fundamental scientific technology are identical or substantially equivalent to legally marketed predicate devices, implying comparable safety and effectiveness. | "The indications for use and materials of the PROFEMUR® RENAISSANCE™ Hip Stem are identical to the predicate devices. The design features... are substantially equivalent to those of the predicate devices. The fundamental scientific technology... has not changed relative to the predicate devices." |
Regarding AI/ML-specific questions:
- 2. Sample size used for the test set and the data provenance: Not applicable. This is a physical medical device.
- 3. Number of experts used to establish the ground truth... and qualifications: Not applicable.
- 4. Adjudication method: Not applicable.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done... effect size: Not applicable.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- 7. The type of ground truth used: For a physical device, "ground truth" would relate to engineering specifications, material properties, and clinical outcomes data from studies of similar devices or the device itself (if clinical trials were performed, though not detailed here for 510k). The 510(k) primarily relies on substantial equivalence to predicate devices.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria (as interpreted for a 510(k) submission):
The "study" or justification for the PROFEMUR® RENAISSANCE™ Hip Stem meeting regulatory requirements is primarily the demonstration of substantial equivalence to legally marketed predicate devices, as detailed in section C, "SUBSTANTIAL EQUIVALENCE INFORMATION" on page 1.
The document states:
"The indications for use and materials of the PROFEMUR® RENAISSANCE™ Hip Stem are identical to the predicate devices. The design features of the PROFEMUR® RENAISSANCE™ Hip Stem are substantially equivalent to those of the predicate devices. The fundamental scientific technology of the modified device has not changed relative to the predicate devices. The safety and effectiveness of the PROFEMUR® RENAISSANCE™ Hip Stem are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification."
This means that instead of conducting a new, elaborate clinical trial (which PMA devices often require), the manufacturer asserts that their device is sufficiently similar to devices already approved and on the market to be considered safe and effective for its stated indications. The supporting data would include:
- Comparison tables: Detailing specifications of the new device against predicate devices (not provided in this summary, but would be in the full submission).
- Material information: Documentation of the titanium alloy (Ti6A14V) and other coatings used, along with biocompatibility data.
- Analysis data: This would typically refer to non-clinical testing, such as mechanical testing (e.g., fatigue, static strength) to ensure the device meets engineering specifications and performs comparably to predicate devices under stress.
The FDA's letter (pages 2-3) confirms that based on the provided information, they found the device substantially equivalent, allowing it to proceed to market.
§ 888.3320 Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis is a two-part device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with a cemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with a cemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with a cemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.