(56 days)
The Rejuvenate Monolithic size 4 Hip Stem is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used with any currently available compatible Howmedica Osteonics acetabular components; V40 femoral heads, V40 Alumina Heads, C-Taper Alumina heads when used with the V40/C-Taper Adaptor and the Biolox® Delta Universal Taper Heads and sleeves.
The indications for use of the total hip replacement prostheses include:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis:
- Rheumatoid arthritis;
- Correction of functional deformity;
- Revision procedures where other treatments or devices have failed: and,
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that is unmanageable using other techniques.
Stryker's Rejuvenate Hip System is intended for cementless use only.
The Rejuvenate Monolithic Size 4 Hip stem is part of the previously cleared Rejuvenate Monolithic Hip System. The size 4 monolithic hip stem is intended for cementless. press-fit application. It is designed for use with the available compatible Howmedica Osteonics' femoral heads, bipolars and their compatible acetabular components.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Rejuvenate Monolithic Size 4 Hip Stem:
Analysis:
This submission is a 510(k) Premarket Notification for a medical device. In 510(k) submissions, the primary "study" that proves the device meets acceptance criteria is often a demonstration of substantial equivalence to an already legally marketed (predicate) device. The acceptance criteria are therefore implicitly the performance characteristics and safety profile of the predicate device.
The provided document does not contain explicit performance acceptance criteria or a formal clinical study report with the specific details requested in your prompt (e.g., sample sizes, expert qualifications, MRMC studies, standalone algorithm performance, training set details). Instead, it focuses on the device's description, intended use, indications for use, and the declaration of substantial equivalence.
Here's a breakdown based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Material Properties: Comparable to predicate device. | "The Rejuvenate Monolithic Hip Size 4 Hip Stem is identical to the stems which are part of the previously submitted Rejuvenate Monolithic Hip System in regard to ... materials..." |
| Mechanical Testing Performance: Comparable to predicate device. | "The Rejuvenate Monolithic Hip Size 4 Hip Stem is identical to the stems which are part of the previously submitted Rejuvenate Monolithic Hip System in regard to ... mechanical testing..." |
| Design: Comparable to predicate device. | "The Rejuvenate Monolithic Hip Size 4 Hip Stem is identical to the stems which are part of the previously submitted Rejuvenate Monolithic Hip System in regard to ... design..." |
| Intended Use: Identical to predicate device. | "The Rejuvenate Monolithic Hip Size 4 Hip Stem is identical to the stems which are part of the previously submitted Rejuvenate Monolithic Hip System in regard to intended use..." The stated intended use for the new device is: "sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function" in cementless press-fit application. |
| Operational Principles: Identical to predicate device. | "The Rejuvenate Monolithic Hip Size 4 Hip Stem is identical to the stems which are part of the previously submitted Rejuvenate Monolithic Hip System in regard to ... operational principles as a hip prosthesis." |
| Safety and Effectiveness: Substantially equivalent to predicate device. | The FDA's letter (K091161) states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the uses stated in the enclosure) to legally marketed predicate devices..." |
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable. This document describes a 510(k) submission based on substantial equivalence, not a clinical trial with a "test set" in the context of AI or advanced statistical validation. The "study" here is the comparison to a predicate device.
- The "data provenance" would refer to the technical and performance data of the predicate device, which is not detailed in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. Since there isn't a "test set" or a new diagnostic algorithm being evaluated for accuracy against established ground truth in the AI sense, this information is not relevant to this type of device submission.
- The closest "experts" involved are the FDA reviewers who assessed the substantial equivalence claim.
4. Adjudication Method for the Test Set
- Not Applicable. See point 3.
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 is a hip stem (implantable medical device), not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Substantial Equivalence to a Predicate Device. The "ground truth" for a 510(k) submission like this is the established safety and effectiveness of the legally marketed predicate device(s). The new device is deemed acceptable if it can demonstrate it performs equivalently and raises no new questions of safety or effectiveness.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" in the context of an AI device for this hip stem. The development of the device would involve engineering design, materials science, and mechanical testing, not machine learning training.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8.
Summary of the "Study" and Acceptance Criteria:
The "study" presented in this 510(k) document is the demonstration of substantial equivalence to existing legally marketed predicate devices. The acceptance criteria are, implicitly, that the new device (Rejuvenate Monolithic Size 4 Hip Stem) is identical in intended use, design, materials, mechanical testing, and operational principles to a previously cleared device within the Rejuvenate Monolithic Hip System. The FDA concurred with this assessment, officially concluding that the device is substantially equivalent to legally marketed predicate devices. This means that the device is considered as safe and effective as the predicate devices without needing independent clinical trials or detailed performance metrics as would be required for a novel device or an AI/diagnostic tool.
§ 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.