(90 days)
The Rejuvenate Monolithic 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 Howmedica Osteonics acetabular components, V40 femoral 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 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 are unmanageable using other techniques.
- Stryker's Rejuvenate Hip System is intended for cementless use only.
Howmedica Osteonics is introducing a monolithic hip prosthesis. The basic design of the Rejuvenate Monolithic Hip System is similar to other total hip systems commercially distributed such as the Secur-Fit HA Stem and the Accolade TMZF HA Stems.
The subject hip is composed of a monolithic stem intended for cementless, press-fit application. It is designed for use with currently available Howmedica Osteonics' femoral heads, bipolars and their compatible acetabular components.
The provided text describes a 510(k) premarket notification for a medical device, the "Rejuvenate Monolithic Stem" (a hip prosthesis). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with detailed acceptance criteria and performance metrics typically seen in studies designed to prove efficacy or meet specific performance targets.
Therefore, the information required for items 1-9 in your request is not explicitly available in the provided document, as a 510(k) summary for a hip prosthesis does not typically include detailed performance data from clinical trials or standalone algorithm evaluations. Instead, it relies on demonstrating equivalence through design, materials, intended use, and mechanical testing.
However, I can extract information related to the device and its claimed equivalence.
Here's an analysis based on the provided text, addressing your points where possible and noting where information is absent:
Analysis of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria for the Rejuvenate Monolithic Stem
The provided document is a 510(k) Summary of Safety and Effectiveness for the Rejuvenate Monolithic Stem, a hip prosthesis. In the context of a 510(k) submission, "acceptance criteria" are generally tied to demonstrating substantial equivalence to legally marketed predicate devices, rather than predefined clinical performance thresholds. The "study" that proves the device meets these criteria primarily involves mechanical testing and comparison of design, materials, and intended use with the predicate devices.
1. A table of acceptance criteria and the reported device performance
As this is a 510(k) submission, explicit "acceptance criteria" in terms of specific performance metrics (like sensitivity, specificity, accuracy) from a clinical study are not provided. The acceptance criteria for a 510(k) are implicitly focused on demonstrating that the device is as safe and effective as a predicate device and performs similarly. The "reported device performance" in this context refers to the outcomes of the mechanical testing and the assertion of substantial equivalence.
| Acceptance Criterion (Implicit for 510(k)) | Reported Device Performance (as stated in the document) |
|---|---|
| Substantial Equivalence to Predicate Devices | "The Rejuvenate Monolithic Hip Stem is substantially equivalent to other commercially available hip systems in regards to intended use, design, materials, and operational principles as a hip prosthesis." |
| Mechanical Performance | "Based upon the mechanical testing, the Rejuvenate Monolithic Hip Stem is substantially equivalent for its intended use to other press-fit femoral hip replacement currently on the market." |
| Intended Use | The device is intended for "primary and revision total hip arthroplasty to alleviate pain and restore function," which aligns with the predicate devices. |
| Material Composition | Implied to be equivalent to predicate devices (e.g., Secur-Fit HA Stem and Accolade TMZF HA Stems). |
| Design and Operational Principles | "The basic design... is similar to other total hip systems commercially distributed..." and "substantially equivalent... in regards to... design, materials, and operational principles." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify a "sample size" in the context of a clinical test set. The evaluation was based on mechanical testing, not patient data. Therefore, the concept of a "test set" with patient data (and its provenance, retrospective/prospective nature) is not applicable here.
- Data Provenance: Not applicable as it refers to mechanical testing data, not human patient data.
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)
- This information is not applicable to a 510(k) submission for a hip prosthesis that relies on mechanical testing. There was no clinical ground truth established by experts for a test set of patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable. No clinical test set requiring expert adjudication was described.
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
- This information is not applicable. The device is a hip prosthesis, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable. The device is a hip prosthesis, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for demonstrating substantial equivalence for this device would be established by engineering standards and mechanical testing results compared against the known performance characteristics of the predicate devices. There is no biological or clinical "ground truth" as would be established by pathology or outcomes data in this submission.
8. The sample size for the training set
- This information is not applicable. There is no "training set" as this is not an AI/machine learning device. The design and manufacturing processes are likely informed by years of historical engineering data and clinical experience with similar devices, but this is not referred to as a "training set."
9. How the ground truth for the training set was established
- This information is not applicable as there is no training set as defined for AI/machine learning devices.
§ 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.