(60 days)
The Rejuvenate™ Modular Hip 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 acctabular 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.
This hip is intended for cementless use only.
This Special 510(k) submission is a line extension to address modifications to the Rejuvenate™ Modular Hip System. This line extension extends the combined head/neck length options.
This is a 510(k) premarket notification for a hip prosthesis, Rejuvenate™ Modular Hip System. The provided text is a summary of safety and effectiveness. It describes a medical device, not an AI/ML powered device, therefore, a study that proves the device meets the acceptance criteria is not applicable in the typical sense of AI/ML performance metrics.
The submission establishes substantial equivalence to existing predicate devices based on intended use, design, materials, and operational principles, rather than performance against specific acceptance criteria derived from a clinical or diagnostic study with a test set, ground truth, and human reader comparisons.
Therefore, many of your requested points are not relevant to this type of regulatory submission. I will address the relevant points and indicate where information is not available or applicable.
1. A table of acceptance criteria and the reported device performance
For this medical device (a hip prosthesis), "acceptance criteria" are not defined as performance metrics like sensitivity, specificity, or AUC, as would be the case for an AI/ML diagnostic. Instead, the acceptance criteria are met by demonstrating substantial equivalence to legally marketed predicate devices. The "reported device performance" in this context refers to the device's characteristics (design, materials, intended use, indications) that are compared to the predicate.
| Acceptance Criteria (Demonstration of Substantial Equivalence to Predicate Devices K071082 and K081044) | Reported Device Performance (Rejuvenate™ Modular Hip System Line Extension) |
|---|---|
| Same Intended Use | "intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function" |
| Same Indications for Use | Noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, correction of functional deformity, revision procedures, treatment of nonunion/fractures. Intended for cementless use only. |
| Similar Design Principles | Line extension to address modifications to combined head/neck length options for a modular hip system. |
| Similar Materials | (Implied to be similar to legally marketed predicate devices, not explicitly detailed in this summary) |
| Similar Operational Principles | (Implied to be similar, not explicitly detailed in this summary) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. This is not an AI/ML study involving a test set of data. The submission relies on comparative analysis with predicate devices and possibly bench testing (though not detailed in this summary) to demonstrate substantial equivalence for a physical medical implant.
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. There is no "ground truth" establishment in the context of a diagnostic test for this type of medical device submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable.
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 not an AI-assisted device.
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 (expert consensus, pathology, outcomes data, etc)
Not applicable. The "truth" in this context is established by the safety and effectiveness profile of the predicate devices.
8. The sample size for the training set
Not applicable. This is not an AI/ML product developed with a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.