(50 days)
The Stryker 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 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.
This hip is intended for cementless use only.
This Special 510(k) submission is a line extension to address modifications to the Stryker Modular Hip System. This line extension extends the combined head/neck length options.
This document describes a Special 510(k) submission for a line extension to the Stryker Modular Hip System, specifically addressing modifications to extend combined head/neck length options for the Rejuvenate Modular Hip System.
This submission is primarily concerned with demonstrating substantial equivalence to a previously cleared predicate device (Stryker Modular Hip cleared under K07182). Therefore, the provided text does not contain typical "acceptance criteria" based on quantitative performance metrics, nor does it detail a study proving device performance against such criteria in the way a diagnostic AI device would. Instead, the "acceptance criteria" here inherently relate to meeting the requirements for substantial equivalence, meaning the modifications do not raise new questions of safety and effectiveness.
Here's an analysis based on the provided information, addressing your requested points where applicable:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, there are no explicit quantitative "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for a medical device like a hip implant line extension in this type of submission. The "acceptance criteria" are the regulatory requirements for demonstrating substantial equivalence. The "reported device performance" is the assertion of equivalence to the predicate.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (as stated in submission) |
|---|---|
| Maintain intended use | "The Rejuvenate Modular Hip System is substantially equivalent to the Stryker Modular Hip cleared under K07182 in regards to intended use..." |
| Maintain design principles/features | "...design..." |
| Maintain material properties | "...materials..." |
| Maintain operational principles | "...and operational principles as a hip prosthesis." |
| No new questions of safety or effectiveness raised by modifications (line extension for head/neck length options) | Implicitly met by the FDA's clearance of substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a submission for a mechanical device (hip implant line extension), not a diagnostic device involving a test set of data. The "test" is an engineering and regulatory assessment, not a clinical data-based evaluation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth as typically understood for diagnostic AI (e.g., expert consensus on medical images) is not relevant for this type of medical device submission. The "ground truth" here is regulatory compliance and engineering principles.
4. Adjudication Method for the Test Set
Not applicable for the same reasons as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for diagnostic imaging or AI performance with human readers. This is a mechanical implant device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No. This is not an algorithmic or AI device.
7. The Type of Ground Truth Used
Not applicable in the context of diagnostic AI. For this device, the "ground truth" for regulatory assessment is based on:
- Engineering design specifications and analysis.
- Material testing.
- Comparison to the predicate device's established safety and effectiveness.
- Compliance with relevant standards (though not explicitly detailed in the provided excerpt).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Summary of the Study Proving the Device Meets Acceptance Criteria
The "study" in this context is the Special 510(k) submission process itself, where the manufacturer (Howmedica Osteonics Corp.) demonstrates that the modified Rejuvenate Modular Hip System (line extension for combined head/neck length options) is substantially equivalent to a previously cleared predicate device, the Stryker Modular Hip (K07182).
The key "proof" provided in the document for meeting this acceptance criterion is the direct statement:
- "With the addition of this line extension The Rejuvenate Modular Hip System is substantially equivalent to the Stryker Modular Hip cleared under K07182 in regards to intended use, design, materials, and operational principles as a hip prosthesis."
This statement, along with the detailed technical information (which is not fully provided in this excerpt but would be part of the complete 510(k) submission), forms the basis for the FDA's decision. The FDA's issuance of the 510(k) clearance letter on June 3, 2008, confirms that the Agency found the device to be substantially equivalent. This means the FDA agreed that the modifications (line extension for head/neck length options) did not introduce new safety or effectiveness concerns compared to the predicate device.
The study is essentially a technical assessment and comparison rather than a clinical trial or performance study against quantitative metrics like those used for AI/diagnostic 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.