(53 days)
The Restoration™ Modular System is intended to be used for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. The stems are intended to be used with Howmedica Osteonics femoral heads, unipolar and bipolar components, and acetabular components. These femoral stems are designed to be press fit into the proximal femur.
The 2 Piece Modular Hip Stem, hereby referred to as the Restoration™ Modular System, is a modular system comprised of a proximal body, distal stem, and locking bolt. These three individual components utilizing a modular junction are assembled by the surgeon in the operating room or in situ to allow independent sizing of the proximal body and distal This system is designed so that all proximal components will be able to mate with stem. all distal components, thus affording optimal flexibility. The Restoration™ Modular System components will be fabricated from Titanium (Ti6Al-4V) Alloy. The Cone and Broached body components as well as the Porous Stems will be offered with plasma spray or plasma spray and hydroxylapatite coatings.
The Restoration™ Modular System is a medical device designed for hip arthroplasty. The provided text outlines a 510(k) summary for a device modification to a 2-piece modular revision stem system. The study conducted to demonstrate its performance focuses on mechanical properties rather than AI/human reader performance.
Here's a breakdown of the requested information based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly based on the mechanical strength and integrity required for femoral hip prostheses, as dictated by relevant international standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meet or exceed defined performance values for mechanical strength of neck, proximal body, and distal stem regions. | "All tested components meet or exceed their defined performance values." |
| Demonstrate substantial equivalence in terms of safety and effectiveness to the legally marketed predicate components' mechanical properties. | "The testing demonstrates that, in terms of mechanical properties, the modified Restoration™ Modular Components are substantially equivalent to the legally marketed predicate components in terms of safety and effectiveness." |
Note: The document does not explicitly state numerical acceptance criteria, but rather general compliance with "defined performance values" and substantial equivalence to a predicate device.
2. Sample Size and Data Provenance for the Test Set
- Sample Size: The document mentions "A series of fatigue tests were performed" and "Most severe case' components/assemblies were tested." However, it does not specify the exact number of samples (sample size) used for the test set.
- Data Provenance: The study was conducted by Howmedica Osteonics Corp., a US-based company. The nature of these tests (fatigue tests on physical components) implies a prospective generation of data in a laboratory setting rather than retrospective analysis of patient data. There is no information on country of origin of data in terms of patient data, as this is a mechanical test.
3. Number of Experts and Qualifications for Ground Truth of Test Set
- Not Applicable: This study is a mechanical performance study of a prosthetic device, not a study evaluating diagnostic accuracy based on expert interpretation of medical images or clinical outcomes. Therefore, there were no human experts used to establish a ground truth for a test set in the traditional sense of a clinical or diagnostic study. The "ground truth" here is the physical performance of the device against engineering standards.
4. Adjudication Method for the Test Set
- Not Applicable: As this is a mechanical performance study, there was no adjudication method for a test set involving human interpretation or consensus. The performance is objectively measured against pre-defined engineering parameters and standards (ISO 7206-4 and ISO 7206-6).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No: The document explicitly states, "A series of fatigue tests were performed to ensure the integrity of the Restoration™ Modular System." This is a mechanical engineering study, not an MRMC study comparing human readers with and without AI assistance. Therefore, no effect size for human readers improving with/without AI assistance is reported.
6. Standalone Performance Study (Algorithm only without human-in-the-loop)
- Not Applicable: This device is a physical medical implant, not a software algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop) performance" does not apply. The study focuses on the standalone mechanical performance of the device itself.
7. Type of Ground Truth Used for the Test Set
- Engineering Standards and Predicate Device Performance: The ground truth for the test set's performance was established by "defined performance criteria" derived from ISO 7206-4 and ISO 7206-6 (international standards for hip joint prostheses) and by comparison to the mechanical properties of a legally marketed predicate device (Restoration™ Modular (2 Piece Modular System) (K013106)).
8. Sample Size for the Training Set
- Not Applicable: This is a mechanical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data used to train a model. The design and testing are based on engineering principles and material science.
9. How the Ground Truth for the Training Set was Established
- Not Applicable: As there is no training set for an AI model, there is no ground truth established for a training set. The device design itself is based on established engineering principles for biomechanics and material compatibility.
§ 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.