(86 days)
This device is indicated in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
1 . Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
2. Inflammatory degenerative joint disease such as rheumatoid arthritis:
3. Correction of function deformity:
Revision procedures where other treatments or devices have 4. failed; and
5. Treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
This device is intended for use with bone cement.
The Dual Offset PERFECTA® IMC Hip Stem is manufactured from cobalt chrome alloy (ASTM F 799). The stem is available in standard and long lengths and features a collar. The stem is designed to be used with bone cement.
This document describes a medical device, the Dual Offset PERFECTA® IMC Hip Stem, and its testing. It is a 510(k) summary, which indicates it's a submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.
Here's the breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Required Performance) | Reported Device Performance | Unit |
|---|---|---|
| Withstand a load of 2300N for at least 5 million cycles | Withstood 2300N for at least 5 million cycles | N for cycles |
| At 10 hertz | Tested at 10 hertz | hertz |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "Submitted testing indicates," implying that the testing was performed on at least one device, but the exact number of units tested is not provided.
- Data Provenance: Not explicitly stated. This is a 510(k) submission from a manufacturer (Wright Medical Technology, Inc.), so the testing was presumably conducted by or for the manufacturer. The country of origin of the data is not specified, but the manufacturer is based in Arlington, Tennessee, USA. The study appears to be a prospective mechanical test, not reliant on patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- This type of mechanical testing study does not involve "experts" establishing ground truth in the traditional sense of clinical studies. The ground truth is the physical properties and performance of the device under specific load conditions, measured by engineering protocols and equipment.
- Therefore, the concept of "number of experts" and their qualifications as typically applied to medical image analysis or clinical diagnosis is not relevant here.
4. Adjudication Method for the Test Set
- Not applicable. This is a mechanical engineering test, not a clinical study requiring adjudication of expert opinions. The outcome is determined by whether the device meets the specified physical performance criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This document describes a mechanical test of a hip stem's durability, not a study involving human readers or AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No, a standalone algorithm performance study was not done. This document describes the mechanical testing of a physical medical device. The concept of an "algorithm" as applied in AI/software is not relevant here.
7. Type of Ground Truth Used
- The ground truth used is based on engineering specifications and mechanical testing results. The "truth" is whether the device physically endured the specified load and cycles without failure.
8. Sample Size for the Training Set
- Not applicable. This is a mechanical test of a physical device, not an AI/machine learning study that would involve a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set in this context.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.