(60 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:
- Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- Inflammatory degenerative joint disease such as rheumatoid arthritis;
- Correction of function 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.
The PERFECTA® RS Lateralized Hip Stem is manufactured from titanium alloy (ASTM F 136). The stem is designed to provide an increased offset during total joint replacement. The stem is available in standard lengths and features a collared and collarless version. The stem has a plasma spray coating on the posterior portion of the stem. The distal portion of the stem features a coronal slot and distal flutes. The stem is designed for press-fit applications.
Here's an analysis of the provided text regarding the acceptance criteria and study for the PERFECTA® RS Lateralized Hip Stem:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meets requirements cited in FDA Guidance Documents. | "Mechanical test data demonstrated that it meets the requirements cited in the FDA Guidance Documents." |
| Substantially equivalent to predicate devices. | "The PERFECTA® RS Lateralized Hip Stem was declared substantially equivalent to the predicate devices." (Predicate devices listed as Dual Offset PERFECTA® IMC Hip Stem and BRIDGE® Hip System). |
| Indicated for specific conditions in total hip arthroplasty (THA). | The device is indicated for reduction or relief of pain and/or improved hip function in skeletally mature patients with: |
- Non-inflammatory degenerative joint disease (e.g., osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, painful hip dysplasia)
- Inflammatory degenerative joint disease (e.g., rheumatoid arthritis)
- Correction of function deformity
- Revision procedures where other treatments or devices have failed
- Treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. |
| Performance demonstrated through "Mechanical test data" | The text explicitly states "Mechanical test data demonstrated that it meets the requirements cited in the FDA Guidance Documents." This implies the performance criteria were related to the mechanical properties and integrity of the hip stem for its intended use. However, the specific numerical or qualitative acceptance thresholds for these mechanical tests are not detailed in the provided summary. |
2. Sample Size Used for the Test Set and Data Provenance
The provided summary does not specify the sample size used for any test set nor does it mention the data provenance (e.g., country of origin, retrospective/prospective). The document refers to "Mechanical test data" but provides no details on the number of samples tested.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The evaluation of the device's performance relies on "Mechanical test data," which typically does not involve human experts establishing ground truth in the same way clinical imaging or diagnostic AI studies would.
4. Adjudication Method for the Test Set
This information is not applicable/provided. Since the evaluation is based on "mechanical test data" rather than expert interpretation of clinical cases, there wouldn't be an adjudication method in the context described (e.g., 2+1 radiologist review).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document focuses on mechanical testing for substantial equivalence, not on comparing performance with or without AI assistance for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone study in the context of an algorithm's performance was not done. This document is about a medical device (hip stem), not an algorithm or AI system. The "stand-alone" evaluation refers to the device's mechanical properties.
7. The Type of Ground Truth Used
The ground truth used was based on benchmarked mechanical properties/performance standards as outlined in FDA Guidance Documents. The "mechanical test data" for the device was compared against these established standards to determine if it "meets the requirements." This is analogous to engineering specifications rather than clinical outcomes, pathology, or expert consensus on clinical cases.
8. The Sample Size for the Training Set
This information is not applicable/provided. The PERFECTA® RS Lateralized Hip Stem is a physical medical device, not an AI model requiring a training set in the conventional sense. The "training" in this context would be the design, manufacturing, and preclinical testing phases, but not a data-driven training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided for the reasons stated in point 8. The "ground truth" for the device's design and manufacturing would be engineering specifications, material properties, and established biomechanical principles, which are inherent to the product development process, not a "training set."
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.