(65 days)
Joint replacement is indicated for patients suffering from disability due to:
- non inflammatory degenerative joint disease including osteoarthritis and avascular necrosis . of the natural femoral head
- rheumatoid arthritis ●
- correction of functional deformity ●
- femoral fracture .
This device may also be indicated in the salvage of previously failed surgical attempts.
The constrained acetabular component is indicated for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuronuscular disease, or intra-operative instability and for who all other options to constrained acetabulati components have been considered.
The device is intended for cementless applications.
This device has an asymmetrical body with an anterior build up that requires right and left components. When a symmetrical implant is used a large amount of cancellus bone often remains in the anterior metaphaseal portion of the femur. The anterior built en paovodes a more complete fill of the proximal femur. The proximal body is trapezoidal in cross-sectional geometry and tapers proximal to distal and lateral to medial. The distal stem portion is slightly conical in shape. The Revelation stem is collarless and has a Morse type taper to receive modular heads. The purpose of this application is to add an alternate porous coating.
The provided 510(k) summary is for a medical device called the "Revelation Porous Coated Hip Stem, Size 8," which is a hip implant. This document focuses on demonstrating substantial equivalence to predicate devices through design features, materials, indications, sterilization, packaging, and intended use, rather than presenting a study that establishes acceptance criteria for "device performance" in terms of algorithm metrics or human-AI effectiveness.
Therefore, many of the requested categories for AI/algorithm-centric studies are not applicable to this 510(k) submission.
Here's the breakdown of the information that can be extracted or inferred from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This type of information is typically for software or AI-driven devices where performance metrics like sensitivity, specificity, or reader accuracy are assessed against pre-defined thresholds. For this hip stem, "acceptance criteria" are not framed in terms of performance metrics like those for an AI device. Instead, the acceptance is based on demonstrating substantial equivalence to legally marketed predicate devices through comparable features and non-clinical testing.
| Acceptance Criteria Category | Reported Device Performance (or Demonstration of Equivalence) |
|---|---|
| Porous Coating Characterization | Non-clinical testing performed. (Details of specific characteristic values and acceptance thresholds are not provided in this summary.) |
| Fatigue Testing | Non-clinical testing performed. (Details of specific fatigue limits and acceptance thresholds are not provided in this summary.) |
| Ceramic Burst Assessment | Non-clinical testing performed. (Details of specific burst pressures/strengths and acceptance thresholds are not provided in this summary.) |
| Design Features | Comparable to predicate devices. |
| Materials | Comparable to predicate devices. |
| Indications for Use | Comparable to predicate devices. |
| Sterilization | Comparable to predicate devices. |
| Packaging | Comparable to predicate devices. |
| Intended Use | Comparable to predicate devices. |
2. Sample size used for the test set and the data provenance
Not applicable. This device is a physical implant, not an AI or software device that uses a "test set" of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically understood for AI/software (e.g., radiologist consensus on images) is not relevant for this physical device. The "ground truth" equivalent would be the established engineering and materials science standards for hip implants.
4. Adjudication method 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 a hip implant, not an AI-assisted diagnostic or therapeutic 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.)
For this device, the "ground truth" for demonstrating safety and efficacy is based on:
- Established engineering and material standards for orthopedic implants, assessed through non-clinical laboratory testing (Fatigue testing, Porous coating characterization, Ceramic burst assessment).
- Predicate device history: The regulatory pathway relies heavily on the safety and effectiveness of already marketed "predicate devices" with similar designs, materials, and intended use.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a "training set."
9. How the ground truth for the training set was established
Not applicable.
Summary of Device and Regulatory Context:
This 510(k) submission is for a Revelation Porous Coated Hip Stem, Size 8, an orthopedic implant. The primary method for demonstrating its acceptance and marketability is through substantial equivalence to previously cleared predicate devices. This involves showing that the new device has comparable design features, materials, indications for use, sterilization, packaging, and intended use, along with supportive non-clinical testing (fatigue, porous coating characterization, ceramic burst assessment) to ensure it meets relevant physical and mechanical standards. No clinical testing was provided for this 510(k) submission, indicating that the FDA found the non-clinical data and comparison to predicates sufficient for clearance.
§ 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.