(78 days)
The indications for the use of the Osteonics® Restoration Acetabular Rings, in keeping with those of other legally marketed Osteonics acetabular components, are as follows:
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid . arthritis, post-traumatic arthritis or late stage avascular necrosis.
- . Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques . are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques o as indicated by deficiencies of the acetabulum.
- . Class II cavitary or protrusio defects.
The Osteonics Restoration Acetabular Rings are single use components which are intended for placement within the acetabulum, and which are intended to provide an articulating surface for corresponding, Osteonics' femoral head/stem components. Each Osteonics" Restoration Acetabular Ring is assembled from two separate components: an Osteonics" Restoration Acetabular Shell and a predicate Osteonics Omnifit "Cup Insert, Osteonics "Concentric Polyethylene Acetabular Cup, or Osteonics Flanged Polyethylene Acetabular Cup.
The bodies of the Osteonics" Omnifit" Cup Insert, Osteonics" Concentric Polyethylene Acetabular Cup, and Osteonics" Flanged Polyethylene Acetabular Cup are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The Osteonics Omnifit" Cup Insert, Osteonics Concentric Polyethylene Acetabular Cup, or Osteonics Flanged Polyethylene Acetabular Cup, when used with the Osteonics" Restoration Acetabular Ring, is intended to be affixed to the shell via polymethylmethacrylate (PMMA) bone cement.
The Osteonics" Restoration Acetabular Rings are manufactured from ASTM F-67 Commercially Pure Titanium (CP Ti). The shells are available in a range of outer diameter shell sizes. The Osteonics Restoration Acetabular Ring features a basic spherical geometry, thirteen or sixteen acetabular dome screw holes (depending on the size of the shell), a built up 20° superior lip, an inferiorly located acetabular notch hook, and satin-finished interior and exterior surfaces.
Bone screws placed through the dome and/or lip of the acetabular shell are used to secure the Osteonics" Restoration Acetabular Ring within the prepared acetabulum. The shells are designed to allow some of the bone cement (used to fix the polyethylene liner to the shell) to be extruded through any unoccupied acetabular dome screw holes. In addition to traditional acetabular dome screws, and in order to further enhance the potential for initial and long term stable shell fixation despite small bony defects, the Osteonics" Restoration Acetabular Ring employs an inferior hook and a superior lip. The inferior hook is crimped around the acetabular notch. The superior lip of the shell covers the superior rim of the acetabular cavity and can be secured to the acetabulum with 6.5mm cancellous bone screws.
The provided document is a 510(k) Premarket Notification Summary for a medical device (Osteonics® Restoration Acetabular Ring). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a full clinical efficacy study with acceptance criteria and performance metrics in the way a novel device might.
Therefore, the document does not contain information typically found in acceptance criteria and study designs for validating AI/software performance, such as sensitivity, specificity, or reader studies. Instead, it relies on demonstrating equivalence through material properties, design, and mechanical testing.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device: | |
| - Substrate material equivalence | - Osteonics® Restoration Acetabular Shells are substantially equivalent in terms of substrate material (ASTM F-67 Commercially Pure Titanium (CP Ti)) to the legally marketed, non-plated cup version in the predicate Osteonics® Restoration Acetabular Cup Series. |
| - Indications for use equivalence | - Osteonics® Restoration Acetabular Shells are substantially equivalent in terms of indications for use to the legally marketed, non-plated cup version in the predicate Osteonics® Restoration Acetabular Cup Series. (Specific indications listed: Painful, disabling joint disease from various arthritides or avascular necrosis; revision of previous unsuccessful procedures; clinical management problems; poor/inadequate bone stock; Class II cavitary or protrusio defects.) |
| - Availability of screw holes for acetabular screw fixation equivalence | - Osteonics® Restoration Acetabular Shells are substantially equivalent in terms of availability of screw holes for the employment of acetabular screw fixation to the legally marketed, non-plated cup version in the predicate Osteonics® Restoration Acetabular Cup Series. (Device features thirteen or sixteen acetabular dome screw holes depending on size). |
| - Basic geometry equivalence | - The cup geometry of the Osteonics® Restoration Acetabular Rings is spherical, and as such, is substantially equivalent in terms of its basic geometry to the predicate Osteonics® Restoration Acetabular Cup Series. |
| - Design and function of inferior hook and superior lip equivalence | - The inferior hook and superior lip of the Osteonics® Restoration Acetabular Rings are substantially equivalent in terms of design and function to similar characteristics featured on the non-plated cup version in the Osteonics® Restoration Acetabular Cup Series. |
| - Required bone screw type equivalence | - The bone screws which are required for use with Osteonics® Restoration Acetabular Ring are the 6.5mm Osteonics® Restoration GAP Plate Screws, implying equivalence or compatibility with the predicate system’s screw requirements. |
| - Insert compatibility | - The inserts used are predicate Osteonics® Omnifit™ Cup Inserts, Osteonics® Concentric Polyethylene Acetabular Cup, or Osteonics® Flanged Polyethylene Acetabular Cup. |
| - Shell/insert assembly method equivalence (cemented fixation) | - These inserts are assembled to the Osteonics® Restoration Acetabular Ring Shells through the use of bone cement. This assembly method is predicated by the Osteonics® Restoration Acetabular Cups, demonstrating substantial equivalence in assembly method. |
| Functional/Mechanical Performance: | |
| - Adequate fatigue strength | - "Mechanical testing has been performed to demonstrate the substantial equivalence of this Osteonics® acetabular ring design to predicate acetabular cup designs in terms of its fatigue strength..." (Specific quantitative results or pass/fail criteria for fatigue strength are not provided in this summary). |
| - Adequate shell/insert assembly strength | - "...and shell/insert assembly method." (Specific quantitative results or pass/fail criteria for assembly strength are not provided in this summary). |
Detailed Study Information (Based on interpretation of a 510(k) submission which does not involve traditional clinical studies):
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2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable in the context of human data. For mechanical testing, the specific number of test articles is not mentioned, but it would typically involve a statistically relevant number to demonstrate fatigue and assembly strength.
- Data Provenance: Not applicable as this is a premarket notification primarily based on design and mechanical equivalence to an existing device. The mechanical testing would have been conducted in a lab environment.
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3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. Ground truth, in the clinical sense, is not established for this type of submission. "Ground truth" here is effectively the accepted design, material, and performance characteristics of the predicate device, against which the new device is compared. This comparison is performed by engineers and regulatory personnel, not clinical experts establishing a diagnosis.
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4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no clinical test set requiring adjudication in the context of expert consensus or diagnostic accuracy.
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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 diagnostic device.
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6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hip implant, not an algorithm.
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7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this submission is implicitly the established safety and efficacy profile, material specifications, and design principles of the predicate device (Osteonics® Restoration Acetabular Cup Series), as demonstrated through historical use and prior FDA clearance. The new device is deemed "substantially equivalent" if it meets these established characteristics. Mechanical testing results for fatigue strength and assembly method further support this equivalence for the physical attributes.
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8. The sample size for the training set
- Not applicable. There is no "training set" for physical device equivalence.
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9. How the ground truth for the training set was established
- Not applicable.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.