(58 days)
Intended Use: The Osteonics® Normalized AD Acetabular Components are single-use devices. The shells are intended for cemented or cementless fixation within the prepared acetabulum. The Osteonics® Normalized AD Acetabular Components are compatible with any appropriately selected Osteonics hip stem/femoral head combination.
Indications: The indications for the use of the Osteonics® Normalized AD Acetabular Components, 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, theumatoid 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 as . indicated by deficiencies of the acetabulum.
Each Osteonics® Normalized AD Acetabular Component consists of two pieces: an Osteonics® Normalized AD Acetabular Shell and an Osteonics® Omnifit® Scalloped Cup Insert. The metal shell is intended for cemented or cementless fixation within the prepared acetabulum.
The Osteonics" Normalized AD Acetabular Shells are characterized by the following features:
- · A basic spherical and tangent radii design.
- An interior geometry which allows a mating polyethylene insert size to be used with more than one shell size.
- Peripheral screw holes. ●
- A dome hole which is compatible with the optional, currently marketed Osteonics" Acetabular . Dome Hole Plugs.
- Circumferential normalizations.
- . A wide range of sizes from 50mm to 80mm.
- One of two screw hole configurations:
- 6 peripheral screw holes and no dome screw holes, ।
- 6 peripheral screw holes, and 5-7 dome screw holes. ।
- . Osteonics' AD (arc deposited) coating.
The Osteonics® Omnifit® Scalloped Cup Inserts are available in 0°, 10°, and 20° configurations. These inserts differ from the predicate Osteonics® Omnifit® Cup Inserts in that they feature a scalloped rim. The scalloped rim allows for clearance between bone screws (which may be placed in the peripheral screw holes of the shell) and the insert's rim.
This document is a 510(k) Premarket Notification Summary for a medical device (an acetabular component system) and focuses on demonstrating substantial equivalence to previously approved predicate devices, rather than presenting a study to prove acceptance criteria in the way one would for a novel, high-risk device or an AI/software device. As such, much of the requested information (like AI-specific performance metrics, sample sizes for test/training sets, expert qualifications, etc.) is not applicable or not provided in this type of submission.
However, I can extract the information relevant to the device's "acceptance criteria" and the "study" demonstrating its meeting those criteria, based on the context of a 510(k) submission for an orthopedic implant.
Here's an analysis of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For this orthopedic implant, the "acceptance criteria" are implied by demonstrating substantial equivalence to a predicate device. This means the new device must perform in a manner that is functionally equivalent and does not raise new questions of safety or effectiveness compared to the predicate. The "performance" is therefore the successful demonstration of this equivalence across various aspects.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: Same indications for use. | The Osteonics® Normalized AD Acetabular Components share the same intended use (cemented or cementless fixation within the prepared acetabulum, compatible with Osteonics hip stem/femoral head) and indications for use (painful, disabling joint disease, revision, clinical management problems where alternatives are less likely to succeed, poor bone stock) as legally marketed Osteonics acetabular components and the predicate devices. |
| Material Equivalence: Same materials for shell and insert. | Shells: Both the subject and predicate (Osteonics® Secur-Fit AD) acetabular shells are manufactured from F-67 CP Titanium and feature Osteonics' AD coating (arc-deposited CP Ti). |
| Inserts: Both the Osteonics® Omnifit® Scalloped Cup Inserts (subject) and predicate Osteonics® Omnifit® Cup Inserts are made from ultra-high molecular weight polyethylene and have a cobalt chromium alloy locking wire. | |
| Design Equivalence (no new safety/effectiveness questions): | The design of the Osteonics Normalized AD Acetabular Shells is consistent with the predicate Osteonics Secur-Fit™-HA PSL® X'tra Acetabular Components with minor differences: |
- Screw Holes: Subject has 6 peripheral screw holes, predicate has 6-8.
- Screw Hole Enclosure: Subject's peripheral screw holes are fully enclosed; predicate's "break out" from the rim.
- Outer Geometry: Subject has hemispherical, tangent radii; predicate has Dual Radius geometry.
- Coating: No HA coating over arc deposition coating on subject.
The Osteonics® Omnifit® Scalloped Cup Inserts differ from predicate in having a scalloped rim. Conclusion: "None of these design differences raises any new questions of safety or effectiveness." |
| Performance Data (AD Coating): Adherence to FDA guidelines for coating. | "A complete battery of tests, in accordance with the following FDA guidelines, was conducted to qualify and characterize the AD coating of the subject devices: FDA's 'Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement, April 28, 1994.'" (Specific results of these tests are not provided in this summary but are referenced as having been done). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of this 510(k) submission. This is a pre-market notification for a physical device, relying on material and design comparisons and established performance data for its components. There isn't a "test set" in the sense of clinical patient data or algorithm performance data that would have a defined sample size. The "testing" refers to benchtop or lab-based characterization of the material and design.
- Data Provenance: Not applicable in the sense of country of origin for patient data. The "data" refers to engineering and material testing performed by the manufacturer, Osteonics Corporation, located in Allendale, NJ, USA. The testing was conducted according to FDA guidelines.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts/Qualifications: Not applicable. Ground truth, in the typical sense of expert consensus for diagnostic accuracy, is not relevant here. The "ground truth" for the device's safety and effectiveness is established by comparison to a legally marketed predicate device, as confirmed by regulatory review and the scientific understanding of the materials and design by engineers and regulatory bodies.
4. Adjudication Method
- Adjudication Method: Not applicable. This concept is typically relevant for studies involving human interpretation or subjective assessments, often in diagnostic imaging. Here, the assessment is based on objective material properties, design specifications, and compliance with established regulatory guidelines.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done, and is not relevant for this type of device submission. This is a common study type for AI-powered diagnostic tools to assess performance with and without AI assistance. This document is for a physical orthopedic implant.
6. Standalone Performance Study
- Standalone Performance Study: No, a "standalone" study in the sense of an algorithm's performance without human-in-the-loop was not done. The performance data mentioned (for the AD coating) refers to benchtop testing validating material properties, not an AI algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: For a 510(k) for an orthopedic implant, the "ground truth" is established by:
- Predicate Device History: The predicate devices used for comparison have a history of safe and effective use in the market.
- Biocompatibility and Material Standards: Adherence to established standards for materials (e.g., F-67 CP Titanium, UHMWPE) and coatings.
- Engineering Principles: Soundness of the mechanical and structural design based on engineering principles.
- Regulatory Guidance: Compliance with FDA's "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement."
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. There is no software or AI algorithm being trained in this context.
9. How the Ground Truth for the Training Set Was Established
- Training Set Ground Truth: Not applicable, as there is no training set mentioned.
§ 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.