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510(k) Data Aggregation
(67 days)
The ULTIMA® Acetabular Roof Reinforcement Ring is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstructive techniques.
The Ultima® Acetabular Roof Reinforcement Ring is secured in the prepared acetabulum using a combination of Polymethylmethacrylate (PMMA) bone cement, bone allograft, and cancellous screws to provide stabilization.
The ULTIMA® Acetabular Roof Reinforcement Ring is a support component for the reconstruction of the acetabulum and is composed of commercially pure titanium (cp Ti). The ULTIMA® Acetabular Roof Reinforcement Ring is a hemispherical shell with a mesh of screw holes covering the shell to allow for use with cancellous screws for additional stabilization.
The ULTIMA® Acetabular Roof Reinforcement Ring is used in conjunction with the ULTIMA® UHMWPE Acetabular Cup and Augmented UHMWPE Cup, and is held into the prepared acetabulum using a combination of Polymethylmethacrylate (PMMA) bone cement, bone allograft, and cancellous screws to provide primary stabilization.
The ULTIMA® Acetabular Roof Reinforcement Rings will be available in a range of designated sizes from 40mm through 62mm in 2mm increments. The nominal outer diameter of the ULTIMA® Acetabular Roof Reinforcement Ring is the same as the designated size.
The instrumentation used for implanting the ULTIMA® Acetabular Roof Reinforcement Ring includes a drill guide, 70mm drill, flexible shaft, depth gauge, tap and screw clamp, hemispherical reamers and a universal screw driver.
The provided text is a 510(k) summary for the ULTIMA® Acetabular Roof Reinforcement Ring, which is a medical device. This type of document is a premarket notification to the FDA, demonstrating that a new device is substantially equivalent to a legally marketed predicate device.
Therefore, the document does not describe "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the context of clinical performance or diagnostic accuracy studies for AI/ML devices.
Instead, the document focuses on demonstrating substantial equivalence to an existing predicate device based on aspects like intended use, materials, design, sterilization, and packaging. The "acceptance criteria" in this context would be the FDA's regulatory requirements for 510(k) clearance, primarily demonstrating that the device is as safe and effective as a legally marketed predicate device.
Here's how to address the prompt based on the provided document:
1. A table of acceptance criteria and the reported device performance
This information is not directly available in the document in the format of a clinical performance study with specific metrics like sensitivity, specificity, or F1 score. The acceptance criteria for this 510(k) revolve around demonstrating substantial equivalence.
| Acceptance Criteria (for 510(k) Clearance) | Reported Device Performance (as per 510(k) Submission) |
|---|---|
| Intended Use: Same as predicate device | The ULTIMA® Acetabular Roof Reinforcement Ring is indicated for total hip replacement procedures for various conditions (rheumatoid arthritis, osteoarthritis, etc.), similar to other existing devices. |
| Materials: Same or equivalent to predicate device | Composed of commercially pure titanium (cp Ti), a commonly used and accepted material in orthopedic implants. |
| Design: Same or equivalent to predicate device | Hemispherical shell with a mesh of screw holes, available in 40mm through 62mm sizes. This design is compared to the Protek Roof Reinforcement Ring (K953578). |
| Sterilization Method: Same or equivalent | (Not explicitly detailed in the provided text, but implied to be standard and equivalent for orthopedic implants.) |
| Packaging: Same or equivalent | (Not explicitly detailed in the provided text, but implied to be standard and equivalent for orthopedic implants.) |
| Performance Standards: Conformance to voluntary standards | Conformance with voluntary performance standards, e.g., ASTM F-67 (Standard Specification for Unalloyed Titanium, for Surgical Implant Applications). This implies the material meets established quality and performance benchmarks. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not applicable/provided. This 510(k) summary does not describe a clinical study with a test set of patient data to evaluate device performance in the way an AI/ML device would be evaluated for diagnostic accuracy. The basis for clearance is substantial equivalence to a predicate device.
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)
This information is not applicable/provided. No ground truth for a test set is established in this summary, as it's not a clinical performance study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable/provided. No adjudication method for a test set is described.
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
This information is not applicable/provided. This is a medical device (an acetabular roof reinforcement ring), not an AI/ML diagnostic or assistive device. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable/provided. The concept of "ground truth" as it applies to clinical performance evaluation (e.g., for diagnostic accuracy) does not apply to this type of medical device submission. The "truth" for this submission is that it is substantially equivalent to a predicate device based on its technical characteristics and intended use.
8. The sample size for the training set
This information is not applicable/provided. This device is not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/provided. This device is not an AI/ML model that requires a training set with established ground truth.
In summary: The provided document is a 510(k) premarket notification for a physical medical implant (an acetabular roof reinforcement ring). It establishes substantial equivalence to a predicate device based on design, materials, and intended use, rather than presenting clinical study data with acceptance criteria for diagnostic performance or AI algorithm accuracy. Therefore, most of the questions posed, which are highly relevant to AI/ML device evaluations, are not applicable to this document.
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