(158 days)
The indications for use of the Ascension Silicone PIP are for cementless replacement of the proximal interphalangeal joint in patients with advanced osteoarthritis, post-traumatic arthritis and rheumatoid arthritis.
The Ascension® Silicone PIP is a single component silicone spacer consisting of a proximal and distal intramedullary stem and a central flexible hinge. The central flexible hinge has a pre-flexed angle of 15 degrees. The Ascension Silicone PIP is available in 6 sizes for use in left or right applications. Device components are provided sterile in individual packaging.
This 510(k) summary (K082231) describes a medical device rather than a software algorithm or AI. Therefore, the concepts of "acceptance criteria," "study," "test set," "ground truth," "MRMC," and "standalone performance" as they relate to software performance evaluation are not applicable in this context.
The document discusses the Ascension® Silicone PIP, a finger joint prosthesis. For such devices, the "acceptance criteria" and "study" typically refer to bench testing, material characterization, biocompatibility testing, mechanical performance testing, and comparison to legally marketed predicate devices to demonstrate substantial equivalence.
Here's how the provided information relates to the typical evaluation of a medical device like this:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not present a table of specific numerical acceptance criteria (e.g., accuracy thresholds) and reported device performance metrics in the way one would for a software algorithm. Instead, the "acceptance criteria" for a physical medical device are inherently met through the demonstration of substantial equivalence to predicate devices and adherence to relevant standards.
The "reported device performance" is inferred from its similarity to the predicate devices and the physical characteristics described.
| Criterion Category (Inferred) | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Material Composition | Similar to predicate devices | Silicone |
| Design Features | Similar to predicate devices | Single component silicone spacer, proximal and distal intramedullary stem, central flexible hinge, 15-degree pre-flexed angle. |
| Intended Use | Replacement of PIP joint for advanced osteoarthritis, post-traumatic arthritis, rheumatoid arthritis. | Matches the predicate devices' intended use. |
| Surgical Technique | Similar to predicate devices | Implied to be similar to predicate devices. |
| Biocompatibility | Compliant with relevant standards for silicone implants (implied by 510k process). | Not explicitly stated but assumed to be met through standard regulatory pathways for implantable materials. |
| Mechanical Performance | Sufficient strength and durability for indicated use (implied by 510k process and similarity to predicates). | Not explicitly stated, but assumed to be comparable to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
This is irrelevant for a physical medical device. There isn't a "test set" of data in the sense of patient images or clinical records for an AI algorithm. The "test" for a physical device involves various forms of engineering and biocompatibility evaluations.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This is irrelevant for a physical medical device. "Ground truth" for a device like this would involve:
- Material specifications: Established by material science experts and standards organizations.
- Design specifications: Established by biomedical engineers.
- Clinical effectiveness (long-term): Established by clinical trials and post-market surveillance (not part of initial 510k for substantial equivalence).
4. Adjudication Method for the Test Set:
This is irrelevant for a physical medical device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
This is irrelevant. MRMC studies are used to evaluate the diagnostic accuracy of imaging systems or AI algorithms with multiple readers and cases. The Ascension® Silicone PIP is a prosthetic implant, not a diagnostic tool.
6. If a Standalone Performance Study was Done:
This concept doesn't directly apply. The "standalone performance" of a physical device refers to its ability to perform its intended function (e.g., the flexibility and articulation of the joint, material durability). This is typically assessed through bench testing (mechanical, wear, fatigue) and biocompatibility testing, rather than a "standalone study" akin to an algorithm. The 510(k) summary implies that these tests were conducted or that the shared characteristics with predicate devices negate the need for novel extensive testing for this specific submission.
7. The Type of Ground Truth Used:
For a physical medical device submitted via a 510(k), the "ground truth" for substantial equivalence is primarily based on:
- Predicate Device Data: Evidence that the new device is as safe and effective as a legally marketed predicate device. This includes comparing materials, design, intended use, and performance characteristics.
- Engineering Standards: Compliance with recognized national and international consensus standards for medical device design, manufacturing, and materials.
- Biocompatibility Standards: Evidence that the materials used are safe for implantation in the human body.
8. Sample Size for the Training Set:
This is irrelevant for a physical medical device. There is no "training set" in the context of an AI algorithm.
9. How the Ground Truth for the Training Set was Established:
This is irrelevant for a physical medical device.
In summary, the provided 510(k) document is for a medical device (a joint prosthesis) and not a software algorithm. Therefore, the questions posed, which are designed for evaluating AI/software performance, are not directly applicable.
The "study that proves the device meets the acceptance criteria" for a physical device in a 510(k) submission generally refers to:
- Non-clinical testing: Benchtop mechanical testing (fatigue, wear, tensile strength, etc.), material characterization, and biocompatibility testing.
- Comparison to predicate devices: Demonstrating that the new device is substantially equivalent in terms of materials, design, intended use, and performance to one or more legally marketed predicate devices.
The document states: "A comparison of the Ascension Silicone PIP and the DePuy NeuFlex PIP Finger Implant (K001922) and Ascension Silicone MCP (K022892) show similar material, design features, surgical technique and indications." This statement is the core of the "study" described, demonstrating substantial equivalence rather than presenting specific performance metrics from a clinical trial or algorithm test.
§ 888.3230 Finger joint polymer constrained prosthesis.
(a)
Identification. A finger joint polymer constrained prosthesis is a device intended to be implanted to replace a metacarpophalangeal or proximal interphalangeal (finger) joint. This generic type of device includes prostheses that consist of a single flexible across-the-joint component made from either a silicone elastomer or a combination pf polypropylene and polyester material. The flexible across-the-joint component may be covered with a silicone rubber sleeve.(b)
Classification. Class II.