(46 days)
The Universal Bone Plate (UBP) System II is intended to bring together bone fragments in order to augment fracture healing of the small bones of the foot, wrist and hand.
The UBP System II is intended bring together bone fragments in order to augment fracture healing of the small bones of the foot, wrist and hand. The UBP System II consists of canted, variable-distance multi-hole bone plates, cortical and cancellous screws, and instrumentation. The UBP System II instrumentation set consists of the standard instrumentation required for each indicated procedure. Implants are for single use only.
The provided document is a 510(k) premarket notification for the Spinal Concepts, Inc. Universal Bone Plate (UBP) System II. This type of submission is for medical devices that claim substantial equivalence to a predicate device, rather than demonstrating performance against acceptance criteria through clinical studies in the way a pharmaceutical or novel high-risk medical device might.
Therefore, the document does not contain the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, or ground truth establishment relevant to an AI/Software as a Medical Device (SaMD) context.
Instead, the "study" demonstrating the device meets "acceptance criteria" for substantial equivalence is primarily a mechanical testing comparison and a technological comparison to its predicate device.
Here's an interpretation of the request in the context of this document:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Comparable static and fatigue performance to the predicate device and able to withstand clinical loading. | Static and fatigue testing "demonstrated the UBP System II bone plate to be substantially equivalent to the existing UBP System bone plate, and able to withstand clinical loading and maintain mechanical integrity." |
| Material Equivalence: | |
| Same material as the predicate. | Both UBP System II and UBP System (Original/Predicate) implants use Titanium 6AL-4V. |
| Functional Equivalence: | |
| Same intended use. | Both UBP System II and UBP System (Original/Predicate) have the function "To bring together bone fragments in order to augment fracture healing" and the indication "To bring together bone fragments in order to augment fracture healing of the small bones of the foot, wrist and hand." |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified in terms of number of devices. The "test set" here refers to the samples of UBP System II and existing UBP System bone plates used for mechanical testing.
- Data Provenance: The data comes from "Static and fatigue testing" performed directly by Spinal Concepts, Inc. The location or specific laboratory for this testing is not explicitly stated, but it's generated for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a mechanical comparison and does not involve expert-established ground truth for a test set in the clinical or imaging analysis sense.
4. Adjudication method for the test set:
- Not applicable. No adjudication method is described as this is not a diagnostic device involving human interpretation.
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:
- No. This is a bone plate, not an AI or imaging device, so MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm-based device.
7. The type of ground truth used:
- For the mechanical testing, the "ground truth" would be the measured physical properties (e.g., strength, fatigue life) under specific test conditions, compared to the predicate device's measured properties and published data for similar devices. There isn't a "ground truth" in the sense of a definitive diagnostic label.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not a machine learning device.
9. How the ground truth for the training set was established:
- Not applicable.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.