(48 days)
The PRECICE UNYTE System is indicated for open and closed fracture fixation, corrective osteotomies, pseudoarthrosis, mal-unions, limb lengthening, or bone transport of long bones.
The PRECICE UNYTE System is composed of the PRECICE UNYTE Nail (supplied sterile), locking screws, end cap, surgical instruments and an external remote controller (ERC). The Nail is available in various diameters, lengths and screwhole configurations to accommodate a variety of patient anatomies. The locking screws are also available in a variety of diameters and lengths. The PRECICE UNYTE Nail and end cap is supplied sterile by gamma radiation while the locking screws and reusable instruments are supplied non-sterile and must be sterilized prior to use. The UNYTE Nail contains an enclosed rare earth magnet, telescoping lead screw/nut assembly, and planetary gearing. The UNYTE Nail is supplied pre-distracted by 10 mm (femur and tibia models), 15 mm and 20 mm (humeral model), to allow for compression fracture reduction techniques.
The provided text is a 510(k) summary for a medical device (PRECICE UNYTE System) seeking clearance from the FDA. This document primarily focuses on establishing substantial equivalence to previously cleared predicate devices rather than proving the device meets specific acceptance criteria through a clinical study or performance testing in the way an AI/ML device would be scrutinized.
Therefore, the typical metrics and study structures associated with AI/ML device acceptance criteria (e.g., sensitivity, specificity, AUC, sample sizes for test/training sets, ground truth establishment by experts, MRMC studies) are not present in this document.
The document states: "There are no technological or performance changes to the PRECICE UNYTE Nail being made as a result of this submission, therefore all testing that was performed on the predicate PRECICE UNYTE Nail are applicable." This implies that the device's performance, as demonstrated by the predicate device, is considered sufficient and no new performance studies for the new device itself are explicitly detailed or required for this 510(k) submission.
However, I can interpret the existing information in the context of the requested questions, focusing on the equivalence aspect described in the document.
Interpretation based on the provided document:
The "acceptance criteria" here are implicitly related to demonstrating substantial equivalence to legally marketed predicate devices, as per FDA's 510(k) pathway. The "study" proving this is the comparison of indications for use, technological characteristics, and principles of operation between the PRECICE UNYTE System and its predicate/reference devices.
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criterion (Implicit for 510(k) Equivalence) | Reported Device Performance (as per 510(k) Summary) |
|---|---|
| Indications for Use (IFU) Equivalence: | Similar IFU to predicate, with expansion to align with PRECICE family reference devices (limb lengthening, bone transport). |
| - Open and closed fracture fixation | Yes, similar to predicate. |
| - Corrective osteotomies | Yes, similar to predicate. |
| - Pseudoarthrosis | Yes, similar to predicate. |
| - Mal-unions | Yes, similar to predicate. |
| - Limb Lengthening | Expanded to include, aligning with PRECICE Intramedullary Limb Lengthening System (K170346) and PRECICE UNYTE CoCr System (K162927). |
| - Bone Transport | Expanded to include, aligning with AOS Tibial Nail System (K130625). |
| Technological Characteristics Equivalence: | Identical technological characteristics to predicate. |
| - Nail design (diameters, lengths, screwhole configs) | Identical to predicate. |
| - Locking screws (diameters, lengths) | Identical to predicate. |
| - External Remote Controller (ERC) design | No changes to ERC design. |
| Principle of Operation Equivalence: | Same principle of operation as predicate. |
| - Insertion into intramedullary canal | Same as predicate. |
| - Secured with locking screws | Same as predicate. |
| - Adjusted non-invasively by ERC | Same as predicate. |
| Performance Testing (reference to predicate): | All testing performed on the predicate PRECICE UNYTE Nail and ERC are applicable, as there are no technological/performance changes. |
2. Sample sized used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable in the context of a clinical performance study as typically understood for AI/ML devices. This submission relies on demonstrating substantial equivalence to prior FDA-cleared devices, meaning performance data from those predicate devices is implicitly referenced.
- Data Provenance: Not specified as a separate test set. The provenance relates to the historical regulatory clearance of the predicate devices (K160267, K170346, K162927, K130625).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. Ground truth establishment by experts for a specific test set is not a component of this 510(k) submission, which focuses on device design and IFU equivalence to existing devices.
4. Adjudication method for the test set:
- Not applicable. The document does not describe a clinical study requiring an adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done or described in this document. This is not typically required for a 510(k) submission demonstrating substantial equivalence for a mechanical orthopedic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a mechanical intramedullary fixation rod, not an algorithm, so the concept of "standalone performance" for an algorithm doesn't apply.
7. The type of ground truth used:
- Not applicable in the context of a clinical performance study. The "ground truth" for this 510(k) is the regulatory acceptance of its predicate devices, implying their safety and effectiveness have already been established.
8. The sample size for the training set:
- Not applicable. There is no AI/ML algorithm being "trained" as part of this device or its submission.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI/ML algorithm.
In summary: The provided document is an FDA 510(k) clearance letter and summary. It establishes the substantial equivalence of the PRECICE UNYTE System to existing legally marketed devices, primarily the PRECICE UNYTE System (K160267) and other PRECICE family products. The core "study" proving "acceptance criteria" is the detailed comparison and argument that the new device has "similar indications for use, technological characteristics, and principles of operation" to these existing devices, without significant technological or performance changes that would raise new questions of safety or effectiveness. Therefore, the specific types of performance studies and metrics requested in the prompt, typically associated with novel AI/ML software or clinical trials, are not present or applicable to this type of regulatory submission for a mechanical orthopedic implant.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.