(56 days)
The implants of the Xpert Wrist range are intended for the fixation of hand and forearm fractures, osteotomies and arthrodeses in adults.
The Xpert Wrist range consists of plates and screws, designed for the fixation of hand and forearm fractures, osteotomies and arthrodeses in adults. The implants of the Xpert Wrist range will be provided non sterile for sterilization by health care professionals prior to use, or provided sterile by gamma sterilization. The instruments of the Xpert Wrist range will be provided non sterile for sterilization by health care professionals prior to use. Materials: CP Titanium (conform to ASTM F67 and ISO 5832-2) and Titanium alloy Ti-6AI-4V ELI (conform to ASTM F136 and ISO 5832-3). Function: The implants of the Xpert Wrist range are intended for the fixation of hand and forearm fractures, osteotomies and arthrodeses in adults.
This FDA 510(k) summary is for a medical device called "Xpert Wrist," which consists of plates and screws for fixing hand and forearm fractures, osteotomies, and arthrodeses in adults.
The document explicitly states: "No clinical studies were performed." This means that the device was not evaluated through a study to prove its acceptance criteria in the typical sense of measuring device performance against clinical outcomes or human reader performance.
Instead, the substantial equivalence to predicate devices is based on non-clinical tests comparing the Xpert Wrist to previously cleared devices.
Here's an breakdown of the information requested, based only on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a GHTF Type A submission (based on substantial equivalence to predicate devices and no clinical studies), the acceptance criteria are based on mechanical properties being comparable or superior to the predicate devices. The document does not provide specific numerical acceptance criteria (e.g., minimum bending strength in N-mm) or exact performance values from the tests in an easily digestible table format. It states that the analysis "showed that the Xpert Wrist range is substantially equivalent to cleared predicates."
However, we can infer the types of performance assessed:
| Performance Metric (Type of Test) | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Bending Strength (4-point-bending per ASTM F382) | Comparable or superior to predicate devices. | "the analysis showed that the Xpert Wrist range is substantially equivalent to cleared predicates." |
| Torsional Strength (ASTM F543) | Comparable or superior to predicate device screws. | "the analysis showed that the Xpert Wrist range is substantially equivalent to cleared predicates." |
| Axial Pull-out Strength (Chapman equation, FDA-Guidance) | Comparable or superior to predicate device screws. | "the analysis showed that the Xpert Wrist range is substantially equivalent to cleared predicates." |
| Endotoxin Levels (LAL quantitative kinetic chromogenic method) | Acceptable levels for medical devices. | "Endotoxin testing is performed..." (Implied acceptable results for substantial equivalence) |
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Sample Size: Not explicitly stated. The non-clinical tests would involve a certain number of manufactured plates and screws (e.g., n=5 or n=10 per test for mechanical testing).
- Data Provenance: Not applicable in the context of human studies. For mechanical testing, the "data provenance" would refer to tests conducted in a laboratory setting, likely by the manufacturer or a contracted testing facility. No country of origin for the mechanical test data is specified. The tests are non-clinical and conducted to support substantial equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. No clinical studies were performed, and thus no expert ground truth for a clinical test set was established. The "ground truth" here is based on established engineering standards for mechanical performance.
4. Adjudication Method for the Test Set
Not applicable. No clinical studies were performed, and thus no adjudication method for a clinical test set was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states: "No clinical studies were performed."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device (plates and screws), not an AI algorithm.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" refers to established engineering standards (e.g., ASTM F382, ASTM F543) and comparative data from legally marketed predicate devices. The performance of the Xpert Wrist was compared against these benchmarks to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/machine learning device, so there is no "training set" or ground truth for it.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.