(97 days)
APTUS Ulna Plates are indicated for fractures and osteotomies, in particular for the ulna.
The purpose of this submission is to obtain marketing clearance for an additional device design to expand the range of the Medartis APTUS® Ulna Plates, previously cleared under K 103332. The subject device APTUS Distal Ulna Plates is available in four (4) designs with 10 or 12 screw holes. All plates have anatomical designs that are appropriate for either the right ulna. The 10 and 12 hole plates have a length of 53 mm and 66 mm, respectively. The maximum thickness of the plates is 1.6 mm and the maximum width is 15 mm.
The subject device plates include screw holes designed to accommodate appropriately sized bone screws and K-wires presently marketed as part of the APTUS System. The subject device plates are compatible with screws and K-wires previously cleared in K051567 (TriLock), K103332 (cortical), and K092038 (K-wires).
The subject device plates are manufactured from unalloyed titanium, Grade 4, conforming to ASTM F67, and are provided non-sterile and sterile.
This FDA 510(k) summary for the APTUS 2.5 TriLock Distal Ulna Plates does not describe a study involving an AI/Machine Learning device or a diagnostic device. Instead, it describes a medical implant device (bone fixation plates) and its equivalence to previously cleared predicate devices based on mechanical performance data.
Therefore, many of the requested details, such as those related to AI/ML device testing (e.g., test set sample size, ground truth establishment, MRMC studies, training set details), are not applicable to this document.
However, I can extract information relevant to the performance data provided for this specific type of device.
Here's a breakdown of the available information:
1. Acceptance Criteria and Reported Device Performance
For this type of device (bone fixation plates), the "acceptance criteria" and "device performance" are typically related to mechanical integrity and biocompatibility, not diagnostic accuracy.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Strength & Durability: The device must withstand forces without failure and maintain integrity over time, demonstrating equivalence to predicates in: | Mechanical Testing: Fatigue Bending Test and Static Bench Testing were performed. |
| - Bending strength (to prevent fracture/deformation) | Result: "Based on the results of the testing, the performance of the subject device was judged to be substantially equivalent to the primary predicate K103332." |
| - Fatigue resistance (to withstand repetitive loading) | (Specific numerical results are not provided in this summary, but the conclusion of substantial equivalence implies they met comparative benchmarks.) |
| Biocompatibility: The materials must be safe for implantation in the human body. | Biocompatibility: The device uses identical materials and manufacturing processes as previously cleared predicate devices (K103332, K193633, K193554, K192984, K192297, K142906), thus demonstrating substantial equivalence regarding biocompatibility. |
2. Sample Size and Data Provenance
- Sample Size for Test Set: The document does not specify the sample size for the mechanical testing (e.g., how many plates were tested). It simply states that "Mechanical testing Fatigue Bending Test and Static Bench Testing" were performed.
- Data Provenance: The mechanical testing was "non-clinical testing data," meaning it was benchtop testing, not involving human subjects. The country of origin for this testing data is not explicitly stated, but the manufacturer (Medartis AG) is based in Switzerland. The data is retrospective in the sense that it supports a new device's clearance based on established methods and comparison to existing predicates.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable. This is not a diagnostic AI/ML device that requires expert review for ground truth establishment. The "ground truth" for mechanical testing is derived from engineering principles and standards.
4. Adjudication Method for Test Set
- Not Applicable. This is not a diagnostic AI/ML device study requiring adjudication of expert opinions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Applicable. This is not a diagnostic AI/ML device. "Clinical data were not provided in this submission."
6. Standalone Performance (Algorithm only)
- Not Applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
- For mechanical testing: Engineering standards and established benchmarks (comparison to predicate device performance).
- For biocompatibility: Material standards and proven safety of identical materials used in cleared predicate devices.
8. Sample Size for Training Set
- Not Applicable. This is not an AI/ML device with a "training set."
9. How Ground Truth for Training Set was Established
- Not Applicable.
§ 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.