(58 days)
The APTUS 3.5 TriLock Straight Plates are intended for the fixation of fractures, osteotomies and non-unions of the scapula, olecranon, radius, ulna, foot, distal tibia and fibula.
The subject device APTUS 3.5 TriLock Straight Plates are available in eleven (11) designs with 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, or 16 screw holes. The plates have an overall length ranging from 32 mm to 200 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 K193633, K110908, and K092038. The subject device plates are manufactured from titanium alloy conforming to ASTM F136, and are provided non-sterile or sterile to the end user.
This is a 510(k) premarket notification for a medical device, not an AI/ML device. Therefore, the questions related to AI/ML specific aspects like training set, ground truth, expert adjudication, MRMC studies, and standalone performance are not applicable.
The submission focuses on demonstrating "substantial equivalence" to existing legally marketed predicate devices, primarily through non-clinical performance data and comparison of technological characteristics.
Here's a breakdown of the relevant information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a table of explicit acceptance criteria with corresponding performance metrics in the way one might see for an AI/ML diagnostic device with sensitivity/specificity targets. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence through:
- Biocompatibility: Referenced from predicate device K193633. (No specific numerical performance reported for the subject device beyond equivalence).
- Sterilization: Referenced from predicate device K193633 (moist heat for non-sterile, X-ray beam for sterile components). (No specific numerical performance reported for the subject device beyond equivalence).
- Packaging and Sterile Barrier Shelf Life: Referenced from predicate device K193633. (No specific numerical performance reported for the subject device beyond equivalence).
- Mechanical Testing: Performed according to ASTM F382. This standard specifies requirements for metallic bone plates. The document states that mechanical testing was done "according to ASTM F382," implying that the device met the requirements of this standard. No specific numerical performance results (e.g., fatigue life, stiffness) are provided in this summary, but the reference to the standard confirms compliance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility (conforming to established standards) | Referenced from predicate device K193633 (substantially equivalent). |
| Sterilization (effective and compliant with methods) | Referenced from predicate device K193633 (substantially equivalent). |
| Packaging and Sterile Barrier Shelf Life (maintaining sterility) | Referenced from predicate device K193633 (substantially equivalent). |
| Mechanical Performance (meeting bone plate standards) | Met requirements of ASTM F382. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable for this type of device submission. Mechanical testing per ASTM F382 would involve a specific number of samples, but the exact number is not detailed in this summary.
- Data Provenance: The data is "non-clinical testing data," meaning it's from laboratory tests, not human subjects. It does not involve patient data or geographical provenance. It is entirely retrospective in the sense that the testing and its results underpin the submission for marketing clearance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not applicable. This is a medical device for bone fixation, not an AI/ML diagnostic system requiring expert interpretation of images or patient data to establish ground truth.
4. Adjudication Method for the Test Set:
- Not applicable. (See answer to #3).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
- Not applicable. This is not an AI/ML device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. This is not an AI/ML device.
7. The Type of Ground Truth Used:
For the non-clinical performance data, the "ground truth" refers to the established standards and accepted scientific methods:
- Mechanical Testing: The "ground truth" is adherence to the requirements and test methods outlined in ASTM F382.
- Biocompatibility: Adherence to established ISO standards for biocompatibility (referenced implicitly by reliance on the predicate device's clearance).
- Sterilization: Adherence to recognized standards for sterilization methods (e.g., Moist Heat, X-ray beam).
8. The Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. This is not an AI/ML device.
§ 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.