(55 days)
The TriMed Fifth Metatarsal System is indicated for use in stabilization of fractures, malunions and non-unions of the fifth metatarsal.
The TriMed Fifth Metatarsal System implants are non-sterile, non-bioabsorbable implantable devices used as aids to the treatment of certain types of fractures and non-unions that lend themselves to the principle of plate and/or screw fixation. The TriMed Fifth Metatarsal System consists of fixation plates and screws as well as stand-alone screws. The TriMed Fifth Metatarsal System implants are made from implant grade stainless steel.
This is a 510(k) clearance letter for a medical device called the "TriMed Fifth Metatarsal System." This type of document is for physical medical devices and does not pertain to AI/software. Therefore, the questions related to AI/software performance criteria and studies are not applicable.
The provided document describes the device, its intended use, and a summary of non-clinical (mechanical) tests performed to demonstrate substantial equivalence to predicate devices. It does not contain information about acceptance criteria or studies related to AI algorithms, human readers, ground truth establishment, or training sets.
Since the provided text pertains to a physical medical device and not an AI/software device, I cannot fill in the requested information about acceptance criteria and studies typical for AI/software.
However, I can provide the information available in the document regarding the non-clinical testing for this physical device:
The "TriMed Fifth Metatarsal System" consists of fixation plates and screws designed for stabilizing fractures, malunions, and non-unions of the fifth metatarsal.
Summary of Non-Clinical Testing for the Physical Device:
1. A table of acceptance criteria and the reported device performance
The document states that all subject devices "passed and met all acceptance criteria" but does not explicitly list the quantitative acceptance criteria. It only describes the type of tests and general outcomes.
Table of Acceptance Criteria and Reported Device Performance (Based on available information):
| Acceptance Criteria (Type) | Reported Device Performance |
|---|---|
| Plates: Static cantilever loading (peak load) | Subject devices "able to resist higher peak loads than the tested predicate devices." (Specific values and criteria not provided) |
| Plates: Fatigue testing (150,000 cycles) | "All subject plates passed and met all acceptance criteria." (Specific maximum deflection or failure criteria not provided) |
| Screws: Performance per FDA Guidance Document "Orthopedic Non-Spinal Metallic Bone Screws and Washers –Performance Criteria for Safety and Performance Based Pathway" | "All subject screws passed and met all acceptance criteria." (Specific criteria and performance values not provided) |
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the document.
- Data Provenance: Not applicable in the context of mechanical testing. The tests simulate biomechanical conditions in a laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable as the device is a physical implant, not an AI/software device requiring expert interpretation for ground truth.
4. Adjudication method for the test set
- This information is not applicable. Mechanical testing results are based on direct measurements and material science principles, not expert adjudication.
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 not applicable to a physical medical device. The document explicitly states: "Clinical studies were not conducted for the subject devices."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not applicable to a physical medical device.
7. The type of ground truth used
- This information is not applicable. For mechanical testing, the "ground truth" is derived from established engineering standards and physical laws, not clinical outcomes or expert consensus in the medical imaging sense.
8. The sample size for the training set
- Not Applicable. There is no training set for a physical device.
9. How the ground truth for the training set was established
- Not Applicable. There is no training set for a physical 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.