(187 days)
The Forma Medical Optimal Plating System is intended for fixation of fractures, osteotomies, arthrodeses, and bone reconstructions in adult patients with normal or osteopenic bone. Indications include flat (scapula), long (clavicle, upper and lower extremities including metacarpals, and phalanges), irregular (pelvis, hand, foot) bones and joints (wrist, ankle). The Forma Medical Optimal Plating System is not indicated for ribs, sternum, spine, or the skull.
The Forma Medical Optimal Plating System is designed to hold bones in relative stability for fracture fixation and arthrodesis. The plates and screws are available in multiple sizes based on patient anatomy and clinical application. The screws are manufactured from titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F67, F136, F1537, and F138. The plates are manufactured from titanium, titanium alloy, or stainless steel, as specified in ASTM F67, F136, and F138. The system includes plates, screws and instruments. The system instrumentation is manufactured from stainless steel, aluminum, and other surgical grade materials.
The provided text describes mechanical testing performed to demonstrate substantial equivalence for the Forma Medical Optimal Plating System. It does not contain information about an AI/ML-enabled device or a study involving human readers. Therefore, many of the requested fields are not applicable.
Here's the relevant information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criterion (Test) | Reported Device Performance |
|---|---|
| Screw: Torsional Strength per ASTM F543-23 | Mechanical testing results demonstrated substantial equivalence to predicate system screws. |
| Screw: Insertion/Removal Torque per ASTM F543-23 | Mechanical testing results demonstrated substantial equivalence to predicate system screws. |
| Screw: Pullout Strength | Mechanical testing results demonstrated substantial equivalence per the Chapman analytical formula. |
| Plate: Four-Point Bending per ASTM F382-17 | Mechanical testing results demonstrated substantial equivalence to predicate system plates. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size (number of screws or plates) used for each mechanical test. Data provenance (country of origin, retrospective/prospective) is not applicable for mechanical testing of a physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth for mechanical testing is established by engineering standards and measurement, not expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for subjective assessments, not for objective mechanical testing.
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
Not applicable. This device is a physical bone fixation system, not an AI-enabled diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical bone fixation system, not an AI-enabled diagnostic tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the mechanical testing is based on established engineering standards (ASTM F543-23, ASTM F382-17) and an analytical formula (Chapman analytical formula for pullout strength).
8. The sample size for the training set
Not applicable. This is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical device, not an AI model.
§ 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.