(71 days)
A. General indications: In the presence of appropriate additional immobilization or fixation, indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts, and maintenance of relative position of weak bony tissue (e.g., bone grafts, bone graft substitutes, or bone fragments from comminuted fractures), in trauma and reconstructive procedures, and cement restriction in total joint arthroplasty procedures.
B. Specific indications:
- Craniofacial skeleton, cranium, mid-face, maxilla, and mandible
- Metacarpus, proximal and middle phalangeal bones
- Long bones, flat bones, short bones, irregular bones, appendicular skeleton, and thorax
Inion CPS/OTPS FreedomPlate™ implants are made of resorbable polylactic acid / trimethylenecarbonate copolymers and they are provided in sizes typical to this application. Inion CPS/OTPS FreedomPlate 1.5 implants gradually lose their strength during 18-36 weeks in vivo. Bioresorption takes place within two to four years.
Inion CPS/OTPS FreedomPlate™ implants are provided sterile to the user. The shelf life of the device is 3 years.
The provided text is a 510(k) summary for the Inion® CPS/OTPS FreedomPlate™. This document establishes substantial equivalence to predicate devices, rather than outlining a study that proves the device meets specific acceptance criteria in the way a medical AI/software device would.
Therefore, many of the requested categories are not applicable to this type of medical device submission. The device is a physical bone fixation plate, not a software algorithm that performs a diagnostic or predictive task.
Here's an attempt to address the questions based on the provided text, indicating "Not Applicable" where the information is not present or relevant to this type of device.
1. Table of acceptance criteria and the reported device performance
For substantial equivalence, acceptance criteria are typically met by demonstrating that the new device has the same intended use, similar technological characteristics, and no new questions of safety or effectiveness compared to predicate devices. The "performance" is primarily defined by its material properties and degradation profile being comparable.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (as stated in the document) |
|---|---|
| Intended Use: Maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses, bone grafts, maintenance of relative position of weak bony tissue (etc.), in trauma/reconstructive procedures, and cement restriction in total joint arthroplasty procedures. | Substantially equivalent to predicate devices: The intended use of Inion CPS/OTPS FreedomPlate™ is the same as the predicate devices. |
| Material Composition: Biodegradable polymers (polylactic acid / trimethylenecarbonate copolymers). | Made of: resorbable polylactic acid / trimethylenecarbonate copolymers. |
| Technological Characteristics: Loss of strength, bioresorption timeline. | Gradually lose strength: during 18-36 weeks in vivo. Bioresorption: within two to four years. |
| Mechanical Properties: (Not explicitly detailed in numerical values, but implied to be comparable to predicates). | Substantially equivalent to predicate devices: Based on performance data and specifications presented, mechanical properties are substantially equivalent. |
| Degradation Profile: (Not explicitly detailed in numerical values, but implied to be comparable to predicates). | Substantially equivalent to predicate devices: Based on performance data and specifications presented, degradation profile is substantially equivalent. |
| Safety and Effectiveness: No new questions raised compared to predicates. | Conclusion: Differences with predicate devices do not raise new questions of safety and effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a physical medical device (bone fixation plate) being submitted for substantial equivalence, not a software device or diagnostic test. The evaluation is based on material properties, design, and comparison to existing devices, not a clinical trial or AI test set.
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 as typically understood for an AI/software device does not apply here. The evaluation is based on engineering principles, material science, and regulatory comparison.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 plate, not an AI software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the typical sense. The "ground truth" for this submission is regulatory in nature: the established safety and effectiveness of the predicate devices based on their material properties, mechanical performance, and clinical history. The new device demonstrates "substantial equivalence" to this established "truth."
8. The sample size for the training set
Not applicable. This is a physical medical device.
9. How the ground truth for the 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.