(190 days)
The Inion OTPS™ Biodegradable Mini Plating System is intended for use in fixation of non-comminuted diaphyseal fractures of the metacarpal, proximal phalangeal, middle phalangeal and osteotomies in the presence of appropriate immobilization.
The Inion OTPS™ Biodegradable Mini Plating System is consisted of biodegradable screws and plates intended to be used in fractures of phalanges and metacarpal. Implants will be utilized by using common surgical techniques. The Inion OTPS™ Biodegradable Mini Plating System is made of resorbable polylactic acid / trimethylenecarbonate copolymers [Poly (L-lactide-co-D,L-lactide) and poly (L-lactide-co-trimethylenecarbonate)). The Inion OTPS™ Biodegradable Mini Plating System implants gradually lose their strength during 18-36 weeks in vivo with complete strength loss and resorption within two to four years.
The provided text describes a 510(k) submission for the Inion OTPS™ Biodegradable Mini Plating System. It focuses on the device's substantial equivalence to predicate devices and its intended use. However, it does not contain information about specific acceptance criteria, a detailed study proving performance against those criteria, or the methodology typically associated with clinical trial data analysis (like sample sizes for test/training sets, expert consensus for ground truth, or MRMC studies).
Therefore, I cannot fill out the requested table and answer the questions based solely on the provided text. The document is a regulatory submission for premarket clearance, which often relies on comparison to existing legally marketed devices (predicates) and mechanical testing rather than extensive human reader studies or detailed performance metrics against specific acceptance criteria in a clinical setting.
Here's what I can infer or state based on the document's content:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative values. The primary acceptance criterion for a 510(k) submission is "substantial equivalence" to predicate devices.
- Reported Device Performance: The document states, "Mechanical testing demonstrates that the device is substantially equivalent to the predicate ones." It doesn't provide specific mechanical testing results (e.g., tensile strength, fatigue life) or clinical performance metrics (e.g., healing rates, complication rates).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The document primarily references mechanical testing for substantial equivalence, not clinical study data for a "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/Not provided. Ground truth establishment with experts is relevant for studies involving diagnostic or interpretive tasks, not typically for the premarket clearance of devices like bone plating systems where equivalence is established through mechanical and material properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided for the reasons stated above.
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 bone plating system, not an AI or diagnostic imaging device that would involve human readers or AI assistance in a clinical interpretation role.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not explicitly stated for a clinical "ground truth." For mechanical equivalence, the "ground truth" would be established by validated test methods (e.g., ASTM standards) comparing the new device's mechanical properties to those of the predicate devices.
8. The sample size for the training set:
- Not applicable/Not provided. Training sets are relevant for AI/machine learning models, not for this type of physical device.
9. How the ground truth for the training set was established:
- Not applicable for the reasons stated above.
Summary based on the provided text:
The document describes a 510(k) premarket notification for a biodegradable bone plating system. The primary method for demonstrating its suitability for market was through showing substantial equivalence to existing predicate devices (Biomet Inc.'s ReUnite Bone Screw and LactoSorb Hand System, and Synthes Compact Hand 1.0/1.3). This equivalence was supported by mechanical testing, which indicated that the new device had "the same intended use and principles of operation and very similar design characteristics" to the predicates, and that "The differences between the Inion OTPS™ Biodegradable Mini Plating System and predicate devices do not raise new questions of safety and effectiveness."
The text does not provide specific quantitative acceptance criteria or detailed study results (like sample sizes, expert involvement, or clinical outcomes) that would be common when evaluating AI/diagnostic devices against specific performance metrics.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.