(95 days)
These INION OTPSTM BIODEGRADABLE FIXATION SYSTEM implants are intended for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts (i.e., autografts or allografts) in the presence of appropriate additional immobilization (e.g., rigid fixation implants, cast or brace).
Screws are generally intended for alignment and fixation of bone fractures, osteotomies, arthrodeses and bone grafts (i.e., autografts or allografts) in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast or brace). The Inion OTPS™ Screws are offered in several dimensions and lengths typical for this application. The Inion OTPS™ Screws are made of resorbable polylactic acid / trimethylenecarbonate [poly(L-lactide-co-D,L-lactide) and poly (L-lactide-co-trimethylenecarbonate)]. The Inion OTPS™ Screw gradually loses its strength during 18-36 weeks in vivo with complete strength loss and resorption within two to four years.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Inion OTPS™ 2.5/2.8/3.1 Biodegradable Screws:
The provided 510(k) summary (K043142) does not contain specific numerical acceptance criteria or detailed study data to prove the device meets such criteria. The document focuses on demonstrating substantial equivalence to predicate devices based on two general aspects: mechanical characteristics and biocompatibility.
Therefore, many of the requested sections below cannot be populated with specific data from the provided text.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Characteristics: Retain sufficient mechanical characteristics to fulfill their intended function during bone healing according to their indications. | "Inion OTPS™ Screws retain sufficient mechanical characteristics to fulfil their intended function during bone healing according to their indications" |
| Biocompatibility: Material and degradation by-products are biocompatible, with no short- or long-term safety concerns. | "the material and degradation by-products of the Inion OTPS™ Screws are biocompatible, with no short- or long-term safety concerns." |
| New Risks: No new risks compared to predicate biodegradable implants. | "Furthermore, there are no new risks associated with use of the Inion OTPS™ Screws as compared to the predicate biodegradable implants listed above." |
| Substantial Equivalence: Differences between the Inion OTPS™ Screws and predicate devices do not raise new questions of safety and effectiveness. | "Inion OTPS™ Screws are substantially equivalent to predicate Class II devices... because the differences between the Inion OTPS™ Screws and these predicate devices do not raise new questions of safety and effectiveness." |
Study Information (Based on available text)
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Sample size used for the test set and the data provenance:
- The document states "Based on the performance data presented in section I of this premarket notification..." However, Section I is not provided in the given text. Therefore, specific sample sizes for test sets or data provenance (country, retrospective/prospective) are not available here.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not available/not mentioned. The document discusses the device's characteristics and equivalence to predicates, not a study involving expert-established ground truth on a test set.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/not mentioned. This type of adjudication method typically applies to studies where human readers are interpreting images or data, which is not described here.
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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 a medical device (biodegradable screws), not an AI/imaging diagnostic device. Therefore, no MRMC study or AI assistance evaluation would be relevant or conducted for this type of product.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical implant, not an algorithm or software. Standalone performance for an algorithm is not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the demonstration of mechanical characteristics, the "ground truth" would likely be engineering specifications, material testing standards (e.g., ISO, ASTM), and comparison to the known performance of predicate devices.
- For biocompatibility, the "ground truth" would be established through a series of standardized biocompatibility tests (e.g., cytotoxicity, sensitization, irritation, genotoxicity, implantation tests, hemocompatibility) performed according to ISO 10993 standards. These tests have defined pass/fail criteria.
- No "expert consensus," "pathology," or "outcomes data" in the typical sense of a clinical diagnostic study is described as the ground truth. The substantial equivalence argument relies on meeting established engineering and biological safety profiles.
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The sample size for the training set:
- Not applicable/not mentioned. This is not an AI/machine learning device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. As above, no training set for an algorithm is involved.
§ 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.