(87 days)
The Inion OTPSTM Biodegradable Pin is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).
The Inion OTPS™ Biodegradable Pin is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace). Pins are offered in several dimensions and lengths typical for this application.
The Inion OTPS™ Biodegradable Pin is made of resorbable polylactic acid / trimethylenecarbonate copolymers [Poly (L-lactide-co-D,L-lactide) and poly (L-lactide-cotrimethylenecarbonate)]. Pins are offered both undyed and coloured for better visualization during surgical operation. The Inion OTPS™ Biodegradable Pin gradually loses its 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) summary for the Inion OTPS™ Biodegradable Pin, focusing on its substantial equivalence to predicate devices rather than a study with specific acceptance criteria for performance metrics like sensitivity, specificity, or accuracy.
The summary states that "Mechanical testing demonstrates that the device is substantially equivalent to the predicate ones." However, it does not provide the details of this mechanical testing, including specific acceptance criteria or the reported performance outcomes. Instead, the basis for approval is through substantial equivalence, meaning it operates similarly and has comparable design characteristics to already approved devices.
Therefore, many of the requested details about acceptance criteria and a study proving those criteria are not present in this document.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
This information is not explicitly available in the provided text. The document refers to "mechanical testing" to show "substantial equivalence" but does not detail the specific acceptance criteria (e.g., tensile strength, degradation rate limits) or the quantitative results of the Inion OTPS™ Biodegradable Pin against those criteria. The acceptance criterion implied is simply "substantial equivalence" to the predicate devices based on mechanical properties.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not available. The document mentions "mechanical testing" but does not specify the sample size, type of test specimens, or the origin/nature of this data.
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):
This information is not applicable/available. This device is a biodegradable pin, and the "ground truth" for its performance is typically established through mechanical testing and in-vivo/in-vitro studies, not through expert-reviewed "test sets" in the context of diagnostic performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable/available 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:
This information is not applicable/available. This device is a physical medical implant (a pin), not an AI-based diagnostic tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable/available. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The implied "ground truth" for showing substantial equivalence would be mechanical properties comparison and biocompatibility/resorption profiles established through various in-vitro and potentially in-vivo animal studies. The document states the pin "gradually loses its strength during 18-36 weeks in vivo with complete strength loss and resorption within two to four years," which refers to its performance characteristics.
8. The sample size for the training set:
This information is not applicable/available. There is no "training set" in the context of this device.
9. How the ground truth for the training set was established:
This information is not applicable/available. There is no "training set."
Summary of what is available from the document:
The provided document is a 510(k) summary focused on demonstrating substantial equivalence of the Inion OTPS™ Biodegradable Pin to existing predicate devices. The primary method mentioned for this demonstration is "mechanical testing."
- Acceptance Criteria & Reported Performance: The implicit acceptance criterion is "substantial equivalence" in mechanical properties and design characteristics to the predicate devices (Bionx Implants, Inc .; PLLA Pin (K010983), DePuy ACE; OrthoSorb Absorbable Pin (K901456), Synthes; Polypin (K961608)). The document states that "Mechanical testing demonstrates that the device is substantially equivalent to the predicate ones." No specific quantitative performance metrics or acceptance thresholds are provided in this summary.
- Study Details: The document mentions "Mechanical testing" but offers no details on the study design, sample size, data provenance, or explicit results.
- Ground Truth: The "ground truth" for the device's performance is not described in terms of expert consensus or pathology but rather its physical and biological properties (e.g., tensile strength, degradation rate, resorption profile) as determined through generalized mechanical testing and potentially in-vivo/in-vitro studies, which are then compared to the known properties of the predicate devices.
§ 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.