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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 The missi OFF . Breedomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).

Previously 510(k) cleared Inion OTPS™ Biodegradable Pin (K031712) is manufactured by extrusion followed by grinding and cutting. With this special 510(k) we inform for additional manufacturing method by injection moulding followed by cutting. Injection moulded Inion OTPSTM Biodegradable Pins are identical in all the other aspects with the predicate pins except this manufacturing method. Material recipe with copolymer composition is identical. Only difference is that the molecular weight is slightly higher with the extrusion recipe than with the injection moulding recipe.

The provided text is a Special 510(k) Summary for a medical device called the "Inion OTPS™ Biodegradable Pin." This document describes a modification to the manufacturing method of an already cleared device, not the initial approval of a new device or its performance against acceptance criteria in a clinical study.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them, specifically:

• A table of acceptance criteria and reported device performance.
• Sample size and data provenance for a test set.
• Number and qualifications of experts for ground truth.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
• Standalone (algorithm only) performance study.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document focuses on demonstrating substantial equivalence of a modified manufacturing method (injection molding) to a previously cleared manufacturing method (extrusion). It states that the injection-molded pins are "essentially identical" and "substantially equivalent" to the predicate device, with "no new risks associated with use... as compared to the predicate device." This equivalence is "shown by the verification testing," but details of this testing (specific criteria, results, sample sizes, etc.) are not included in this summary.

The document's purpose is to inform the FDA that a manufacturing change does not alter the device's safety or effectiveness, allowing it to remain on the market. It's not a report of a new clinical or performance study establishing new acceptance criteria or proving their fulfillment.

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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.

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