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The OptiFix™ Open Absorbable Fixation System is indicated for the fixation of surgical mesh to tissues during open surgical procedures, such as hernia repair.

The OptiFix" Open Absorbable Fixation System, hereinafter referred to as "OptiFix" Open", is a sterile (via gamma) single use device that is comprised of a deployment component and an absorbable fastener component. The device delivers 20 synthetic absorbable fasteners via a curved shaft. The shaft of the OptiFix™ Open Absorbable Fixation System is 27cm in length. The fasteners are 6.7mm in length, are manufactured from Poly (D, L)-lactide and are dyed with D & C Violet No. 2.

The provided document does not describe the acceptance criteria of an AI device, but rather a medical device (OptiFix™ Open Absorbable Fixation System). It outlines the performance data required to demonstrate substantial equivalence to a predicate device for this non-AI medical device. Therefore, I cannot generate the requested information about acceptance criteria and studies for an AI device based on this input.

The document discusses various tests for the OptiFix™ Open Absorbable Fixation System, including:

• Biocompatibility testing: This evaluated the absorbable fasteners (long-term implants) and the deployment component (transient tissue contact) against ISO 10993-1. All samples met acceptance criteria.
• Product Testing: This included performance and functional testing (Actuation (trigger) Torque, Fastener Deployment, Fastener Gap Height, Ball Burst Testing, Single Fastener Pullout (Pluck) Force) and Resorption Profile Assessment (Physical Properties, Mechanical Shear Force). All samples met established acceptance criteria.

The document states that animal studies and clinical studies were not performed for the proposed device, nor for the predicate device. The in vivo performance was supported by studies on previously cleared reference devices. Electrical safety, electromagnetic compatibility, and software verification/validation were not applicable as the device is not electro-mechanical and does not contain software.

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The OptiFix™ Absorbable Fixation System is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.

The OptiFix™ Absorbable Fixation System is a sterile (via gamma) single use product that is comprised of a deployment component and an absorbable fastener component. Two product ordering codes are to be packaged for distribution; each contains the same ergonomically designed deployment device. The variation will be the preloaded fasteners; either 15 or 30. The shaft of the OptiFix™ Absorbable Fixation System is 39 cm in length and is designed for use with 5mm trocars. The fasteners are designed with retention features and are manufactured from Poly (D, L)-lactide.

The provided document is a 510(k) summary for the OptiFix™ Absorbable Fixation System. It details the device's characteristics and compares it to a predicate device to demonstrate substantial equivalence, rather than providing the results of a primary clinical study establishing acceptance criteria and device performance against those criteria. Therefore, most of the questions cannot be answered directly from the provided text.

However, I can extract information related to the performance data provided to support the substantial equivalence determination, specifically focusing on the non-clinical tests and their "acceptance criteria" which is implicitly "met the established acceptance criteria" in the context of the document.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document states: "All samples tested met the established acceptance criteria." However, the specific quantitative acceptance criteria for each test are not provided. The "reported device performance" is summarized as the device passing these tests.

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for the non-clinical tests (e.g., how many devices were tested for "Actuation torque"). It only states "All samples tested."

The data provenance is from non-clinical bench testing performed by Davol Inc. for the proposed OptiFix™ Absorbable Fixation System and the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable as there were no clinical studies described, and thus no "ground truth" established by experts in this context. The "truth" for the non-clinical tests would be the measurement results against engineering specifications, not expert consensus on medical images or diagnoses.

4. Adjudication method for the test set

Not applicable. There was no clinical study with human readers requiring adjudication.

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. No MRMC study was performed, and this device is a surgical fixation system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable as the device is a physical surgical fixation system, not an algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" would be the engineering specifications and established test protocols that define what constitutes a passing performance for each parameter (e.g., a specific torque range, a specific deployment force, a certain gap height). The document indicates "All samples tested met the established acceptance criteria," implying such specifications were used.

For the biocompatibility evaluation, the ground truth was based on recognized standards: "FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA."

8. The sample size for the training set

Not applicable. This device is a physical surgical device, not a machine learning algorithm that requires a "training set."

9. How the ground truth for the training set was established

Not applicable, for the same reason as point 8.

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The OPTIFIX™ Absorbable Fixation System is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.

The OPTIFIX™ Absorbable Fixation System is a sterile single use device that delivers either 15 or 30 synthetic absorbable fasteners via a straight shaft. The shaft of the OPTIFIX™ Absorbable Fixation System is 39 cm in length. The fasteners are designed with a retention feature on the end and are manufactured from Poly (D, L)-lactide.

The provided document describes the OPTIFIX™ Absorbable Fixation System, a medical device, and its substantial equivalence to a predicate device, SorbaFix™, based on non-clinical and animal studies. However, the document does not contain information about a study proving the device meets acceptance criteria in the context of an AI/algorithm-driven device. It is a traditional medical device submission for a physical surgical fixation system.

Therefore, many of the requested fields related to AI/algorithm performance (e.g., test set, ground truth experts, MRMC studies, standalone performance, training set) are not applicable to this document.

Here's an attempt to extract relevant information from the provided text, acknowledging that the request is geared towards AI/algorithm studies, which isn't the subject of this 510(k) summary.

1. Table of acceptance criteria and the reported device performance

The document states that the OPTIFIX™ Absorbable Fixation System passed various non-clinical and animal test requirements, and "All samples tested met the acceptance criteria." However, the specific quantitative acceptance criteria values are not explicitly stated in the provided text. The performance is reported as meeting these (unstated) criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not explicitly stated for each test, but implied to be "All samples tested." The specific number of samples for each non-clinical or animal study is not provided.
• Data Provenance: Not explicitly stated. The studies are described as "non-clinical tests," "animal in-vivo studies," and "Ex-vivo Burst Strength on Pig wall." Country of origin or retrospective/prospective nature is not mentioned.

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. This document describes the testing of a physical medical device. The "ground truth" for the performance metrics (e.g., shear strength, mass loss, burst strength) would be established by direct physical measurements and observations, not by human expert consensus or interpretation in the way it's done for AI models.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not Applicable. See explanation above. The assessment of physical and biological properties is based on experimental protocols and quantitative analysis, not expert adjudication of interpretations.

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 is a physical device, not an AI/algorithm. No human "readers" are involved in interpreting its output, and there's no AI assistance being evaluated.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not Applicable. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" in this context refers to the measured physical and biological properties of the device and its interaction with tissue. This includes:
  • Direct measurements of shear strength, mass, dimensions, viscosity, glass transition temperatures, and residual monomer content.
  • Observations from animal in-vivo studies (e.g., contracture, tissue ingrowth, histology) which are typically assessed by pathologists or researchers following established protocols.
  • Measurements of burst strength on ex-vivo tissue (pig wall).

8. The sample size for the training set

• Not Applicable. This is not an AI/algorithm-driven device; therefore, there is no "training set."

9. How the ground truth for the training set was established

• Not Applicable. See explanation above.

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