Search Results

The Su2ura® Approximation Device is indicated in endoscopic surgery for the placement of interrupted or running stitches in soft tissue.

The Anchora Su2ura® Approximation Device is a sterile single use device is indicated in endoscopic surgery for the placement of interrupted or running stitches in soft tissue. The device is a 5mm single-use endoscopic suturing device loaded with threaded anchors. It is designed to deploy up to 19 anchors by a trigger action of the handle of the delivery system. After deployment, each anchor is anchored within the tissue in which it was deployed. After deployment of 2 or more anchors, the suture that passes between the anchors can be tightened to pull the anchors toward each other and approximate the tissue. The delivery system consists of a plastic handle and a 36-cm stainless steel shaft. The handle includes a Trigger, a Knob, and a Toggle Button. A Cap can be added at the distal edge of the Shaft to advance extracorporeal suture knots. The anchors can be deployed in single-stitch or running- stitch configuration. The device deploys the anchors through a needle with an outer diameter of 2.1 mm, available in two lengths: 5 mm and 9 mm protrusion. The Anchor is advanced outside of the needle by a Pushrod. Each anchor, made of stainless steel, is threaded with an off-the-shelf UHMWPE suture manufactured by Teleflex Medical. The device provides the anchors already threaded on this suture. The device is sterile packaged and designed for single use only. The device is manufactured from medical grade materials (mainly plastics and stainless steels).

The Su2ura Approximation Device is a sterile, single-use endoscopic suturing device with the following acceptance criteria and reported performances:

1. Acceptance Criteria and Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Biocompatibility: Not explicitly stated as a test set with a specific sample size of biological samples, but rather a set of material characterization studies (extractables and leachables) and toxicological risk assessments. The input does not provide information on the number of samples for these tests.
• Human Factors: 18 representative users. The provenance of the users (e.g., country of origin, whether they were clinicians or laypersons, etc.) is not specified. The study appears to be prospective.
• Pre-Clinical Performance (Animal Study): 8 pigs (5 for test items, 3 for control items). The provenance of the data is a GLP animal study. It is a prospective study.
• Mechanical Performance, MRI Safety, Packaging Integrity: These involved various bench tests. The sample sizes for each specific test (e.g., number of devices tested for tensile strength or deployment reliability) are not explicitly stated in the provided text. The data provenance is from laboratory/bench testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Biocompatibility: No explicit external experts are mentioned for establishing ground truth. Compliance was based on ISO standards.
• Human Factors: The "representative users" assessed usability. It's not stated whether these were "experts" in the sense of clinicians or if their feedback constituted a "ground truth" to be adjudicated. Their feedback was used to confirm usability.
• Pre-Clinical Performance (Animal Study): Not explicitly stated how many experts were involved in evaluating the histopathological data, but it would typically involve veterinary pathologists. Their specific qualifications are not detailed.
• Mechanical Performance, MRI Safety, Packaging Integrity: Ground truth for these studies relies on recognized ASTM and USP standards and internal engineering measurements. No external "experts" were mentioned for ground truth establishment beyond standard scientific and engineering practices.

4. Adjudication Method for the Test Set

The document does not specify any formal adjudication method (like 2+1 or 3+1) for the various studies conducted as part of the regulatory submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a surgical tool, and its effectiveness is not assessed through human reader interpretation of images, but rather through direct use in surgery, performance in bench tests, and pre-clinical animal studies. Clinical testing was expressly stated as "not required to demonstrate substantial equivalence."

6. Standalone Performance Study

The studies described (bench testing, animal study, human factors) are essentially "standalone" in the sense that they evaluate the device itself. However, the term "standalone performance" often refers to the algorithm-only performance of AI devices without human-in-the-loop. This device is a mechanical surgical tool, not an AI or imaging diagnostic device, so this concept does not directly apply.

7. Type of Ground Truth Used

• Biocompatibility: Compliance with ISO 10993 standards (e.g., acceptable levels of extractables/leachables, lack of toxicological risk).
• Human Factors: User feedback and observed usability were used to confirm clarity of training and IFU, and the overall usability of the device. This is a form of self-reported or observed performance against predetermined usability goals.
• Pre-Clinical Performance (Animal Study): Histopathological data (from tissue analysis) and clinical monitoring of animals provided the ground truth for safety and performance (e.g., successful closure, similar long-term safety profile to controls).
• Mechanical Performance, MRI Safety, Packaging Integrity: These rely on objective measurements and adherence to established industry standards (ASTM, USP) and predefined product specifications.

8. Sample Size for the Training Set

This question is not applicable. The Su2ura® Approximation Device is a mechanical surgical device, not a machine learning or AI model, so there is no "training set" in the context of algorithm development.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as there is no training set for this type of device.

Ask a specific question about this device

PERMATAPE™ Suture is indicated for use in general soft tissue approximation, and/or ligation, including use with allograft tissue for orthopedic procedures.

PERMATAPE™ Suture is a synthetic, sterile, flat braided suture composed of dyed and un-dyed, non-absorbable polyethylene.

This document is a 510(k) summary for a medical device called PERMATAPE™ SUTURE. The document details the device's characteristics, intended use, and a comparison to predicate devices to establish substantial equivalence.

Based on the provided text, here is the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like a typical AI/ML study would. Instead, it refers to industry standards and predicate device comparisons.

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

This information is not provided in the document. The document describes a physical medical device (surgical suture), not a software or AI/ML device that would typically involve test sets of data. The testing mentioned (USP Tensile Strength, bacterial endotoxin) would involve physical samples of the suture, but the sample sizes for these tests are not specified, nor is the "data provenance" as it would apply to data in an AI context.

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

This information is not applicable to this document. This is a physical medical device submission, not an AI/ML device where "experts" would establish ground truth for a test set. The "ground truth" for a suture would be its physical properties, which are measured using standardized methods.

4. Adjudication method for the test set

This information is not applicable to this document. Adjudication methods like "2+1, 3+1" are relevant for AI/ML device studies where discrepancies in expert labels or model predictions need resolution. For a physical device, performance is measured against established standards.

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 to this document. An MRMC study is relevant for AI/ML devices that assist human readers (e.g., radiologists interpreting images). This device is a surgical suture, which does not involve human "readers" or AI assistance in that context.

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

This information is not applicable to this document. The device is a surgical suture; it is not an algorithm and does not have "standalone" performance in the context of AI.

7. The type of ground truth used

For the physical characteristics of the suture, the "ground truth" is established by adherence to established industry standards and test methods, specifically:

• USP Tensile Strength for Surgical Sutures
• FDA's Special Controls Guidance document for Surgical Sutures
• Requirements for bacterial endotoxin testing

8. The sample size for the training set

This information is not applicable and not provided. This is a physical medical device, not an AI/ML device requiring a "training set" of data in the common sense. The manufacturing process of the suture is the "training" in a very loose analogy, but it's not a data-driven training set.

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

This information is not applicable and not provided. As explained above, this device does not utilize a "training set" in the context of AI/ML. The "ground truth" for the manufacturing process would be established by quality control procedures and specifications for materials and manufacturing methods, but these details are not provided in this regulatory summary.

Ask a specific question about this device