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The SuperStitch 5F, 12F & EL sizes are indicated for use in performing vascular stitching in general surgery, including endoscopic procedures. The SuperStitch 5F, 12F & EL are not intended for blind vascular closure.

The SuperStitch 5F, 12F & EL versions are hand-held and manually operated suturing devices designed to allow a physician to place a suture to a remote site either directly, through a cannula/introducer, or through a laparascopic access device. The device contains the following components and accessories: a suture delivery device, monofilament polypropylene suture, a pre-loaded guidewire, a KnotPusher accessory for advancing the knot to the wound site, and a KwiKnot accessory.

The provided text is a 510(k) summary for a medical device (SuperStitch® 5F, 12F & EL Vascular Suture Delivery Device). This document is a regulatory submission to the FDA for market clearance and focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results or acceptance criteria in the manner typically seen for novel AI/software as a medical device (SaMD) products.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, and ground truth establishment are not present in this type of document because the device relies on existing technology and a predicate device.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable/present in this document. The 510(k) focuses on demonstrating substantial equivalence, not meeting specific performance metrics from a detailed clinical study with pre-defined acceptance criteria. The claim is that the device has "the same intended use and indications for use, principles of operation, and fundamental technological characteristics as the currently marketed SuperStitch," with only minor modifications in diameter or length. This implies the performance is expected to be equivalent to the predicate device.

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

Not applicable. This device is a manual surgical suturing device, not an AI/software device that would typically have a "test set" in the context of AI performance evaluation. The submission relies on the established safety and effectiveness of its predicate device, the original SuperStitch Vascular Suturing Device, without presenting a specific clinical "test set" for the new iterations.

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

Not applicable. Ground truth establishment, in the context of expert consensus, is typically for evaluating diagnostic or prognostic algorithms. This device is a surgical instrument.

4. Adjudication Method for the Test Set

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

Not applicable. MRMC studies are typically for evaluating the impact of AI on diagnostic performance of human readers. This device is a surgical tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an AI/algorithm-only device.

7. The Type of Ground Truth Used

Not applicable. For this type of device, safety and effectiveness would be demonstrated through bench testing, biocompatibility, sterilization validation, and potentially animal or limited human use data, all aimed at showing that the device performs its intended function safely and effectively, similar to its predicate. The concept of "ground truth" as used in AI evaluation does not directly apply here.

8. The Sample Size for the Training Set

Not applicable. This is not an AI device that requires a training set.

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

Not applicable.

Summary of what is available in the document regarding how the device meets acceptance criteria (through the lens of substantial equivalence):

The device (SuperStitch 5F, 12F & EL) gained market clearance based on its substantial equivalence to a previously cleared predicate device, Sutura's SuperStitch Vascular Suturing Device.

• Acceptance Criteria (Implied by Substantial Equivalence): The device is considered to meet acceptance criteria if it:

  • Has the same intended use.
  • Has the same indications for use.
  • Has the same principles of operation.
  • Has fundamental technological characteristics that are equivalent.
  • Any differences do not raise new questions of safety or effectiveness.

• Study Proving Acceptance Criteria (Demonstration of Substantial Equivalence):

  • The "study" here is the 510(k) submission itself, which argues for substantial equivalence.
  • The document explicitly states: "The SuperStitch 5F, 12F & EL has the same intended use and indications for use, principles of operation, and fundamental technological characteristics as the currently marketed SuperStitch, except that the SuperStitch 5F, 12F & EL provide the option of diameter or lengths for use by the physician. This minor modification to the SuperStitch does not raise any new questions of safety or effectiveness. Thus, the SuperStitch 5F, 12F & EL are substantially equivalent."

In essence, for this specific K062125 submission, the "acceptance criteria" were met by demonstrating that the new devices are essentially minor variations of an already cleared and accepted device, and therefore share its established safety and effectiveness profile. No new clinical trials or performance studies specific to these minor modifications were required or presented in this summary document.

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The SuperStitch GW is indicated for use in performing vascular stitching in general wascular closure.

SuperStitch GW Models 06-15-04-GW; 08-15-04-GW

The provided text is a 510(k) summary for the Sutura, Inc.'s SuperStitch GW. This document primarily focuses on establishing substantial equivalence to a predicate device and obtaining regulatory clearance for market access. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria as would typically be found in performance evaluation reports.

Therefore, many of the requested details, such as a table of acceptance criteria, reported device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC study results, standalone performance, and ground truth establishment, are not available in the provided text.

The document indicates the following:

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

• Not available. The document is a 510(k) summary, which focuses on establishing substantial equivalence for regulatory clearance rather than presenting detailed performance study results against predefined acceptance criteria.

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

• Not available. No information about a specific test set or data provenance is provided.

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 available. No information about ground truth establishment or experts is provided.

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

• Not available. No information about adjudication methods is provided.

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 available. This device is a surgical suture delivery device, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant and not mentioned.

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

• Not applicable. This is a medical device (a suture delivery tool), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.

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

• Not available. The document does not describe performance studies that would require a defined ground truth.

8. The sample size for the training set

• Not available. The SuperStitch GW is a physical medical device, not an AI or machine learning algorithm that requires a training set in that context.

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

• Not applicable. As a physical medical device, the concept of a "training set" with established ground truth is not relevant in the context of AI/ML models.

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SuperStitch is indicated for use in performing vascular stitching in general surgery, including endoscopic procedures. It is not intended for blind vascular closure.

The SuperStitch Vascular Suture Delivery Device is a hand-held and operated device designed for use with or without an access device (e.g. trocar, sheath, or cannula), depending on the endoscopic technique, for use during minimally invasive surgical procedures, or for application directly to a vessel or wound site in an open setting. The SuperStitch applies one nonabsorbable monofilament suture. After deployment of the device, the physician completes the closure by tying the appropriate surgical knots. Optional accessories for use with the SuperStitch include the KnotPusher for advancing the knot to the wound site and the Kwiknot knot tying device. The principal difference between the modified SuperStitch and the cleared SuperStitch is a change in one of the shaft materials. The Sutura SuperStitch is a prescription device, restricted to use by or on the order of physicians. The Sutura SuperStitch is sterilized by ethylene oxide and is non-pyrogenic in an unopened undamaged package, for single use only.

The provided text describes a 510(k) premarket notification for a medical device, the SuperStitch® Vascular Suture Delivery Device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with specific acceptance criteria, and thus the provided text does not contain the detailed information requested in the prompt (acceptance criteria, study details, sample sizes, ground truth establishment, MRMC studies, etc.).

Here's a breakdown of what can be extracted or inferred from the provided information, and what cannot:

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

• Cannot be extracted. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It does not typically include a table of pre-defined acceptance criteria (e.g., specific performance metrics like accuracy, sensitivity, specificity) for device performance or reported device performance against such criteria. The "study" mentioned is a comparison to a predicate, not a performance study against specific acceptance metrics for a "new" device.

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

• Cannot be extracted. Since there isn't a "test set" in the sense of a clinical or image-based study to evaluate performance metrics, this information is not present. The "testing" referred to is around design control and material properties, not a clinical performance validation against specific disease states or measurements.

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):

• Cannot be extracted. No ground truth establishment for a test set is mentioned.

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

• Cannot be extracted. No adjudication method is mentioned as there's no test set requiring ground truth establishment.

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:

• Cannot be extracted. This device is a surgical suture delivery device and not an AI/imaging device. Therefore, MRMC and human reader improvement with AI assistance are not relevant and are not discussed.

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

• Cannot be extracted. This is not an algorithm-based device.

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

• Cannot be extracted. No ground truth is established for device performance in the context of clinical outcomes or diagnostic accuracy. The "ground truth" for this submission would be the performance and safety characteristics of the predicate device.

8. The sample size for the training set:

• Cannot be extracted. This is not an AI/machine learning device. No training set is used.

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

• Cannot be extracted. No training set or associated ground truth establishment is mentioned.

Summary based on the provided text:

The provided document, K020940, describes a 510(k) premarket notification for the Sutura SuperStitch® Vascular Suture Delivery Device. The primary purpose of this submission is to demonstrate substantial equivalence to a previously cleared predicate device (Sutura SuperStitch®, K012865), rather than to establish specific performance criteria through a standalone clinical study.

Acceptance Criteria and Device Performance:

• The acceptance criteria for this 510(k) submission are implicitly tied to demonstrating that the modified SuperStitch device performs as safely and effectively as the predicate device.
• The "reported device performance" is essentially that the device maintains the same intended use, functionality, and reliability as the predicate device, following a material change in one of the shaft components.
• The document states: "The differences in the technological characteristics and size of the modified SuperStitch have been evaluated through appropriate design control procedures. These methods assessed the new characteristics with regard to functionality and reliability under simulated and actual conditions of use. Results of scientific testing have ensured that the materials are biocompatible and physical properties are appropriate for the intended use."
• No specific quantitative performance metrics (e.g., success rates, complication rates, specific mechanical test results with associated acceptance thresholds) are provided in this summary document. This level of detail would typically be in the full submission, not the public summary.

Study Type and Details:

• The "study" conducted for this 510(k) was a comparison to a predicate device to demonstrate substantial equivalence. It was not a comparative effectiveness study involving human readers or a standalone performance study with defined clinical endpoints.
• The evaluation focused on material changes, biocompatibility, and physical properties under simulated and actual conditions of use.
• Sample Size, Ground Truth, and Adjudication: These concepts (test set, training set, ground truth established by experts, adjudication methods, MRMC studies) are not applicable to this type of device and 510(k) submission. The assessment was primarily engineering and material-based, ensuring the modified device's characteristics were equivalent to the cleared predicate.

In conclusion, the requested detailed information (acceptance criteria, specific study parameters, sample sizes, ground truth, MRMC, etc.) is not present in this 510(k) summary because it primarily addresses substantial equivalence for a non-AI surgical device with a material modification, rather than a clinical performance study with predefined metrics for a "new" device concept.

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SuperStitch® is indicated for use in performing vascular stitching in general surgery, including endoscopic procedures. It is not intended for blind vascular closure.

The SuperStitch® Vascular Suture Delivery Device is a hand-held and operated device designed for use with or without an access device (e.g. trocar, sheath, or cannula), depending on the endoscopic technique, for use during minimally invasive surgical procedures, or for application directly to a vessel or wound site in an open setting. The SuperStitch® applies one nonabsorbable monofilament suture. After deployment of the device, the physician completes the closure by tying the appropriate surgical knots, Optional accessories for use with the SuperStitch® include the KnotPusher™ for advancing the knot to the wound site and the Kwiknot™ knot tying device.

The principal differences between the modified SuperStitch® and the cleared SuperStitch® are: (1) changes made within the operating mechanism to improve manufacturability; (2) the addition of longer lengths to accommodate longer (i.e., 25cm) sheaths; (3) change in package to a single sterile barrier; (4) the inclusion of a modified KnotPusher™ accessory that is packaged with the SuperStitch® (5) a change in one of the cannula materials; and (6) the addition of a smaller (6 French) size for compatibility with 6 French procedural sheaths.

The Sutura SuperStitch® is a prescription device, restricted to use by or on the order of physicians.

The Sutura SuperStitch® is sterilized by ethylene oxide and is non-pyrogenic in an unopened undamaged package, for single use only.

The provided text does not contain detailed information about acceptance criteria, specific studies with device performance metrics, sample sizes, expert qualifications, or ground truth methodologies. The document is a 510(k) summary for a medical device (SuperStitch® Vascular Suture Delivery Device) seeking substantial equivalence to a predicate device.

Instead, the summary focuses on establishing substantial equivalence based on comparisons of design, indications, materials, and principle of operation with a previously cleared device. It states that "The differences in the technological characteristics and size of the modified SuperStitch® have been evaluated through appropriate design control procedures. These methods assessed the new characteristics with regard to functionality and reliability under simulated and actual conditions of use. Results of scientific testing have ensured that the materials are biocompatible and physical properties are appropriate for the intended use."

However, it does not provide specific details on:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, or the number/qualifications of experts.
• Adjudication methods.
• Multi-reader multi-case comparative effectiveness studies or their effect sizes.
• Standalone algorithm performance studies.
• The type of ground truth used.
• Sample sizes for training sets or how their ground truth was established.

Therefore, I cannot provide the requested table and information based directly on the provided text. The document serves as regulatory submission highlighting equivalence rather than a detailed study report with specific performance metrics against defined acceptance criteria.

Ask a specific question about this device

SuperStitch® is indicated for use in performing vascular stitching in general surgery, including endoscopic procedures. It is not intended for blind vascular closure.

The SuperStitch® device is designed for use with or without an access device (e.g., trocar, sheath, or cannula) depending on the endoscopic technique, for use during minimally invasive surgical procedures, or for application directly to a vessel or wound site in an open setting. SuperStitch® applies one nonabsorbable sterile surgical suture. The knot pusher is comprised of two components: a snare to capture one strand of the The safet positive is veniprises or used to advance the tied knot to the surface of the tissue.

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) premarket notification letter from the FDA regarding the "SuperStitch® Vascular Suturing Device", and it primarily discusses regulatory classification, indications for use, and a summary of safety and effectiveness related to establishing substantial equivalence to predicate devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the given text.

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