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The NobleStich EL is indicated for use in the placement of sutures for soft tissue approximation in cardiovascular procedures. The NobleStitch EL is not intended for blind vascular closure.

The NobleStich EL device is a single-use surgical device, indicated for use in direct contact within the vascular and cardiovascular system. The NobleStitch EL device may be used by insertion through an access device (e.g. trocar, sheath or cannula), already in place following diagnostic or interventional procedures.

Based on the provided text, the device in question is the NobleStitch EL Suturing Device, a non-AI/ML device. The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study for an AI/ML diagnostic tool.

Therefore, the requested information regarding acceptance criteria, study design for AI/ML performance, ground truth establishment, expert adjudication, sample sizes for training/test sets, and MRMC studies cannot be extracted from this document as it pertains to a traditional medical device clearance process, not an AI/ML device approval.

The document discusses "Non-Clinical Test Summary" which details bench testing and clinical simulations, but these are for the physical device's functionality and performance, not for an AI/ML algorithm's diagnostic or predictive capabilities.

Summary of what can be extracted/inferred from the document regarding the device's testing, not related to AI/ML device performance:

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

• Acceptance Criteria (Implicit - demonstrated through testing): The device functions as intended and is as safe and effective as the predicate device (K113494).
• Reported Device Performance (as summarized):
  • Functional Tests: Passed visual inspection and operation.
  • Performance Tests: Actuation and verification of preloaded formed suture.
  • Clinical Simulation Tests: Actuated using a clinical simulation porcine model.

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

• Sample Size: Not specified in terms of numerical quantity for the tests. It mentions "a clinical simulation porcine model" but doesn't quantify how many uses or simulations were performed.
• Data Provenance: The "clinical simulation porcine model" suggests animal data, likely controlled laboratory conditions inherent to non-clinical bench testing. Country of origin not specified. These are non-clinical, likely prospective tests for the device's function.

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 / Not mentioned. This document describes testing for a physical suturing device, not an AI/ML algorithm requiring expert interpretation of medical images or data.

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

• Not applicable / Not mentioned. Adjudication methods are typically for resolving discrepancies in expert interpretations in AI/ML performance studies.

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 document is not about an AI/ML device requiring MRMC studies.

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

• Not applicable. This is not an AI/ML algorithm. The device itself is a standalone physical instrument.

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

• For the non-clinical tests, the "ground truth" would be the successful mechanical function of the device, proper suture deployment, and usability in the porcine model as defined by predetermined engineering and functional specifications. It's not a medical "diagnosis" ground truth.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that undergoes "training."

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

• Not applicable.

Conclusion: The provided text is a 510(k) clearance document for a physical medical device (suturing device), not an AI/ML diagnostic or therapeutic system. Therefore, the questions specifically pertaining to AI/ML device performance evaluation methods (e.g., training/test sets, expert adjudication, MRMC studies, ground truth for AI algorithms) are not addressed in this document. The "Non-Clinical Test Summary" describes traditional bench and simulation testing for the physical device's functionality.

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The NobleStitch™ EL, MR, and TA sizes are indicated for use in performing vascular stitching in general surgery, including endoscopic procedures. The NobleStitch™ EL, MR, and TA are not intended for blind vascular closure.

The NobleStitch™ EL, MR. and TA 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 KnotPusher™ accessory for advancing the knot to the wound site, and/or a KwiKnot™ accessory.

This is a 510(k) premarket notification for the NobleStitch™ EL, MR, and TA vascular suturing devices. As such, the documentation provided focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical studies with specific acceptance criteria and performance metrics.

Here's an analysis of the provided text in relation to your questions:

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

The provided 510(k) summary does not contain a table of acceptance criteria and reported device performance in the way you might expect for a typical study. This is common for predicate pathway 510(k) submissions, where the primary argument is that the new device is "substantially equivalent" to an already cleared device.

Instead of formal performance metrics against acceptance criteria, the submission makes the argument of equivalence based on:

• Intended Use/Indications for Use: Identical to the predicate device.
• Technological Characteristics: Essentially the same as the predicate, with minor modifications related to "different diameters or lengths with improved handle ergonomics."
• Principles of Operation: Identical to the predicate device.

The core assertion is that "The minor modifications to the NobleStitch™ do not raise any new questions of safety or effectiveness." This statement implies that the new device will perform equivalently to the predicate, and therefore, no new performance data or acceptance criteria are explicitly required beyond demonstrating that the modifications do not negatively impact safety or effectiveness.

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

The document does not describe any specific test set, sample size, or data provenance for a clinical study. The submission relies on the concept of substantial equivalence to a predicate device (SuperStitch® Vascular Suturing Device). This means that the safety and effectiveness are inferred from the predicate, and new clinical data typically isn't required unless the changes are significant enough to raise new questions of safety or effectiveness.

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 detailed in the provided document as there is no mention of a clinical study involving a test set that required expert ground truth establishment.

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

This information is not applicable or mentioned because no clinical test set requiring adjudication is described.

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 or mentioned. The device is a manual vascular suturing device, not an AI-assisted diagnostic tool.

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

This information is not applicable or mentioned. The device is a manually operated surgical instrument, not an algorithm.

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

This information is not detailed as no specific clinical study with ground truth data is described. The "ground truth" for this 510(k) submission is effectively the established safety and effectiveness of the predicate device.

8. The sample size for the training set

This information is not applicable or mentioned as the device is a manual surgical instrument and not an AI or algorithmic system that requires a training set.

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

This information is not applicable or mentioned for the same reason as point 8.

In summary:

This 510(k) submission is a "predicate pathway" submission, which means it seeks to demonstrate that the new device (NobleStitch™ EL, MR, and TA) is "substantially equivalent" to an already legally marketed device (SuperStitch® Vascular Suturing Device). For such submissions, the FDA typically does not require new comprehensive clinical studies with detailed acceptance criteria, sample sizes, and expert adjudications, unless the changes from the predicate raise new questions of safety or effectiveness. The core argument here is that minor ergonomic and diameter/length changes do not alter the fundamental safety or effectiveness demonstrated by the predicate device.

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The SRM-Stitch™ 8F version is indicated for use in performing vascular stitching in general surgery, including endoscopic procedures. The SRM-Stitch™ 8F is not intended for blind vascular closure.

The SRM-Stitch™ 8F version is 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, and a KwiKnot™ accessory. The optional KnotPusher™ accessory has been eliminated from current packaging configuration of SRM-Stitch™ 8F.

This document is a 510(k) premarket notification for a medical device and does not contain the specific information requested about acceptance criteria or a study that proves the device meets those criteria.

The 510(k) summary (Sections {0} and {1}) states that the SRM-Stitch™ 8F is substantially equivalent to a predicate device (SuperStitch® Vascular Suturing Device) because it has the same intended use, indications for use, principles of operation, and fundamental technological characteristics. The document mentions "minor modifications" to the suture sleeve and guidewire port but asserts these "do not raise any new questions of safety or effectiveness."

The FDA letter (Sections {2} and {3}) confirms the substantial equivalence determination for the device based on the information provided in the 510(k) submission.

Therefore, I cannot provide the requested information, which typically would be found in a detailed study report or clinical trial summary. This 510(k) entry is a regulatory filing focused on demonstrating equivalence to an already approved device rather than presenting new performance study data against defined acceptance criteria.

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