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The Modified Endo Stitch™ 10 mm single use suturing device has application in endoscopic surgery for the placement of interrupted or running stitches in soft tissues

The Modified Endo Stitch™ is an endoscopic suturing device that contains two jaws at its distal end, with opposing handles and a toggle lever at its proximal end.

The provided text describes a 510(k) premarket notification for a medical device called the "Modified Endo Stitch™ Endoscopic Suturing Device." However, the document does NOT contain explicit acceptance criteria, detailed study designs, or specific performance metrics that would typically be found in a clinical study report.

The information primarily focuses on the device description, intended use, materials, and a general statement about performance data.

Therefore, many of the requested details cannot be extracted from the provided text. Below is an attempt to answer the questions based on the available information and to indicate where the information is not present.

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

Based on the provided text, specific acceptance criteria and detailed quantitative performance metrics are not explicitly stated. The document only broadly mentions:

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

This information is not provided in the document. The text mentions "In-vitro and in-vivo testing has been performed" but does not specify sample sizes, origin of data, or study design (retrospective/prospective).

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 provided in the document. Such details would typically be part of a detailed study report, which is not present here.

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

This information is not provided in the document.

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 device is an endoscopic surgical suturing device, not an AI-powered diagnostic or imaging interpretation tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human reader improvement with or without AI assistance is not relevant to this type of device and is not described in the provided text.

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 manual surgical tool and not an algorithm.

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

The document only states that "In-vitro and in-vivo testing has been performed in support of the intended use of this device." (Page 21, {1}). It does not specify the type of ground truth used for these tests. In the context of a surgical device, "ground truth" would likely relate to the successful and safe performance of the suturing function, potentially evaluated through physical-mechanical testing (in-vitro) and animal or human studies (in-vivo) assessing factors like suture strength, tissue closure, and absence of complications, but these specifics are not elaborated.

8. The sample size for the training set

This information is not provided in the document. The concept of a "training set" is usually associated with machine learning or AI models, which is not the nature of this device.

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

This question is not applicable as the device is a manual surgical tool and not an AI-powered system that requires a "training set" with established ground truth in the typical sense.

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