Search Results

This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of endoscopic marking, hemostasis for mucosal/submucosal defects less than 3 cm in the upper GI tract, bleeding ulcers, arteries less than 2 mm, and polyps less than 1.5 cm in diameter in the GI tract. This device is not intended for the repair of GI tract lumenal perforations.

The Instinct Endoscopic Hemoclip is a sterile, single use device that consists of metal clip that detaches from the introducer to maintain approximation of tissue to achieve hemostasis in the gastrointestinal tract. The device is compatible with endoscopes with a minimum accessory channel of 2.8 mm. The Instinct Endoscopic Hemoclip is 230 cm long. The deployed clip portion of the Instinct Endoscopic Hemoclip is stainless steel and nitinol while the introducer is nylon, stainless steel and nitinol.

The provided text describes a 510(k) summary for the Instinct Endoscopic Hemoclip. This document assesses the substantial equivalence of a new medical device to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not directly available in this document.

However, I can extract information related to the device's performance assessment as presented in the submission.

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

Based on the provided text, specific numerical acceptance criteria are not detailed. The performance assessment focused on demonstrating that the device met "performance requirements" through non-clinical bench testing.

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 mentions "non-clinical bench testing." This typically refers to laboratory-based evaluations.

• Sample Size: Not specified.
• Data Provenance: Non-clinical bench testing data. Country of origin not specified (implied to be within the company's testing facilities, likely in the USA where the company is based). The data is generated prospectively during the device development and testing phase.

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 applicable to non-clinical bench testing. Ground truth for mechanical performance tests is typically established by engineering specifications and objective measurements, not by expert consensus.

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

This information is not applicable to non-clinical bench testing. Mechanical test results are objective and measured against predefined specifications.

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

An MRMC study is not mentioned. This type of study is typically for evaluating diagnostic imaging devices with human interpretation, not for mechanical devices like a hemostasis clip.

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

This concept is not applicable to a mechanical medical device like a hemoclip. There is no "algorithm only" performance for such a device; its function is mechanical and directly applied by a clinician.

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

The "ground truth" for the non-clinical bench testing would be the pre-defined engineering specifications and measurable performance standards for visual verification and tensile strength.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of mechanical bench testing for a device like this. Machine learning algorithms, which require training sets, are not mentioned.

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

Not applicable, as there is no training set mentioned.

Ask a specific question about this device