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The Elastic Traction System is indicated for adult only for use in flexible Endoscopy to provide retraction to assist in tissue resection, exposure, and removal of tissue within the stomach and colon.

The proposed device, Elastic Traction System, consists of 2 components, an Elastic Traction Device, and a clipping device (Fig. 1). Two components are single use device.

The Elastic Traction Device is a single use tissue traction device. It is consisting of clip assembly, silicone band and delivery system. The silicone band is consisting of three rings. Ring A is preloaded with the clip.

The Clipping Device is a single use device, and its purpose is to use it as a second clip. The second clip is used to engage the silicone band of the previously anchored clip of Elastic Traction Device.

The provided text describes the Micro-Tech (Nanjing) Co., Ltd. Elastic Traction System, an endoscopic traction device. The information details the device's characteristics, its comparison to a predicate device, and the non-clinical performance data used to establish substantial equivalence.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria appear to be framed around demonstrating substantial equivalence to the predicate device, ProdiGI Traction Wire (DEN220006), across various performance aspects that confirm safety and effectiveness for its intended use. While explicit numerical acceptance criteria values are not given in this summary, the document states that tests were performed to demonstrate that the device performs as intended under anticipated conditions of use and is considered safe and effective for its intended use.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify the exact sample sizes used for each individual bench test. It mentions that "bench tests below were tested and evaluated." For the animal study, it states an "animal test" was conducted, implying one study, but the number of animals or procedures is not specified.
• Data Provenance: The data provenance is from non-clinical studies (bench tests, animal study, usability assessment, shelf-life, sterilization, biocompatibility testing) conducted by Micro-Tech (Nanjing) Co., Ltd. The animal study was conducted according to 21 CFR §58 (GLP Regulations), suggesting it was a prospective study. The bench tests are laboratory-based.

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

• This information is not provided in the document. For non-clinical performance tests, "ground truth" is typically established by engineering specifications, validated test methods, and regulatory standards rather than expert consensus on observational data.

4. Adjudication Method for the Test Set

• This information is not applicable/provided as the performance data is derived from objective, replicable tests (bench, animal, etc.) rather than subjective assessments requiring adjudication.

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

• No MRMC comparative effectiveness study was done. The document explicitly states: "No clinical study is included in this submission."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• This information is not applicable. The device is a physical medical device (an endoscopic traction system), not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The performance data presented refers to the device's physical and functional characteristics.

7. Type of Ground Truth Used

• For the non-clinical performance tests (bench tests), the ground truth is based on engineering specifications, established test methods, and compliance with relevant international standards (e.g., ASTM F1980, ISO 11135, ISO 10993-1).
• For the animal study, the ground truth for safety and effectiveness would be established through direct observation of the device's performance in vivo and histological examination or other relevant biological assessments, evaluated against pre-defined success criteria.

8. Sample Size for the Training Set

• This information is not applicable. The device is a physical medical device, not an AI algorithm that requires a training set.

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

• This information is not applicable as there is no training set for a physical medical device.

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