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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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ProdiGI Traction Wire: The Medtronic ProdiGI Traction Wire is indicated to grasp tissue within the esophagus, stomach, and colon of adults during an Endoscopic Submucosal Dissection (ESD) procedure.

ProdiGI Traction Magnet: The Medtronic ProdiGI Traction Magnet is indicated to grasp tissue within the stomach and colon of adults during an Endoscopic Submucosal Dissection (ESD) procedure.

The ProdiGI Traction System includes the Traction Wire and Traction Magnet devices. The Traction Wire and Traction Magnet are not intended to be used together. Both devices are used in adults only and are used to provide improved visualization of the submucosal space during an endoscopic submucosal dissection (ESD) procedure.

ProdiGI Traction Wire Device: The Traction Wire consists of two graspers: a primary tissue grasper with traction wire attached (ERD-TW20 and ERD-TW35), and a secondary tissue grasper (ERD-TWSG) without a wire. The secondary tissue grasper is used to secure the distal end of the traction wire. The traction wire is a nitinol shape-memory loop (2.0 cm or 3.5 cm in length) that provides tension to the attached tissue after deployment. The nitinol wire is attached to the grasper with a stainless-steel crimp.

ProdiGI Traction Magnet Device: The traction magnet (ERD-TMST and ERD-TMLG) consists of two identical tissue graspers with a permanent neodymium magnet attached to the grasper via a suture. The sutured magnet provides tension to the attached tissue after deployment.

Here's an analysis of the provided text to describe the acceptance criteria and the study proving the device meets them, based on your requested format:

Acceptance Criteria and Device Performance for ProdiGI

The ProdiGI device underwent non-clinical/bench studies and usability testing to demonstrate its safety and effectiveness. Importantly, no clinical data was provided. The primary studies proving the device meets acceptance criteria are summarized in the "Performance Testing - Bench", "Usability Testing", and "Performance Testing - Animal" sections of the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document presents acceptance criteria and reported performance in a narrative and tabular format for both bench and usability testing. I will consolidate the key performance criteria for each device type into a single table. Note that specific numerical results (e.g., 'b)(4)') were often redacted in the original text, so I will indicate where this occurs.

Table 1: Consolidated Acceptance Criteria and Reported Device Performance (Bench and Usability)

2. Sample Sizes and Data Provenance

• Bench Testing: The document states that the longest nitinol wire device (ERD-TW35) was used as a representative model for Traction Wire testing. For the Traction Magnet, both models (ERD-TMLG and ERD-TMSM) were used. The sample sizes for each mechanical test are not explicitly stated as numerical values (e.g., "n=X") but are implied by the performance claims that "The device passed all the tests." The provenance is internal bench testing, likely conducted prospectively by the sponsor.
• Usability Testing:
  • Traction Wire: A total of (b)(4) procedures were performed (mixture of different organs and with/without traction). Specifically, (b)(4) procedures with Traction Wire and (b)(4) procedures without Traction (control) for Visualization (N1.1) and Perforation (N1.4). (b)(4) procedures with Traction and (b)(4) without for Procedure Time (N1.2). (b)(4) procedures each in esophagus, stomach, and colorectal for anatomical locations (N1.3). (b)(4) procedures with (b)(4) cm lesions for lesion size (N1.5). (b)(4) procedures for trauma (N1.6) and complications (N1.7). The data provenance is described as "Ex-vivo porcine and bovine tissue from the esophagus, stomach and colon."
  • Traction Magnet: Sample sizes are largely redacted (indicated as (b)(4)). Two procedures each in the stomach and colon were used for testing. (b)(4) procedures with Traction Magnet and (b)(4) without Traction for Visualization (NL1), Procedure Time (NL2), and Perforation (NL4). Minimum (b)(4) successful dissections each in stomach and colorectal for anatomical locations (NL3). Minimum (b)(4) with (b)(4) lesions and minimum (b)(4) with (b)(4) lesions for lesion size (NL5). The data provenance is also "Ex-vivo porcine and bovine tissue from the esophagus, stomach and colon."
• Animal Testing (In Vivo):
  • Animals: (b)(4) animals for traction wire testing and (b)(4) animals for traction magnet testing. Each animal was the subject of device procedures and control procedures.
  • Procedures: Table 5 (redacted) outlines the number of procedures for each device and tissue type. Specifically, N=8 procedures for control and N=8 procedures for test for both Traction Wire and Traction Magnet endpoints in Tables 6 and 7, respectively. Lesions of (b)(4) to (b)(4) cm were created.
  • Provenance: This was a GLP-compliant study using live porcine models, described as in vivo testing.

3. Number of Experts and Qualifications for Ground Truth

• Usability Testing: The document states "All clinicians participating in the study were trained in therapeutic endoscopy, including training in submucosal dissection." It specifically stratified physicians by experience:
  • Novice: < 3 years and/or < 20 ESD cases to date.
  • Moderate: 3-5 years of experience and/or 1-2 ESD cases per month.
  • Skilled: > 5 years of experience and three or more ESD cases per month.
  • For the Traction Wire, "skilled by moderate and provice physicians participated."
  • For the Traction Magnet, "two skilled, two moderate and two novice physicians participated."
  • The observations and ratings from these physicians formed the basis of the usability ground truth.
• Animal Testing: Bleeding, perforation, mucosal laceration, visualization, ease of removal, and ease of procedure were assessed by "study physicians intraoperatively via endoscopic visualization." No specific number of physicians is given for the animal studies, but they are implied to be experts in therapeutic endoscopy and ESD.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1) for the usability or animal studies. It appears that the expert physicians directly provided the ratings and assessments which were then used to calculate means and comparisons. For perforation in the animal study, it notes a singular assessment that was then reviewed for causality ("unrelated to the device use or design or the control procedure").

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

While not explicitly termed an "MRMC study," the usability testing and animal (in vivo) testing were designed as comparative effectiveness studies where human readers (physicians/experts) performed procedures with and without AI (device) assistance. The "AI" here refers to the device itself as providing assistance, not an AI algorithm in the traditional sense of image analysis.

• Effect Size of Human Readers (with device vs. without):
  • Visualization: For both Traction Wire and Traction Magnet, the device showed PASS for visualization, meaning the average visualization score with the device was equal to or better than without. This indicates a positive effect on visualization compared to unassisted procedures. For the animal study, Visualization (Start, Mid, End) was consistently rated as Traction better than Control for both devices.
  • Procedure Time: For the Traction Wire, procedure time was PASS (device time <= control time). For the Traction Magnet, procedure time was PASS but the result was "Control better than Traction," meaning the control group completed faster, but this was deemed acceptable due to expected deployment time.
  • Perforation: For both usability and animal studies, "Perforation rate with traction device <= perforation rate without traction device" was generally met, indicating no increase in perforation risk. In the animal study, the Traction Magnet even showed "Perforation: Traction better than Control."
  • Ease of Procedure: In the animal study, "Ease of Procedure (Easiness, Temporal, Effect)" was consistently rated as Traction better than Control for both devices, suggesting an improvement in user experience with the device assistance.

These results indicate that the device (as an assistive tool) leads to improved or similar performance across several key metrics for human operators, with specific advantages in visualization and ease of procedure.

6. Standalone (Algorithm Only) Performance

This question appears to be primarily applicable to AI/ML algorithms. The ProdiGI device is a physical endoscopic traction device, not a software algorithm. Therefore, no standalone (algorithm only) performance was conducted or is applicable. The "performance" of this device is inherently tied to its use by a human operator.

7. Type of Ground Truth Used

• Bench Testing: Engineered specifications, mechanical measurements, and direct observation of device function against predetermined thresholds.
• Usability Testing: Expert consensus/subjective rating scales (e.g., 3-point or 5-point visualization scales) provided by trained clinicians performing procedures on ex-vivo tissue, combined with objective measures like procedure time and observed adverse events.
• Animal Testing (In Vivo): Direct intraoperative observation by study physicians (using Likert scales for bleeding, binary for perforation, and subjective scales for visualization and ease of use) and necropsy findings (for perforation and mucosal laceration), performed on live porcine models. This represents a form of outcomes data (physiological effects, procedural outcomes) directly observed by experts.

8. Sample Size for the Training Set

This question is typically relevant for AI/ML models where a distinct "training set" and "test set" are used. For a physical medical device undergoing traditional non-clinical and usability testing, there isn't a "training set" in the AI sense. The development of the device itself would involve iterative design and testing, but not a formally defined "training set" for an algorithm.

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

As noted above, a "training set" for a physical device is not typically defined in the same way as for an AI/ML model. The "ground truth" for the device's design and functionality would be established through engineering specifications, clinical needs assessments, and iterative testing/refinement during its development lifecycle, prior to formal validation studies described here.

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