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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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The Prodigio Stain Kit is a porcelain stain system designed for easy application and natural fluorescent properties. This dental porcelain stain system can be used with most commercially available porcelain's ability to mimic natural tooth appearance is important. The system provides optimum esthetics with the most consistently reliable results for the full range of shades.

The Prodigio Stain Kit is ideal for high and low production laboratories and is available in 16 classic Vita® shades as well as Neutral Brown, Complex Gray, Ochre; Rust and Red for matching bleached dentition with CTE Ranges of 13.7 to 15.1. The full assortment is 22 Stains, 1 powdered glaze and 1 liquid glaze.

The stains in the Prodigio Stain Kit fire at 900 degrees C

Prodigio Stain Kit is identical to the SN2000Y kit in function and content except that the stains in the SN2000Y kit fire at 750 degrees C

The Prodigio Stain Powder includes the following 6 sets of stains and dental porcelains:

Prodigio Stain Kit is a porcelain stain system designed for easy application and natural fluorescent properties. This dental porcelain stain system can be used with most commercially available porcelain's ability to mimic natural tooth appearance is important. The system provides optimum esthetics with the most consistently reliable results for the full range of shades.

The Prodigio Stain Kit is ideal for high and low production laboratories and is available in 16 classic Vita® shades as well as Neutral Brown, Complex Gray, Ochre; Rust and Red for matching bleached dentition with CTE Ranges of 13.7 to 15.1. The full assortment is 22 Stains, 1 powdered glaze and 1 liquid glaze.

The stains in the Prodigio Stain Kit fire at 900 degrees C

Prodigio Stain Kit is identical to the SN2000Y kit in function and content except that the stains in the SN2000Y kit fire at 750 degrees C

The provided text does not contain any information about acceptance criteria or a study proving device performance.

The document is a 510(k) premarket notification letter from the FDA regarding "Prodigio Stain Powder". It states that the device is substantially equivalent to legally marketed predicate devices, meaning it meets the general controls provisions of the Act for medical devices.

The content focuses on:

• Identification of the device: Prodigio Stain Powder (K171167).
• Regulatory classification: Class II, Product Code EIH.
• General regulatory compliance: Registration, listing, labeling, good manufacturing practices, etc.
• Indications for Use: Describes the Prodigio Stain Powder as a porcelain stain system for dental use, emphasizing its easy application, natural fluorescent properties, and ability to mimic natural tooth appearance. It also mentions two specific kits (Prodigio Stain Kit and SN2000Y kit) with different firing temperatures and available shades.

Therefore, I cannot provide the requested table or details about a study as this information is not present in the given text.

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