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The PADLOCK CLIP™ EFTR Device is an electrosurgical device that is designed for a flexible endoscope. It is intended for diagnostic tissue acquisition and full thickness resection through the removal of lesions in the colon and rectum.

The PADLOCK CLIP™ EFTR Device is indicated for the resection of lesions less than 3cm in the colon and rectum. Resection sizes may be less than 3cm due to targeted tissue thickness and degree of fibrosis.

The disposable RAPTOR Grasping Device is intended to be used to grasp tissue and/or retrieve foreign bodies, excised tissue and stents during endoscopic procedures.

The TOUCHSOFT Coagulator is used to provide monopolar therapeutic hemostasis and tissue ablation in the gastrointestinal tract through a flexible endoscope by a trained physician or clinician.

The PADLOCK CLIP Endoscopic Full Thickness Resection (EFTR) Device is an electrosurgical, single use tissue resection system. The system is part of a kit that consists of a preloaded, radiopaque, Super Elastic NiTi (Nitinol) single use clip within a mechanical delivery system along with a preloaded snare for tissue resection. The PADLOCK CLIP EFTR Device is mounted over the distal tip of a flexible endoscope. The linking cables run along the outside of the endoscope and are attached to the handle. The PADLOCK CLIP EFTR Device includes a tissue chamber that resides on the distal tip of the endoscope.

The kit's two additional devices, the TOUCHSOFT Coagulator Monopolar Single Use Device, and RAPTOR Grasping Device are used in conjunction with the PADLOCK CLIP EFTR Device through the flexible endoscope's accessory channel. The TOUCHSOFT Coagulator Monopolar Single Use Device (ablation device) will be used to mark a lesion by ablating the lesion's perimeter, thereby indicating the area for resection. Instructions for Use for the TOUCHSOFT Coagulator Monopolar Single Use Device are included within the kit. The RAPTOR Grasping Device will be used to grasp and retract the target lesion into the tissue chamber. Instructions for Use for the RAPTOR are included within the kit.

These devices are used for colorectal lesions that would otherwise not be resectable by standard polypectomy techniques.

The PADLOCK CLIP EFTR Device includes a resection clip made of super elastic nitinol and a snare made of stainless steel. The PADLOCK CLIP EFTR Device also includes handle components molded from ABS material, Stainless Steel drive wires, HDPE catheter, and a scope attachment assembly made of TPE and Polycarbonate.

This document is a 510(k) clearance letter for a medical device (PADLOCK CLIP EFTR Kit). It does not contain information about an AI/ML medical device, clinical study performance metrics, or the specific details typically requested for AI/ML device approval. The 510(k) is for a physical electrosurgical device and states that the proposed device is "the same device with an updated Instructions for Use" as its predicate.

Therefore, many of the requested points related to AI/ML device study design, such as expert ground truth, MRMC studies, training set details, etc., are not applicable to this document.

However, based on the provided text, I can extract the following information about the device's acceptance criteria and the (non-AI/ML) study that proves it meets those criteria:

Acceptance Criteria and Device Performance for PADLOCK CLIP EFTR Kit

This document describes the 510(k) clearance for a physical electrosurgical device, not an AI/ML-driven device. Therefore, the "study" described is verification testing for a physical modification (updated Instruction for Use) rather than a clinical performance study with human readers or AI.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document describes "Verification Testing" on "simulated tissue." It does not specify a numerical sample size for this test. Since it's a physical device verification using simulated tissue and not clinical data, "data provenance" in terms of country of origin or retrospective/prospective is not applicable.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable. This is a physical device verification, not a study requiring expert ground truth for diagnostic or interpretative tasks. The "ground truth" here is the objective functional success of the device (clip deploys and snare closes on simulated tissue).

4. Adjudication Method for the Test Set

Not Applicable. This is a physical device verification test. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in image interpretation studies, which is not relevant here. The "Pass" result suggests direct observation of the device's functionality.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for AI/ML devices or diagnostic tools where human interpretation is a key component. This document pertains to a physical electrosurgical device used for tissue resection.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not Applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used was the functional success of the device's mechanical actions on simulated tissue. Specifically, the acceptance criterion was whether the "Clip deploys, and the snare closes on the simulated tissue."

8. The Sample Size for the Training Set

Not Applicable. This is a physical medical device, not an AI/ML model that requires a training set. The "testing" referred to is product verification testing to ensure the device performs as intended with updated instructions, not the training of a predictive model.

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

Not Applicable. As there is no AI/ML model or training set, there is no corresponding ground truth establishment process.

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The PADLOCK CLIP™ EFTR Device is a device that is designed for a flexible endoscope. It is intended for diagnostic tissue acquisition and full-thickness resection through the removal of lesions in the colon and rectum.

The PADLOCK CLIP™ EFTR Device is indicated for the resection of lesions less than 3cm in the colon and rectum. Resection sizes may be less than 3cm due to targeted tissue thickness and degree of fibrosis.

The disposable RAPTOR Grasping Device is intended to be used to grasp tissue and/or retrieve foreign bodies, excised tissue and stents during endoscopic procedures.

The TOUCHSOFT Coagulator is used to provide monopolar therapeutic hemostasis and tissue ablation in the gastrointestinal tract through a flexible endoscope by a trained physician or clinician.

The PADLOCK CLIP Endoscopic Full Thickness Resection (EFTR) Device is an electrosurgical, single use tissue resection system. The system is part of a kit that consists of a preloaded, radiopaque, Super Elastic NiTi (Nitinol) single use clip within a mechanical delivery system along with a preloaded snare for tissue resection. The PADLOCK CLIP EFTR Device is mounted over the distal tip of a flexible endoscope. The linking cables run along the outside of the endoscope and are attached to the handle. The PADLOCK CLIP EFTR Device includes a tissue chamber that resides on the distal tip of the endoscope.

The kit's two additional devices, the TOUCHSOFT Coagulator Monopolar Single Use Device, and RAPTOR Grasping Device are used in conjunction with the PADLOCK CLIP EFTR Device through the flexible endoscope's accessory channel. The TOUCHSOFT Coagulator Monopolar Single Use Device (ablation device) will be used to mark a lesion by ablating the lesson's perimeter, thereby indicating the area for resection. Instructions for Use for the TOUCHSOFT Coagulator Monopolar Single Use Device are included within the kit. The RAPTOR Grasping Device will be used to grasp and retract the target lesion into the tissue chamber. Instructions for Use for the RAPTOR are included within the kit. These devices are used for colorectal lesions that would otherwise not be resectable by standard polypectomy techniques.

The PADLOCK CLIP EFTR Device includes a resection clip made of super elastic nitinol and a snare made of stainless steel. The PADLOCK CLIP EFTR Device also includes handle components molded from ABS material, Stainless Steel drive wires, HDPE catheter, and a scope attachment assembly made of TPE and Polycarbonate.

The provided document is a 510(k) summary for the PADLOCK CLIP EFTR Kit, which is a medical device for endoscopic full-thickness resection. The document outlines verification, validation, animal, and other testing to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and the Data Provenance:

The document summarizes the types of tests performed (Simulated Use, Packaging Requirements, Component Force and Functional Requirements, Validation Testing, Animal Test - Design Validation, MRI Testing, Electrical Testing, Biocompatibility, Human Factors, EMC Testing) and their outcomes ("Pass"). However, it does not provide details on the specific sample sizes used for each test set within these categories.

Similarly, the document does not mention the data provenance (e.g., country of origin, retrospective or prospective nature) for any of the non-clinical tests.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth for any of the tests. The acceptance criteria are generally phrased as "Meets Design Requirements" or conformity to international standards, implying compliance with engineering specifications and regulatory benchmarks rather than a human-expert-derived ground truth.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method like 2+1 or 3+1. The tests listed are primarily performance-based and compliance-based, with results indicated as "Pass," suggesting a direct comparison to pre-defined specifications rather than expert consensus requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

The document does not mention or describe a multi-reader multi-case (MRMC) comparative effectiveness study. The PADLOCK CLIP EFTR Kit is a mechanical and electrosurgical device, not an AI-powered diagnostic or assistive tool, so such a study would not be relevant in this context.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done:

This question is not applicable as the PADLOCK CLIP EFTR Kit is a physical medical device, not an algorithm or software requiring standalone performance testing in the typical sense of AI/software. Its performance is evaluated through a series of engineering, functional, and biological tests.

7. The Type of Ground Truth Used:

The ground truth for most of the tests appears to be engineering design requirements, predefined specifications, and compliance with established international standards (e.g., ASTM, IEC, ISO). For the animal study, the "ground truth" for success was the device's ability to "facilitate healing after the removal of lesions up to 3cm in the GI tract," which would be assessed by veterinary or pathology evaluation of the animal tissue post-procedure.

8. The Sample Size for the Training Set:

The concept of a "training set" is typically associated with machine learning or AI models. Since the PADLOCK CLIP EFTR Kit is a physical medical device, there is no mention of a training set in this context. The non-clinical tests are verification and validation efforts, not machine learning model training.

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

Again, as there is no "training set" in the context of this device, this question is not applicable. The ground truth for the device's performance is established through adherence to design specifications and regulatory standards.

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