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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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The Padlock Clip™ is indicated for use in flexible Endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the gastrointestinal organs.

The Padlock Clip™ is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of:

• · Endoscopic marking of lesions
• · Hemostasis for:
  • o Mucosal/Submucosal defects
  • o Bleeding Ulcers
  • o Arteries

The Padlock Clip™ ligation clip consists of a preloaded, radiopaque, single use, coin sized ligation clip made of superelastic shape memory alloy for tissue approximation with opening sizes of 6 to 24mm on a flexible delivery system.

The Padlock Clip™ defect closure device is mounted and secured at the distal tip on the outside surface of a flexible endoscope. The Padlock Clip™ is deployed using an independent hand control. The linking cable to the hand control is not located within the endoscopic accessory channel. The Padlock Clip™ delivery system includes a central "tissue chamber" that resides on the distal tip of the endoscope. Clinically efficacious tissue manipulation techniques may be used to pull target tissue into this "tissue chamber" to approximate a larger volume of tissue than would otherwise be approximated by deploying the clip alone. The Padlock Clip™ delivery system is compatible with flexible endoscopes with distal tip outer diameters ranging from 9.5mm to 14mm.

The provided document is a 510(k) premarket notification for a medical device called the "Padlock Clip Pro-Select™ defect closure system". The purpose of this submission is to demonstrate substantial equivalence to a predicate device (K180689), specifically due to the addition of an alternate supplier for a component.

Therefore, the study described mainly focuses on non-clinical testing to ensure that the change in supplier does not affect the safety or effectiveness of the device. There are no clinical studies involving human patients or AI algorithms in this document.

As such, I cannot provide information on many of the requested points, such as sample size for test sets (as it's not applicable in the context of clinical data), number of experts for ground truth, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth for training sets.

However, I can extract information related to the acceptance criteria and the performance results from the non-clinical testing performed.

Here's the information that can be extracted:

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

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This document describes non-clinical laboratory testing, not a clinical study involving a test set of human data. Therefore, "sample size for the test set" as it pertains to patient data is not applicable. The tests are performed on the device itself and its components. The provenance of the data is from the manufacturer's (STERIS Corporation) testing, presumably in the USA.

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)

Not applicable, as this is a non-clinical device performance study, not a study relying on expert human interpretation of medical images or data.

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

Not applicable, as there is no human adjudication of medical data involved in this non-clinical study.

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

Not applicable. This submission is for a medical device (a clip system), not an AI algorithm, and does not involve human readers interpreting medical images with or without AI assistance.

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

Not applicable. This is not an AI algorithm.

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

The "ground truth" for this device evaluation is based on established scientific and regulatory standards for medical device biocompatibility and functional performance. It relies on:

• ISO 10993 series standards (parts 3, 5, 6, 10, 11): These are international standards for the biological evaluation of medical devices.
• ASTM F2129: An ASTM standard related to corrosion susceptibility.
• FDA guidance documents: Specifically, "Technical Considerations for Non-Clinical Assessment of Medical Devices containing Nitinol Draft Guidance for Industry and Food and Drug Administration Staff, April 19, 2019."
• Predicate device methodology: Using the same test methodology as used for the predicate device (K180689 or K120814).

8. The sample size for the training set

Not applicable. This is not an AI algorithm development or clinical study with a training set.

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

Not applicable.

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The Padlock Clip™ is indicated for use in flexible Endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the wall of the gastrointestinal organs.

The Padlock Clip™ is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of:

• Endoscopic marking of lesions
• Hemostasis for:
  • Mucosal/Submucosal defects
  • Bleeding Ulcers
  • Arteries

The Padlock Clip™ ligation clip consists of a preloaded, radiopaque, single use, coin sized ligation clip made of superelastic shape memory alloy for tissue approximation with opening sizes of 6 to 24mm on a flexible delivery system.

The Padlock ClipTM defect closure device is mounted and secured at the distal tip on the outside surface of a flexible endoscope. The Padlock ClipTM is deployed using an independent hand control. The linking cable to the hand control is not located within the endoscopic accessory channel. The Padlock ClipTM delivery system includes a central "tissue chamber" that resides on the distal tip of the endoscope. Clinically efficacious tissue manipulation techniques may be used to pull target tissue into this "tissue chamber" to approximate a larger volume of tissue than would otherwise be approximated by deploying the clip alone. The Padlock ClipTM delivery system is compatible with flexible endoscopes with distal tip outer diameters ranging from 9.5mm to 14mm.

Below is the requested information regarding the acceptance criteria and the study proving the device meets these criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

The provided text does not specify the sample sizes used for the test set or the provenance (e.g., country of origin, retrospective/prospective) of the data. The tests listed are primarily non-clinical performance and biocompatibility tests.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

The provided text does not mention the use of experts to establish ground truth for a test set. The evaluation focuses on non-clinical performance and biocompatibility.

4. Adjudication method for the test set:

The provided text does not specify an adjudication method. The tests conducted are objective measurements against defined standards.

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:

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This document describes the modification of a medical device (Padlock Clip™) and its non-clinical performance and biocompatibility, not an AI-assisted diagnostic tool.

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

A standalone performance study as described (algorithm only without human-in-the-loop) was not done. This document is for a mechanical medical device, not an algorithm.

7. The type of ground truth used:

The "ground truth" for the tests performed appears to be the established standards and specifications outlined in the ISO standards for biocompatibility tests (ISO 10993-5, 10993-10, 10993-11) and the device's internal specifications for functional and component strength tests.

8. The sample size for the training set:

A training set is relevant for machine learning algorithms. Since this submission is for a modified mechanical medical device, there is no mention of a training set or its sample size.

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

As there is no mention of a training set, the method for establishing its ground truth is not applicable and therefore not provided in the document.

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The Aponos Medical Padlock Clip™ is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the wall of gastrointestinal organs.

The Padlock Clip is indicated for clip placement within the Gastro-intestinal (GI) tract for the purpose of:

• Endoscopic marking of lesions. .
• Hemostasis for .
  • Mucosal/Sub mucosal defects o
  • o Bleeding Ulcers
  • Arteries

The Padlock Clip™ ligation clip consists of a preloaded, radiopaque, single use, coin sized ligation clip made of superelastic shape memory alloy (Nitinol®) for tissue approximation device with opening sizes of 6 to 24mm on a flexible delivery system.

Here's an analysis of the provided text regarding the Aponos Medical Padlock Clip™, focusing on acceptance criteria and supporting studies.

Based on the provided document (K120814), the details regarding acceptance criteria and a study to prove the device meets them are very limited. This document is a 510(k) summary and clearance letter, indicating it focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results and acceptance criteria in the way a PMA submission might.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified in this document.
• Data Provenance: The document mentions "animal and performance testing" but does not specify the country of origin or whether these were retrospective or prospective studies.

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

• Not applicable/Not specified. The document does not describe the use of an expert panel to establish ground truth for a test set in the context of clinical performance evaluation. The testing mentioned appears to be more focused on technical performance and animal studies.

4. Adjudication Method for the Test Set

• Not applicable/Not specified. There is no mention of a clinical test set requiring adjudication in this 510(k) summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. An MRMC study is not mentioned. This type of study is typically for evaluating the performance of AI algorithms in interpreting medical images, and the Padlock Clip™ is a physical medical device, not an AI diagnostic tool.

6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done

• Not applicable. This question pertains to AI algorithms. The Padlock Clip™ is a physical device, so a "standalone" algorithm performance study is not relevant. The document refers to "animal and performance testing" which are standalone device evaluations, but not in the context of AI.

7. The Type of Ground Truth Used

• The document implies that "appropriate testing" and "animal and performance testing" were conducted to demonstrate safety and effectiveness. However, it does not detail the specific "ground truth" used for these tests. For a device like a ligation clip, ground truth would typically come from direct observation of outcomes (e.g., successful hemostasis, complete closure, proper marking) by trained personnel during the "animal and performance testing."

8. The Sample Size for the Training Set

• Not applicable. This question refers to the training of an AI algorithm. The Padlock Clip™ is a physical device, not an AI system, so there is no "training set."

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

• Not applicable. As above, this pertains to AI algorithms.

Summary and Limitations:

The provided document is a 510(k) summary for a medical device (Padlock Clip™), not for an AI algorithm. Therefore, many of the questions regarding AI-specific studies (MRMC, standalone algorithm performance, training/test sets for AI, expert ground truth for AI) are not applicable.

For the physical device itself, the document states that "appropriate testing" and "animal and performance testing" were conducted, concluding that the device is "acceptable for its intended use" and shows "no new issues of safety or effectiveness." However, it does not provide specific details about:

• The acceptance criteria (e.g., quantitative thresholds for success rates).
• The exact protocols, sample sizes, or results of these "animal and performance testing."
• The specific methods for establishing ground truth during these tests.

This level of detail is typically found in the full 510(k) submission or supporting technical documentation, which is not included in this public summary. The purpose of this summary is primarily to establish substantial equivalence to a predicate device (OVESCO Endoscopy AG OTSCTM).

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Light Bond is intended for use as an orthodontic bracket adhesive.

Pad Lock® is intended for use as a fluorescing, light cure Orthodontic Bracket Adhesive.

Light Bond and Pad Lock are light cure, orthodontic bracket adhesives available in a variety of viscosities for bonding to metal, ceramic and composite surfaces. Both Light Bond and Pad Lock are available in fluoride and non-fluoride formulas and come in syringe style or tip dispensing.

In addition, Pad Lock fluoresces to ease clean-up of flash for the user.

The provided document is a 510(k) summary for orthodontic bracket adhesives (Light Bond™ and Pad Lock®). It is not a study report for an AI-powered device. Therefore, I cannot extract information about acceptance criteria or a study proving that an AI device meets acceptance criteria, as an AI device is not described in this document.

The document discusses the substantial equivalence of the Light Bond™ and Pad Lock® products to a predicate device (QUICK CURE, K001048), focusing on their intended use and mechanical/physical properties as orthodontic bracket adhesives.

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