Search Results

Ask a specific question about this device

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.

Ask a specific question about this device

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

1. Endoscopic marking
2. Hemostasis for:

• Mucosal/sub-mucosal defects

The Resolution™ Clip is a sterile device consisting of a pre-loaded, radiopaque, single-use, endoscopic clipping device consisting of two main components: the delivery system and the clip.
The delivery system consists of a handle assembly and delivery catheter. The clip delivery system is offered in a 155cm and 235cm working length. The clip consists of a stainless-steel capsule and clip arms, a cobalt chrome yoke, and a styrene tension breaker. The clip is deployed from the delivery system during use. The clip jaws are engineered such that they can be opened and closed up to five times prior to deployment, aiding in repositioning of the clip at the lesion site. Re-opening and closing may be limited by clinical circumstances and patient anatomy, among other factors. The Resolution™ Clip is designed to be compatible with endoscopes with working channels equal to or greater than 2.8 mm. There are no associated accessories included with this device.

The provided text is a 510(k) summary for a medical device (Resolution Clip) and does not describe acceptance criteria or a study proving the device meets acceptance criteria for an AI/ML-driven medical device.

The document discusses a physical medical device, specifically a hemostatic clip for the GI tract. The 510(k) submission is for a modification to an existing device (removal of an outer sheath component). The "performance data" mentioned refers to non-clinical bench testing to confirm that the modified physical device still meets performance requirements (e.g., proper device removal from endoscope, passability within endoscope, absence of endoscope damage).

Therefore, I cannot extract the requested information about acceptance criteria or a study proving an **AI/ML-**driven device meets acceptance criteria from the provided text. The questions regarding sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment for training sets are not applicable to this type of device modification submission.

Ask a specific question about this device

The The Haemostasis Clips are indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of:

1. Endoscopic marking.
2. Hemostasis for:
   Mucosal/sub-mucosal defects

The Haemostasis Clips are sterile devices consisting of a pre-loaded, radiopaque, single-use, endoscopic clipping device consisting of two main components: the delivery system and the clip part. The delivery system consists of a handle assembly and delivery catheter assembly. The delivery system is constructed using stainless steel and polyester materials. The delivery system will allow for the device to rotate at the distal end. The delivery system is offered in 1650mm, 1950mm and 2350mm working lengths. The clip part consists of a stainless steel tightening capsule, movable pin and clip arms. The clip is deployed from the delivery system during use. The hemoclip jaws are engineered such that they can be opened and closed up to five times prior to deployment, aiding in repositioning of the clip at the lesion site. Re-opening, closing, and rotation capability may be limited by clinical circumstances and patient anatomy. There are no associated accessories included with this device.

The provided text describes the 510(k) premarket notification for the "Haemostasis Clips" device. It outlines non-clinical testing performed to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets specific acceptance criteria based on clinical outcomes or a multi-reader, multi-case study in the traditional sense of AI/software device evaluation.

The device is a medical instrument (Haemostasis Clips), not a software device or AI system, so many of the requested categories for AI/software evaluation (like MRMC studies, training set details, or ground truth establishment by experts for performance metrics) are not applicable. The evaluations are focused on the physical and performance characteristics of the clips themselves.

Here's a breakdown of the information that can be extracted and which requested points are not applicable in this context:

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

The document doesn't explicitly list numerical acceptance criteria for each test. Instead, it states that the tests were performed and the results "Pass" or "meet the requirement". For biocompatibility, specific outcomes like "Non-cytotoxic" are listed.

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

The document does not specify the sample sizes for each of the bench or biocompatibility tests. It also does not mention data provenance as these are non-clinical (laboratory/bench) tests on manufactured devices, not data-driven studies from human subjects.

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. These are non-clinical, bench and biocompatibility tests for a physical medical device. "Ground truth" in the context of expert consensus on medical images or clinical outcomes is not relevant here. The "ground truth" for these tests are objective, measurable physical and chemical properties and biological reactions determined by standardized test methods.

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

Not applicable. This concept relates to human expert review and consensus, which is not part of the non-clinical bench or biocompatibility testing described.

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. The device is a physical medical instrument (Haemostasis Clip), not an AI/software device. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance was performed or is relevant.

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

Not applicable. The device is a physical medical instrument, not an algorithm.

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

Not applicable. The "ground truth" for these tests are the inherent physical, chemical, and biological properties measured against established standards (e.g., ISO standards, "Pass" criteria for physical performance).

8. The sample size for the training set

Not applicable. This information pertains to machine learning models, which are not relevant to this device.

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

Not applicable. This information pertains to machine learning models, which are not relevant to this device.

Ask a specific question about this device

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.

Ask a specific question about this device

The BARS Set is indicated for clip placement within the context of flexible endoscopy in the GI tract for the purpose of:

• Hemostasis for:
  • Mucosal/submucosal defects

The subject device constitutes an over-the-scope clip application device used within the context of flexible endoscopy in the gastrointestinal tract. The over-the-scope clip application capabilities center around a memory-shape alloy clip mounted on a transparent plastic cap. Cap (and clip) are mounted on the distal end of an endoscope. Endoscopic instruments are provided in the BARS Set to facilitate insertion and for mobilization of target tissue into the cap lumen. With the target tissue inside the cap lumen, the memory-shape alloy clip is applied onto the target tissue using a thread mechanism. Contents of the BARS Set are: - BARS (readily assembled unit of memory-shape alloy clip, transparent plastic cap, thread deployment components, working channels, and guide elements)

• Endoscopic instruments (BARS Anchor silver, BARS Anchor black, Insertion Balloon, Space Keeper Balloon, Guide Wire)

The provided text is a 510(k) Premarket Notification from the FDA for a device called the BARS Set. It describes the device, its indications for use, and a summary of non-clinical tests. However, the document explicitly states "Not applicable - no clinical testing submitted for demonstration of substantial equivalence."

Therefore, I cannot provide the detailed information requested regarding acceptance criteria and a study that proves the device meets those criteria from this document alone. The questions posed in your prompt (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are all related to clinical or performance studies with human data/expert review, which were not submitted for this 510(k).

The document focuses on demonstrating substantial equivalence through bench testing and comparison to predicate and reference devices, rather than a new clinical study.

Here's what I can extract based on the provided text, primarily regarding the non-clinical bench testing:

Non-Clinical Bench Testing Summary (based on the device's substantial equivalence pathway):

• Acceptance Criteria for Non-Clinical Bench Testing & Reported Device Performance: This information is not presented in a table with specific criteria and results. The document states:

  • "Performance bench testing settings investigated key aspects of device safety and effectiveness."
  • "The established precedent from these devices were met as evidenced by application of acceptance criteria and / or comparison to their respective performance bench testing substantial equivalence."
  • The tests mentioned for the subject device are:
    • Functional capability and robustness
    • Endoscope compatibility
    • Clip application ring strength
    • Space keeper balloon capability and robustness
    • Usability
    • MRI suitability
  • However, specific quantitative acceptance criteria (e.g., "Clip application force > X N") and the numerical results the BARS Set achieved are not detailed in this public summary. The document only confirms that the device "met" these criteria or "the established precedent" set by reference devices.

• Sample Size Used for the Test Set and Data Provenance:

  • Not applicable as no clinical test set (i.e., human subject data for performance claims) was submitted. The tests mentioned were bench tests.
  • The provenance of any data used for bench testing (e.g., whether conducted in the US, Germany, etc.) is not specified.

• Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Experts:

  • Not applicable as no clinical test set or expert-adjudicated ground truth was submitted for device performance evaluation. The "ground truth" for the non-clinical tests would be defined by engineering specifications and physical measurements.

• Adjudication Method for the Test Set:

  • Not applicable as no clinical test set requiring expert adjudication was submitted.

• If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

  • No, explicitly stated: "Not applicable - no clinical testing submitted for demonstration of substantial equivalence."

• If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

  • Not applicable. This device is a mechanical medical device, not an AI/algorithm.

• The Type of Ground Truth Used:

  • For the non-clinical bench tests, the "ground truth" would be the engineering specifications and physical properties of the device and its components, and comparison to the performance of legally marketed predicate/reference devices. This is not clinical ground truth (e.g., pathology, outcomes data).

• The Sample Size for the Training Set:

  • Not applicable. This is not an AI/ML device that requires a training set.

• How the Ground Truth for the Training Set was Established:

  • Not applicable.

In summary: The provided FDA 510(k) summary focuses on demonstrating "substantial equivalence" of the BARS Set to existing predicate and reference devices through non-clinical bench testing, without the need for new clinical data or human-in-the-loop performance studies like those typically conducted for AI/software devices. The document confirms that the device "met" acceptance criteria related to its physical and functional characteristics based on these bench tests.

Ask a specific question about this device

The device is used for endoscopic clip placement within the gastrointestinal(GI) tract for the purpose of endoscopic marking, hemostasis for mucosal/submucosal defects less than 3cm, bleeding ulcers, arteries less than 2mm, polyps less than 1.5cm in diameter and diverticula in the colon. Anchoring to affix jejunal feeding tubes to the wall of the small bowel. Closure of Gl tract lumenal perforations less than 20mm that can be treated conservatively.

The Single Use Hemoclip is a sterile, single use device that consists of metal clip that detaches from the introducer to maintain approximation of tissue to achieve hemostasis and endoscopic marking in the gastrointestinal tract. The device is provided sterile (EO). The large clip opening design meets various clinical treatment demands. It can be opened and closed repeatedly and can achieve repositioning. The 360 rotatable design is convenient for clinical use. lt consists of two main components, delivery system and clip assembly. And it is offered in different dimensions.

The provided document is a 510(k) summary for a medical device (Single Use Hemoclips) and does not describe a study involving acceptance criteria and device performance in the context of AI or software. Instead, it details the substantial equivalence of the subject device to a predicate device through non-clinical bench testing.

Therefore, I cannot provide the requested information about acceptance criteria and study details related to device performance, sample sizes, data provenance, expert ground truth adjudication, MRMC studies, standalone performance, training set details, or how ground truth was established for a study because this information is not present in the given text.

The document focuses on non-clinical testing to demonstrate substantial equivalence to a predicate device, as required for 510(k) clearance by the FDA.

Ask a specific question about this device

The Disposable Hemostatic Clips is indicated for Endoscopic clip placement within the Gastrointestinal tract in adult populations only via a straight or side viewing flexible endoscope for the purpose of : 1) Endoscopic marking; 2) Hemostasis for: A) Mucosal/sub-mucosal defects

The proposed device is consisted of a clip section. The delivery section. The delivery section include: slide bar, slip ring, protective sleeve, rotation head, coated spring tube, slip ring holder, traction assembly, connecting tube, decoupled piece, decoupled shrapnel, rotation sleeve. And the clip section include: clip, sliding block, shaft and rocker arm. The clip is made of stainless steel. The clip can be opened and closed more than five times prior to deployment, aiding in repositioning of the lesion site. The proposed device is available in single ring and three ring models, and each case is divided into rotatable and non-rotatable clip. The effective length of the proposed device includes 1250mm, 1650mm, 2350mm and the opening width is 9mm, 11mm. 13mm and 16mm. The proposed devices are provided in sterile and single use.

The provided text describes the 510(k) submission for a medical device, the "Disposable Hemostatic Clips." This submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. Crucially, the document explicitly states: "No clinical study is included in this submission."

Therefore, I cannot provide information regarding:

• Acceptance Criteria and Reported Device Performance (Table): There are no clinical performance metrics of the device against "acceptance criteria" presented from a clinical study. The document details non-clinical tests and their pass/fail status, indicating they met product requirements, but not against specific acceptance criteria for clinical performance.
• Sample size and data provenance (test set): No clinical test set.
• Number of experts and qualifications (ground truth for test set): Not applicable for a clinical test set.
• Adjudication method (test set): Not applicable.
• MRMC comparative effectiveness study: Not conducted.
• Standalone (algorithm only) performance: Not applicable as this is a mechanical device, not an AI algorithm.
• Type of ground truth used (clinical): No clinical data to establish ground truth.
• Sample size for training set: No clinical training set.
• How ground truth for training set was established: No clinical training set.

However, I can provide information based on the non-clinical testing summarized in the document, framed as how the device "meets the acceptance criteria" for functional and safety performance, as demonstrated by bench testing and biocompatibility assessments.

Non-Clinical Acceptance Criteria and Reported Device Performance

The device's performance was evaluated through a series of non-clinical tests to verify it met design specifications and standards, demonstrating substantial equivalence to the predicate device. The "acceptance criteria" for these tests are implicitly that the device passes the specified tests and complies with the relevant ISO and ASTM standards.

Here's a summary of the non-clinical tests and their outcomes:

• Appearance
• Rotation performance
• Release force
• Clamping strength
• Relocation
• Tensile strength
• Dimension
• Mechanical integrity of clip assembly
• Scope compatibility/usability
• Endoscope damage
• Torque
• Clip approach
• Three ring handle strength

Specifically noted that the three-ring model's tension tests showed results similar to the predicate device, able to withstand clinical use forces. |

Study Proving the Device Meets Acceptance Criteria (Non-Clinical)

The "study" proving the device meets its non-clinical acceptance criteria consists of the comprehensive set of Non-Clinical Tests and Biocompatibility Testing.

1. Sample sizes used for the test set and the data provenance:

   • The document does not specify the exact sample sizes for each non-clinical test (e.g., number of units tested for tensile strength or rotation performance). It states "all tests were passed."
   • Data Provenance: The tests were performed by Ningbo Xinwell Medical Technology Co., Ltd. (China) or their designated testing facilities, as per the submission. This is internal testing data for the 510(k) submission.

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

   • Not applicable in the context of non-clinical, bench testing. The "ground truth" for these tests is defined by the established industry standards (ISO, ASTM, USP) and the device's design specifications. Conformance to these standards and specifications is evaluated through laboratory testing.

3. Adjudication method for the test set:

   • Not applicable as this refers to human review of clinical data. Non-clinical tests have pass/fail criteria based on objective measurements against defined standards.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done:

   • No, a MRMC comparative effectiveness study was not done. The submission states: "No clinical study is included in this submission." This implies no clinical performance data involving human readers or patients, only bench and biocompatibility testing. The comparison to the predicate device is based on functional equivalence and meeting, or not raising new questions about, safety and effectiveness through non-clinical data.

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

   • Not applicable. This device is a mechanical hemostatic clip and delivery system, not an algorithm or AI-powered device.

6. The type of ground truth used:

   • For non-clinical performance and safety: The ground truth is defined by established international and national standards (ISO 10993, ISO 11135, ASTM F1929, ASTM F88/F88M, ASTM F1886/F1886M, USP , ASTM D4169, ASTM F1980) and the device's internal design specifications and requirements. The "truth" is whether the device's physical properties and performance characteristics meet these objective, measurable standards.

7. The sample size for the training set:

   • Not applicable as there is no clinical study data, training set, or machine learning component cited.

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

   • Not applicable as there is no clinical study data, training set, or machine learning component cited.

Ask a specific question about this device

The Single Use Reloadable Clip Applicators HX-810 Series, Long Clip HX-610 Series, Short Clip HX-610 Series and Super Short Clip HX-610-135XS have been designed to be used with an Olympus endoscope for endoscopic Clip placement within the gastrointestinal (GI) tract in adult patients only for the purpose of:

(1) Endoscopic marking,

(2) Hemostasis for

(a) Mucosal/sub-mucosal defects

The instruments (AKA EZClip) have been designed to be used with an Olympus endoscopic Clip placement within the gastrointestinal (GI) tract in adult patients only for the purpose of:

(1) Endoscopic marking,

(2) Hemostasis for

(a) Mucosal/sub-mucosal defects

The provided text is a 510(k) summary for a medical device cleared by the FDA. It does not include information about a study based on analyzing medical images/data, establishing ground truth using experts, or evaluating AI performance. Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving a device meets those criteria for such a system.

The document describes pre-clinical (bench) testing performed on a physical medical device (endoscopic clip applicator) and its components to demonstrate substantial equivalence to a predicate device.

Here's an analysis of what is available in the document, which primarily focuses on engineering and performance characteristics of the physical device:

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

The document lists performance tests conducted, but it does not provide a table detailing specific acceptance criteria values and the quantitative reported performance for each criterion. It only states that "The subject Single Use Reloadable Clip Applicators (HX-810 Series) have satisfied the pre-defined acceptance criteria for each test item described in the test plan."

The tests performed were:

• Insertability
• Clip opening width
• Clip rotatability
• Clip capability
• Withdrawal from Endoscope
• Mechanical integrity of clip assembly
• Tensile Strength/coil to handle strength
• Applicator repetition

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

This information is not available in the provided text. The tests were performed on "finished devices, prior to and after simulated distribution and accelerated aging." This indicates bench testing rather than clinical data from human subjects.

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)

This is not applicable to the type of device and testing described. Ground truth established by medical experts is typically for diagnostic or prognostic systems that interpret medical data. The tests here are physical performance tests of a medical instrument.

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

Not applicable. Adjudication methods are relevant for expert review of data/images, which is not what was performed for this device. These were bench tests against engineering specifications.

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 is for an AI-powered diagnostic/interpretive system, not a physical medical instrument.

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)

For the physical device, the "ground truth" would be the engineering specifications and performance standards against which the device was tested (e.g., a clip's opening width must be X mm, a tensile strength must be Y Newtons). These are not established by expert consensus or pathology in the medical sense, but rather by engineering design and regulatory requirements.

8. The sample size for the training set

Not applicable. This is not a data-driven model that requires a training set.

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

Not applicable.

Ask a specific question about this device

The Disposable Dual Action Tissue Closure Device is intended for use in flexible endoscopy for the compression of tissue in the gastrointestinal tract for adult patient only.

The Disposable Dual Action Tissue Closure Device is indicated for clip placement within the gastrointestinal tract for the purpose of:

1. Endoscopic marking:

2. Hemostasis for:

a.Mucosal/sub-mucosal defects

The proposed device Disposable Dual Action Tissue Closure Device is a sterile, single-use endoscopic clipping device, intended to be used in flexible endoscopy for the compression, manipulation of tissue in the gastrointestinal tract. It consists of two main components, delivery system and clip assembly. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 106 and placed in a sterility maintenance package to ensure a shelf life of 3 years.

This document outlines the acceptance criteria and supporting studies for the Micro-Tech (Nanjing) Co., Ltd. Disposable Dual Action Tissue Closure Device (K233772).

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the device as substantially equivalent to a predicate device (K212748) except for one indication and shelf-life, and therefore, directly stated acceptance criteria are not explicitly presented as separate quantitative values for each performance test. Instead, the document relies on demonstrating that the proposed device performs the same or better than the predicate device for all shared characteristics, and that the changes in indications and shelf-life are supported by additional testing or literature.

Below is a table summarizing the performance data presented, emphasizing the comparison to the predicate device.

• Open width (15 mm)
• Working Length (1650, 1950, 2350 mm)
• Minimal working channel of endoscopy (3.2 mm) |
  | Material / Configuration | Same as predicate (K212748) | Same as predicate (K212748) |
  | Principles of Operation | Same as predicate (K212748) | Same as predicate (K212748) |
  | Endoscopic Marking Indication | Same as predicate (K212748) | Same as predicate (K212748) |
  | Hemostasis for Bleeding Ulcers | Same as predicate (K212748) | Same as predicate (K212748) |
  | **Hemostasis for Polyps (

Ask a specific question about this device