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The GripTract-Gl Endoscopic Tissue Manipulator (GripTract) is an accessory intended to assist in positioning the distal end of an endoscope from the mucosal surface and assist with optical visualization, diagnosis, and endoscopic treatment.

GripTract is indicated for use in the large intestine with any standard endoscope that has a distal tip outer diameter of 11.5 - 12.0 mm and working length of 168 - 170 cm.

GripTract is a single-use, non-sterile, endoscope accessory intended to ensure complete positioning of an endoscope and assist with optical visualization, diagnosis, and endoscopic treatment. It is indicated for use in the large intestine with any standard endoscope that has a distal tip outer diameter of 11.5 - 12.0 mm and a working length of 168 - 170 cm.

The GripTract Handpiece attaches to the endoscope control body just below the working channel. The soft End Cap with two integrated Fingers for tissue manipulation is placed on the distal end of the endoscope. Two Control Knobs in the Handpiece each operate a corresponding Finger, permitting the User to rotate and extend/retract the Fingers for tissue manipulation and visualization independent of the endoscope's movement or the presence of other tools in the endoscope's working channel.

The provided text describes the regulatory clearance for the GripTract-GI Endoscopic Tissue Manipulator (K231254). It outlines the device's intended use and provides non-clinical performance data to demonstrate its safety and effectiveness.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Key Takeaway: The provided document is a 510(k) summary for a medical device (GripTract-GI Endoscopic Tissue Manipulator). It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific numerical performance acceptance criteria typical of AI/ML device studies. Therefore, many of the requested criteria (e.g., specific quantitative metrics, sample sizes for training/test sets for AI, expert numbers for ground truth, MRMC studies) are not directly applicable or explicitly stated in this type of regulatory submission for a mechanical device.

However, I can extract the information related to the device's performance and the studies conducted to show its safety and effectiveness.

Acceptance Criteria and Device Performance (based on provided text)

The acceptance criteria for this device are primarily related to its functional performance, safety, and compatibility, demonstrated through various non-clinical tests. The "performance" is reported as "Pass" for each test, indicating that the device met the pre-defined criteria for that specific test.

Study Details (based on provided text)

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

   • Usability Testing: "A total of 15 Users" for both "Set-Up" and "Use" usability tests.
   • Porcine Testing: Number of animals or procedures is not specified, but it's an "in vivo porcine testing" in "worst-case procedure."
   • Other Bench Tests: Sample sizes are not explicitly stated for product specification verifications, distribution, shelf-life, reliability, or bench safety (other than the endoscope viewing area comparison).
   • Data Provenance: The studies are non-clinical, primarily bench and animal (porcine) testing. No explicit mention of country of origin for the data or whether it's retrospective/prospective (these terms are more relevant for human clinical studies).

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

   • This information is not provided. For non-AI mechanical devices, the "ground truth" is typically established by engineering specifications, validated test methods, and potentially expert interpretation for things like tissue damage in animal studies. The "users" in usability testing are relevant, but their "qualification" is broadly "intended user population" (medical specialists).

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

   • Not applicable/mentioned for this type of non-clinical device testing.

4. 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 device is a mechanical accessory, not an AI-powered diagnostic tool requiring human reader comparison studies.

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

   • Not applicable. This is a mechanical device, not an algorithm. Bench tests evaluate the device's standalone performance.

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

   • Bench Performance: Engineering specifications and ASTM/ISO standards.
   • Usability: Defined user tasks and absence of serious use errors, likely determined by observation and user feedback against pre-defined criteria.
   • Biocompatibility: ISO 10993 standards and their associated pass/fail criteria (e.g., lack of cytotoxicity, sensitization).
   • Porcine Testing: Visual and histological mucosal damage assessment compared to a control (endoscope-only procedures), suggesting pathology as a component of ground truth for tissue effects.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device, so there is no "training set."

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

   • Not applicable.

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The Captivator TM EMR Device is indicated for endoscopic mucosal resection in the upper GI tract.

The Captivator™ EMR Device is an endoscopic mucosal resection device consisting of a ligator cap with ligation bands, a band ligator handle, an electrosurgical snare, and a pathology kit. The ligator cap and band ligator handle are attached to an endoscope, and bands are deployed one at a time to capture mucosal tissue as pseudopolyps, which are clectrosurgically removed using the snare. The device is capable of performing multiple resections. The banding portion of the device is made up of a clear ligator cap with elastic bands stretched around the outer circumference of the cap. Bands are deployed by actuating the handle. The ligator device allows the introduction of an electrosurgical snare for endoscopic therapies. A pathology kit is also provided as a procedural aid which is used to handle tissue samples for histological processing.

The provided text describes a 510(k) premarket notification for the Captivator™ EMR Device. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in relation to clinical outcomes or AI performance.

The document focuses on demonstrating substantial equivalence to existing predicate devices through non-clinical testing, primarily bench testing and biocompatibility assessments. Therefore, I cannot extract the requested information in the format you provided.

Here's what can be inferred from the text regarding the nature of the "performance data" presented, and why it doesn't align with your request:

• Acceptance Criteria & Reported Device Performance (Table): Not provided. The document states "Non-clinical comparative performance bench testing was successfully completed to establish substantial equivalence" and lists types of tests (e.g., system suction delivery efficiency with snare, band ultimate tensile force, and snare loop to pull wire tensile strength). However, it does not provide specific acceptance values for these tests or the measured performance of the Captivator™ EMR Device against those values. The goal was substantial equivalence, not meeting predefined clinical performance metrics.
• Sample Size for Test Set & Data Provenance: Not applicable in the context of clinical performance data. The "test set" here refers to components used in non-clinical bench testing.
• Number of Experts & Qualifications for Ground Truth: Not applicable. Ground truth for clinical performance or AI evaluation is not discussed.
• Adjudication Method: Not applicable.
• Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: No MRMC study was performed or mentioned.
• Standalone (algorithm only) performance: Not applicable, as this is a physical medical device, not an AI algorithm.
• Type of Ground Truth Used: Not applicable in the requested sense (e.g., pathology, outcomes data). The "ground truth" for the non-clinical comparative bench testing would be the performance of the predicate device.
• Sample Size for Training Set: Not applicable.
• How Ground Truth for Training Set was established: Not applicable.

In summary: This 510(k) submission establishes substantial equivalence through non-clinical laboratory testing, not through clinical trials or studies involving AI performance, human readers, or specific clinical acceptance criteria with corresponding performance data. The "performance data" discussed are engineering and bench test results.

Therefore, I cannot fulfill your request to create a table of acceptance criteria and device performance based on the provided document alone, as this type of information is not present.

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To be attached to the distal end of the endoscope to facilitate endoscopic therapy, to be used for the following:

• Keeping the suitable depth of endoscope's view field
• Helping the endoscope with being inserted into the gastrointestinal tract

The Arc EndoCuff has a short tube like shape with flexible hairs and is attached to the distal end of the endoscope to facilitate endoscopic therapy.

The Arc EndoCuff is designed to fit specific endoscopes (as designated on the packaging), and is supplied sterile following radiation sterilization and is single use only.

The provided 510(k) summary for the Arc EndoCuff does not describe quantitative acceptance criteria or a study designed to rigorously prove that the device meets such criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices through qualitative comparisons and bench testing.

Here's an analysis of the provided information based on your requested categories:

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

No explicit quantitative acceptance criteria are provided in the document, nor are specific performance metrics reported against such criteria. The document states:

"The bench testing demonstrates that the Endocuff design combines some of the benefits of both being a slim cylindrical device (like the Olympus product) and being able to stabilise and view the mucosa effectively on a greater diameter (as does the Fujinon balloon) but within the one product."

And concludes:

"The performance data showed that the sterilisation method selected...has not introduced any additional risks and the patient contacting materials have been tested for biocompatibility with reports demonstrating no negatives in safety or effectiveness."

"The bench testing has demonstrated that the device does not introduce any additional risks when undertaking endoscopic therapy and meeting the intended use."

These statements are qualitative and comparative, focusing on the absence of additional risks and meeting intended use, rather than predefined measurable acceptance criteria.

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 describes "bench testing" but does not specify a "test set" in the context of clinical data, as it's not a clinical study. The testing appears to be primarily laboratory-based to assess material properties, sterilization effectiveness, and mechanical characteristics. Therefore, sample sizes for a patient test set are not applicable here.

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 was not a clinical study involving diagnosis or interpretation where expert ground truth would be established. The evaluations described ("bench testing") would likely involve engineers and materials scientists ensuring the device's physical and functional properties meet design specifications and are comparable to predicates.

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

Not applicable, as this was not a clinical study requiring adjudication of expert interpretations.

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 device is a mechanical accessory (EndoCuff) for an endoscope, not an AI or imaging interpretation device. Therefore, MRMC studies and "human readers improving with AI" are not relevant to this submission.

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

Not applicable. This is not an algorithm or AI-based device.

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

The concept of "ground truth" as typically used in AI or diagnostic device evaluations (e.g., pathology, clinical outcomes) is not directly applicable. For "bench testing," the "truth" would be established by validated engineering specifications, material standards (e.g., USP Class VI for biocompatibility), and direct physical measurements or observations of device function and integrity under controlled conditions.

8. The sample size for the training set

Not applicable. This is not an AI or machine learning device that requires a training set.

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

Not applicable.

Overall Conclusion on Acceptance Criteria and Study:

The Arc EndoCuff 510(k) summary primarily demonstrates substantial equivalence to existing legally marketed devices (Olympus Distal Attachment and Fujinon BS-2 balloon). The "study" referenced is bench testing, which compared the "design," "materials," and "size" of the EndoCuff to its predicates. The performance data focused on proving that:

• The device combines benefits of both predicate types (slim cylindrical + ability to stabilize/view mucosa effectively).
• The sterilization method does not introduce additional risks.
• Biocompatibility testing showed no negatives in safety or effectiveness for patient-contacting materials.
• The device does not introduce additional risks during endoscopic therapy and meets its intended use.

The acceptance criteria implicitly derive from the predicate devices' established safety and effectiveness. The "study" (bench testing) was deemed sufficient to show that the minor technological differences "do not raise different questions of safety and effectiveness" and that the device is "as safe and effective" as the predicates. No specific quantitative performance metrics or clinical study results against predefined acceptance criteria are provided because the regulatory pathway chosen emphasizes equivalence rather than novel performance claims.

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The Duette™ Multi-Band Mucosectomy Device is intended for endoscopic mucosal resection in the upper gastrointestinal tract.

The Duette TM Multi-Band Mucosectomy Device has a ligation component consisting of a barrel with latex bands and a Ligator handle. This barrel is attached to the distal end of an endoscope and bands are deployed by actuating the handle. The barrel allows introduction of an electrosurgical snare for endoscopic therapies.

This document describes a medical device called the Duette™ Multi-Band Mucosectomy Device and its 510(k) submission to the FDA. The submission focuses on substantial equivalence to a predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics. Therefore, I cannot provide the requested information in its entirety because the provided text does not contain the specific acceptance criteria, study details, and performance data you've asked for.

Here’s what I can extract and what is missing, based on the provided text:

Missing Information:

The provided text does not contain any information regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets.
• Data provenance (country of origin, retrospective/prospective).
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness study, effect size.
• Standalone algorithm performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for either test or training sets.
• Sample size for training sets.
• How ground truth for training set was established.

Information Extracted from the Provided Text:

This 510(k) submission for the Duette™ Multi-Band Mucosectomy Device primarily relies on non-clinical testing to demonstrate substantial equivalence to a predicate device, rather than on clinical studies with performance metrics against acceptance criteria.

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

   • Not provided. The document states, "Non-Clinical testing was performed on characteristics and operational functions of the Duette™ Multi-Band Mucosectomy Device deemed necessary to verify safety and performance." However, specific acceptance criteria or performance metrics from these non-clinical tests are not disclosed in this document.

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

   • Not provided. The document refers to "non-clinical testing," implying bench or laboratory tests, not clinical human-subject test sets with data provenance.

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/Not provided. Since the document only mentions non-clinical testing, there is no mention of human experts defining ground truth for a test set.

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

   • Not applicable/Not provided. As above, no clinical test set is 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/Not provided. This device is a mechanical Mucosectomy Device, not an AI or imaging diagnostic device.

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

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

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

   • Not provided. For the non-clinical testing, ground truth would likely refer to engineering specifications or validated test methods, but details are not given.

8. The sample size for the training set:

   • Not applicable/Not provided. This is a mechanical device, not an AI or software device that would have a "training set."

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

   • Not applicable/Not provided. As above, a training set is not relevant for this type of device.

Summary of the Device and Submission:

• Device Name: Duette™ Multi-Band Mucosectomy Device
• Intended Use: Endoscopic mucosal resection in the upper gastrointestinal tract.
• Device Description: Ligation component (barrel with latex bands), Ligator handle. Attaches to an endoscope; bands deployed by actuating the handle. Allows introduction of an electrosurgical snare.
• Submission Type: 510(k) Premarket Notification (K050578)
• Basis for Clearance: Substantial Equivalence to predicate devices (Olympus Distal Attachment, K984358).
• Testing Basis: Non-Clinical testing performed on "characteristics and operational functions... deemed necessary to verify safety and performance." No details on these tests, acceptance criteria, or results are provided in this excerpt.

This document is a 510(k) summary, which often provides less granular detail about studies compared to a full 510(k) submission or clinical trial report. The focus of this specific 510(k) is on the substantial equivalence of device design and intended use, supported by non-clinical testing, rather than a detailed clinical performance study with specific acceptance criteria as might be expected for novel diagnostic or AI-driven devices.

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