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When properly installed: (i) the ScopeSeal® Duodenoscope Protective barrier at the scope's distal end to significantly reduce the level of contamination of the distal end during use and prior to reprocessing, and (ii) the ScopeSeal®'s working channel also provides a protective barrier sealing the duodenoscope's elevator area during use, and (iii) the ScopeSeal® device provides an additional protective benefit after use when kept in place during the ScopeSeal Pre-Cleaning Procedure™ performed after use.

The ScopeSeal® is compatible for use with the Olympus Duodenoscope Model TJF-Q180V.

The GI Scientific ScopeSeal® Duodenoscope Protective Device is provided as a sterile, single-use device that attaches to the distal end of a duodenoscope. When properly installed the device creates a protective barrier or shield that seals the distal end of the duodenoscope to protect it from contamination during the procedure. The device is designed to preserve the mechanical and optical functionality of the duodenoscope. The ScopeSeal® Duodenoscope Protective Device includes a flexible Working Channel Extension™ that seals against the end of the duodenoscope's working channel, providing a sealed, passageway from the end of the duodenoscope's working channel through the ScopeSeal® device's working channel extension and out to the patient's gastrointestinal tract. This element of ScopeSeal®'s design allows instruments to be passed down the duodenoscope's working channel, through the ScopeSeal® device's Working Channel Extension™, and out to the patient's gastrointestinal tract, without instruments coming into contact with the duodenoscope's elevator, effectively sealing over the elevator area of the duodenoscope. The ScopeSeal® allows passage of device up to 10.7Fr (3.5mm) in diameter.

The provided text describes the regulatory clearance of a medical device, the ScopeSeal® Duodenoscope Protective Device, via a 510(k) premarket notification. This process determines substantial equivalence to a legally marketed predicate device, rather than requiring the extensive clinical studies typically associated with proving a device meets specific acceptance criteria in the comprehensive manner of a de novo or PMA submission.

Therefore, the information focuses on non-clinical performance testing and a comparison to a predicate device to demonstrate substantial equivalence rather than defining a detailed set of acceptance criteria for clinical efficacy and a direct study proving the device meets those criteria.

However, based on the provided "Performance Data" section, we can infer the implied acceptance criteria and the nature of the study that was conducted (non-clinical performance testing).

Here's an attempt to answer your request based on the available information, acknowledging that a full clinical trial with precise acceptance criteria for human outcomes is not detailed as part of this 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states: "No animal or clinical studies were required to demonstrate substantial equivalence."
The performance data described are stated as "Nonclinical performance testing."

• Test Set Sample Size: Not specified for the non-clinical tests. The tests would likely involve a specific number of devices or simulated use cycles, but the exact number is not provided.
• Data Provenance: The data is from "Nonclinical performance testing" conducted by G.I. Scientific LLC. There is no mention of country of origin for this testing or whether it was retrospective or prospective in the sense of a clinical study. It would inherently be prospective in the context of laboratory testing.

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

Given that "No animal or clinical studies were required," there was no "test set" in the sense of patient data requiring expert ground truth for diagnosis/outcomes. The performance data seems to be based on engineering and laboratory testing. Therefore, this information is not applicable from the provided text.

4. Adjudication Method for the Test Set

Not applicable, as there was no test set of patient data requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No animal or clinical studies were required to demonstrate substantial equivalence."

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

This pertains to an AI/Software as a Medical Device (SaMD). The ScopeSeal® Duodenoscope Protective Device is a physical medical device. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable to this device.

7. The Type of Ground Truth Used

For the non-clinical performance testing and biocompatibility, the "ground truth" would be established by:

• Engineering specifications and test methodologies: For seal integrity, scope compatibility, function maintenance, and delivery/retention.
• Established ISO standards (ISO 10993) and laboratory protocols: For biocompatibility testing (Cytotoxicity, Intracutaneous Irritation, Sensitization, Systemic Toxicity).

8. The Sample Size for the Training Set

This refers to a training set for an AI/machine learning model. Since the ScopeSeal® is a physical device and not an AI/ML product, the concept of a "training set" in this context is not applicable.

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

Not applicable, as there is no training set for an AI/ML model for this device.

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The LumenR Tissue Retractor System is indicated for use in conjunction with an endoscope for tissue or foreign body manipulation and/or where multiple removal and reinsertions of the endoscope are required.

The LumenR Tissue Retractor System (LRS) is an intra-luminal surgical device facilitating tissue manipulations inside the lumen.. It is a non-powered, handmanipulated device. The LumenR Tissue Retractor System includes a LumenR Instrument Guide (LIG) and LumenR Cannula Retractor (LCR). The LIG and LCR are single use devices that are provided non-sterile. LumenR Cannula Retractor (LCR) is provided in various Lengths and Diameters in order to accommodate individually variable natural body lumens. The LumenR Cannula Retractor (LCR) comprises of (1) Handle (proximal end located outside of a patient), (2) Retractor (chamber-like expandable retractor located at the device's distal end), and (3) flexible Shaft (located in between the handle and a Retractor). LumenR Instrument Guide (LIG) is an instrument guide or a hollow conduit for existing flexible endoscopic instruments, for example, tissue forceps, which helps guide the instrument towards the target tissue, but doesn't directly interact with the tissues.

This document is a 510(k) premarket notification for the LumenR Tissue Retractor System, a medical device. It does not contain the structured information about acceptance criteria and a study proving device performance as typically expected for an AI/ML-based medical device.

The document focuses on demonstrating substantial equivalence to a predicate device (Megachannel Endoscopic Overtube - K080550) rather than proving performance against specific acceptance criteria with detailed statistical analysis.

However, I can extract information related to performance testing that was conducted to support the claim of substantial equivalence.

Here's an analysis based on the provided text, outlining why a complete answer to your request regarding acceptance criteria and a "study that proves the device meets the acceptance criteria" cannot be fully provided from this document:

Missing Information & Why it's Not Present:

• Acceptance Criteria for Performance: The document does not explicitly state quantitative acceptance criteria (e.g., "Device must achieve a minimum seal strength of X N/mm"). Instead, it lists standards followed (e.g., ASTM F088/ASTM F088M-09 Standard Test Method for Seal Strength of Flexible Materials) and types of tests performed. The results are used to show similarity to the predicate or compliance with general safety/performance aspects, not to meet pre-defined "acceptance criteria" in the context of device accuracy or specific performance metrics in clinical use.
• Reported Device Performance against Criteria: Since specific acceptance criteria are not detailed in a quantitative manner, direct "reported device performance" against such criteria is also not present in the format you requested.
• AI/ML Specifics: This device, the LumenR Tissue Retractor System, is a mechanical surgical instrument. It is not an AI/ML-based device. Therefore, questions 2, 3, 4, 5, 8, and 9 from your prompt (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size, training set GT) are not applicable to this document.
• "Study that proves the device meets the acceptance criteria": The document describes "Performance Testing / Shelf Life Study" and "Comparison Testing to Predicate Device." These are studies conducted, but they are aimed at demonstrating substantial equivalence and general safety/efficacy per regulations for this type of mechanical device, rather than a specific validation study against an AI/ML model's performance criteria.

Based on the available information, here's an attempt to answer your request, focusing on the types of performance testing and standards used, as actual acceptance criteria and corresponding quantitative performance metrics are not explicitly detailed:

The provided document describes the LumenR Tissue Retractor System, a mechanical intra-luminal surgical device used in conjunction with an endoscope for tissue or foreign body manipulation. It is not an AI/ML-based device, therefore many sections of your request regarding AI/ML performance metrics are not applicable.

The "study" referenced in this document is a series of performance tests and comparison testing to a predicate device conducted to demonstrate substantial equivalence, safety, and efficacy for its intended use.

1. Table of "Acceptance Criteria" and Reported Device Performance

As mentioned, explicit quantitative acceptance criteria for device performance (e.g., "Seal Strength > X N/mm") are not provided in this 510(k) summary. Instead, the document lists standards and types of tests performed. The "reported performance" is implicitly that the device met the requirements of these standards and performed comparably to the predicate where applicable, supporting the claim of substantial equivalence.

Regarding your specific numbered points:

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

   • This information is not provided in the summary. For mechanical devices, testing typically involves a statistically relevant number of manufactured units, but the specific quantity is not disclosed here. As it's a mechanical device verification, "data provenance" like country of origin or retrospective/prospective is not applicable in the same way it would be for clinical data or AI model training data.

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 mechanical device, not an AI/ML diagnostic tool requiring expert ground truth for image interpretation or diagnosis.

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

   • Not applicable for a mechanical device.

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 as this is a mechanical device, not an AI-assisted diagnostic tool.

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

   • Not applicable as this is a mechanical device, not an algorithm.

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

   • For the mechanical tests, the "ground truth" is adherence to engineering specifications, national/international standards (e.g., ASTM, ISO), and performance comparable to a legally marketed predicate device. There isn't a "ground truth" derived from clinical experts or patient outcomes in the way you'd apply it to a diagnostic AI.

8. The sample size for the training set:

   • Not applicable as this is a mechanical device, not an AI/ML model that requires a training set.

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

   • Not applicable as this is a mechanical device.

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The Megachannel Endoscopic Overtube is indicated for use in conjunction with an endoscope for tissue or foreign body manipulations and/or where multiple removal and reinsertions of the endoscope are required.

The Megachannel Endoscopic Overtube is a disposable flexible PVC tube that is to be used with an endoscope. The overtube includes a proximal handle with insufflation sealing cap that accommodates a standard 12.8 mm diameter colonoscope. A removable introducer plug is attached to the distal tip to facilitate the introduction of the overtube through the gastrointestinal tract.

The provided text describes a medical device called the "Megachannel Endoscopic Overtube" and its 510(k) submission for market clearance. This document is a summary of the device and its claimed substantial equivalence to predicate devices, rather than a detailed study report on acceptance criteria and performance of an AI-powered device.

Therefore, most of the information requested in your prompt (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) is not applicable or not available in this specific document, as it pertains to a traditional medical device (an overtube) and not an AI/ML-powered one. The submission focuses on functional and safety testing to demonstrate equivalence, not on AI model performance metrics.

However, I can extract the information that is present according to your categories:

1. Table of acceptance criteria and reported device performance

The document does not explicitly state numerical "acceptance criteria" or "reported device performance" in the way one would for an AI algorithm (e.g., sensitivity, specificity, AUC). Instead, the performance demonstration is based on functional and safety testing to show equivalence to predicate devices.

2. Sample sized used for the test set and the data provenance

• Sample Size for Test Set: Not specified. The document states "functional testing" was performed, but does not detail the number of devices tested or the specific conditions/data used for this testing.
• Data Provenance: Not applicable/not specified. This is a physical device, and "data provenance" (country of origin, retrospective/prospective) is typically associated with data used to train and test AI models.

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

• Number of Experts: Not applicable/not specified. The device is an overtube, and "ground truth" as typically defined for AI algorithms is not relevant to its functional testing. Testing would involve engineering and performance assessments (e.g., material strength, dimensions, sealing capabilities).
• Qualifications of Experts: Not applicable/not specified.

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

• Adjudication Method: Not applicable/not specified. This concept is relevant to establishing ground truth for diagnostic AI, not for functional testing of a physical medical device like an overtube.

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

• MRMC Study: No. This document describes a physical medical device, not an AI-powered one that would assist human readers.
• Effect Size: Not applicable.

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

• Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.

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

• Type of Ground Truth: Not applicable in the context of AI. For this device, "performance" would be validated against engineering specifications, user requirements, and comparison to predicate device performance. This would likely involve measurements of physical properties, durability, and user interface elements, rather than diagnostic "ground truth" data.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is a physical device; there is no "training set" in the AI sense.

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

• Ground Truth for Training Set: Not applicable. As there is no AI training set, this question is irrelevant to the provided document.

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Endoscopic real-time ultrasonic imaging, ultrasound guided needle aspiration and other endoscopic procedures as follows:
Clinical Application: Trans-esoph. (non-Card.), Other (spec.)
Mode of Operation: B, M, Combined (Spec.) B+M, Other (Spec.) Note 1
Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, and imaging for guidance of biopsy.
Note 2: Specification for "Other" (1) the airways and tracheobronchial tree.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Trans-esoph. (non-Card.), Other (spec.)
Mode of Operation: B, M, Combined (Spec.) B+M, Other (Spec.) Note 1
Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, and imaging for guidance of biopsy.
Note 2: Specification for "Other" (1) the airways and tracheobronchial tree.

Not Found

This document is a 510(k) summary for the OLYMPUS BF type UC160F-OL8 EVS EXERA Ultrasonic Bronchofibervideoscope.

The provided document describes the intended use and clinical applications of the device, which are limited to Diagnostic Ultrasound Indications for Use.

However, it does not contain information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies (MRMC or standalone).

Therefore, I cannot provide the requested information based on the provided text. The document is primarily a regulatory submission outlining the device's classification and intended uses for substantial equivalence to a predicate device, not a performance study report.

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