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Flexible Overtube is a device used in conjunction with a flexible endoscope for tissue or foreign body retrieval, and/or for endoscopic procedures requiring multiple endoscope intubations.

Flexible Overtube™ provides an access for repeated insertion and withdrawal of an endoscope for tissue or foreign body retrieval, and/or for endoscopic procedures requiring multiple endoscope intubations. Prior to inserting an endoscope into a patient, the user passes the endoscope through Flexible Overtube™. Flexible Overtube™ is placed after the endoscope is inserted into the patient. The endoscope can be inserted and withdrawn through properly placed Flexible Overtube™.

Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance:

Crucially, the provided text describes a 510(k) submission for a medical device (Flexible Overtube™) seeking substantial equivalence to a predicate device. This type of submission generally does not involve clinical studies with human subjects to prove a device meets specific performance criteria in the way a de novo or PMA submission would. Instead, it focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, primarily through technological comparison, material biocompatibility testing, and functional bench testing.

Therefore, many of the typical questions for AI/diagnostic device performance studies (like sample sizes for test sets, expert ground truth, MRMC studies, etc.) are not applicable to this document. The focus here is on the "acceptance criteria" for establishing substantial equivalence, which are different from those for proving a diagnostic algorithm's accuracy.

The "study" here refers to the testing and comparisons done to support the claim of substantial equivalence.

Understanding the Context: 510(k) Premarket Notification

This submission (K182520) is a 510(k) Traditional Premarket Submission. The FDA review process for 510(k)s focuses on demonstrating substantial equivalence to a predicate device. This means the new device is:

• Intended for the same use as a predicate device.
• Has the same technological characteristics as the predicate device, OR
• Has different technological characteristics, but the information submitted by the applicant demonstrates that the device is as safe and effective as a legally marketed predicate device, and does not raise different questions of safety and effectiveness.

This is different from proving absolute performance against a set of clinical criteria for a diagnostic/AI device.

Analysis of the Provided Information:

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

The "acceptance criteria" in this context are not quantitative performance metrics for a diagnostic algorithm, but rather the criteria for demonstrating substantial equivalence to the predicate device. The "reported device performance" is mainly shown through qualitative comparisons and results of bench tests.

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

• Sample Size for Test Set: Not applicable in the traditional sense of a clinical test set for diagnostic performance. The "test set" here would refer to the physical devices used for bench testing (tensile strength, simulated use, insufflation seal, biocompatibility). The number of samples tested is not specified in the provided summary, but device submissions typically outline these in detailed test reports.
• Data Provenance: Not applicable. This is not clinical data from patients. The data comes from in vitro (bench) testing of the device itself and its materials.

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

• Not applicable. There is no "ground truth" to establish for a diagnostic decision in this context. The testing is physical and chemical verification of device characteristics and safety.

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

• Not applicable. No human adjudication of results is mentioned or would typically be required for this type of physical/material testing.

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

• No. An MRMC study is not relevant for this device. This is a physical medical device (an overtube for endoscopy), not an AI-assisted diagnostic tool.

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

• No. This is not an algorithm or AI device.

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

• Not applicable. For this device, "ground truth" refers to established engineering standards, material safety standards (e.g., ISO, AAMI), and the functional requirements for an overtube. For example, the ground truth for biocompatibility is whether the materials elicit an adverse biological response when tested against ISO 10993 standards.

8. The sample size for the training set

• Not applicable. This device does not involve a training set as it is not an AI/machine learning product.

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

• Not applicable. (See point 8).

In summary, the provided document details a 510(k) submission for a physical medical device (Flexible Overtube™). The "acceptance criteria" and "proof" relate to demonstrating substantial equivalence to a predicate device through a comparison of technological characteristics, confirmed by various bench tests (e.g., biocompatibility testing, tensile strength, seal testing). It does not involve clinical studies with human subjects or the evaluation of an AI algorithm's diagnostic performance.

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The SB Knife® is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703 W, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue including Zenker's diverticulum within the digestive tract using high-frequency current.

The SB Knife® is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703 W, MD-47706 and MD-47703L).

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment for a medical device. The document is a 510(k) clearance letter from the FDA for the SB Knife®, which states that the device is substantially equivalent to legally marketed predicate devices. It outlines regulatory requirements and indications for use, but it does not include performance study data, sample sizes, expert qualifications, or details about how ground truth was established, which are necessary to answer your request.

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SB Soft Hood is intended for use with SB Knife for endoscopic submucosal dissection within the gastrointestinal tract and for use in keeping the suitable depth of endoscopic field of view.

SB Soft Hood™ is a transparent distal attachment applied to the tip of an endoscope. It is used in endoscopic submucosal dissection (hereinatter ESD) procedures. The subject device is used for maintaining visualization during the dissection phase of the procedure. The subject device is disposable and in a variety of diameters that correspond to different endoscope sizes. Each model of the subject device contains a drainage side hole that allows egress of water and blood.

This document is a 510(k) Summary for the SB Soft Hood™ device. It details the device's description, indications for use, comparison to a predicate device, and non-clinical testing performed to demonstrate substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in the format typically seen for algorithm performance (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implied by the non-clinical tests performed and the conclusion of "no new concern" or meeting "in-house standard which was determined based on expected worst-case."

Here's an interpretation of the implied acceptance criteria and reported 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 device is a physical medical device, not an AI/software device that processes data or images. Therefore, the concepts of "test set sample size" and "data provenance" (country of origin, retrospective/prospective) stemming from AI/machine learning studies are not applicable to this submission. The tests performed are non-clinical, laboratory-based tests on the device itself.

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)

Again, the device is a physical medical accessory for endoscopy, not an algorithm requiring expert-established ground truth from images or data. Therefore, this information is not applicable. The "ground truth" for the non-clinical tests is based on established engineering and biological standards (e.g., ISO, USP, ASTM).

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

Since this is not an AI/imaging study with subjective interpretation, an adjudication method for a "test set" is not applicable. The test results are objective measurements against established standards.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI systems on human interpretation, which is not applicable to a physical endoscopic accessory. The document explicitly states: "Clinical testing was not performed for SB Soft Hood™."

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

No, a standalone performance study (algorithm only) was not done because this is a physical medical device, not an algorithm.

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

The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., pathology, clinical outcomes) is not applicable here. For the non-clinical tests performed, the "truth" or reference is defined by:

• Established international and national standards (e.g., ISO 10993-5, ISO 10993-10, ISO 10993-11, USPC 151, ISO 11135-1:2007, ASTM F1929, ASTM F88/F88M, ISO10993-7:2008, USP).
• "In-house standard which was determined based on expected worst-case" for performance testing.

8. The sample size for the training set

This is not applicable as the device is not an AI/machine learning product and does not involve training data.

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

This is not applicable as the device is not an AI/machine learning product and does not involve training data or ground truth establishment for a training set.

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The SB Knife™ is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue within the digestive tract using high-frequency current.

The SB Knife™ is a single-patient use EtO-sterilized hand-held device that connects to an external high frequency (HF) generator and is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue within the digestive tract using high-frequency current. Varying generator power, cycle and duration results in a control of these surgical capabilities. The SB Knives are designed to connect with Olympus and ERBE connectors and use the disposable or reusable Olympus or ERBE grounding plates and connecting cables intended for the generators.

The device is not life supporting or life sustaining. It is designed as a short-term limited contact device (less than 24 hours), has no software, and has been certified to comply with IEC 60601-1 and IEC 60601-2-2 and IEC 60601-2-18 by UL Japan

This document is a 510(k) premarket notification for the SB Knife, an electrosurgical knife. It does not describe an AI medical device or a study involving acceptance criteria for an AI device's performance. Therefore, I cannot extract the requested information regarding acceptance criteria and studies that prove the device meets these criteria in the context of AI.

The document discusses the following:

• Device Name: SB Knife Jr Type, SB Knife Short Type, SB Knife Standard Type, SB Knife Jr Type - Long
• Regulation Number: 21 CFR 876.4300
• Regulation Name: Endoscopic Electrosurgical Unit and Accessories
• Regulatory Class: Class II
• Product Code: KNS
• Predicates: Olympus Medical Systems, Corp. IT Knife 2/ Hook Knife/ Flex Knife/ Triangle Tip Knife Electrosurgical Knife (K092309)
• Indications for Use: To be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors, and patient grounding plates to cut tissue within the digestive tract using high-frequency current.
• Non-Clinical Testing: Comparative bench and animal tissue testing was performed for tissue ablation, resection, incision, cauterization, hemostasis, coagulation, vaporization, and dissection of tissues using Olympus and ERBE monopolar HF generators.
• Clinical Testing: "Clinical testing was not performed for this medical device."

Since the SB Knife is a physical electrosurgical tool and not an AI device, the provided information does not contain the specific details requested for an AI acceptance criteria study (e.g., sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for AI).

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