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The HX-5/6-1 Clip Fixing Devices are intended to be used with an Olympus endoscope for the purpose of:
(1) endoscopic marking,
(2) hemostasis for
(a) mucosal/sub-mucosal defects <3cm,
(b) bleeding ulcers,
(c) arteries <2mm,
(d) polyps <1.5cm in diameter,
(e) diverticula in the colon,
(3) as a method for endoscopic closure of
(a) mucosal/sub-mucosal defects <3cm,
(b) polyps <1.5cm in diameter,
(c) diverticula in the colon,
(d) fistulas <20mm that can be treated conservatively.

Not Found

The provided text is a 510(k) summary for the Olympus HX-5/6-1 Endoscopic Clipping Device. While it describes the device's intended use and provides a comparison to predicate devices, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone performance studies.

Therefore, I cannot extract the requested information from the given text.

The document discusses:

• Device Name: Rotatable Clip Fixing Devices HX-5/6-1
• Manufacturer: Olympus Optical Co., Ltd.
• Regulation Number: 21 CFR 876.4400 (Hemorrhoidal Ligator, Class II)
• Intended Use: Endoscopic marking, hemostasis (for mucosal/sub-mucosal defects, bleeding ulcers, arteries <2mm, polyps <1.5cm, diverticula in the colon), and as an aid to clip closure of GI tract perforations <20mm that can be treated conservatively.
• Predicate Devices: HX-5/6-1 Endoscopic Clipping Device #K963160 and Olympus HX-5/6 Endoscopic Clipping Device #K990687.

The document is primarily a regulatory filing (510(k) summary) demonstrating substantial equivalence to previously marketed devices rather than a detailed report of performance testing against specific acceptance criteria.

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Olympus HX-5/6-1 Endoscopic Clip Fixing Device has been designed for endoscopic clip placement within the gastrointestinal (GI) tract for the purpose of endoscopic marking, hemostasis in the upper GI tract for mucosal/submucosal defects <3cm, bleeding ulcers and arteries <2mm, polyps<1.5cm in diameter, and anchoring to affix jejunal feeding tubes to the wall of the small bowel. This device is not intended for the repair of GI tract lumenal perforations.

The HX-5/6-1 Endoscopic Clipping Device is available as a set consisting of the HX-5/6-1 Endoscopic Clipping Device main body and clips. These clips are attached to the hook when the wire is advanced out of the distal end of the device. Applying tension to the control wire will "seat" a step on the clip onto the distal end of the stainless steel coil. The FEP tube sheath may then be advanced to cover the distal end of the coil and the attached clip. The device may then be inserted through the instrument channel of the appropriate endoscope. When the device has been advanced to the area of interest, the tube sheath is retracted by moving the tube joint distally until an audible "click" is heard. When the control section slider is pulled proximally, the control wire is tensioned, and the clip is pulled into the clip body (pipe). Due to the shape of the clip itself, when the clip is pulled into the clip pipe, it will initially open wider. As it is pulled in even further, the clip pipe will force the clip arms to close on the target tissue and deploy.

The provided document (K990687) is a 510(k) summary for the Olympus HX-5/6-1 Endoscopic Clipping Device. It primarily focuses on demonstrating substantial equivalence to a predicate device and specifying the intended use, rather than detailing a study with specific acceptance criteria and performance metrics.

Therefore, many of the requested sections (e.g., sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, specific ground truth types) are not available in this type of regulatory submission. This document does not describe a study to prove the device meets acceptance criteria in the way a clinical trial report would. Instead, it describes the device and its intended use, and asserts its substantial equivalence to a previously cleared device.

However, I can extract information related to the device's functional description and intended use, which inherently defines some performance expectations.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state "acceptance criteria" in a quantitative, measurable sense. The "performance" described is largely functional and mechanical, demonstrating how the device operates and what it is designed to achieve in clinical use. The "criteria" are inferred from the device's intended use and design description, and the "performance" is a description of its operational mechanics.

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

• Sample Size for Test Set: Not specified. This document does not detail a study involving a test set of data or subjects.
• Data Provenance: Not applicable, as no external data set or study is described in this summary. The information pertains to the device's design and intended function.

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

• Number of Experts: Not applicable. Ground truth establishment for a test set is not described.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No test set or ground truth adjudication process is mentioned.

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

• MRMC Study: No. The document does not describe a comparative effectiveness study involving human readers with or without AI assistance. The device is a mechanical clipping device, not an AI-assisted diagnostic tool.

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

• Standalone Study: No. This is a medical device, not an algorithm, so this concept is not applicable. The device is designed for human-in-the-loop operation by a clinician performing an endoscopic procedure.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable. The document is not about evaluating a diagnostic algorithm against a ground truth. Its purpose is to demonstrate substantial equivalence of a physical medical device. The "ground truth" here is implied by the clinical context in which such clipping devices are used, as established by medical practice and guidelines for endoscopic hemostasis and marking.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This concept applies to machine learning algorithms, not a physical medical device like an endoscopic clipper.

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

• Ground Truth Establishment for Training Set: Not applicable, as there is no training set for this type of device.

In summary: The provided 510(k) summary (K990687) is a regulatory filing for an endoscopic clipping device, not a report of a study involving clinical data, AI algorithms, or a detailed breakdown of acceptance criteria and performance against those criteria. It describes the device's design, intended use, and asserts its substantial equivalence to a predicate device already on the market.

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The Olympus HX-5/6-1 Endoscopic Clipping Device is intended for endoscopic clip placement within the gastrointestinal (GI) tract for the purpose of endoscopic marking, hemostasis in the upper GI tract for mucosal/submucosal defects <3 cm, bleeding ulcers and arteries <2 mm, polyps <1.5 cm in diameter, and anchoring to affix jejunal feeding tubes to the wall of the small bowel. This device is not intended for the repair of GI tract lumenal perforations.

The Olympus HX-5/6-1 Endoscopic Clipping Device is specifically designed for endoscopic clipping for marking, hemostasis, and temporary anchoring within the GI tract. The Olympus HX-5/6-1 Endoscopic Clipping Device is based on the design of predicate clipping devices and is substantially equivalent in design, method of operation, and safety to these predicate devices.

The provided document is a 510(k) premarket notification for the Olympus HX-5/6-1 Endoscopic Clipping Device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics. Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

The document states that the Olympus HX-5/6-1 Endoscopic Clipping Device "is substantially equivalent in design, method of operation, and safety to these predicate devices" (Olympus HX-2, HX-3, and HX-4 Clipping Devices). The FDA's letter further confirms that they have determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use.

To answer your specific questions:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided document. A 510(k) submission generally relies on demonstrating similarity to existing devices rather than new performance data against specific acceptance criteria.
2. Sample sizes used for the test set and the data provenance: Not applicable/not provided. No new clinical trials are described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. No new clinical trials are described.
4. Adjudication method for the test set: Not applicable/not provided. No new clinical trials are 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. This device is a mechanical clipping device, not a diagnostic AI system, and no MRMC study is mentioned.
6. 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.
7. The type of ground truth used: Not applicable/not provided. No new clinical trials are described.
8. The sample size for the training set: Not applicable/not provided. This is a mechanical device, not an AI or machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable/not provided. This is a mechanical device, not an AI or machine learning algorithm.

In summary, the provided document is a regulatory approval for a medical device based on its substantial equivalence to previously approved predicate devices, not on the presentation of novel study data against specific performance acceptance criteria.

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