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The USGI Shape Locking Endoscopic Overtube is intended to be used with an endoscope to facilitate intubation, e.g., colonoscopy, change of endoscopes, removal of multiple polyps and/or foreign bodies.

The USGI Shape Locking Endoscopic Overtube is an endoscopic accessory designed to provide external support to an endoscope without hindering its flexibility and maneuverability. It is an overtube guide that can conform to any bend configuration of the scope and then be shape locked in that form. In the "shape locked" configuration, the scope can be further advanced or withdrawn repeatedly. The USGI Shape Locking Endoscopic Overtube is a shape locking tube with an atraumatic tip, a slip coated inner liner, a smooth outer skin, and a handle. The Shape Locking Tube is constructed from multiple nested links that are held together by four cables. Applying tension to the cables squeezes the links together. The friction between links maintains their relative positions, allowing the practitioner to "lock in" a shape.

The provided document is a 510(k) premarket notification letter from the FDA to USGI Medical, Inc. regarding their Endoscopic Sheath. It primarily focuses on the device's substantial equivalence to a previously cleared predicate device (K023902).

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the context of an AI/algorithm-based device. The testing described is bench testing of the physical device. Therefore, information regarding sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable in this context. The document refers to the device itself and its components.

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

This information is not applicable as the document describes a physical medical device and its mechanical/functional performance, not an AI or algorithm-based diagnostic tool requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated in point 3.

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

This information is not applicable. The device is a physical endoscopic overtube, not an AI or algorithm that assists human readers.

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

This information is not applicable as the device is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the biocompatibility aspect, the ground truth is established by the "long history of use in medical devices" of the materials, implying a track record of safety and acceptance as biocompatible.

For the mechanical and functional performance, the ground truth is based on the device's ability to "perform as intended" as demonstrated by bench testing. This refers to engineering and design specifications rather than clinical ground truth (like pathology or outcomes data).

8. The Sample Size for the Training Set

This information is not applicable as the document describes a physical medical device, not an AI or algorithm that requires a training set.

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

This information is not applicable for the reasons stated in point 8.

In summary, the provided document describes a 510(k) submission for a physical medical device, the USGI Endoscopic Sheath. The acceptance criteria and testing focus on the device's physical and functional performance, as well as the biocompatibility of its materials, by demonstrating substantial equivalence to a predicate device through bench testing. The concepts of AI/algorithm performance, training/test sets, expert ground truth, and MRMC studies are not relevant to this document.

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The USGI Endoscopic Overtube is intended to be used with an endoscope to facilitate intubation, e.g., colonoscopy, change of endoscopes, removal of multiple polyps and/or foreign bodies.

The USGI Endoscopic Overtube is an endoscopic accessory designed to provide external support to an endoscope without hindering its flexibility or maneuverability. It is a shape locking tube with an atraumatic tip, a slip coated inner liner, a smooth outer skin, and a handle. The overtube is constructed from multiple nested links that are held together by four cables. Each link is bowl shaped, but without a bottom and has four equally spaced annular holes running longitudinally through the wall thickness. The purpose of the holes is to accommodate the tension wires which pass through each link. The wires are connected to the tip but slide freely through all other links. Applying tension to the wires squeezes the links together. The friction between links maintains their relative positions, allowing the practitioner to "lock in" a shape.

The provided document is a 510(k) summary for the USGI Endoscopic Overtube. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report as typically seen for novel device performance or AI/software evaluations.

Based on the information available in the document:

1. Table of acceptance criteria and reported device performance:

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics for the USGI Endoscopic Overtube. Instead, it states that "Performance Data: All components that come in direct contact with the patient have a long history of use in medical devices and are biocompatible. This 510(k) notice includes mechanical and functional bench testing that demonstrate that the USGI Endoscopic Overtube performs as intended."

And for the "Basis for Determination of Substantial Equivalence," it states: "Bench testing demonstrates that the devices are functionally equivalent."

This phrasing indicates that the acceptance criteria were likely implicitly linked to the functional equivalence of the device to its predicates, ensuring it performs "as intended" and is "functionally equivalent." No specific quantitative metrics or target values for performance are provided.

2. Sample size used for the test set and the data provenance:

The document mentions "mechanical and functional bench testing" but does not specify the sample size for these tests (e.g., number of devices tested, number of test cycles). It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective nature) as these are not typically relevant to bench testing for mechanical devices in this context.

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

Not applicable. This device is a mechanical endoscopic overtube, not a diagnostic or AI device that requires expert-established ground truth for its performance evaluation in this 510(k) context. The evaluation relies on engineering principles and comparison to predicate devices.

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

Not applicable. As noted above, this is a mechanical device evaluation, not one involving expert adjudication of diagnostic outcomes.

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 not an AI-assisted device.

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

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

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

Not applicable in the sense of clinical 'ground truth' for diagnostic performance. The "ground truth" for this device's performance would be its ability to mechanically function as designed and as demonstrated by its predicate devices, validated through mechanical and functional bench testing.

8. The sample size for the training set:

Not applicable. This is a mechanical device, not an AI/machine learning model that requires a training set.

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

Not applicable. As above, no training set for an AI/machine learning model.

In summary, the provided document is a regulatory submission for a mechanical medical device (USGI Endoscopic Overtube) seeking clearance based on substantial equivalence to existing predicate devices. The performance evaluation relies on mechanical and functional bench testing to demonstrate that the new device performs "as intended" and is "functionally equivalent" to the predicates. It does not contain the detailed information on acceptance criteria, clinical study designs, expert reviews, or AI-specific evaluations that would be relevant for a typical AI/Software as a Medical Device (SaMD) submission.

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