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The USGI TransPort Endoscopic Guide is intended to be used with an endoscope to facilitate intubation of the endoscope and as a guide for various flexible endoscopic instruments.

The TransPort Endoscopic Access Device is comprised of a flexible shaft that can be rigidized and locked into position, a steerable tip and multiple lumens that allow insertion and exchange of flexible instruments. It is supplied as two separately packaged components, i.e., a reusable, metal body and a strerile, single use disposable sheath.

The provided text describes a 510(k) summary for the USGI TransPort™ Endoscopic Access Device. This device is an "Endoscopic Overtube" and its submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies. Therefore, much of the requested information regarding acceptance criteria and performance studies is not directly available in this document.

Here's a breakdown of what can be extracted and what is not applicable:

1. Table of acceptance criteria and the reported device performance

This information is not present in the provided 510(k) summary. The summary states: "Bench testing was conducted to ensure that the device performs as intended when used according to its instructions for use." However, it does not detail specific acceptance criteria or the reported performance metrics from this bench testing.

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

No test set data for performance evaluation (e.g., in a clinical study) is described in this 510(k) submission. The "bench testing" mentioned suggests in-vitro or simulated use, not a human-based test set from a specific country or retrospective/prospective data.

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

This information is not applicable as the summary does not describe a clinical study requiring ground truth establishment by experts.

4. Adjudication method for the test set

This information is not applicable as the summary does not describe a clinical study requiring adjudication.

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 an endoscopic access device, not an AI-powered diagnostic tool. Therefore, MRMC studies or AI assistance are not relevant.

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 not an algorithm or AI-powered.

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

This information is not applicable as the summary describes functional "bench testing" for a physical device, not a diagnostic or AI algorithm requiring ground truth.

8. The sample size for the training set

This information is not applicable as the device is not an AI algorithm requiring a training set.

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

This information is not applicable as the device is not an AI algorithm requiring a training set and ground truth establishment.

Summary of available information from the K072405 document:

• Device Name: USGI TransPort™ Endoscopic Access Device
• Intended Use: To be used with an endoscope to facilitate intubation of the endoscope and as a guide for various flexible endoscopic instruments.
• Comparison Basis: Substantially equivalent to predicate devices (USGI Medical TransPort™ Endoscopic Access Device K061216 and ShapeLock™ Endoscopic Access Device K033954) in terms of intended use, technology, and materials.
• Performance Claim: "Bench testing was conducted to ensure that the device performs as intended when used according to its instructions for use." (No specific criteria or results provided in this summary).

In conclusion, the provided 510(k) summary for K072405 focuses on demonstrating substantial equivalence through comparison and general bench testing, not on providing detailed acceptance criteria and performance data from a clinical or AI-centric study. Therefore, most of the requested fields are not applicable to the content of this specific document.

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The Endoscopic Access Device is an instrument access portal for use during endoscopic surgery.

The Endoscopic Access Device is an instrument access portal for use during endoscopic surgery. It is designed to be substantially equivalent to the presently marketed AMT Esophageal Overtube. The devices' internal flange is inserted into the incision site and allowed to expand freely. Once in place, the internal flange retains the device in place and allows for the access of a variety of surgical instruments. The shaft is angulated at 30° but can range from 20° to 90°, depending on the specific application. The external flange reduces site contamination and trauma. It also easily defines the access into the region. The Endoscopic Access Device is injection molded from the same biocompatible Dow Corning silicone (Q7-4840) as the AMT Button (K943392). The Endoscopic Access Deivce is sold sterile for single use.

This 510(k) summary for K960232 provides very limited information about performance criteria and studies. It describes a medical device, an Endoscopic Access Device, and states its intended use. However, it does not include the detailed information requested in the prompt regarding acceptance criteria, specific study results, sample sizes, ground truth establishment, or expert involvement.

Here's a breakdown of why it's not possible to answer the prompt with the provided text, and what can be inferred:

Inference from the Provided Text:

The document is a 510(k) summary for a relatively simple medical device (an access portal for endoscopic surgery), not a diagnostic AI/ML device. This type of device typically relies on simpler performance tests like bench testing for mechanical integrity and biocompatibility, rather than complex clinical studies involving human readers, AI algorithms, or extensive ground truth adjudication.

Specific to the Prompt's Requirements:

1. A table of acceptance criteria and the reported device performance
* Not provided. The text only mentions "Bench testing has been performed on the minimum pull out force versus the the strength of the device to ensure mechanical integrity for functional performance (see Exhibit VIa)." It does not state specific acceptance criteria (e.g., "minimum pull-out force must be > X Newtons") nor does it report the tested performance values (e.g., "device demonstrated a pull-out force of Y Newtons").

2. Sample size used for the test set and the data provenance
* Not provided. The term "bench testing" implies laboratory testing of physical samples, but the number of samples tested is not mentioned. Data provenance (country of origin, retrospective/prospective) is irrelevant for this type of mechanical bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
* Not applicable/Not provided. This device does not have "ground truth" in the diagnostic sense. Its performance is assessed through objective physical measurements (e.g., force, strength), not expert interpretation of outputs.

4. Adjudication method for the test set
* Not applicable/Not provided. No adjudication method would be used for bench testing of mechanical properties.

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, and not applicable. This is not an AI/ML device, nor is it a diagnostic device that would involve human readers interpreting data.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
* No, and not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
* Not applicable. The "ground truth" for this device's performance would be the objectively measured physical properties (e.g., actual tensile strength, actual biocompatibility).

8. The sample size for the training set
* Not applicable/Not provided. This device doesn't have a "training set" in the machine learning sense. The design and manufacturing process would involve internal testing and iterations, but this isn't reported as a formal "training set."

9. How the ground truth for the training set was established
* Not applicable.

Summary of available information regarding performance:

• Test Performed: Bench testing on "minimum pull out force versus the strength of the device."
• Purpose of Test: To "ensure mechanical integrity for functional performance."
• Reference: "see Exhibit VIa" (which is not provided)
• Biocompatibility: Stated to be "injection molded from the same biocompatible Dow Corning silicone (Q7-4840) as the AMT Button (K943392)," implying equivalence in material biocompatibility based on a previously cleared device. This acts as a form of "data provenance" for the material's safety.

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