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The USGI g-Prox Endoscopic Grasper is intended for use in minimally invasive procedures to facilitate tissue grasping and manipulation.

The g-Prox Endoscopic Grasper is a sterile, single patient use device used for tissue grasping and mobilization. It includes a lumen that can accept the g-Cath Tissue Anchor Delivery Catheter and other small diameter instruments.

The provided document is a 510(k) summary for a medical device (USGI g-Prox Endoscopic Grasper) and primarily focuses on regulatory approval based on substantial equivalence to predicate devices, rather than a detailed study proving performance against acceptance criteria in the context of AI or advanced analytical devices. As such, most of the requested information (related to AI performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, and standalone performance) is not available or applicable to this type of submission.

The relevant information from the document is summarized below:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "Bench testing was conducted to ensure that the modified device performs as intended." However, it does not specify the sample size, type of data (e.g., in vitro, ex vivo, in vivo), country of origin, or whether it was retrospective or prospective.

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. This device is a surgical instrument, and its performance is evaluated through bench testing and comparison to predicate devices, not typically through expert-established ground truth in the context of diagnostic or analytical performance.

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

Not applicable. The document refers to "Bench testing," but provides no details on adjudication methods.

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 a surgical instrument, not an AI-assisted diagnostic or analytical device.

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

Not applicable. This is a surgical instrument, not an algorithm.

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

For bench testing, the "ground truth" would likely be engineering specifications, material properties, and functional performance benchmarks (e.g., grasping force, durability, tissue damage assessment), rather than clinical ground truth like pathology or expert consensus. No specific type is mentioned.

8. The sample size for the training set

Not applicable. The device is not an AI algorithm requiring a training set.

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

Not applicable. The device is not an AI algorithm requiring a training set.

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The g-Cath Tissue Anchor Delivery Catheter is intended for approximation of soft tissue in minimally invasive gastroenterology procedures.

The g-Prox Endoscopic Grasper is intended for use in minimally invasive procedures to facilitate tissue grasping and mobilization.

The g-Prox Endoscopic Grasper is a sterile, single patient use device used for tissue grasping and mobilization. It is also used as an accessory to the g-Cath Tissue Anchor Delivery Catheter for placement of tissue anchors for soft tissue approximation in minimally invasive gastroenterology procedures. A nitinol/polyester tissue anchor pair is deployed through the g-Cath Tissue Anchor Delivery Catheter lumen and compressed to approximate soft tissue. Anchor tensile strength meets USP for a size 4-0 nonabsorbable suture. The anchor does not meet USP for diameter and is oversized by 100% compared to a 4-0 nonabsorbable suture.

The provided text describes a 510(k) submission for the g-Cath Tissue Anchor Delivery Catheter and g-Prox Endoscopic Grasper, focusing on their substantial equivalence to predicate devices. It does not present acceptance criteria or a study proving that the device meets specific acceptance criteria in the way a clinical performance study would for an AI/ML device.

Instead, the submission focuses on:

• Comparison with Predicate Devices: Demonstrating that the new devices are comparable to existing legally marketed devices in terms of intended use, technology, design, and materials.
• Preclinical Testing: Stating that "Bench and animal testing demonstrated satisfactory performance of the g-Prox Endoscopic Grasper and g-Cath Tissue Anchor Delivery Catheter." This is a general statement of satisfactory performance, not a detailed report against specific, quantified acceptance criteria.
• Compliance with Industry Standards: The g-Cath Tissue Anchor's tensile strength is stated to meet USP for a size 4-0 nonabsorbable suture, although its diameter is oversized. This is the closest thing to a specific performance metric mentioned.

Given this context, I cannot extract the information requested as it pertains to AI/ML device performance studies. The provided document is for a medical device clearance (510(k)) that relies on preclinical testing and substantial equivalence to predicate devices, not a human-in-the-loop or standalone AI/ML performance study.

Therefore, most of your requested table and points regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies for AI performance cannot be answered from the provided text.

Here's a breakdown of what information can be extracted or inferred based on the document's nature:

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

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

• Sample Size: Not specified for bench or animal testing. The text only states "Preclinical testing was performed..."
• Data Provenance: The testing was "Bench and animal testing," indicating lab-based and in-vivo animal studies. Country of origin is not specified but implicitly US-based given the FDA submission. These are prospective tests for device validation.

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

• Not applicable/Not provided. The "ground truth" here would relate to the physical and functional properties of the device, likely assessed by engineers and veterinarians/pathologists in animal studies, not human experts establishing ground truth for diagnostic AI.

4. Adjudication method for the test set

• Not applicable/Not provided. Adjudication methods are typically relevant for human reader studies or expert consensus, not for mechanical or animal performance 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. This is not an AI/ML device, and no MRMC study was mentioned.

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

• No. This is not an AI/ML device. The "standalone performance" was the physical device independent of human assistance in a diagnostic context.

7. The type of ground truth used

• Bench Testing: Ground truth would be based on established engineering standards, physical measurements (e.g., tensile strength testing against USP standards), and functional tests.
• Animal Testing: Ground truth would be based on physiological observations, histological assessment of tissue approximation, and veterinary pathology.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device where a "training set" would be used in the same context.

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

• Not applicable. (See #8)

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