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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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The ClearMedical Reprocessed Used, Disposable Endoscopic Scissors and Graspers have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection, and transaction of tissue.

The Reprocessed SUD (Reprocessed Used, Disposable Endoscopic Scissors and Graspers) is a sterilized SUD. The reprocessed Endopath endoscopic instruments are sterile, single patient use instruments that have a rotating insulated shaft and are designed for use through appropriate surgical trocars. The rotation knob located on the handle rotates the shaft 360 degrees in either direction. Some instruments have a monopolar cautery connector extending from the top of the handle and can be used for electosurgery when properly attached to standard cautery cables and appropriate generators. Other instruments have rachet handles, which allow the instrument jaws to be locked in place. The instrument jaws or scissor blades are activated by compression and release of the ring handles. See instructions for complete mode of operation details. The Reprocessed SUD (Reprocessed Used, Disposable Endoscopic details. The Reprosesses Coasted using EtO sterilization.

The provided text is a 510(k) summary for a reprocessed medical device, the "Reprocessed Used, Disposable Endoscopic Scissors and Graspers." It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study to prove meeting those criteria in the way a new device would.

Therefore, much of the requested information regarding acceptance criteria, device performance tables, sample sizes for test/training sets, expert qualifications, ground truth establishment, adjudication methods, and MRMC studies is not present in this document. This document is a regulatory submission for substantial equivalence based on similarity to an existing device.

Here's an analysis of what can be extracted and what is missing:

Description of Acceptance Criteria and Study to Prove the Device Meets Them:

The document does not describe specific acceptance criteria and a detailed study designed to quantitatively prove the reprocessed device meets those criteria with performance metrics (e.g., accuracy, sensitivity, specificity, mechanical performance thresholds). Instead, the submission argues for substantial equivalence to a predicate device based on similar design, materials, intended use, and technological characteristics. The "study" here is implicitly the comparison made to the predicate device to satisfy the FDA's regulatory requirements for substantial equivalence.

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

• Not provided. The document does not contain a table of acceptance criteria or quantitative performance metrics for the reprocessed device. The submission relies on the concept that if the reprocessed device is substantially equivalent to a legally marketed predicate device, its performance is implicitly acceptable for its intended use.

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

• Not specified. The document does not describe a "test set" in the context of performance evaluation with a specific sample size. The substantial equivalence argument is based on a comparison to a predicate device's characteristics, not an independent performance study on a separate dataset of reprocessed devices.

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/Not specified. This type of information is pertinent to performance studies involving expert review (e.g., for image analysis algorithms). For a reprocessed surgical instrument, "ground truth" would typically relate to functional performance, sterility, and material integrity, which are assessed through engineering and quality control tests, not expert interpretation of data. The document does not detail such specific testing experts.

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

• Not applicable/Not specified. Adjudication methods are typically used in clinical or imaging studies where multiple readers interpret data and discrepancies need to be resolved. This is not relevant to the type of substantial equivalence argument presented for a reprocessed surgical instrument.

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 such study was done or reported. MRMC studies are relevant for evaluating the impact of AI or new diagnostic tools on human reader performance. This device is a surgical instrument, not an AI-powered diagnostic tool, so an MRMC study is inapplicable here.

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

• Not applicable. This device is a manual surgical instrument. It does not operate as a standalone algorithm.

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

• Implied Regulatory Ground Truth: The "ground truth" for this submission is the legally marketed predicate device (Ethicon Endoscopic Surgical Instruments, K930933). The substantial equivalence argument posits that the reprocessed device is functionally equivalent to this predicate, thus implicitly sharing its established "ground truth" performance and safety profile from its original approval. Specific, independent "ground truth" data for the reprocessed device's performance, as would be generated for a novel device, is not described.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device, so there is no training set in that context. The "training" for the reprocessed device would be in the quality control processes and procedures established for reprocessing, but this is not discussed in terms of a "training set" for statistical analysis.

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

• Not applicable. See point 8.

Summary of available information from the document:

• Device Name: Reprocessed Used, Disposable Endoscopic Scissors and Graspers
• Predicate Device: Ethicon Endoscopic Surgical Instruments (K930933), cleared June 22, 2003.
• Basis for Equivalence: Similarities in intended use, material, design, performance, and physical characteristics to the predicate device.
• Reprocessing Method: Ethylene Oxide (EtO) sterilization.
• Intended Use: "indicated for use in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection, and transaction of tissue."

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