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The Bard® Endoscopic Suturing System is used for endoscopic placement of suture(s) in the soft tissue of the esophagus and stomach and for the approximation of tissue for the treatment of symptomatic Gastroesophageal Reflux Disease.

Device Description

The Bard® Endoscopic Suturing System consists of a capsule assembly with suction tubing and a fixed head knotpusher that attaches to the distal end of a flexible endoscope or a through-the-scope knot pusher, plus a needle assembly, pusher wire, guidewire and suture cutter that all pass through an endoscope's biopsy channel. Also, included is a suture loader to facilitate loading suture tags into the needle, a syringe for flushing the suction tubing, and an detachable knot pusher handle. Only Bard® Suture Tags and the Bard® Endoscopic Handle may be used with the Bard® Endosocpic Suturing System.

AI/ML Overview

The provided document is a 510(k) summary for the Bard® Endoscopic Suturing System, indicating its substantial equivalence to predicate devices. It does not contain the specific acceptance criteria or a detailed study justifying how the device meets those criteria, largely because 510(k) submissions typically focus on demonstrating equivalence rather than establishing new safety and effectiveness through extensive performance studies against pre-defined acceptance criteria.

However, based on the information provided, here's what can be extracted and inferred regarding performance data:

The document states: "Performance Data: Biocompatibility, in vitro bench testing, animal and clinical testing has been completed and supports the safety and effectiveness of the Bard® Endoscopic Suturing System for its intended use."

Here's an attempt to structure the answer based on the prompt's requirements, noting significant limitations due to the nature of the provided text:

Acceptance Criteria and Device Performance Study for Bard® Endoscopic Suturing System

1. Table of Acceptance Criteria and Reported Device Performance

Performance Criterion	Acceptance Criteria	Reported Device Performance
Biocompatibility	Not explicitly stated (implied to meet relevant biocompatibility standards)	"The biocompatibility test results show that the materials used in the design and manufacture of the device are non-toxic and non-reactive to biologic tissues consistent with their intended use."
Bench Testing	Established specifications for consistent performance	"Bench test results show that the materials chosen and the design utilized in manufacturing the Bard® Endoscopic Suturing System, meet the established specifications necessary for consistent performance during their intended use."
Animal Studies	Safety and effectiveness in placing sutures in soft tissues without complications/adverse reactions	"The animal studies support the safety and effectiveness of the Bard® Endoscopic Suturing System. The studies document there were no complications/adverse reactions reported, and that the system is capable of safely and consistently placing sutures in the soft tissues within the stomach and esophagus."
Human Clinical Experience	Safety and effectiveness for its intended use	"Finally, the summary of human clinical experience under a 64 patient prospective randomized investigation and the non-U. S. patient experience supports the safety and effectiveness of the Bard® Endoscopic Suturing System for its intended use."

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

Human Clinical Experience (Test Set): 64 patients.
Data Provenance: "64 patient prospective randomized investigation" (likely multi-center or within a specific region, though not explicitly stated as US or international for this specific 64-patient cohort). There was also "non-U. S. patient experience" mentioned, indicating some international data. The study type is explicitly prospective and randomized.

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

This information is not provided in the document. The document describes a clinical investigation but does not detail how the clinical outcomes (ground truth) were adjudicated or by whom.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not provided. The device is an endoscopic suturing system, not an imaging AI diagnostic tool, so an MRMC study comparing human readers with and without AI assistance would not be applicable in this context. The clinical study mentioned is for the device's performance, not an AI component.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable. The Bard® Endoscopic Suturing System is a medical device used by a human operator, not an autonomous algorithm.

7. Type of Ground Truth Used

Clinical Outcomes/Safety and Effectiveness: For the human clinical experience and animal studies, the "ground truth" would be related to clinical endpoints such as:
- Absence of complications/adverse events.
- Successful placement of sutures.
- Approximation of tissue.
- Treatment of symptomatic Gastroesophageal Reflux Disease.
- These are based on observations, clinical assessments, and potentially follow-up data from the patients and animals.

8. Sample Size for the Training Set

This information is not provided and is not applicable in the context of this device. "Training set" refers to data used to train machine learning models. This device is a mechanical/manual instrument, not an AI algorithm.

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

This information is not provided and is not applicable for the reasons stated above.

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