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The neoClose device is intended to facilitate the delivery of absorbable AutoAnchors through soft tissues of the body during endoscopic/ laparoscopic surgery.

The neoClose device is intended to facilitate the delivery of absorbable AutoAnchors through soft tissues of the body during endoscopic/ laparoscopic surgery. There are two neoClose product codes, neoClose Hasson and neoClose Universal, each consisting of an AccuGuide and two AutoAnchors loaded onto two Drivers.

The neoClose Hasson is designed to provide sealed anchoring of a laparoscopic trocar and suture placement for subsequent soft tissue approximation. The neoClose Universal is equivalent to the neoClose Hasson design in its method of soft tissue approximation but does not provide for sealed anchoring of a trocar. Soft tissue approximation is facilitated by delivering two AutoAnchors, through an AccuGuide with a Driver. The AutoAnchors and Drivers for both the neoClose Hasson and Universal are identical but the AccuGuides differ in construction. The Hasson AccuGuide features Suture Locks, a flexible Sleeve, and two Guide Channels while the Universal AccuGuide features a Thumb Grip and one Guide Channel.

The provided text describes a 510(k) summary for a medical device called neoClose. This submission focuses on establishing substantially equivalent to a previously marketed predicate device (neoClose, K123280), rather than outlining acceptance criteria and a study to prove new performance claims for an innovative device.

Therefore, many of the requested categories for a study proving device performance against acceptance criteria cannot be directly extracted from this document. The document explicitly states that the technical characteristics of the applicant device are substantially equivalent to the predicate device, with the only change being an extension of shelf life. The "study" mentioned is primarily focused on demonstrating this equivalence rather than measuring new performance metrics against predefined acceptance criteria.

Here's an analysis of the information provided in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not available in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device, not on establishing and meeting new performance acceptance criteria for a novel device. The "performance" section states: "Design Verification bench testing support the use of the neoClose device and demonstrate that it is at least as safe and effective as the predicate device, neoClose (K123280)." This implies comparison to the predicate's performance, not to specific, new acceptance criteria.

Note: If specific performance criteria and results were provided for the predicate device (K123280) regarding the "delivery of absorbable AutoAnchors through soft tissues", then the bench testing for K131688 would have been compared against those. However, these details are absent from this summary.

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

The document mentions "Design Verification bench testing" and a "GLP Animal Study completed with the predicate device." It does not specify sample sizes for these tests, nor the data provenance (e.g., country of origin, retrospective/prospective). The animal study was done with the predicate, not the present device, and is used to infer safety and effectiveness based on the very minor change to the current device (shelf life extension).

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not applicable/not available. The document describes a medical device for surgical procedures, not diagnostic software that requires expert-established ground truth. The equivalency is based on design, materials, and bench/animal testing, not expert consensus on interpretations.

4. Adjudication Method for the Test Set

This information is not applicable/not available. Adjudication methods like 2+1 or 3+1 are typically used for diagnostic studies involving human readers, not for demonstrating substantial equivalence of a surgical device through bench and animal testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

This information is not applicable/not available. MRMC studies are associated with diagnostic imaging or similar interpretation tasks, often involving AI assistance. This device is a surgical instrument, and the submission is for substantial equivalence, not a comparative effectiveness study involving human readers with and without AI.

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

This information is not applicable/not available. This is a physical surgical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the bench testing, the "ground truth" would implicitly be the performance characteristics of the predicate device (K123280), as the goal was to demonstrate that the modified device is "at least as safe and effective." For the GLP Animal Study, the "ground truth" would be the observed safety and effectiveness outcomes in the animal model for the predicate device.

8. The Sample Size for the Training Set

This information is not applicable/not available. This device is not an AI/ML algorithm that requires a training set.

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

This information is not applicable/not available. As this is not an AI/ML algorithm, there is no training set or ground truth in that context.

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The neoClose device is intended to facilitate the delivery of absorbable AutoAnchors through soft tissues of the body during endoscopic/ laparoscopic surgery.

The neoClose device is intended to facilitate the delivery of absorbable AutoAnchors through soft tissues of the body during endoscopic surgery. There are two neoClose product codes, neoClose Hasson and neoClose Universal, each consisting of an AccuGuide and two AutoAnchors loaded onto two Drivers. The neoClose Hasson is designed to provide sealed anchoring of a laparoscopic trocar and suture placement for subsequent soft tissue approximation. The neoClose Universal is equivalent to the neoClose Hasson design in its method of soft tissue approximation but does not provide for sealed anchoring of a trocar. Soft tissue approximation is facilitated by delivering two AutoAnchors, through an AccuGuide with a Driver. The AutoAnchors and Drivers for both the neoClose Hasson and Universal are identical but the AccuGuides differ in construction. The Hasson AccuGuide features Suture Locks, a flexible Sleeve, and two Guide Channels while the Universal AccuGuide features a Thumb Grip and one Guide Channel.

The provided text describes a 510(k) summary for the neoClose device, which is a suture passer for endoscopic/laparoscopic surgery. However, the document does not contain the specific details required to answer your request about acceptance criteria and a study proving the device meets those criteria, especially in the context of an AI/human reader study.

Here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated as quantifiable metrics. The document broadly refers to "at least as safe and effective as the predicate devices."
• Reported Device Performance: The document states that "Design Verification bench testing and an acute GLP Animal Study support the performance of the neoClose device and demonstrates that it is at least as safe and effective as the predicate devices." No specific quantitative performance metrics (e.g., tensile strength, closure time, success rate) are provided or compared against defined acceptance criteria.

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

• Test Set Sample Size: Not specified.
• Data Provenance: Not specified, beyond mentioning "Design Verification bench testing and an acute GLP Animal Study." The country of origin for the animal study is not mentioned, nor is whether the data was retrospective or prospective.

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

• Not applicable. The studies mentioned (Design Verification bench testing and GLP Animal Study) do not involve human expert interpretation in the way an AI diagnostic device study would. The performance appears to be assessed via scientific and clinical endpoints in animal models and bench tests.

4. Adjudication Method for the Test Set

• Not applicable. See point 3.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve With AI vs. Without AI Assistance

• No, an MRMC study was not done. This device is a surgical tool, not an AI-assisted diagnostic device. The documentation focuses on equivalence to a predicate device through bench and animal testing, not on human reader performance with or without AI.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• For bench testing: Likely engineering specifications, physical measurements, and possibly simulated clinical conditions.
• For the GLP Animal Study: Clinical and pathological observations in an animal model. The specific endpoints or "ground truth" (e.g., successful tissue approximation, absence of complications, healing outcomes) are not detailed.

8. The Sample Size for the Training Set

• Not applicable. This device does not use machine learning, so there is no training set in the AI sense.

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

• Not applicable. See point 8.

In summary: The provided 510(k) summary is for a physical surgical device and discusses its substantial equivalence to a predicate device through bench and animal testing. It does not provide the kind of information requested regarding AI performance, human reader studies, or detailed acceptance criteria with quantitative results, as would be expected for an AI/ML-based diagnostic device.

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