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The JustRight Surgical® Vessel Sealing System is indicated for use in open and laparoscopic general surgical procedures to seal blood vessels and vascular bundles up to and including 5 mm in diameter for use in adult and pediatric populations, wherever vessel ligation is required.

The device is contraindicated for use in ENT procedures.

The JustRight Surgical® Vessel Sealing System consists of the JustRight™ Generator and a JustRight™ Sealer. The JustRight™ Generator is designed to provide low power bipolar RF energy for vessel-sealing applications. The JustRight™ Generator is for use only with JustRight™ Sealer instruments. The JustRight™ Sealer is a hand held ring handle design with either a 10 cm or a 20 cm shaft length that is compatible with a 3mm (ID) cannula. The JustRight™ Sealer attaches to the generator via a 10' cord.

The provided text describes the 510(k) premarket notification for the JustRight Surgical® Vessel Sealing System. It focuses on demonstrating substantial equivalence to predicate devices, particularly for an expanded indication to include pediatric use.

Here's an analysis of the acceptance criteria and the study information based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific numerical targets. Instead, it relies on demonstrating equivalence through various tests and a literature review. The performance claims are comparative to predicate devices.

2. Sample Size for the Test Set and Data Provenance

• Animal Testing: The document states "Animal testing... conducted," but does not specify the sample size (number of animals or number of seals) used for the in vivo evaluation.
• Data Provenance:
  • Bench Testing: Internal JustRight Surgical LLC.
  • Animal Testing: Not explicitly stated, but typically conducted in a laboratory setting.
  • Literature Review: Publicly available medical literature, including meta-analyses, focusing on complication rates in pediatric vs. adult populations using vessel sealers.
  • Post-Market Feedback: Data collected on the existing JustRight Surgical® Vessel Sealing System.

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

This type of information is not applicable or not provided in the context of this 510(k) submission. The document describes engineering and animal studies, not human clinical trials or diagnostic AI studies requiring expert ground truth establishment for a test set.

4. Adjudication Method for the Test Set

This is not applicable as the studies are technical and animal tests, not clinical or diagnostic studies requiring expert adjudication of results.

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

No, an MRMC comparative effectiveness study was not done. The document focuses on device performance and equivalence to predicate devices, not on human reader performance with or without AI assistance.

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

This question is not applicable as the device is a physical surgical instrument (vessel sealing system), not an AI algorithm.

7. The Type of Ground Truth Used

• Bench Testing: Engineering specifications and standardized test methods (e.g., electrical safety standards, force/pressure measurements for seals, durability cycles).
• Animal Testing: Direct observation of vessel sealing efficacy in an in vivo model, likely based on burst pressure and histological assessment of sealed vessels, comparing outcomes to the predicate device.
• Literature Review: Published clinical outcomes and complication rates for vessel sealing devices.
• Post-Market Feedback: Real-world data reported by users of the device.

8. The Sample Size for the Training Set

This is not applicable. The device is a hardware system, not an AI algorithm that requires a "training set." The development of the device would involve engineering design and testing, not machine learning model training.

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

This is not applicable for the same reason as point 8.

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