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The Dissecting Balloon System is indicated for patients undergoing laparoscopic surgery requiring tissue separation of the extraperitoneal space.

Applied Medical's Dissecting Balloon System consists of a rigid cannula with an inflatable balloon attached at the distal end that achieves separation of tissue planes during laparoscopic surgery. The system is provided sterile. The system includes three main components: An introducer that facilitates insertion of the balloon through an abdominal incision. A dissecting cannula with attached balloon, which is compatible with a 10mm endoscope to allow for visualization during tissue separation. Two balloon configurations will be offered (oval and round). An inflation bulb that is used to manually inflate the balloon

This document is a 510(k) Premarket Notification for the Applied Medical Resources Corp. Dissecting Balloon System. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific performance criteria in a clinical setting. The "performance testing" section describes bench-top functional assessments and biocompatibility, which are primarily aimed at showing that the new device functions similarly and is as safe as the predicate, not necessarily that it achieves a specific clinical outcome with a quantifiable performance metric.

Therefore, many of the requested elements regarding clinical performance studies, such as sample sizes for test and training sets, expert qualifications, adjudication methods, and MRMC studies, are not applicable in the context of this 510(k) submission.

Here's a breakdown of the information that can be extracted or deduced from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not provide a table of explicit, quantifiable acceptance criteria with corresponding device performance metrics in a clinical context. The "performance testing" section describes functional equivalence testing.

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

• Sample Size: Not specified for the functional performance bench testing.
• Data Provenance: The document describes "side-by-side bench top testing," which implies laboratory-based, prospective testing conducted by the manufacturer. No information on country of origin for clinical data is applicable as it's not a clinical study.

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

• Number of Experts: Not applicable. The "ground truth" for functional performance was likely established by engineers or technicians assessing the physical properties and operation of the devices in a bench-top setting, not clinical experts.
• Qualifications of Experts: Not specified or applicable in the human reader / clinical context.

4. Adjudication Method for the Test Set:

• Not applicable. The bench-top testing would have involved objective measurements or direct observation of device function, not an adjudication process by human readers or clinical experts.

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

• No, an MRMC comparative effectiveness study was not done. This 510(k) submission focuses on demonstrating substantial equivalence through bench-top testing and biocompatibility, not clinical effectiveness studies involving human readers or AI.

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

• Not applicable. This device is a mechanical surgical tool (dissecting balloon system), not an AI algorithm. Therefore, there is no "algorithm only" performance to evaluate.

7. Type of Ground Truth Used:

• Functional Performance: The ground truth for functional performance was based on direct observation and measurement of the device's physical operation and its ability to perform its intended mechanical functions (insertion, tissue separation, visualization, deflation, removal) in a bench-top setting, compared to the predicate device. It is not clinical ground truth like pathology or outcome data.
• Biocompatibility: The ground truth was established through adherence to the FDA's guidance document and international standard ISO 10993-1, with results based on laboratory tests for cytotoxicity, irritation, sensitization, and systemic toxicity.

8. Sample Size for the Training Set:

• Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

• Not applicable. As there's no AI model or training set, this information is not relevant.

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