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The reusable FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator is an access device indicated for use with a disposable 8.5 - 13mm Cannula Seal manufactured by Applied Medical to provide a passageway for the introduction of endoscopic instruments in general laparoscopic procedures. The access device is compatible with the da Vinci Si Surgical System.

The FloShield 10mm Endoscopic Conical Blunt Obturator is a re-usable stainless steel endoscopic instrument delivered non-sterile with the FloShield 10mm Endoscopic Cannula to the hospital where it is cleaned, sterilized (steam / moist heat), and assembled prior to surgery. The FloShield 10mm stainless steel Cannula mates with a disposable Applied Medical 8.5 -13mm Cannula Seal manufactured and supplied sterile by Applied Medical. The stainless steel Cannula has the ability to connect to a standard male luer fitting, via the female luer that is present on the Cannula. The device will accommodate a standard 8.5mm to 10mm endoscopic instrument (outside diameter). The stainless steel Obturator has a conical blunt style tip which facilitates the insertion of the cannula through an incision site.

This document describes a 510(k) premarket notification for the FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator. The acceptance criteria and supporting study details are heavily focused on demonstrating equivalence to a predicate device rather than establishing new performance benchmarks for a standalone AI system.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The submission is for a medical device (endoscopic cannula and obturator), not an AI algorithm. Therefore, the "acceptance criteria" are related to mechanical and functional performance, as well as biological compatibility and sterilization, rather than diagnostic accuracy or AI model metrics.

2. Sample Size for the Test Set and Data Provenance

The document does not specify a "test set" in the context of an AI algorithm evaluating data. The performance testing described is for a physical medical device.

• Sample Size for Test Set: Not applicable in the context of an AI test set. The number of physical devices tested for performance (e.g., leak resistance, insertion force) is not specified.
• Data Provenance: Not applicable in the context of an AI algorithm. The performance testing would be conducted in a laboratory or simulated environment, not on patient data from a specific country.
• Retrospective or Prospective: Not applicable for device performance testing.

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

This is not applicable as the device is a physical instrument, not an AI diagnostic tool. Ground truth in this context would be defined by engineering specifications, validated test methods, and regulatory standards, not by expert consensus on patient data.

4. Adjudication Method

Not applicable for a physical device's performance testing.

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

Not applicable. This device is not an AI system. The comparison is between the new device and its predicate, primarily on functional and material equivalence, not human reader performance with or without AI assistance.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable. This is a physical medical device.

7. Type of Ground Truth Used

The "ground truth" for this medical device's performance is based on:

• Engineering specifications and design requirements: For functional metrics like leak resistance, flow rates, insertion/removal force, and snap retention.
• Established industry standards: For sterilization (ISO 17665, ANSI/AAMI ST81) and for biocompatibility.
• Predicate device characteristics: The new device must demonstrate comparable characteristics to the legally marketed predicate.

8. Sample Size for the Training Set

Not applicable. There is no AI model or training set involved.

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

Not applicable. There is no AI model or training set involved.

Summary for the FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator:

This submission is for a physical medical device, not an AI algorithm. Therefore, many of the requested categories related to AI performance metrics (like test set size, data provenance, expert ground truth, MRMC studies, training sets) are not applicable.

The study presented in the 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device (FloShield 10mm Endoscopic Cannula and Blunt Obturator - K141272) through:

• Comparison of technological characteristics: Verifying similar design, materials (stainless steel), and intended use. The only noted difference is the tip style of the obturator (conical blunt vs. full blunt).
• Performance and functional testing: To ensure the device fulfills its intended mechanical functions during simulated laparoscopic surgery. This included tests for creating/maintaining port of entry, maintaining pneumoperitoneum, leak resistance, insufflating flow rates, insertion/removal force, and snap retention, all of which were found to be "comparable to the predicates."
• Sterilization validation: Conforming to relevant ISO and ANSI/AAMI standards for reusable devices.

The "acceptance criteria" are met by demonstrating that the new device performs equivalently to the predicate and complies with relevant safety and performance standards for medical devices.

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