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The AirSurgN Insufflator is intended for use during diagnostic and/or therapeutic laparoscopic procedures to distend the abdominal cavity and maintain pneumoperitoneum by filling it with carbon dioxide (CO2) gas. The AirSurgN Insufflator provides user-selectable variable CO2 gas flow and pressure rates.

The AirSurgN Insufflator is intended for use during diagnostic and/or therapeutic laparoscopic procedures to distend the peritoneal cavity and maintain pneumoperitoneum by filling the cavity with carbon dioxide (CO2) gas and to evacuate surgical smoke. The device helps establish and maintain a path of entry for laparoscopic instruments. The AirSurgN Insufflator is intended to be used in a hospital setting on the adult population of 22 years and older.

The AirSurgN Insufflator is a microprocessor-based CO2 insufflator, controlling pneumatic valves, vacuum pump, and pressure sensors. User input to an LCD touchscreen graphical user interface (GUI) initiates the selected pressure, flow rate, and displays the output. Feedback control loop manages pneumoperitoneum. If smoke evacuation is desired, the user can activate this vacuum function for a fixed time period before shutting off automatically.

The device is reusable. It is not intended to be used in the sterile field and cannot be sterilized.

The provided FDA 510(k) clearance letter for the AirSurgN Insufflator mentions performance testing in general terms but does not include specific acceptance criteria or detailed study results for each test. For medical devices like insufflators, performance testing typically involves evaluating aspects such as pressure accuracy, flow rate stability, volume delivery, and response to various physiological conditions.

Here's an interpretation based on the standard information expected for such a clearance, noting that the specific numerical data and detailed methodology for the "acceptance criteria" and "reported device performance" are not explicitly present in the provided document. The document primarily focuses on what tests were done and that they met the criteria, without listing the criteria themselves or the exact results.

Description of Acceptance Criteria and Study Proving Device Meets Criteria

The AirSurgN Insufflator's performance was evaluated through a series of non-clinical/bench tests to demonstrate its safety and substantial equivalence to the predicate device (PNEUMOCLEAR, K170784). While the document states that "The results met the predetermined acceptance criteria," it does not explicitly list these criteria or the numerical results for the AirSurgN Insufflator. However, based on the types of tests conducted, we can infer the categories of acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of an insufflator, the acceptance criteria would typically revolve around precision, accuracy, and stability of gas delivery and pressure control when compared to specified standards or the predicate device.

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The use of the SDC4K Information Management System with Device and Voice Control Package is to allow for voice control and remote control of medical device settings by surgeons or operating room personnel, thereby eliminating the need to manually operate those devices compatible with the SDC4K Information Management System with Device and Voice Control Package or to rely on verbal communication between the surgeon and other operating room personnel in order to adjust the surgical equipment. It also has additional digital documentation functionality capture, transfer, store and display medical device data (non-medical device function), which is independent of the functions or parameters of any attached Stryker device.

The SDC4K Information Management System with Device and Voice Control Package is a network compatible hardware platform that carries out Medical Device Data System (MDDS) functionalities and allows the user to control the state, selection, and settings of compatible connected endoscopic and general surgery devices both wired and wirelessly.

The SDC4K Information Management System with Device and Voice Control Package consists of the following components:

• 1. SDC4K Console which includes:
  • a) Class I Medical Device Data System (MDDS) functionality
  • b) Optional Device Control feature
  • c) Optional Voice Control feature
• 2. Device Control Package (software activation USB dongle and a handheld Infrared (IR) remote control)
• 3. Voice Control Package (software activation USB dongle and a wireless headset and base station)
• 4. Connected OR Spoke (Class I MDDS)

The SDC4K console carries out the Medical Device Data System (MDDS) functionalities (i.e. Class I device function or Non-medical function) and can be marketed as a standalone device. When upgraded with the Device Control and/or Voice Control package, the SDC4K Console extends its functionality to control compatible devices from its touchscreen graphical user interface (GUI), spoken commands via headset (voice control input), and an IR remote control or directional keypad from a camera head (device control input). The received user commands are then processed and communicated with the connected controllable devices, allowing the user to control the state, selection, and settings of those devices. In addition, the SDC4K Information Management System with Device and Voice Control Package also provides compatibility with the Connected OR Spoke (also referred to as "Spoke") which is a standalone Class I Medical Device Data System. Once the SDC4K is connected to the Spoke, Device Control can be extended to compatible devices connected to the Spoke.

The provided FDA 510(k) summary for the SDC4K Information Management System with Device and Voice Control Package outlines its performance data through various tests. However, it does not include a detailed table of acceptance criteria and reported device performance for specific functional metrics, nor does it describe a study design that would prove the device meets such criteria in terms of accuracy or clinical effectiveness.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Connected OR Hub with Device and Voice Control, K212055) by verifying compliance with recognized standards.

Here's an attempt to answer your questions based only on the provided text, highlighting what is included and what is explicitly not included:

1. A table of acceptance criteria and the reported device performance

The document provides a table of tests conducted and their outcomes, indicating "Pass" for each. These are related to safety, EMC, software validation, usability, and bench performance based on specifications and intended use. Specific quantitative performance metrics (e.g., accuracy, latency, success rate for voice control commands) against defined acceptance criteria are not provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for any test sets mentioned (e.g., for usability or bench performance). It also does not mention data provenance, as the tests are primarily engineering and compliance-based rather than involving patient data or clinical studies. The document explicitly states: "the subject device does not require clinical studies to support the determination of substantial equivalence."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The tests described are largely against technical standards and internal specifications, rather than requiring expert consensus on a "ground truth" derived from clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication methods are not described, as the type of studies conducted (compliance and engineering tests) typically do not involve such processes.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned and is not applicable to this device, as it is an information management and control system, not an AI-assisted diagnostic or interpretative tool. The document states "the subject device does not require clinical studies to support the determination of substantial equivalence."

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The device itself (SDC4K Information Management System with Device and Voice Control Package) includes human interaction (remote control, voice control, GUI). Therefore, a "standalone algorithm only" performance without human-in-the-loop is not directly relevant or described. The performance bench tests would assess the functionality of the system components and their integration, but not in a purely algorithmic, non-interactive context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The concept of "ground truth" as typically understood in the context of diagnostic or AI performance evaluation (e.g., against pathology reports or clinical outcomes) is not applicable to the type of testing described. The "ground truth" in this context would be the successful execution of device commands, adherence to electrical safety, EMC, software, and usability standards, and meeting internal device input specifications.

8. The sample size for the training set

This information is not applicable and not provided. The device is an information management and control system, not a machine learning or AI algorithm that relies on a "training set" for its core function (beyond potentially voice recognition models, which are likely integrated commercial solutions and their training data is not discussed here).

9. How the ground truth for the training set was established

This information is not applicable and not provided for the reasons stated in point 8.

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