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The GMP|Surgical Solutions Inc. Laparocision™ Scope Controller System is indicated for thoracic, gynecologic, orthopedic, and abdominal procedures for the purpose of holding and controlling the movement of standard laparoscopes or rigid endoscopes within inflated surgical cavities during minimally invasive laparoscopic surgery.

The GMP|Surgical Solutions Laparocision™ Scope Controller System allows for surgeons to control the movement and position of conventional laparoscopes or endoscopes during thoracic, gynecologic, orthopedic, and abdominal laparoscopic procedures by means of an electromechanical arm which is controlled by either a hand controller or a foot controller. The purpose of an endoscope is to allow visualization of a surgical cavity during minimally invasive laparoscopic procedures.

The device is comprised of the following five main components:

1. The Laparocision™ Reusable Arm Assembly
2. The Disposable Zoom Assembly (DZA)
3. The Foot Control and the Hand Control
4. The Steri-Sleeves
5. The Power Supply

The GMP|Surgical Solutions Inc. Laparocision™ Scope Controller System is a device designed to assist surgeons in controlling the movement and position of laparoscopes during various minimally invasive surgical procedures.

Here's an analysis of the acceptance criteria and the study proving the device meets these criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not specify a sample size for a "test set" in the context of clinical trials or data analysis. The testing described is in-vitro (laboratory-based) electrical, EMC, mechanical, and functional testing of the device itself, rather than studies involving patient data or human subjects. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable in this context.

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

This information is not applicable to the provided document. The testing conducted was technical validation against engineering and safety standards, not a diagnostic or clinical performance study that would require expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not applicable. The testing involved objective measurements against established technical standards, not subjective interpretations requiring adjudication.

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

This information is not applicable. The Laparocision™ Scope Controller System is an electromechanical arm for controlling an endoscope, not an AI-powered diagnostic or interpretive tool that assists human readers. Therefore, an MRMC study related to AI assistance is not relevant to this device.

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

This information is not applicable. The device is a physical, electromechanical system controlled by a human operator (surgeon). It does not operate as an algorithm only. The "functional testing" performed likely evaluated its standalone mechanical and control capabilities as intended.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed was established by recognized industry standards and engineering specifications. For electrical safety and EMC, the ground truth was compliance with UL, CSA, and IEC standards. For mechanical and functional testing, the ground truth was the device's design and performance requirements as defined by the manufacturer, likely benchmarked against the predicate device.

8. The Sample Size for the Training Set

This information is not applicable. The device is an electromechanical system that does not utilize a "training set" in the context of machine learning or AI algorithms. Development and validation rely on engineering design, manufacturing processes, and adherence to technical standards.

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

This information is not applicable for the reasons stated above.

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The GMP|Wireless Medicine LifeSync™ System is indicated for use when ECG monitoring is needed and a wireless cable-free connection is desired between the patient and the ECG Monitor. The LifeSync™ System will also transmit the patient respiration waveform for those ECG systems that include a respiration function.

The GMP/Wireless Medicine LifeSync™ System is intended for use as a radiofrequency signal transmitter and receiver of diagnostic electrocardiographic physiological signals which are displayed on the ECG monitors of various manufacturers' systems that have been validated for compatibility. ECG systems that are not currently wireless in operation will now be able to be used in a wireless fashion by virtue of being connected to the GMP system. The LifeSync™ System will also transmit the patient respiration waveform for those ECG systems that include a respiration function.

The GMPIWireless Medicine LifeSync™ System will eliminate the wires between the ECG patient and the ECG monitor and will replace the traditional ECG cable with a radio link. The GMP|Wireless Medicine LifeSync™ System will support the standard 5-lead ECG hook-up (via the Continuous Leadwear™) for monitoring and has the capability to add the remaining V1-V6 precordial leads (via the Discrete Leadwear™) for 12-lead discrete ECG recording.

The GMP|Wireless Medicine LifeSync™ System is comprised of 4 primary components and 1 accessory component: 1) a patient wearable 5-electrode array called the Continuous Leadwear™, 2) a patient wearable 6-electrode array called the Discrete Leadwear™, 3) LifeSync™ Patient Transceiver-with Armband , and 4) a LifeSync™ Monitor Transceiver. The accessory component is: 5) an optional Multi-Unit Battery Charger.

The LifeSync™ Patient Transceiver will be responsible for sampling ECG waveforms from the electrode array and converting these signals into digital data. It will then transmit this data over a wireless Bluetooth link to the Monitor Transceiver. The LifeSync™ Monitor Transceiver will reconstruct the analog signals from the received digital data and present these signals to the normal inputs of a standard Continuous Cardiac Monitor or Discrete Diagnostic ECG System. The LifeSync™ System has been validated for use with several ECG systems of various manufacturers.

The provided 510(k) summary for the GMP|Wireless Medicine LifeSync™ System does not contain detailed information regarding acceptance criteria or a specific study that proves the device meets such criteria in the way typically expected for AI/Machine Learning devices. Instead, the document focuses on demonstrating substantial equivalence to a predicate device through conformity to established performance standards for ECG devices.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative table format (e.g., "sensitivity > X%, specificity > Y%"). Instead, device performance is "accepted" if it conforms to the requirements of the listed industry standards. The reported performance is a general statement of compliance.

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

This information is not provided in the document. The testing described is "in-vitro performance testing" against standards, not a clinical study on a patient test set with specific sample sizes.

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

This information is not applicable/not provided. Ground truth in the context of this device's testing relates to the established technical specifications and performance characteristics defined by the industry standards, rather than expert interpretation of medical images or signals.

4. Adjudication Method

This information is not applicable/not provided. As the testing focuses on technical compliance with standards, an adjudication method for conflicting expert opinions would not be relevant.

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

No, an MRMC comparative effectiveness study was not done and is not mentioned. The device is a signal transmission system, not an AI for interpretation that would typically involve human readers.

6. If a Standalone (Algorithm Only) Performance Study Was Done

The testing described is essentially "standalone" in the sense that the system (transmitter and receiver) was tested to ensure it accurately transmits ECG signals according to the technical requirements of the standards. However, it's not a standalone AI algorithm in the modern sense. The "algorithm" here refers to the signal processing and transmission capabilities of the device itself, rather than an AI interpreting the signals. The testing demonstrates that the device functions as intended without human intervention in its core signal transmission.

7. The Type of Ground Truth Used

The ground truth used for this device's testing is the objective technical specifications and performance requirements outlined in the referenced ANSI/AAMI and IEC standards. These standards define acceptable levels of signal accuracy, noise, frequency response, electrical safety, electromagnetic compatibility, etc., for ECG devices.

8. The Sample Size for the Training Set

This information is not provided and is not applicable in the context of this device. The LifeSync™ System is a hardware device for signal transmission, not a machine learning model that requires a training set.

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

This information is not provided and is not applicable. See point 8.

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