The AutoLap System is indicated for General laparoscopic, Gynecologic and Urologic procedures for the purpose of holding and controlling the movement of a standard laparoscope or rigid endoscope within surgical cavities during minimally invasive laparoscopic surgery.

Device Description

The AutoLap System is designed to hold and control and the movement of a laparoscope or rigid endoscope during laparoscopic procedures. The AutoLap System includes both software and hardware. Hardware components include a Processing Unit, which includes the system's electronics and software algorithms, a Base Unit and a Laparoscopic Unit that include motors and sensors. The Base Unit is mounted on the operating bed. An accessory cart that is used for placing the system's components during the procedure and their storage afterwards is also provided.

To maneuver the laparoscope to the desired position, the surgeon presses a single button, referred to as Command Unit, which is affixed to his/her hand or to the surgical instrument and transmits RF signals to the system. The movement of the laparoscope may be controlled as a simple joystick, enabling movements to up/down, left/right, zoom out directions or be guided by the movement of a designated tool within the field of view, enabling movement in oblique trajectories. Additionally, the system enables the surgeon to manually perform larger movements of the laparoscope using the Manual Activation Button affixed to the AutoLap system.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the AutoLap System, a device designed to hold and control the movement of a laparoscope during minimally invasive surgery. It details performance testing conducted but does not specify acceptance criteria in a quantitative table or the details of a study that directly proves the device meets such criteria for diagnostic accuracy or clinical effectiveness in the way an AI diagnostic device typically would.

However, based on the provided text, here's an attempt to structure the information according to your request, with the understanding that many specific details you asked for (e.g., sample sizes for test sets, number of experts for ground truth, MRMC studies) are not present in this type of FDA document for a device primarily focused on mechanical assistance.

Overview of the Device and Study Purpose:

The AutoLap System is a robotic laparoscope holder and controller. The premarket notification (K152848) is for a modified version of an already cleared device, with the primary changes being an added mode of movement control (guided by a designated tool within the field of view) and the ability to connect a separate monitor for parallel display. The "study" described is a series of performance tests to demonstrate the safety and effectiveness of the modified device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in the format of a table with specific thresholds for sensitivity, specificity, accuracy, or similar metrics typically associated with AI diagnostic devices. Instead, the performance evaluation for this robotic system focuses on safety, functionality, and meeting engineering specifications.

Acceptance Criterion Category	Reported Device Performance (Summary)
Electrical Safety	Device tested in accordance with ANSI/AAMI 60601-1:2005.
Electromagnetic Compatibility (EMC)	Device tested in accordance with IEC 60601-1-2:2007.
Bench Testing - Image Stability	Evaluated and demonstrated acceptable stability.
Bench Testing - Image Processing, System Functionality, and Performance to Move Camera	Evaluated and demonstrated system's ability to move the camera to the requested position using different modes of operation.
Bench Testing - Connection, Receipt, and Display of Video	Evaluated and demonstrated proper connection and display on a separate monitor.
Animal Testing - New Movement Control Mode	Demonstrated the performance of the added mode of movement control.

Overall Conclusion of Performance Testing: "All performance testing demonstrates that the modified AutoLap System performs according to specifications and functions as intended."

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

Test Set Sample Size: Not specified. The document refers to "bench testing" and "animal testing" but does not quantify the number of tests performed or the number of animal subjects.
Data Provenance: The device manufacturer, M.S.T. Medical Surgery Technologies Ltd., is located in Israel. The testing was conducted to evaluate the modified device. It is implied these were prospective tests specifically conducted for this 510(k) submission.

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

This information is not applicable and not provided in the document. The type of device (robotic laparoscope holder) and the nature of the testing (electrical, EMC, bench, animal for functionality) do not typically involve human experts establishing diagnostic "ground truth" for a test set in the way an AI diagnostic algorithm would. The "ground truth" for these tests would be objective measurements and observations of the device's physical and electronic performance against engineering specifications.

4. Adjudication Method for the Test Set

Not applicable and not specified. Adjudication methods like 2+1 or 3+1 are used for human-reviewed data to establish ground truth from multiple readers. This device's testing did not involve such a process.

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

Was it done? No, an MRMC comparative effectiveness study was not performed.
Effect Size of Human Readers Improve with AI vs. Without AI Assistance: Not applicable, as this is a robotic surgical assistant, not an AI diagnostic tool designed to assist human readers in image interpretation. The device assists the surgeon by holding and moving the laparoscope, thereby potentially freeing up a human assistant or improving camera stability, but its performance isn't measured in terms of improving human reader diagnostic accuracy.

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

Was it done? The "bench testing" and "animal testing" represent the closest equivalent to a standalone performance evaluation, as they assess the device's intrinsic mechanical and algorithmic capabilities. The description of these tests ("Image stability," "Image processing, system functionality, and performance to move the camera," "performance of the added mode of movement control") focuses on the device's direct output and function. However, it's not a standalone diagnostic performance study as would be conducted for an AI image analysis tool.

7. Type of Ground Truth Used

The "ground truth" for the tests performed was based on:

Compliance with recognized electrical safety and EMC standards (ANSI/AAMI 60601-1:2005, IEC 60601-1-2:2007).
Engineering specifications for image stability, system functionality, camera movement, and video display connection.
Observed functional performance in an animal model for the new mode of movement control.

This is fundamentally different from ground truth derived from pathology, expert consensus, or outcomes data, which are typical for diagnostic imaging AI.

8. Sample Size for the Training Set

Training Set Sample Size: Not applicable. The AutoLap System is a robotic device with integrated software and hardware. The document describes modifications to an existing device and its performance testing, but it does not refer to a machine learning model that requires a distinct "training set" in the conventional sense of AI development for diagnostic tasks. Its "training" is more akin to traditional software development and calibration processes, which are not quantified in typical dataset terms.

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

Not applicable, as there is no specific "training set" with associated "ground truth" in the context of machine learning model training described for this device. The software algorithms and controls are likely developed and validated through engineering principles and testing against defined operational specifications rather than through supervised learning with labeled data.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human figure in profile, with three overlapping faces suggesting community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the emblem.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

M.S.T. Medical Surgery Technologies Ltd % John Smith, M.D., J.D. Regulatory Counsel Hogan Lovells Us LLP 555 Thirteenth Street NW Washington, District of Columbia 20004

November 17, 2015

Re: K152848

Trade/Device Name: Autolap System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: September 29, 2015 Received: September 29, 2015

Dear Dr. Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

{1}------------------------------------------------

related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. For Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page

510(k) Number (if known)

K152848

Device Name

AutoLap

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

& Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (1/14)

{3}------------------------------------------------

510(k) SUMMARY

MST's AutoLap

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

M.S.T Medical Surgery Technologies Ltd. Kochav Yokneam Building. Floor 5. Yokneam Ilit 2069200, Israel Phone: +972-73-796-5570 Facsimile: +972-73-796-5571 Contact Person: Tami Harel

Date Prepared: November 12, 2015

Name of Device and Name/Address of Sponsor

AutoLap System M.S.T Medical Surgery Technologies Ltd. Kochav Yokneam Building, Floor 5, Yokneam Ilit 2069200, Israel

Common or Usual Name Laparoscope Holder

Classification Name Laparoscope, General and Plastic Surgery

Predicate Devices AutoLap manufactured by M.S.T. Medical Surgery Technologies (K131375)

Purpose of the 510(k) notice

The AutoLap is a modification to the cleared AutoLap device.

Indications for Use Statement

Technological Characteristics

{4}------------------------------------------------

Base Unit is mounted on the operating bed. An accessory cart that is used for placing the system's components during the procedure and their storage afterwards is also provided.

Performance Data

The following testing was repeated to evaluate the modified device:

. Electrical safety was tested in accordance with ANSI/AAMI 60601-1:2005 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
. Electromagnetic Compatibility (EMC) was tested in accordance with IEC 60601-1-2:2007 -Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
. Bench testing was conducted in order to demonstrate that the AutoLap system performs according to its requirements and specifications. Testing evaluated the following:
- o Image stability
- O lmage processing, system functionality, and performance to move the camera to the requested position using different modes of operation"
- Connection, receipt and display of video Connection and display on separate monitor o
. Animal testing demonstrated the performance of the added mode of movement control.

All performance testing demonstrates that the modified AutoLap System performs according to specifications and functions as intended.

Substantial Equivalence

The modified AutoLap system has the same intended use and indications, similar principles of operation, and technological characteristics as the cleared AutoLap system. The modified AutoLap includes an additional mode of operation that can be selected by the surgeon which allows for laparoscope camera movement to be controlled by the movement of a designated tool within the field of view. Additionally, the modified AutoLap includes means for the connection of a separate monitor to allow for a parallel display. The minor differences in the modified AutoLap technological characteristics do not raise any new or different questions of safety or effectiveness. Performance data demonstrates that the modified AutoLap system is as safe and effective as the cleared AutoLap device. Thus, the modified AutoLap system is substantially equivalent to its predicate devices.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.