The provided text is a 510(k) summary for the Visionsense Ltd.'s VSII System, a stereoscopic vision system for general endoscopic and laparoscopic surgical procedures. It primarily focuses on demonstrating substantial equivalence to a predicate device (ELRAN 01 Stereoscopic Laparoscope) rather than detailing performance studies and acceptance criteria for entirely new device claims.

Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, and expert involvement is not present in the provided document. The 510(k) process for substantial equivalence often relies on demonstrating that the new device performs "as safe and effective" as the predicate, rather than establishing entirely new performance benchmarks through extensive studies typically associated with novel or high-risk devices.

Here's what can be extracted and what is missing:

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

Acceptance Criteria (Inferred from Substantial Equivalence)	Reported Device Performance (Inferred)
Same intended use as predicate device	"The VSII System has the same intended use..."
Similar indications to predicate device	"...and similar indications..."
Similar principles of operation to predicate device	"...principles of operation..."
Similar technological characteristics to predicate device	"...and technological characteristics as the ELRAN 01 Stereoscopic Laparoscope."
Minor differences in technological characteristics do not raise new safety/effectiveness questions	"The minor differences in the modified device's technological characteristics do not raise any new questions of safety or effectiveness."
Performance data demonstrates safety and effectiveness comparable to predicate device	"Performance data demonstrates that the VSII System is as safe and effective as the ELRAN 01 Stereoscopic Laparoscope."

Missing: Specific quantitative acceptance criteria (e.g., minimum resolution, field of view, illumination levels, specific accuracy metrics for stereoscopy) and the quantitative results of the VSII System against these criteria. The document states "Performance data demonstrates," but does not provide the specifics of this data or the defined acceptance thresholds.

2. Sample size used for the test set and the data provenance

Missing: The document does not mention any specific "test set" in the context of device performance evaluation, nor does it provide details on sample size or data provenance (country of origin, retrospective/prospective). The assessment appears to be based on a comparison to the predicate device's established performance rather than a new standalone clinical study.

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

Missing: This information is not provided because there is no mention of a "test set" and corresponding ground truth establishment by experts for the VSII system in this summary.

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

Missing: Not applicable, as no test set or expert adjudication is described.

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

Missing: This is not applicable to the VSII System, which is a stereoscopic vision system, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned.

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

The document does not describe a "standalone" algorithmic performance study in the context of AI. The VSII system is a viewing system, not an algorithm. The "performance data" mentioned is likely related to engineering tests and optical characteristics to ensure similar performance to the predicate device.

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

Missing: No "ground truth" in the clinical AI sense is mentioned, as there are no diagnostic claims or classifications being made by the device itself that would require clinical ground truth.

8. The sample size for the training set

Missing: Not applicable, as this is a hardware vision system, not an AI model that undergoes "training."

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

Missing: Not applicable for the same reason as above.

Summary

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Image /page/0/Picture/0 description: The image shows a sequence of alphanumeric characters, specifically "K073279". The characters are written in a bold, sans-serif font, and they appear to be handwritten or stylized. The sequence likely represents a code, serial number, or identifier.

Visionsense Ltd.'s VSII System 510(k) Summary

MAR - 5 201

Name of Device	VSII - Visionsense Stereoscopic Vision System
Common or Usual Name	Laparoscope system
Classification Names	Laparoscopes and accessories (21 C.F.R. § 876.1500)
Product Codes	GCJ
Submitter	Visionsense Ltd.20 Hamagshimim StreetP.O. Box 7149Petach Tikva 49348IsraelPhone: 011-972-3-924-4339Facsimile: 011-972-3-924-4335
Contact Person:	Gerard J. Prud'hommeHogan & Hartson LLP555 13TH Street, NWWashington, DC 20004Phone: (202) 637-5735Facsimile: (202) 637-5910
Date Prepared:	November 20, 2007

Predicate Devices

ELRAN 01 Stereoscopic Laparoscope (K002431), Visionsense Ltd. (previously known as Envision Advanced Medical Systems Ltd.)

Intended Use

The VSn System is intended for viewing internal surgical sites during general endoscopic and laparoscopic surgical procedures.

Substantial Equivalence

The VSn System is a modification to the ELRAN 01 Stereoscopic Laparoscope (K002431). The VSn System has the same intended use and similar indications, principles of operation, and technological characteristics as the ELRAN 01 Stereoscopic Laparoscope. The minor differences in the modified device's technological characteristics do not raise any new questions of safety or effectiveness. Performance data demonstrates that the VSn System is as safe and effective as the ELRAN 01 Stereoscopic Laparoscope. Thus, the VSn System is substantially equivalent to its predicate device.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure with three stylized wing or feather shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Visionsense, Ltd. % Hogan & Hartson, LLP Mr. Gerard J. Prud'homme Columbia Square 555 Thirteenth Street, Northwest Washington, District of Columbia 20004

Re: K073279

Trade/Device Name: VSn - Visionsense Stereoscopic Vision System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: February 29, 2008 Received: February 29, 2008

Dear Mr. Prud'homme:

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.

MAR - 5 2008

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 - Mr. Gerard J. Prud'homme

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Crompliary, at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Presmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Syvenos at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K073279 Device Name: VSII - Visionsense Stereoscopic Vision System Indications For Use: The VS』system is intended for viewing internal surgical sites during general endoscopic and laparoscopic surgical procedures.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil RP. Oulun tw mxn

(Division Sign-Off)

Divisio and Neurological Devines

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510(k) Number K073279

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.