The VivaScope® System is intended to acquire, store, retrieve, display and transfer in vivo images of tissue, including blood, collagen and pigment, in exposed unstained epithelium and the supporting stroma for review by physicians to assist in forming a clinical judgment.

Device Description

The VivaScope System is a reflectance confocal microscope, full color macroscopic imager, and software that captures images of in vivo tissue specimens from the exposed surface of the tissue, through the unstained epithelium and into the superficial supporting stroma. It provides non-invasive in vivo images of the epithelium and supporting stroma. The VivaScope® System does NOT provide automated analysis or diagnosis of the images it produces. It is capable of imaging cells in the epidermis of skin and the fibrous tissue (primarily collagen and fibrin) in the dermis. In addition, it is possible to visualize circulation of blood cells (including both erythrocytes and leukocytes) in capillaries and other small vessels.

The VivaScope System produces horizontal sections of the skin using safe, low power infrared laser light at nominal wavelength of 830 nm (CDRH laser Class I). Horizontal sections make it straightforward to view the various layers of the skin in sequence, from the outer surface of the stratum comeum, through the granular, spinous and basal layers, to the level of the superficial reticular dermis.

The VivaScope® System produces high resolution images of the skin using confocal laser scanning microscopy. The key feature of confocal microscopy is the ability to produce in-focus images of thick specimens called "optical sectioning". The system is able to accomplish this by having the point source laser light, the illuminated spot in the sample, and the pinhole all lie in optically conjugate [ocal planes. The size of the pinhole (located in front of the photodiode) is matched to the size of the illuminated spot to reject out of focus light allowing for imaging of thin optical sections.

The VivaScope® System can image, display, store, retrieve, import and export in vivo confocal
and macroscopic color images using the VivaScan operating software and supportin hardware. Images are saved and stored using standard lossless image compression algorithms. Images are communicated to other devices using DICOM standard functionality that is incorporated into the VivaScan® operating software.

The VivaScope® System is comprised of four (4) major functional components: an imager, a display, a PC and a cart. A VivaScope® System will have either a VivaScope® arm mounted imaging head or a VivaScope® handheld imaging head, or both, and optionally, a VivaCam® full color macroscopic imaging head.

AI/ML Overview

The provided document is a 510(k) summary for the VivaScope® System, which is a medical device intended to acquire, store, retrieve, display, and transfer in vivo images of tissue for review by physicians.

Based on the document, here's how the requested information can be extracted or inferred:

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

The document does not explicitly state "acceptance criteria" and "reported device performance" in a quantitative manner as one might expect for a typical performance study of a new medical device. Instead, the 510(k) summary focuses on demonstrating substantial equivalence to predicate devices. The "performance" is primarily described in terms of its functional capabilities and similarities to the predicates.

Acceptance Criteria (Implied for Substantial Equivalence to Predicates)	Reported Device Performance (as described in 510(k) submission)
Intended Use: Acquire, store, retrieve, display, and transfer in vivo images of tissue for physician review to assist in clinical judgment.	The VivaScope® System has the same intended use as its predicates: to acquire, store, retrieve, display and transfer in vivo images of tissue, including blood, collagen and pigment, in exposed unstained epithelium and the supporting stroma for review by physicians to assist in forming a clinical judgment.
Imaging Capability: Provide in vivo images of skin components (e.g., pigment, blood, collagen) for diagnostic review.	Capable of imaging cells in the epidermis and fibrous tissue in the dermis. Possible to visualize circulation of blood cells in capillaries. Produces high-resolution images of the skin using confocal laser scanning microscopy. Produces horizontal sections of skin.
Technological Characteristics: Similar major functional components and operating principles as predicates.	Major functional components: imager, display, PC, cart. Uses the same operating principle: reflected light. Capable of acquiring, storing, displaying, and transmitting images.
Safety: Safe light source and compliance with safety standards.	Uses a safe, low-power infrared laser light (830 nm, CDRH laser Class I). Energy output is within the range of its predicates and complies with FDA's safety requirements. Conforms to FDA and internationally recognized safety standards.
Image Handling: Ability to save, store, communicate images using standard formats.	Images are saved and stored using standard lossless image compression algorithms. Images are communicated using DICOM standard functionality.
Automated Analysis/Diagnosis: Not intended to provide automated analysis.	Does NOT provide automated analysis or diagnosis of the images it produces.

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 report any sample size for a test set or provide details on data provenance (country of origin, retrospective/prospective). This 510(k) summary focuses on demonstrating substantial equivalence based on technological characteristics and intended use, rather than a clinical performance study with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Since no clinical performance study with a test set is described, there is no information regarding experts used to establish ground truth or their qualifications.

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

As no clinical performance study is described, there is no information on an adjudication method for a test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The VivaScope® System is described as not providing automated analysis or diagnosis, indicating that it is not an AI-assisted device in that sense, but rather an imaging tool for physician review. Therefore, there is no information on the effect size of human reader improvement with/without AI assistance.

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

The document explicitly states: "The VivaScope® System does NOT provide automated analysis or diagnosis of the images it produces." This indicates that a standalone algorithm performance study was not conducted because the device is not an AI-based diagnostic tool. Its function is to acquire and display images for human review.

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

Since no clinical performance study or test set with specific ground truth evaluation is described, this information is not available in the document.

8. The sample size for the training set

The document does not mention a training set. This is consistent with the device not being an AI-based diagnostic algorithm requiring training data.

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

Since there is no mention of a training set, this information is not applicable and not provided.

Summary of focus from the document:

This 510(k) submission primarily focuses on demonstrating substantial equivalence of the VivaScope® System by:

Comparing its intended use to legally marketed predicate devices.
Detailing its technological characteristics (e.g., imaging capabilities, components, operating principle, image handling) and highlighting similarities and differences with predicates.
Addressing safety aspects, particularly regarding the laser light source, and ensuring compliance with standards.

The document is a regulatory filing for an imaging device, not an AI/CADe/CADx device, and therefore does not include the typical performance study details (test sets, ground truth, expert readers, AI metrics) often found for such technologies.

Summary

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

March 10, 2017

Lucid, Inc. c/o Mr. James Joy Quality Assurance and Regulatory Manager 2320 Brighton Henrietta Town Line Road Rochester, New York 14623

Re: K080788

Trade/Device Name: VivaScope® System Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: PSN Dated: September 5, 2008 Received: September 8, 2008

Dear Mr. Joy:

This letter corrects our substantially equivalent letter of September 17, 2008.

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

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Page 2 - Mr. James Joy

device-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" (21CFR 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,

Jennifer R. Stevenson -S

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

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name:

VivaScope® System

Indications for Use:

Prescription Use J X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ision Sign-Off) Division of General, Restorative, and Neurological Devices

Page 1 of 1

510(k) Number K080677

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SEP 1 7 2008

K080788

510(k) Summary

Submiller: Lucid, Inc. 2320 Brighton Henrictta Town Line Road Rochester, New York 14623 Telephone (585) 239-9800 Fax (585) 239-9806

Contact: James Joy Quality Assurance Manager Telephone (585) 239-9800 Fax (585) 239-9806
Date Prepared: March 17, 2008
VivaScope® System Proprietary Name:
Common Name: In vivo confocal reflectance microscope

Classification Name: Light, Surgical, Floor Standing (21 CFR 878.4580, Product Code FSS)

510(k) Numbers and Product Codes of Equivalent Devices

MicroDERM® 510(k) Number: K()40)171 Product Code: FSS CFR Section: 878.4580 Visiomed AG, Ft. Lauderdale, FL

SiaScope II 510(k) Number: K023729 Product Code: FSS CFR Section: 878.4580 Astron Clinica, Ltd., Crofton, MD

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Intended Usc

Device Description

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Conclusion

The VivaScope System has the same intended use as its predicates and similar indication. All of the devices provide in vivo images of the skin for physician diagnostic review and referral purposes, and are capable of imaging the skin's components, including pigment, blood and/or collagen.

Additionally, the VivaScope® System's technological characteristics are very similar to the predicates, except for the light source. The VivaScope System has the same major functional components as the predicates, i.e., imager, display, computer and cart, and uses the same operating principle, i.e., reflected light, to capture images of the skin. It also has the same technological capabilities in that it is capable of acquiring, storing, displaying and transmitting images.

The main difference in technology relates to the light source: the VivaScope® System uses laser as its light source and the predicate devices use LEDs. This difference, however, does not raise new types of safety or effectiveness questions, because the laser allows the VivaScope® System, like its predicates, to produce detailed images of the skin and its cnergy output is within the range of its predicates and complies with the FDA's safety requirements. Further, the VivaScope® System conforms to the same FDA and internationally recognized safety standards as the predicates.

For the forgoing reasons, the VivaScope® System is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 878.4580 Surgical lamp.

(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.