The SIAscope is a non-invasive skin analysis system, which provides color bitmaps called 'SIAscans' that show the relative location of blood, collagen and pigment.
CAUTION : This device should only be used to scan the patient's skin.

Device Description

The SIAscope is a quick, non-invasive device for imaging skin conditions. It uses a technique known as 'Spectrophotometric Intracutaneous Analysis' (SIAscopy) to identify and display graphically the separate components of the skin. SIAscopy uses a digital camera and light (both visible and near-infrared) to investigate the skin's interior structure.
The SlAscope operates by illuminating the skin with LEDs and measuring the intensity of remitted light. The intensity of the illumination is similar to the emission from a typical hand held torch or remote control unit.

AI/ML Overview

Here's the analysis of the provided text regarding the SIAscope V device, focusing on acceptance criteria and supporting studies:

The provided text is a 510(k) Summary for the SIAscope V, and it primarily focuses on establishing substantial equivalence to a predicate device (SIAscope II). It does not contain information about specific acceptance criteria, a standalone study proving the device meets acceptance criteria, sample sizes for test or training sets, ground truth establishment methods, or Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.

The document states that "Where alterations have been make this have been design to improve the imaging performance, reliability and safety of the device over and above the predicate device." However, no specific performance metrics or studies are provided to substantiate these improvements, nor are there acceptance criteria defined.

Therefore, many of the requested sections will be marked as "Not Available in Document."

Acceptance Criteria and Study Information for SIAscope V

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

Acceptance Criteria (Not explicitly stated for SIAscope V)	Reported Device Performance (Not explicitly stated for SIAscope V)
Not Available in Document	The document states "alterations have been make... to improve the imaging performance, reliability and safety of the device over and above the predicate device." However, no specific quantitative performance metrics are provided to demonstrate this improvement or against which to define acceptance criteria.

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

Sample Size for Test Set: Not Available in Document
Data Provenance: Not Available in Document (The document focuses on device design and comparison, not clinical study data).

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)

Number of Experts: Not Available in Document
Qualifications of Experts: Not Available in Document

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

Adjudication Method: Not Available in Document

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

MRMC Study Done?: No, an MRMC study is not mentioned or described in the document. The SIAscope is described as providing "SIAscans" to show relative location of blood, collagen, and pigment, implying it's an imaging tool for analysis, not an AI-assisted diagnostic tool for human readers in the context usually implied by MRMC studies of AI.
Effect Size of Improvement: Not Applicable / Not Available in Document.

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

Standalone Study Done?: Not Available in Document. The document mentions "software algorithms" for SIAscopy, but it does not describe a standalone performance study. The device provides "color bitmaps" or a "synthesized image" for analysis, suggesting it's an image acquisition and processing system rather than an algorithm producing a diagnostic output without human interpretation.

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

Type of Ground Truth: Not Available in Document. As no study is described to validate the device's diagnostic performance, no ground truth is mentioned. The device's output is "relative location of blood, collagen and pigment," which is an imaging characteristic rather than a definitive diagnosis requiring a ground truth like pathology.

8. The sample size for the training set

Sample Size for Training Set: Not Applicable / Not Available in Document. The document states that the "software algorithms and theory of SIAscopy is the same as found in the predicate device." This suggests the algorithms were developed prior to this submission and are not described as being subject to a new training phase for the SIAscope V.

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

Ground Truth Establishment for Training Set: Not Applicable / Not Available in Document. As noted above, the algorithms are stated to be the same as the predicate, and no training data or ground truth establishment is described for this submission.

Summary

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

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus features a staff with two snakes entwined around it.

Public Health Service

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

March 10, 2017

Astron Clinica Limited c/o Smith Associates Mr. E.J. Smith 1676 Village Green, Suite A Crofton. Maryland 21114

Re: K062736

Trade/Device Name: SIAscope V Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: PSN Dated: June 15, 2007 Received: June 18, 2007

Dear Mr. Smith:

This letter corrects our substantially equivalent letter of September 14, 2007.

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

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

Page 2 - Mr. E. J. Smith

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

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

Indications for Use

510(k) Number (if known): K062736

Device Name: SIAscope V

Indications for Use:

The SIAscope is a non-invasive skin analysis system, which provides color bitmaps called 'SIAscans' that show the relative location of blood, collagen and pigment'.

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sig: Off)	Page 1 of 1
Division of General, Restorative, and Neurological Devices
10(k) Number	L062736

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

62736

SEP 1 4 2007

510(k) Summary

September 6, 2007

Company Name & Address: Astron Clinica Ltd The Mount Toft Cambridge, United Kingdon CB3 7RL

Contact Name:

E.J. Smith 1676 Village Green, Suite A Crofton, MD 21114 Phone: 888-729-9674 Fax: 410-793-0448 Email: ESmith9746@aol.com

Date Summary Prepared:

August 31, 2006

Device Identification:

Classification Name:	Light, Surgical, Floor Standing
Common/Usual Name:	Skin Analysis System
Proprietary Name:	SIAscope
Establishment Registration Number:	3004519907
Regulation Number:	21 CFR 878.4580
Product Code:	FSS
Classification Panel:	General & Plastic Surgery
Device Classification:	Class II

Intended Use

The SIAscope is a non-invasive skin analysis system, which provides color bitmaps called 'SIAscans' that show the relative location of blood, collagen and pigment.

CAUTION : This device should only be used to scan the patient's skin.

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

KO62736

Device Overview

The SlAscope operates by illuminating the skin with LEDs and measuring the intensity of remitted light. The intensity of the illumination is similar to the emission from a typical hand held torch or remote control unit.

Description of SIAscans

Unlike biopsy, SIAscopy provides an array of readings of the skin that are displayed in graphical form creating a synthesized image called a SIAscan.

Predicate Product Comparison

The SIAscope V operates in a very similar fashion to the predicate device. Where alterations have been make this have been design to improve the imaging performance, reliability and safety of the device over and above the predicate device.

Although the design of the user interface has changed, these changes have been made to make the device easier and more intuitive to use for the clinical practitioner. However, the software algorithms and theory of SIAscopy is the same as found in the predicate device.

We assert that the SIAscope V substantially equivalent to the SIAscope II (K023729)

Parameter	SIAscope V	SIAscope II (K023729)
Product Code	FSS	FSS
Intended Use	SIAscope is a non-invasive skinanalysis system, which providescolor bitmaps called 'SIAscans' thatshow the relative location of blood,collagen and pigment.	SIAscope is a non-invasive skinanalysis system, which provides asynthesized 'image' showing therelative location of blood, collagenand pigment.
Illumination For:	Skin	Skin
Illumination:	LED	LED
Imager Chip:	CMOS	CCD

Summary comparison of features and specification SIAscope V vs. SIAscope II

{5}------------------------------------------------

长662736

Power Source:	USB via PC	AC
External Materials:(Caseworks)	Glass, ABS & TPE Plastics	Glass, Aluminium
PC Connection:	USB 2.0	Proprietary Umbilical Cable
Weight:	250grams	1Kg
Calibration Method:	Factory Calibrated	Factory Calibrated
Viewfinder:	Colour (3.2 MegaPixel)	Monochrome (0.7 MegaPixel)
Software:	DERMETRICS™- New User Interface- SIAscopy algorithms unchanged	SIAscope II

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.