SILHOUETTE, MODEL 1000.01 by ARANZ MEDICAL LIMITED

The provided text describes the Silhouette Wound Measurement and Documentation System (K070426) and its 510(k) summary, but it does not contain the specific acceptance criteria or the study details to prove the device meets those criteria.

The document primarily focuses on:

Device identification and classification.
Comparison to predicate devices.
Indications for use.
FDA's substantial equivalence determination.

Therefore, many of the requested details cannot be extracted from this text.

Here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Cannot be extracted. The document mentions that "Standard wound measurements made with Silhouette are more accurate than those made with the predicate devices," but it does not specify what "more accurate" quantitatively means, nor does it list specific acceptance criteria (e.g., minimum accuracy, precision, or other performance metrics) or precise reported device performance values.

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

Cannot be extracted. The document does not provide details about any specific test set, its sample size, or the provenance of the data used for performance claims.

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

Cannot be extracted. The document makes no mention of expert involvement in establishing ground truth for any test or validation.

4. Adjudication Method:

Cannot be extracted. No information is provided regarding adjudication methods.

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

Cannot be extracted. There is no mention of an MRMC study or quantitative effect sizes for human readers with/without AI assistance. The device is a "Wound measurement and documentation system" that includes a camera and PDA, implying that it assists human measurement rather than being a standalone AI system in the modern sense.

6. Standalone Performance Study:

Cannot be extracted. While the system itself could be considered "standalone" in its function of acquiring images and measuring wounds, the document does not describe a formal standalone performance study with specific metrics, particularly in the context of an AI algorithm as implied by the question. Its comparison to predicate devices is noted, but not in the format of a standalone study against defined criteria.

7. Type of Ground Truth Used:

Cannot be extracted. The document does not specify how "ground truth" for wound measurements was established or what type it was (e.g., manual caliper measurements, pathology, etc.).

8. Sample Size for the Training Set:

Cannot be extracted. There is no mention of a "training set" as this device predates the widespread use of machine learning that requires such sets, or at least the explicit reporting of them in 510(k) summaries. The device performs measurement and documentation based on image capture, not an AI model trained on a large dataset.

9. How Ground Truth for the Training Set was Established:

Cannot be extracted. Similar to point 8, no training set is described.

Summary

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	K070426
	510(k) Premarket Notification		QF-00
	Silhouette		2007-00001
aranzapplied research associates ltd	510(k) Summary of Safety and	Rev: 1.0	Approved

510(k) Summary of Safety and Effectiveness

: •

Submitter:	ARANZ Medical Limited	JUN 29 2007
Address:	Ground Floor, St Elmo Courts47 Hereford Street, PO Box 3894Christchurch 8013
Phone:	+64 3 3746120 ext 217
Fax:	+64 3 3746130
Contact:	Shane Goodwin
Trade name:	Silhouette
Common name:	Wound measurement and documentation system
Classification name:	Surgical camera and accessories (21 CFR 878.4160)
Class:	Class I (general controls)
Predicate Devices:	Verge Videometer (Verg Incorportated)Visitrak (Smith & Nephew)
Device Description:	Silhouette consists of a camera connected to a PDA, for themeasurement and tracking of wounds
Indications for Use:	Silhouette is indicated for wound measurement and documentationand can be used on all external wound types.
Intended Use:	The intended use of the Silhouette system is to measure anddocument the progression of external wounds over time. TheSilhouette system is comprised of a camera (SilhouetteCamera)connected to a PDA running a software application(SilhouetteMobile Software) to capture and document images takenby the user. A software accessory (SilhouetteServer) on a PC maybe used to transfer images and documentation to a third-partypatient information database. The system is non-contact withrespect to the patient.
Comparison to Predicates:	Silhouette is substantially equivalent the predicate devices,considered in light of the comparison of the indications for use, theintended use, the workflow of the devices and the technologicalprinciples being applied. Standard wound measurements made withSilhouette are more accurate than those made with the predicatedevices. These differences do not raise questions safety andeffectiveness over the predicate devices.
Date of Summary:	17 January 2007

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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 stylized caduceus symbol, which is a staff with two snakes entwined around it, and three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 9 2007

Aranz Medical Limited % Shane Goodwin Regulatory Scientist St. Elmo Courts Ground Floor 47 Hereford Street P.O. Box 3894 Christchurch, New Zealand

Re: K070426

Trade/Device Name: Silhouette Wound Measurement and Documentation System Regulation Number: 21 CFR 878.4160 Regulation Name: Surgical camera and accessories Regulatory Class: I Product Code: FXN Dated: June 18, 2007 Received: June 20, 2007

Dear Shane Goodwin:

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.

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

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Page 2 - Shane Goodwin

CFR Part 807); labeling (21 CFR Part 801); 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,

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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 vours

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): K070426

Device Name: Silhouette Wound Measurement and Documentation System

Indications For Use:

Silhouette is indicated for wound measurement and documentation and can be used on all external wound types.

Prescription Use(Part 21 CFR 801 Subpart D)	✓	AND/OR	Over-The-Counter Use(21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative,

and Neurological Devices

510(k) Number	467424
Page	1 of 1

Regulation Number and Section

§ 878.4160 Surgical camera and accessories.

(a)
Identification. A surgical camera and accessories is a device intended to be used to record operative procedures.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.