HANSON MEDICAL CALF IMPLANT by HANSON MEDICAL, INC.

The Hanson Medical Calf Implant (Silicone Carving Block) is for augmentation and reconstructive surgery. The Hanson Calf Implant will be carvable, allowing the physician to customize the device shape for muscular defects.

Device Description

Hanson Medical Calf Implants are intended for augmentation, or as reconstruction to minimize muscular defects. The Hanson Calf Implant is carvable, allowing the physician to adapt the device shape to individual patient contours. They are manufactured using heat cured, medical grade, two part. liquid silicone system (LSR), silicones that meet FDA requirements for replacement of Dow's discontinued medical grade silicone analogues.

Hanson Calf Implants will be offered non-sterile. The implants will be packaged in autoclavable peel pouches labeled with a detachable traceability tab for patient record files. Autoclave sterilization details are provided in the package insert. The implants are finally boxed with package insert materials and labeled for shelving and shipping traceability.

AI/ML Overview

The provided text is related to a 510(k) submission for the Hanson Medical Calf Implant. This document is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study with detailed acceptance criteria and clinical efficacy data typically found for diagnostic AI devices.

Therefore, the information requested in your prompt (especially regarding acceptance criteria tables, sample sizes for test/training sets, expert ground truth, MRMC studies, and standalone performance) is not present in the provided document. The document describes the device, its intended use, and its substantial equivalence to previously marketed devices, but does not detail a study proving its performance against specific acceptance criteria in the manner you've outlined for an AI-enabled device.

To directly answer your specific points based on the provided text:

A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on substantial equivalence based on materials, manufacturing methods, and dimensions compared to predicate devices.
Sample size used for the test set and the data provenance: Not applicable. No "test set" in the context of an AI performance study is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is mentioned.
Adjudication method for the test set: Not applicable. No test set requiring adjudication is mentioned.
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: Not applicable. This is not an AI-enabled device, and no MRMC study is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI-enabled device and no algorithm performance is mentioned.
The type of ground truth used: Not applicable. The "ground truth" here is the established safety and efficacy of the predicate devices.
The sample size for the training set: Not applicable. No training set for an AI model is mentioned.
How the ground truth for the training set was established: Not applicable. No training set for an AI model is mentioned.

Summary based on the document:

The Hanson Medical Calf Implant is presented as substantially equivalent to existing predicate devices (Hanson Medical Silicone Carving Block, AART, Inc and Silimed LLC Calf Implants). The basis for this equivalence is that it employs "the same materials, methods of manufacture, and are identical in dimension and very similar in others." The intended use is for augmentation or reconstruction to minimize muscular defects, and the device is carvable for customization. The regulatory review acknowledges the substantial equivalence to these predicate devices for the specified indications for use.

Summary

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KO30808

APR 2 1 2003

ATTACHMENT 7

510k SUMMARY STATEMENT

March 5, 2003

Applicant:

Hanson Medical, Inc. PO Box 1160, Kingston, Washington, 98346 Tel: 800.771-2215) Fax: 360.297-1998

Contact Representative:

John Harrison Medical Devices Associates. International Tel/Fax: 805.961-9334) Email: joli@west.net

Proprietary Name: Common Name: Classification Name: Hanson Medical Calf Implant Silicone Carving Block Elastomer, Silicone Block

Hanson Calf Implants are substantially equivalent to itself (Hanson Medical Silicone Carving Block), and to the Calf Implants made by AART, Inc and Silimed LLC. Hanson Calf Implants employ the same materials, methods of manufacture, and are identical in dimension and very similar in others, to these predicate devices.

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three wavy lines, which are meant to represent a human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 1 2003

Hanson Medical, Inc. c/o John Harrison, Ph.D. Medical Devices Associates, International 5662 Calle Real, #331 Goleta, California 93117

Re: K030808 Trade Name: Hanson Medical Calf Implant Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, Nose, and Throat Synthetic Polymer Material Regulatory Class: II Product Code: MIB Dated: March 5, 2003 Received: March 13, 2003

Dear Dr. Harrison:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 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.

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Page 2 - John Harrison, Ph.D.

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 (301) 594-4659- 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K030808
Page 1 of 1

K030808 510K NUMBER:

Hanson Medical Calf Implant DEVICE NAME:

INDICATIONS FOR USE:

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Over-The-Counter-Use (Optional Format)

Miriam C. Provost

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

510(k) Number K030806

Regulation Number and Section

§ 874.3620 Ear, nose, and throat synthetic polymer material.

(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.