Tennis Racquet inserts are intended for use in Radiation Therapy to facilitate treatment of the patient when laying prone or supine on the treatment couch. Tennis Racquets provide a beam path that is considered attenuation free while supplying firm support for the patient.

Device Description

The AKTINA Medical Physics Corporation Tennis Racquet Insert is intended for use in Radiation Therapy as an aid in suporting the patient during external beam irradiation.

AI/ML Overview

This appears to be a 510(k) submission for a non-diagnostic device (a 'Tennis Racquet Insert' for radiation therapy patient support), not a diagnostic AI device. Therefore, the provided documents do not contain the information required to answer the questions about acceptance criteria, study details, ground truth, or AI performance that are typically associated with diagnostic AI systems.

The submission focuses on establishing substantial equivalence to a predicate device, which is a different regulatory pathway than demonstrating performance of a diagnostic algorithm.

Here's a breakdown of why this information is missing:

Acceptance Criteria/Reported Performance: These are typically for diagnostic accuracy (sensitivity, specificity, AUC) or other quantifiable performance metrics. This device doesn't have such metrics. Its "performance" is about supporting a patient without introducing new safety/effectiveness issues compared to similar devices.
Sample Size (Test Set), Data Provenance, Number of Experts, Adjudication, MRMC, Standalone Performance, Type of Ground Truth, Training Set Size, Training Set Ground Truth: All these points relate specifically to studies designed to evaluate the accuracy and reliability of a diagnostic algorithm, often against a human gold standard or pathology. This device is a physical support apparatus, not a diagnostic tool, so these types of studies were not applicable or performed.

What the document does state regarding "performance":

Performance Standards: "The FDA under Section 514 of the Food, Drug and Cosmetic Act has not established performance standards for Tennis Racquet Inserts." This indicates there are no specific, pre-defined quantitative performance metrics for this type of device from the FDA.
Summary of Substantial Equivalence: "This device is similar in design and construction, and identical in materials, intended use and performance characteristics to the predicate devices. No new issues of safety or effectiveness are introduced by using this device." This is the core "performance" claim – that it performs identically to existing, legally marketed devices.

In summary, because this device is a physical medical device for patient support during radiation therapy, and not an AI-powered diagnostic tool, the typical criteria and study design questions you've asked are not applicable to the provided documentation.

Summary

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K993522
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Summary of Safety and Effectiveness Compliance with 513 (i) of the Federal Food, Drug and Cosmetic Act

October 1, 1999

1. General Provisions

Trade Name: Tennis Racquet Insert Tennis Racquet Insert Common Name:

Applicant Name and Address:

AKTINA Medical Physics Corporation 360 North Route 9 W Congers, New York, 10920 Phone: 914-268-0101 FAX: 914-268-1700 Registration Number: 2436865

2. Name of Predicate Devices

Siemens ZXT Therapy Treatment Table (K910971) 1

Any statement made in conjunction with this submission regarding substantial equivalence to any other product only relates to whether the product can be lawfully marketed without pre-market approval or reclassification and is not to be interpreted as an admission or used as evidence in patent infringement litigation. As the Commissioner of the FDA has indicated, "... a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act relates to the fact that the product can be lawfully marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits." 42 Fed. Reg. 42,520 et seg. (1977).

3. Classification

This device is classified as a class II device according to 21 CFR 892.5770.

4. Performance Standards

The FDA under Section 514 of the Food, Drug and Cosmetic Act has not established performance standards for Tennis Racquet Inserts.

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5. Intended Use and Device Description

The AKTINA Medical Physics Corporation Tennis Racquet Insert is intended for use in Radiation Therapy as an aid in suporting the patient during external beam irradiation.

6. Biocompatibility

The Tennis Racquet is not in contact with the patient at any time when in use as a sheet is to be placed between the patient's skin surface and the treatment support when in use. Additionally there are no new materials introduced in the manufacture of this device, therefore, no biocompatibility studies were undertaken for the device.

7. Summary of Substantial Equivalence

This device is similar in design and construction, and identical in materials, intended use and performance characteristics to the predicate devices. No new issues of safety or effectiveness are introduced by using this device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 0 2000

Aktina Medical Physics Corporation

Re:

K993522 Tennis Racquet Insert Dated: October 14, 1999 Received: October 18, 1999 Regulatory class: II 21 CFR 892.5770/Procode: 90 JAI

Dear Ms. Zacharopoulos:

Joan Zacharopoulos

360 North Route 9W

Congers, NY 10920

Vice President

We have reviewed vour Section 510(k) 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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number:

93522

Device Name: Tennis Racquet Insert

Indications for Use:

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT
Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) Number	K993522
Prescription Use:(Per 21 CFR 801.109)	or	Over-The Counter Use:

Regulation Number and Section

§ 892.5770 Powered radiation therapy patient support assembly.

(a)
Identification. A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy.(b)
Classification. Class II.