External beam radiation therapy is typically delivered from a linear accelerator with either photon or electron beams, or from a radioactive source (high and low dose rate variants) to patients in the prone or supine position, lying on a patient support assembly (also known as the treatment couch). AKTINA Medical Physics Corporation has designed and manufactured a replacement table top of carbon fiber that is compatible with the Elekta Precise Patient Support System. A treatment couch top that is made of carbon fiber provides the structural strength necessary to support a broad range of patients while being light weight. In addition carbon fiber is radiolucent which allows a wide range of beam angle orientations to be used in external beam radiation therapy.

Device Description

AKTINA Medical Phvsics Corporation has designed and manufactured a replacement table top of Carbon Fiber that is compatible with the Elekta Precise Patient Support System. A treatment couch top that is made of carbon fiber is provides the structural strength necessary to support a broad range of patients while being light weight. In addition carbon fiber is radiolucent which allows a wide range of beam angle orientations to be used in external beam radiation therapy.

AI/ML Overview

The provided document (K032248) is a 510(k) premarket notification for a medical device: "Precise Carbon Fiber Table Top". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive new clinical studies to prove effectiveness with specific performance metrics against acceptance criteria.

Therefore, much of the requested information regarding acceptance criteria, specific study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness (MRMC or standalone AI performance) is not applicable to this type of regulatory submission. The document explicitly states that "The FDA under Section 514 of the Food, Drug and Cosmetic Act has not established performance standards for this product," which further indicates that specific, predefined acceptance criteria and a detailed study proving performance against them are not required or provided in this context.

The summary emphasizes substantial equivalence to predicate devices (Elekta AB, K983678 and AKTINA Medical Physics Corporation, K991546), focusing on similar design, intended use, and performance characteristics, and asserting that "No new issues of safety or effectiveness are introduced by using this device." The demonstration of safety and effectiveness for such a device would primarily revolve around material properties (biocompatibility, structural integrity, radiolucency) and compatibility with existing patient support systems, rather than diagnostic accuracy or human performance improvement.

Given these limitations, here's a breakdown of what can be extracted and what is not available from the provided text:

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

Acceptance Criteria	Reported Device Performance
Biocompatibility	Shown to be biocompatible for its intended use based on FDA Blue Book Memorandum G95-1 (ISO 10993-1) and an evaluation of product testing and field experience for equivalent applications.
Structural Strength	Provides the structural strength necessary to support a broad range of patients (stated as a feature of carbon fiber, implied to be met by the device).
Light Weight	Is light weight (stated as a feature of carbon fiber, implied to be met by the device).
Radiolucency	Is radiolucent, allowing a wide range of beam angle orientations (stated as a feature of carbon fiber, implied to be met by the device).
Compatibility	Compatible with the Elekta Precise Patient Support System.
Safety and Effectiveness	Similar in design, intended use, and performance characteristics to predicate devices. No new issues of safety or effectiveness are introduced.

Note: The document does not provide specific quantitative acceptance criteria (e.g., maximum deflection under load, specific radiolucency percentages) or quantitative performance data, but rather states qualitative claims of compliance and equivalence.

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

Not applicable / Not provided. This type of device (a patient support table top) does not typically involve a "test set" or "training set" in the context of diagnostic or AI performance evaluation. The "evaluation of product testing" mentioned for biocompatibility and "field experience for equivalent applications" would likely refer to engineering tests and general clinical usage knowledge for similar devices, not a formal study with a defined patient sample size.

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)

Not applicable / Not provided. Ground truth establishment by experts is relevant for diagnostic devices (e.g., image analysis algorithms). This device is a component of a radiation therapy system, and its evaluation would not involve expert ground truthing in that manner.

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

Not applicable / Not provided. See point 3.

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

Not applicable / Not done. MRMC studies are used for evaluating diagnostic performance, often related to AI applications. This device is not an AI-driven diagnostic tool.

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

Not applicable / Not done. See point 5.

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

Not applicable / Not provided. The "ground truth" for this device would be established through engineering specifications, material science evaluations, and compatibility testing with the Elekta Precise Patient Support System, rather than clinical ground truth methods like pathology or outcomes data.

8. The sample size for the training set

Not applicable / Not provided. See point 2.

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

Not applicable / Not provided. See point 2 and 7.

Summary

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SEP 2 5 2003

Ko32248

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

June 30, 2003

1. General Provisions

Trade Name: Precise Carbon Fiber Table Top Common Name: Patient Support Assembly

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

Elekta AB, K983678 and AKTINA Medical Physics Corporation, K991546 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 this product.

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5. Intended Use and Device Description

6. Biocompatibility

The Aktina Medical Corporation Precise Carbon Fiber Table Top has been shown to be biocompatible for its intended use based on the requirements of the FDA Blue Book Memorandum G95-1 (ISO 10993-1) and an evaluation of product testing and field experience for equivalent applications.

7. Summary of Substantial Equivalence

This device is similar in design and intended use and performance characteristics to the predicate device. 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 a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized graphic of an eagle or other bird with three curved lines extending from its head, resembling feathers or wings. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 5 2003

Mr. Tony Spaccarotella Direstor, QA/RA AKTINA Medical Corporation 360 North Route 9W CONGERS NY 10920

Re: K032248

Trade/Device Name: Precise Carbon Fiber Table Top Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system

Regulatory Class: II Product Code: 90 IYE Dated: July 18, 2003 Received: July 25, 2003

Dear Mr. Spaccarotella:

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. Iisting 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 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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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 one of the following numbers, based on the regulation number at the top of the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Page 2

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Indications for Use

510(k) Number: K032298

Device Name: Precise Carbon Fiber Table Top

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: V

Over-The Counter Use:

(Per 21 CFR 801.109)

David R. Lyman

(Division Sign-Of Division of Reprodi and Radiological D 510(k) Numbe

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.