The NOMOS Motorized CRANE II is intended to be used as an accessory to powered radiation therapy patient support tables. The NOMOS Motorized CRANE II verifies and describes, via a set of Z and X coordinates, the set-up of the table/patient prior to treatment.

Device Description

The NOMOS Motorized CRANE II is a powered version of the manual NOMOS CRANE II. It is an accessory to radiation therapy patient support tables. Like the NOMOS CRANE II, the Motorized CRANE II attaches to the stationary base Elle the NOWOO OF through a permanently installed interface plate and clamps to the accessory rails of the moveable table top. The Motorized CRANE II can be the acod from the treatment table when its use is not required, leaving only the interface plate remaining on the stationary base of the treatment table. The Motorized CRANE II uses precision ball screw drive positioning mechanisms (one for the Z-axis and one for the X-axis) to position the table top relative to the stationary base of the treatment table. While these positioning mechanisms retain the small hand cranks employed in the predicate CRANE II to allow manual operation when needed, the primary drive force is provided by two electric motors – one for each axis of movement. These motors le provided and operator interface is provided through two touch screen are ooltware oon. One located on the device and one remote panel that can be placed in the treatment control room. The control panels display the position of the patient treatment table, and allow the operator to specify and initiate movement in the Z and X axes. Using the NOMOS CRANE II, the operator can move the treatment table over a range of 300 mm in each axis. When attached to a treatment table loaded to a maximum weight of 300 ounds, the NOMOS Motorized Crane II is capable of +/- 0.1 mm accuracy in the Zaxis, and +/- 0.4 mm accuracy in the X-axis. The Motorized CRANE II retains the battery-powered digital scales from the Crane II as an independent means of position verification.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the NOMOS Motorized CRANE II:

The document provided (K013036) is a 510(k) summary for the NOMOS Motorized CRANE II, which focuses on demonstrating substantial equivalence to a predicate device (NOMOS CRANE II). Crucially, this document does not contain a detailed study report with methods, results, or statistical analysis. Instead, it states the specifications and claims equivalence.

Therefore, I cannot populate all the requested fields with specific study details. I will extract the available information and explicitly state when information is not provided in the document.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated Expectation)	Reported Device Performance (Claimed Performance)
Accuracy in Z-axis: +/- 0.1 mm (when attached to a treatment table loaded to a maximum weight of 300 pounds)	Accuracy in Z-axis: +/- 0.1 mm (The document states the device is capable of this accuracy. It doesn't present data to prove it, but rather claims this as its specification, mirroring the predicate.)
Accuracy in X-axis: +/- 0.4 mm (when attached to a treatment table loaded to a maximum weight of 300 pounds)	Accuracy in X-axis: +/- 0.4 mm (The document states the device is capable of this accuracy. It doesn't present data to prove it, but rather claims this as its specification, mirroring the predicate.)
Range of Movement (Z-axis): 300 mm	Range of Movement (Z-axis): 300 mm
Range of Movement (X-axis): 300 mm	Range of Movement (X-axis): 300 mm
Independent Position Verification: Retains battery-powered digital scales	Independent Position Verification: Retains battery-powered digital scales

Study Details (Based on available information)

Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document states "When attached to a treatment table loaded to a maximum weight of 300 pounds," implying a specific loading condition for testing, but does not detail the number of tests performed or readings taken.
- Data Provenance: Not specified. As this is a 510(k) summary focusing on equivalence, it doesn't describe originating data, but rather claims to meet specifications. It's likely internal engineering testing by NOMOS Corporation. The country of origin would presumable be USA, given the applicant's address.
- Retrospective or Prospective: Not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. This device's performance is objective (positional accuracy), not subjective (like image interpretation). Ground truth would be established by high-precision measurement tools (e.g., laser interferometers, precision calipers, etc.), not human experts.
- Qualifications of Experts: Not applicable.
Adjudication method for the test set:
- Adjudication method: Not applicable. As the ground truth is objective measurement of mechanical precision, human adjudication is not relevant.
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: No. This is a mechanical positioning device, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: The claims regarding +/- 0.1 mm and +/- 0.4 mm accuracy are standalone specifications of the device's mechanical and control system performance. While operators control the movement, the inherent accuracy is a characteristic of the device itself. The document does not describe a formal "standalone study" with methodology, but rather states the device "is capable of" this performance. No algorithm performance is described beyond the basic controls for movement.
The type of ground truth used:
- Type of Ground Truth: Objective mechanical measurement using high-precision metrology tools (e.g., highly accurate encoders, laser measurement systems, etc.) to verify the actual position of the table.
The sample size for the training set:
- Sample Size: Not applicable. This device utilizes electric motors and software controls for mechanical movement, not a machine learning or AI algorithm that requires a "training set" in the typical sense. The software would be developed and tested through traditional software engineering verification and validation (V&V) processes.
How the ground truth for the training set was established:
- How Ground Truth Established: Not applicable, as there is no "training set" in the AI/ML sense. The "ground truth" for the device's control system development would be the desired mechanical behavior and accuracy specifications, which are translated into software requirements and tested against using established engineering principles.

Summary

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DEC 0 7 2001

Image /page/0/Picture/1 description: The image shows the word "NOMOS" in bold, black letters. Above the word is a graphic of a person standing on a pyramid-like structure with a grid pattern. Above the graphic is the number "K013036" written in black ink.

Section 2 - 510(k) Summary

Summary of Safety and Effectiveness NOMOS Motorized CRANE® II

Pursuant to Section 513(i) of the Federal Food, Drug, and Cosmetic Act

A. General Information:

Medical charged-particle radiation therapy system Classification Name: accessory (Sec. 892.5050)

Caliper Common/Usual Name:

Trade/Proprietary Name: NOMOS Motorized CRANE® II

Applicant's Name and Address: Francis X. Dobscha Director of Quality

NOMOS Corporation 2591 Wexford Bayne Road Sewickley, PA 15143

724-934-8242 Phone: 724-934-5488 FAX:

NOMOS CRANE II (K991966) B. Name of predicate device:

Class II C. Classification:
D. Performance Standards: None established
E. Intended Use and Device Description:

Intended Use:

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Device Description:

The NOMOS Motorized CRANE II is a powered version of the manual NOMOS CRANE II. It is an accessory to radiation therapy patient support tables.

Like the NOMOS CRANE II, the Motorized CRANE II attaches to the stationary base Elle the NOWOO OF through a permanently installed interface plate and clamps to the accessory rails of the moveable table top. The Motorized CRANE II can be the acod from the treatment table when its use is not required, leaving only the interface plate remaining on the stationary base of the treatment table.

The Motorized CRANE II uses precision ball screw drive positioning mechanisms (one for the Z-axis and one for the X-axis) to position the table top relative to the stationary base of the treatment table.

While these positioning mechanisms retain the small hand cranks employed in the predicate CRANE II to allow manual operation when needed, the primary drive force is provided by two electric motors – one for each axis of movement. These motors le provided and operator interface is provided through two touch screen are ooltware oon. One located on the device and one remote panel that can be placed in the treatment control room.

The control panels display the position of the patient treatment table, and allow the operator to specify and initiate movement in the Z and X axes. Using the NOMOS CRANE II, the operator can move the treatment table over a range of 300 mm in each axis. When attached to a treatment table loaded to a maximum weight of 300 ounds, the NOMOS Motorized Crane II is capable of +/- 0.1 mm accuracy in the Zaxis, and +/- 0.4 mm accuracy in the X-axis.

The Motorized CRANE II retains the battery-powered digital scales from the Crane II as an independent means of position verification.

F. Summary of Substantial Equivalence

Indications:

The indications for the NOMOS Motorized CRANE II are the same as for the predicate device, the NOMOS CRANE II; that is, to verify and describe the set-up of the table/patient position prior to treatment.

Design:

The design of the NOMOS Motorized CRANE II is equivalent to the NOMOS CRANE II, with the addition of electric drive motors, operator interface displays, and software controls.

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Materials:

The materials used in the NOMOS Motorized CRANE II are equivalent to those used in the predicate NOMOS CRANE II.

Manufacturing:

The manufacturing processes used in the production of the NOMOS Motorized CRANE II are equivalent to those used in the manufacture of the predicate NOMOS CRANE II and are performed at the same facility.

Specifications:

The operating specifications of the NOMOS Motorized CRANE II are equivalent to the predicate NOMOS CRANE II, particularly with respect to range of movement and accuracy.

Conclusions:

The addition of electric motors and software controls to the design do not raise any new issues relating to safety and effectiveness. NOMOS thus considers the now loads follang to SNE II to be substantially equivalent to the predicate device the NOMOS CRANE II.

Note:

Any statement made in conjunction with this submission regarding substantial equivalence to any other product only relates to whether the product can be legally marketed according to FDA regulations and is not relevant 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 lawfully be marketed without premarket approval or reclassification. This determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits." 42 Fed. Reg. (1977).

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three wing-like shapes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 7 2001

Mr. Francis X. Dobscha Director of Quality NOMOS Corporation 2591 Wexford Bayne Road SEWICKLEY PA 15143

Re: K013036

Trade/Device Name: NOMOS Motorized Crane II Regulation Number: 21 CFR 892.5770 Regulation Name: Powered radiation therapy patient support assembly Regulatory Class: II

Product Code: 90 JAI Dated: August 21, 2001 Received: September 10, 2001

Dear Mr. Dobscha:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 3 ro(x) premained is substantially equivalent (for the indications ferenced above and nave decemined the asketed predicate devices marketed in interstate for use stated in the enclosure) to regally manced produced Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Medical Device American Ford, B commerce prior to May 20, 1970, the classified in accordance with the provisions of the Federal Food, Drug, devices that have been reclassince in acceraanse val of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval ap and Cosmelle Act (Act) that do not require approvide controls provisions of the Act. The You may, merelore, market the device, belyer to more
general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the fict labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (Scc above) into entine regulations affecting your device can be it may be subject to additional controls. Extrums ---------------------------------------------------------------------------------------------------------------------------found in the Code of I cacial resguinering your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issualled of a backed in the requirements of the Act that I DA has made a dolorimiation administered by other Federal agencies. You must of any Federal Statures and regulations and limited to: registration and listing comply with an the Act 3 requirements, meading of the manufacturing practice requirements as set (21 CFR Part 807), laoching (21 CFR Part 820); and if applicable, the electronic forth in the quality 3) stems (QD) rog.ssm.
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 510(k) premarket I his lotton will and in you diostantial equivalence of your device to a legally marketed nontheation. The I Dr I include of section 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 If you desire specific at one of the following numbers, based on the regulation number at the top of this 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 Other or Somphares to premarket notification" (21 CFR Part 807.97). Other general information on by releases to promised the Act may be obtained from the Division of Small Manufacturers, Jour responsible in the manner 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. Snogdin

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

Enclosure

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Page 1 of 1

Not Assigned 510(k) Number:

K013036

NOMOS® Motorized CRANE II Device Name:

Indications for Use:

The NOMOS Motorized CRANE II is intended to be used as an accessory to powered The NOWOS Motorized OrdNet in to Interiables. The NOMOS Motorized CRANE II verifies and Tadiation therapy patient Support tables: The set-up of the table/patient prior to treatment.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. de Yuson

(Division Sign, Off) Division of Reproductive, Abdominal and Radiningical Dev 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

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.