ClearVue, a breast radiation therapy patient support, is an accessory for medical linear accelerator radiation therapy systems. ClearVue is intended to be used to position and reposition patients for breast radiation therapy. ClearVue may be used with CT and MR scanners to acquire images for radiation therapy planning.

Device Description

ClearVue is a prone-breast table top attachment, which allows for multi-angle access to the treatment anatomy. This device is compatible with mainstream linear accelerators as well as compatible with most existing CT scanners. ClearVue is placed on top of the existing treatment or imaging modality couch. ClearVue does not have motors for mechanical motion. ClearVue is compatible with both left and right breast patients by the use of variable inserts. An optional support cushion is used should one find it necessary to tilt the patient. ClearVue passes through a standard CT opening with the patient on top (these range from 70 to 85 cm in diameter). The distance between the layer on which the patient rests and the layer which rests on the therapy system couch is 18 to 30 cm to accommodate most breast sizes. The table is made from carbon-fiber to minimize thickness and radiation absorption. A soft, cushion lining is attached to the patient layer for comfort.

AI/ML Overview

This looks like a 510(k) premarket notification for a medical device called the "ClearVue Prone Breast Treatment Table." Based on the provided text, this document declares the device to be substantially equivalent to a predicate device, meaning it does not require a new study to prove its efficacy or safety. The document uses a comparison chart rather than a study with acceptance criteria and device performance metrics.

Here's a breakdown of why the requested information cannot be fully provided from the given text:

No new study was performed: This is a 510(k) submission, which aims to demonstrate "substantial equivalence" to an already cleared predicate device (Bionix RT-6025 Prone Breast System). It does not involve a new clinical or performance study with defined acceptance criteria for the new device itself. Instead, it compares the characteristics of the new device to the predicate.
No 'algorithm' or 'AI' is involved: The ClearVue is a physical medical device (a prone breast treatment table), not a software or AI-driven diagnostic tool. Therefore, terms like "algorithm only performance," "AI assistance," "effect size," and "ground truth" (in the context of diagnostic accuracy) are not applicable.
Ground truth and experts for a physical device: For a physical support table, the "ground truth" isn't about diagnostic accuracy based on expert consensus, pathology, or outcomes data in the way it would be for an AI model. Instead, it's about physical properties, safety, and functionality, which are assessed through engineering specifications, materials testing, and intended use validation.

However, I can extract information related to the comparison with the predicate device, which serves a similar purpose to demonstrating equivalence in a 510(k):

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

Since this is a 510(k) for a physical device demonstrating substantial equivalence, direct "acceptance criteria" and "reported device performance" in the typical study sense (e.g., sensitivity, specificity for an AI) are not present. Instead, the comparison to the predicate device serves as the basis for acceptance. The table below outlines the characteristics compared, with the predicate device's characteristics acting as the de facto "acceptance criteria" for the new device to claim equivalence.

Characteristic	Acceptance Criteria (from Predicate Device - Bionix RT-6025)	Reported Device Performance (ClearVue)
Intended Use	To position and re-position patients for breast radiation therapy; may be used with CT/MR for planning.	Same (ClearVue Prone Breast Treatment Table, a breast radiation therapy patient support, is an accessory for medical linear accelerator radiation therapy systems. ClearVue is intended to be used to position and re-position patients for breast radiation therapy. ClearVue may be used with CT and MR scanners to acquire images for radiation therapy planning.)
Connection to accelerator patient table	Locks to table	Rests on table with high friction feet to prevent movement. An optional fixture locks to the table.
Prone position for breast treatment	Same	Same
Patient cushion	Massage-style face cushion supports the head with openings for air flow.	Cushioned body and head support
Contralateral breast protection	Same	Same
Comfortable foam support during treatment	Same	Same
Height	9"	7" to 12"
Weight	18 pounds	28 pounds

Study Proving Device Meets Acceptance Criteria:

The "study" proving the device meets the acceptance criteria is the 510(k) Premarket Notification itself, specifically the section detailing the "Comparison to the predicate device." The conclusion explicitly states: "The Clear Vue is substantially equivalent to the Bionix RT-6025 Prone Breast System with respect to intended use, safety, and effectiveness." This "substantial equivalence" is the regulatory standard that allows the device to be marketed without a new clinical efficacy study.

2. Sample size used for the test set and the data provenance:

Not applicable. No clinical or performance test set, in the sense of patient data or algorithm evaluation, was used or reported in this 510(k) for the ClearVue device. The evaluation is based on characteristic comparison to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. There was no "test set" and thus no "ground truth" established by experts in the context of diagnostic accuracy for this physical medical device in this filing. The regulatory body (FDA) reviews the comparison document.

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

Not applicable. As there was no test set in the traditional sense, no adjudication method was used.

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:

No. This is a physical support device, not an AI or imaging diagnostic tool, so an MRMC study is not relevant or applicable.

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

No. ClearVue is a physical medical device, not an algorithm.

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

For this 510(k) submission, the "ground truth" for the device's acceptability is the characteristics and performance of the legally marketed predicate device (Bionix RT-6025 Prone Breast System). The company demonstrates that its new device is "substantially equivalent" in its intended use, design, and performance characteristics to that predicate. This is a regulatory "ground truth" for market clearance, rather than a clinical ground truth for diagnostic accuracy.

8. The sample size for the training set:

Only applicable if a new study or design validation was performed for the device, beyond the scope of a typical 510(k) summary provided here. For a physical device, "training set" might refer to engineering prototypes or design iterations, but this information is not disclosed in the provided 510(k) summary. Given the nature of a 510(k) (substantial equivalence), no new "training set" for performance evaluation in the typical sense of machine learning or clinical trials is required or described here.

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

Not applicable for the reasons stated above (physical device, no AI/algorithm, focus on substantial equivalence to a predicate).

Summary

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KC90349

MAR - 9 2009

510(k) Summary

Date prepared	February 10, 2008
510(k) Owner	Orbital Therapy, LLC8 Alfred CircleBedford, MA 01730
	Phone: 508-202-7224Fax: 508-371-3434
Contact	Natalya Koshnitsky, Manager, Regulatory Affairs
Trade name	ClearVue Prone Breast Treatment Table
Common name	Breast radiation therapy patient support
Classification Name	Medical charged-particle radiation therapy system
Regulation:	21 CFR 892.5050
Product code:	IYE
Predicate device	Bionix RT-6025 Prone Breast System, which was cleared to marketin 510(k) # K905007
Device description	ClearVue is a prone-breast table top attachment, which allows formulti-angle access to the treatment anatomy. This device iscompatible with mainstream linear accelerators as well ascompatible with most existing CT scanners. ClearVue is placed ontop of the existing treatment or imaging modality couch. ClearVuedoes not have motors for mechanical motion. ClearVue iscompatible with both left and right breast patients by the use ofvariable inserts. An optional support cushion is used should onefind it necessary to tilt the patient. ClearVue passes through astandard CT opening with the patient on top (these range from 70 to85 cm in diameter). The distance between the layer on which thepatient rests and the layer which rests on the therapy system couchis 18 to 30 cm to accommodate most breast sizes. The table ismade from carbon-fiber to minimize thickness and radiationabsorption. A soft, cushion lining is attached to the patient layer forcomfort.

Y ﮩﺴ

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Intended use

Clear Vue Prone Breast Treatment Table, a breast radiation therapy patient support, is an accessory for medical linear accelerator radiation therapy systems. ClearVue is intended to be used to position and re-position patients for breast radiation therapy. Clear Vue may be used with CT and MR scanners to acquire images for radiation therapy planning.

Comparison to the predicate device

Characteristic	ClearVue	Bionix RT-6025
Connection toaccelerator patienttable	Rests on table withhigh friction feet toprevent movement.An optional fixturelocks to the table.	Locks to table
Prone position forbreast treatment	Same	Same
Patient cushion	Cushioned body andhead support	Massage-style facecushion supports thehead with openingsfor air flow.
Contralateral breastprotection	Same	Same
Comfortable foamsupport duringtreatment	Same	Same
Height	7" to 12"	9"
Weight	28 pounds	18 pounds

Conclusion

The Clear Vue is substantially equivalent to the Bionix RT-6025 Prone Breast System with respect to intended use, safety, and effectiveness.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake entwined around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 9 2009

Orbital Therapy, LLC % Mr. Chas Burr President Chas Burr Q/R Services, Inc. 11 Mystic Avenue WINCHESTER MA 01890

Re: K090349

Trade/Device Name: ClearVue Prone Breast Treatment Table Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: February 10, 2009

Received: February 11, 2009

Dear Mr. Burr:

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 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.

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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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os 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 this letter.

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	(240) 276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	(240) 276-0115
21 CFR 892.xxx	(Radiology)	(240) 276-0120
Other		(240) 276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures. 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.suppot/index.html.

Sincerely yours,

Janine M. Morris

anine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known): K 090349

Device Name: ClearVue Prone Breast Treatment Table

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulin Perner

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices

10(k) Number

ClearVue 510(k)

Page 16 of 72

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.