The provided document, K971382, describes a Premarket Notification [510(k)] for the "Prone Breast Positioning Board, Model #37-018." This submission primarily focuses on establishing substantial equivalence to a predicate device, rather than proving a novel device meets specific performance acceptance criteria through an independent study.

Therefore, many of the requested elements for describing acceptance criteria and a study proving a device meets them are not applicable (N/A) in the context of this 510(k) submission. This is because the 510(k) pathway is designed to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and technological characteristics, or different technological characteristics that do not raise new questions of safety and effectiveness. It does not typically require extensive novel clinical studies with predefined acceptance criteria in the same way a Premarket Approval (PMA) pathway might.

However, based on the information provided, we can extract details related to the comparison performed to establish substantial equivalence.

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

Since this is a 510(k) submission for substantial equivalence, the "acceptance criteria" are implicitly tied to demonstrating that the new device is as safe and effective as the predicate device. The performance is reported through a comparative analysis rather than meeting predefined quantitative metrics for a new claim.

Criterion Type (Implicit for 510(k))	Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance
Intended Use	Same as predicate device (positioning in primary breast irradiation)	"To be used as a positioning device in patient set-up for primary breast irradiation."
Safety	No new issues relating to safety compared to predicate device	"The conclusions drawn... demonstrate that the Prone Breast Board... presents no new issues relating to safety and effectiveness..."
Effectiveness	No new issues relating to effectiveness compared to predicate device; Clinical and Dosimetric advantages demonstrated	"...and is substantially equivalent to the legally marketed predicate device..." Clinical benefits (large/pendulous breasts, lung/heart avoidance, reduced skin reaction, simplifies breast boosts) and Dosimetric benefits (reduced internal scatter, minimized scatter to contralateral breast, no wedges needed). Sample treatment plans showed uniform dose distribution vs. hot spots in supine treatment.
Technological Characteristics	Differences do not raise new questions of safety/effectiveness	Differs from predicate in prone vs. supine positioning, with claimed advantages supported by literature and sample treatment plans.

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

Test Set Sample Size: The document explicitly mentions "Two sample treatment plans (exhibits F and G) labeled 'Jones, Pearl' are attached." This indicates a sample size of one patient with two treatment plans (prone and supine for comparison) were used for the non-clinical performance data portion.
- For the clinical study/test data, the submission references two external articles (Exhibits "H" and "I"). The sample sizes for these articles are not provided in this 510(k) document.
Data Provenance:
- The "Jones, Pearl" treatment plans are presented as internal data to the submission, likely from the manufacturer or an affiliated institution. Country of origin is not explicitly stated but implied to be the US, given the submission to the FDA. The nature (retrospective/prospective) of these specific plans is not stated.
- The external articles (Exhibits "H" and "I") would have their own data provenance, which is not detailed in this 510(k) summary. One article is from "The Official Journal," suggesting a peer-reviewed publication.

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

For the "Jones, Pearl" sample treatment plans: The creation and interpretation of these treatment plans would typically be performed by medical physicists and/or radiation oncologists. The document references the expertise of the authors of the referenced articles ("Thomas E. Merchant, D.O., and Beryl McCormick, M.D."). These are medical doctors, likely radiation oncologists, but the exact number of experts involved in the "ground truth" for the submitted sample plans is not specified.
For the referenced articles (Exhibits H and I): The ground truth would be established by the authors and peer reviewers of those respective studies, whose qualifications are not detailed in this 510(k) summary.

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

None explicitly stated for the "Jones, Pearl" treatment plans. It appears to be an internal comparison exercise rather than a multi-reader, adjudicated study.
The referenced articles (Exhibits H and I) would have their own research methodologies which are not detailed here.

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 MRMC comparative effectiveness study was done. This device is a physical positioning board, not an AI-assisted diagnostic or therapeutic tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

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

Not applicable. This is a physical medical device (breast positioning board), not a software algorithm.

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

For the "Jones, Pearl" sample treatment plans: The "ground truth" for demonstrating dosimetric advantages is based on medical physics calculations and interpretation of dose distributions, which represents an expert-driven simulation and analysis, possibly reflecting accepted clinical practice for judging treatment plan quality.
For the referenced articles: The ground truth would be based on the methodologies specific to those studies (e.g., clinical outcomes, dosimetric measurements, simulated patient data), but this is not specified within the 510(k) document.

8. The sample size for the training set:

Not applicable. This submission focuses on demonstrating substantial equivalence of a physical device. There is no AI algorithm being "trained" in this context. The "training data" for the concept of prone breast positioning would be general medical knowledge and the body of scientific literature, implicitly represented by the referenced articles.

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

Not applicable. As above, there is no discrete "training set" in the AI sense for this physical device. The information supporting the benefits of prone breast positioning is derived from established medical literature and clinical understanding, as evidenced by the cited articles.

Summary

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K971382

Premarket Notification [510(k)] Summary as required by section 807.92(c)

JUN - 6 1997

Date Summary was prepared:

March 4, 1997

Submitter's Name:

な Victoreen, Inc. 6000 Cochran Road Cleveland, Ohio 44139-3395

Contact Person:

Linda S. Nash Director of Regulatory Affairs and Quality Assurance 216-248-9300 Phone: Fax: 216-248-9301

Device Name:

Prone Breast Positioning Board, Model #37-018

Classification Name:

Medical Charged-Particle Radiation Therapy System

Predicate Device:

Med-Tec, Breast Board, Mt, 510(k) #935411

Device Description:

The Prone Breast Positioning Board is a linear accelerator couch-mounted platform which enables the breast to hang in a comfortable, gravity-dependent fashion for treatment with opposed tangential photon beams. Women with large or pendulous breasts, in whom supine treatment would result in an unacceptable dose inhomogeneity, are targeted as the

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group who would benefit most from this device. Where dose to lung, heart or other normal tissue is also concerned, prone breast treatment offers advantages over supine treatment. The prone breast positioning device allows women to complete treatment expeditiously and minimize toxicity.

Intended Use:

To be used as a positioning device in patient set-up for primary breast irradiation.

Similarities to predicate device:

Both the Med-Tec Breast Board and the Prone Breast Positioning Board are used as positioning devices in patient set-up for primary breast irradiation.

Differences to predicate device:

The Med-Tec Breast Board is for supine positioning in treatment of the breast. The Prone Breast Positioning Board is for prone positioning in treatment of the breast. Listed below are the clinical and dosimetric advantages to prone breast positioning. (Please reference the attached article form The Official Journal, entitled "Prone Position Breast Irradiation," by Thomas E. Merchant, D.O., and Beryl McCormick, M.D.)

Clinical advantages:

Women with large or pendulous breast may be treated with ease: 1.
-facilitates breast conserving therapy for large breasted women

-improves reproducibility of treatment for large breasted women

1. The lung and heart may be avoided through this positioning technique:
  -important for women with pre-existing cardiac and pulmonary conditions

-reduces the chance of long-term effects on heart and lungs

1. Significantly reduces skin reaction through improved does homogeneity:
  -treatment breaks are less likely due to improved skin tolerance

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-allows treatment to be given in a continuos course-oncologically superior -may facilitate simultaneous administration of chemotherapy in some women

-may allow patients with connective tissue disorder to receive treatment

Prone positioning simplifies breast boosts by making photon treatment possible: 4.
- -avoids the need for electron capability when treating breast patients 11:48:00 -skin-sparing boost treatment (photons) decreases skin reactions

Dosimetric advantages:

The amount of internal scatter is markedly reduced: 1.
-the volume of chest wall irradiated can be reduced by this technique
Radiation scatter to the contralateral (opposite) breast can be minimized: 2.
-the opposite breast can be moved away from the field edge
Beam attenuators (wedges) are not required to improve homogeneity: 3.
-the number of accelerator monitor units required for treatment is less

-internal scatter and scatter to the opposite breast are further minimized

Non-clinical Performance Data:

Two sample treatment plans (exhibits F and G) labeled "Jones, Pearl" are attached. The treatment plan marked with the 0.75, 0.75 scale is a prone treatment plan and supine on the same page for the same patient. The one with the 0.5, 0.5 scale is a conventional (parallel opposed) supine treatment plan. The sample treatment plans clearly show that in the supine treatment the dose to the chest wall is 90% of the max dose, whereas in the supine plan it is 110% of the max dose. Also the supine plan has hot spots near both beam entrance points of 123% of max dose, while the prone position provides a very uniform distribution with a uniform gradient through the breast. It is important to note that in

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breast conserving treatment, radiation therapy is treating the intact breast and a uniform, homogeneous dose distribution is desired if one is to achieve local control without complications such as skin reactions.

Cinical Study/Test Data:

Please reference:
Exhibit "H"	The article from The Official Journal, entitled "PronePosition Breast Irradiation," by Thomas E. Merchant,D.O., and Beryl McCormick, M.D.
Exhibit "I"	The article entitled "Dose to Lung in Primary BreastIrradiation"

Safety and Effectiveness Conclusion:

The conclusions drawn from the enclosed medical physics test data (see sample treatment plan/180 dose distributions in "F" and "G" Exhibits), and the supportive clinical articles (Exhibits "H" and "I") demonstrate that the Prone Breast Board (Model 37-018) presents no new issues relating to safety and effectiveness and is substantially equivalent to the legally marketed predicate device listed on page one of this document.

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Image /page/4/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 is a staff with two snakes coiled around it. The caduceus is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The text is in all caps and is evenly spaced around the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 3200 Corporate Boulevard Rockville MD 20850

JUN - 6 1997

Linda S. Nash Director of Regulatory Affairs and Quality Assurance · Victoreen, Inc. 6000 Cochran Road Cleveland, OH 44139-3395

Re: K971382 Prone Breast Positioning Board, Model #37-018 Dated: March 4, 1997 Received: April 14, 1997 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE

Dear Mr. Nash:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have decemined 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 Devices that have been reclassified in accordance with the provisions of the Foderal 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 does not affect any obligation you might have under sections 51 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 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. 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/dsmamain.html"

Sincerely yours,

William Y

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Page 1 of 1

510(k) Number:

Prone Breast Positioning Board, model number 37-018 Device Name:

Indications for Use:

The Prone Breast Positioning Board, model number 37-018 is to be used as a positioning device in patient set-up for primary breast irradiation.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Seymour
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT,
and Radiological Devices and Radiological Devi 510(k) Number J

Prescription Use V

Over-The-Counter Use

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.