(34 days)
The p.d software takes a Treatment Planning System design of a compensating filter used for radiation therapy which contains steep, narrow, and unmachinable areas and then smoothes them out into a machinable surface. The customer will use the software in-house before sending the file to .decimal to be manufactured. Each filter must be QA'd by the customer before use on a patient.
.decimal created a software translator to be used with a Radiation Therapy Treatment Planning Systems (TPS). The software takes the TPS design of a compensating filter used for radiation therapy which contains steep, narrow, and unmachinable areas and then smoothes them out into a machinable surface.
The provided text, K061440, describes a software translator called "p.d" designed to smooth out unmachinable areas in radiation therapy compensating filters. The document is a 510(k) summary for a premarket notification to the FDA in 2006.
However, the K061440 document does not contain the detailed acceptance criteria or a study that addresses the specific points requested in the prompt. It provides general information about the device, its intended use, and substantial equivalence to a predicate device, but lacks the specific performance data, sample sizes, expert qualifications, or study methodologies that would typically be found in a comprehensive validation or clinical study report.
Here's an analysis of what is and is not present in the provided text in relation to your request:
1. Table of acceptance criteria and the reported device performance:
- Not present. The document states that "p.d Software Validation" (PD-11) is attached in Section 11 and "Summary of Clinical Testing" is in Section 12, but these sections are not included in the provided text. Therefore, specific acceptance criteria (e.g., maximum deviation from original design, smoothing parameters, processing time) and quantitative performance metrics are not available.
2. Sample size used for the test set and the data provenance:
- Not present. The document mentions "clinical testing" but does not provide any details about the test set size, data origin (country), or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not present. There is no mention of experts, ground truth establishment, or their qualifications. The intended use states the customer verifies the filters, but this is an operational process, not a ground truth methodology for a study.
4. Adjudication method for the test set:
- Not present. Without details of a test set or ground truth establishment, an adjudication method is not mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- Not present. This type of study is not mentioned. The device is a software translator for manufacturing, not an AI-assisted diagnostic tool that human readers would interpret.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Implicitly yes, but no details of the study. The device is a "software translator" that takes a TPS design and smoothes it out. Its function is inherently standalone in that it performs an automated transformation of a digital design. However, there is no study described that evaluates its standalone performance against specific metrics. The "clinical testing" summary is referenced but not provided.
7. The type of ground truth used:
- Not explicitly stated, but inferred to be a comparison against the original "steep, narrow, and unmachinable areas" and the requirement for a "machinable surface." For this type of device, ground truth would likely involve geometric accuracy, smoothness criteria, and mechanical machinability assessments. However, the document does not specify how this ground truth was established for study purposes.
8. The sample size for the training set:
- Not present. As this is from 2006 and the device is described as a "software translator" to smooth designs, it's less likely to be a deep learning model requiring a large training set in the modern sense. It's more likely rule-based or algorithmic. Regardless, no training set size is mentioned.
9. How the ground truth for the training set was established:
- Not present.
In summary, the provided document K061440 primarily focuses on the regulatory submission for substantial equivalence. It points to validation and clinical testing summaries (Sections 11 and 12) which are not included in the provided text. Therefore, the specific details regarding acceptance criteria and study methodologies, as requested, cannot be extracted from this document alone.
{0}------------------------------------------------
JUN 2 7 2006
Section 807.87 (h) A 510(k) Summary as described in Section 807.92 or a 510(k) statement as described in 807.93
Premarket Notification [510(k)] Summary as required by 21 CFR 807.92
Date summary was prepared:
May 2006
Submitter's Name:
.decimal, Inc. 121 Central Park Pl Sanford, Fl 32771 Contact Person:
Daniel L. Bennett Quality Manager Phone: 407-330-3300 Fax: 407-322-7546 Email:dbennett(@dotdecimal.com
Device Name:
p.d
Classification Name:
90 MUJ 21 CFR892.5050 Class II
Predicate Device(s):
Computerized Medical Systems Inc. (CMS) Xio Radiation Treatment Planning System, K032762
Intended Use:
.decimal created a software translator to be used with a Radiation Therapy Treatment Planning Systems (TPS). The software takes the TPS design of a compensating filter used for radiation therapy which contains steep, narrow, and unmachinable areas and
{1}------------------------------------------------
then smoothes them out into a machinable surface. The customer will use the software in-house before sending the file to .decimal to be manufactured. Each filter must be verified as being correct by the customer prior to use on a patient.
Summary of Technological Characteristics:
The technological characteristics of p.d are listed below and attached in section 11 of this document:
PD-11 p.d Software Validation DMR-04 p.d Device Master Record
Summary of Clinical Testing:
Please see Section 12 of this document for the summary of clinical testing.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human services.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUN 2 7 2006
Mr. Daniel L. Bennett Quality Manager .Decimal, Inc. 121 Central Park Place SANFORD FL 32771
Re: K061440
Trade/Device Name: p.d Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: May 16, 2006 Received: May 24, 2006
Dear Mr. Bennett:
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 ica 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 thei have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmen 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, 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 Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/2/Picture/10 description: The image shows a circular logo with the letters "FDA" in large, bold font in the center. Above the letters, the years "1906 - 2006" are printed. Below the letters, the word "Centennial" is written in cursive, with three stars underneath. The logo is surrounded by text that follows the circular shape, but the text is too blurry to read. The logo appears to be a commemorative emblem for the FDA's centennial anniversary.
Protecting and Promoting Public Health
{3}------------------------------------------------
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 muz. 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 us set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the elections 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 51011 } premarket notification. The FDA finding of substantial equivalence of your device to a legal|y marketed predicate device results in a classification for your device and thus, permits you follow to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). (1) blease 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 894.xxx | (Radiology) | 240-276-0122 |
| Other | 240-276-0122 |
Also, please note the regulation entitled. "Misbranding by reference to premarket natified icre (21CFR Part 807.97). You may obtain other general information on woman within the Act from the Division of Small Manufacturers, International and Comment Assista - - Lin toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/edrh/industry/support/index.in-
Sincerely yours,
Nancy C.Bogden
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2 -
{4}------------------------------------------------
Page 1 of 1
510(k) Number (if known)
Device Name: p.d
Indication for Use: The p.d software takes a Treatment Planning System design of a compensating filter used for radiation therapy which contains steep, narrow, and unmachinable areas and then smoothes them out into a machinable surface. The customer will use the software in-house before sending the file to .decimal to be manufactured. Each filter must be QA'd by the customer before use on a patient.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | ✓ |
|---|---|
| OR | |
| Over-The-Counter Use ________ |
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number: K061440
510(k) Number ________________________________________________________________________________________________________________________________________________________________
§ 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.