(213 days)
The proposed Strata system must be used by a qualified clinical staff member (generally a Medical Physicist or Dosimetrist), the results should then be approved by a licensed Radiation Oncologist.
The proposed Strata device is intended to assist the clinician in determining optimal placement of Low Dose Rate radioisotopes about a lesion or tumor (benign or malignant) seated in human tissue. The information gathered in this planning system is used for localization, visualization of regional interest, calculating dose of implanted radioisotopes, and finally out putting data in hardcopy form (printer/plotter).
Strata is not intended to prescribe dose, invade the patient or control hardware which can directly harm the patient.
The proposed Strata device is a computer system developed for the use of assisting in the placement of anatomical localization and low dose rate isotope implants. This treatment planning procedure is used for lesions, benign or malignant, seated in human tissue. Strata uses multiple two dimensional images including Ultrasound and DICOM (imaging file format) images which are outlined by a qualified medical staff member, then reconstructed to create three dimensional structures and matrices. The information gathered is used for localization, visualization of regional interest, calculating dose of implanted radioisotopes, and finally out putting data in hardcopy form (printer/plotter).
This 510(k) submission for the STRATA Brachytherapy Treatment Planning System (K981678) does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.
The provided documents primarily focus on:
- A 510(k) Summary, which describes the device, its intended use, and claims substantial equivalence to predicate devices.
- The FDA's clearance letter, stating that the device is substantially equivalent to legally marketed predicate devices.
Missing Information:
The crucial information about specific acceptance criteria and the performance study proving their achievement is not present in these documents. This type of detailed study report, often referred to as a Verification and Validation (V&V) report, would typically be part of the full 510(k) submission but is not included in this publicly available summary and clearance letter.
Therefore, I cannot fill out the requested table or answer the specific questions about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
Based on the available information, I can only state that:
1. A table of acceptance criteria and the reported device performance:
* Not provided in the given documents. The documents assert substantial equivalence but do not detail specific performance metrics or acceptance criteria for the STRATA device itself, nor any study results demonstrating these.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
* Not provided in the given documents.
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 provided in the given documents. While the intended use mentions "qualified medical staff member" and approval by a "licensed Radiation Oncologist," this refers to clinical use, not necessarily the experts involved in establishing ground truth for a performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not provided in the given documents.
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 provided in the given documents. The device is described as "assisting in the placement" and "determining optimal placement," implying human-in-the-loop, but no MRMC study or effect size is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not provided in the given documents. The device's description suggests it's an assistance tool for clinicians, making a purely standalone performance less likely to be the primary focus for a medical planning device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
* Not provided in the given documents.
8. The sample size for the training set:
* Not provided in the given documents.
9. How the ground truth for the training set was established:
* Not provided in the given documents.
In summary, the provided K981678 FDA submission documents are a summary and clearance letter, not a detailed performance study report. Therefore, they lack the specific technical and clinical validation data required to answer most of your questions.
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Image /page/0/Picture/0 description: The image shows the logo for "Rosses Medical" with a shamrock in the middle of the word "Rosses". The logo is in black and white. Above the logo, the date "DEC 11 1998" is printed.
10620 Guilford Road, Suite 201 Jessup, Maryland 20794 (301) 490-2304 · (301) 490-2982 (fax)
510(k) Summary
The 510(k) summary information required by 21 CFR 807.92 is as follows:
Source, Brachytherapy, Radionuclide or Accelerator, Classification Name: Linear, Medical or Other
Common/Usual Name: Brachtherapy Treatment Planning System
Proprietary Name: STRATA
Substantial equivalence: Prowess 2000 (SSGI, Inc.) and Therpac PLUS B3D TUI (Multimedia Medical Systems, Inc.)
Device description: The proposed Strata device is a computer system developed for the use of assisting in the placement of anatomical localization and low dose rate isotope implants. This treatment planning procedure is used for lesions, benign or malignant, seated in human tissue. Strata uses multiple two dimensional images including Ultrasound and DICOM (imaging file format) images which are outlined by a qualified medical staff member, then reconstructed to create three dimensional structures and matrices. The information gathered is used for localization, visualization of regional interest, calculating dose of implanted radioisotopes, and finally out putting data in hardcopy form (printer/plotter).
Intended Use: The proposed Strata device is to used only by a qualified clinician, Medical Physicist or Dosimetrist, the results should then be approved by a licensed Radiation Oncologist. Strata is intended to assist the clinician in determining optimal placement of Low Dose Rate radioisotopes. Strata is not intended to prescribe dose, invade the patient or control hardware which can directly harm the patient.
Technological characteristics: The proposed Strata device is similar to predicate devices, and existent methodologies in its intended use.
The proposed device is different than the predicate devices in that it gives the user more flexibility with image acquisition and structure definition.
Submitted,
Rosses Medical Systesm
Rene Spector
Reme Spector Regulatory/SQA Manager Phone/Fax
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Image /page/1/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of what appears to be a symbol representing health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 1 1998
Rene Spector Regulatory/SQA Manager Rosses Medical Columbia Gateway Drive Suite 160 Columbia, Maryland 21046 Re: K981678
STRATA ( Brachytherapy RTP System) Dated: September 28, 1998 Received: September 28, 1998 Regulatory class: II 21 CFR 892.5730/Procode: 90 MUJ
Dear Mr. Spector:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined 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 Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal 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 (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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 submission does not affect any obligation you might have under sections 531 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 device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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/cdrfvdsmardsmamain.html".
Sincerely yours,
Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (If known):
Device Name:
Indications For Use:
The proposed Strata system must be used by a qualified clinical staff member (generally a Medical Physicist or Dosimetrist), the results should then be approved by a licensed Radiation Oncologist.
The proposed Strata device is intended to assist the clinician in determining optimal placement of Low Dose Rate radioisotopes about a lesion or tumor (benign or malignant) seated in human tissue. The information gathered in this planning system is used for localization, visualization of regional interest, calculating dose of implanted radioisotopes, and finally out putting data in hardcopy form (printer/plotter).
Strata is not intended to prescribe dose, invade the patient or control hardware which can directly harm the patient.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Leggett
Division of Reproductive, Abdominal, El and Radiological 510(k) Number
Prescription Use (Per 21 CFR 801.109)
Over-the-Counter Use
(Optional Format 1-2-96)
OR
§ 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.