(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.
§ 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.