(43 days)
The BEST Model No. 81-01 Series Sources are intended for the delivery of therapeutic doses of gamma radiation for the purpose of brachytherapy treatments (e.g., interstitial, intracavitary, intralumen, or topical radiation therapy).
BEST Model Nos. 81-01-11, 81-01-14, and 81-01-14 sources. These sources are pure Ir-192 sources.
Acceptance Criteria and Study for BEST Model Nos. 81-01-11, 81-01-14, and 81-01-17 Ir-192 Sources
This document describes the acceptance criteria and the study performed to demonstrate the safety and effectiveness of the BEST Model Nos. 81-01-11, 81-01-14, and 81-01-17 Ir-192 sources.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for these devices are based on substantial equivalence to the BEST Model No. 81-01 source, which is documented in the AAPM's TG-43 report, and compliance with FDA recognized standards for Photon-emitting Brachytherapy Sources.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to the BEST Model No. 81-01 source, as described in AAPM's TG-43 document, regarding dosimetry. This implies the new sources exhibit comparable gamma ray spectrum and dosimetric characteristics. | Air kerma measurements at NIST and TG-43 parameter measurements at the University of Kentucky for the BEST Model No. 81-01-17 intermediate downsize source showed it is a pure Ir-192 source whose dosimetry is in substantial agreement with that of TG-43. The BEST Model Nos. 81-01-11 and 81-01-14 sources have the same pure Ir-192 gamma ray spectrum as the 81-01-17 source. Therefore, for brachytherapy applications, the dosimetry of all three new sources (81-01-11, 81-01-14, and 81-01-17) are considered to be the same and substantially equivalent to that of TG-43 (and by extension, to the predicate 81-01 source). |
| Compliance with FDA recognized standards for Photon-emitting Brachytherapy Sources, specifically ANSI N43.6-1977 Classification of Sealed Radioactive Sources and ISO 2919 Sealed radioactive sources - General requirements and classification. | BEST provided testing data to the NRC (as part of an amendment to NRC to register these sources under NRC Registration Certificate NR-187-S-101-S) that demonstrated these new sources meet the FDA recognized standards ANSI N43.6-1977 and ISO 2919. This commitment was made by BEST. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "test set" in the traditional sense of a clinical or image-based AI study. Instead, the "testing data" refers to physical measurements and characterizations of the sources themselves.
- Sample Size: The study involved measurements on at least one representative model: the BEST Model No. 81-01-17 intermediate downsize source. The text implies that the other two models (81-01-11 and 81-01-14) were considered to have the "same pure Ir-192 gamma ray spectrum" as the 81-01-17, suggesting that detailed individual measurements might have been carried out for 81-01-17 which then was extrapolated. The specific number of physical sources tested or measurements taken is not detailed beyond "measurements" for 81-01-17.
- Data Provenance:
- Air kerma measurements: Conducted at NIST (National Institute of Standards and Technology), an institution located in the USA.
- TG-43 parameter measurements: Conducted at the University of Kentucky, an institution located in the USA.
- Compliance testing for FDA recognized standards: Data provided to the NRC (Nuclear Regulatory Commission) for source registration. The location where these tests were performed is not explicitly stated, but given the context of NRC registration in the USA, it's highly probable the testing was conducted in the USA or at facilities complying with US regulatory standards.
- Retrospective or Prospective: This type of testing is inherently prospective as it involves the physical characterization of newly manufactured devices under controlled conditions.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The concept of "experts" for establishing ground truth in this context differs from an AI study involving human interpretation of clinical data. Here, "ground truth" is established by:
- Scientific consensus/standards: The AAPM's TG-43 document provides the established dosimetry parameters for Ir-192 sources, representing a consensus among medical physicists.
- National metrology institutes: NIST performs highly calibrated physical measurements, establishing a reference "ground truth" for physical quantities like air kerma.
- Academic institutions: The University of Kentucky performed TG-43 parameter measurements, implying expertise in medical physics and dosimetry.
The document does not specify the number or specific qualifications of individual experts at NIST or the University of Kentucky explicitly, but their departmental and institutional affiliations imply:
- Qualifications: Experts would be highly qualified medical physicists with expertise in brachytherapy dosimetry, radiation measurement, and knowledge of the TG-43 formalism and relevant ANSI/ISO standards. Their experience would be implicit in their roles at these institutions.
4. Adjudication Method for the Test Set
Not applicable in this context. The "test set" consists of physical measurements and characterizations against established standards (TG-43, ANSI, ISO), not subjective interpretations requiring adjudication. Agreement is based on meeting numerical parameters and qualitative characteristics (e.g., pure Ir-192 spectrum).
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a pre-market notification for a medical device (brachytherapy source), not an AI algorithm intended for interpretation or diagnostic assistance. Therefore, no MRMC study involving human readers or AI assistance was performed.
6. Standalone (Algorithm Only) Performance Study
Not applicable. There is no AI algorithm involved in the function or evaluation of these brachytherapy sources. The devices are physical radioactive sources.
7. Type of Ground Truth Used
The ground truth used is a combination of:
- Established scientific consensus and guidelines: The AAPM TG-43 document defines the expected dosimetric properties of Ir-192 sources.
- Metrological standards: NIST provides a gold standard for physical measurements (e.g., air kerma).
- Recognized industry standards: ANSI N43.6-1977 and ISO 2919 define safety and classification requirements for sealed radioactive sources.
8. Sample Size for the Training Set
Not applicable. There is no AI algorithm being trained for this device. The "training set" concept is not relevant here.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
§ 892.5730 Radionuclide brachytherapy source.
(a)
Identification. A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.(b)
Classification. Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.