(80 days)
Implant Sciences Model HDR 4140 Source Assembly, with individual activity up to 27Ci, is indicated for temporary interstitial, intracavitary, intraluminal or intraoperative or surface application to treat selected localized tumors. This source can be used as primary treatment for a variety of anatomical sites commonly treated with high dose rate brachytherapy, including the cervix, vagina, endometrium, rectum, esophagus, bronchus, head and neck, bile duct, brain, skin, prostate, lung, pancreas, and breast and for treatment of sarcomas and for intraoperative radiation therapy. This source may be used concurrently with or following treatment with other interventions, such as external beam radiation therapy, hyperthermia or chemotherapy.
Implant Sciences Corp. Model HDR-4140 is a doubly-encapsulated 100 tterbium Brachytherapy Source. It consists of a plasma-welded titanium capsule containing solid radioactive 169Ytterbium pellets. The inner capsule is subsequently sealed in a stainless steel outer capsule that is attached to a cable to permit manipulation by the remote afterloading system.
The provided document is a 510(k) summary for the Implant Sciences Corp. Model HDR-4140, a brachytherapy source. This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance rather than presenting a detailed study with specific acceptance criteria and detailed performance metrics as one might find for a diagnostic or AI-driven device.
Therefore, much of the requested information (acceptance criteria, specific performance metrics, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable or not present in this type of regulatory submission. The document primarily establishes the device's technical characteristics and intended use in comparison to existing, cleared devices.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance:
This information is not explicitly stated in the provided 510(k) summary. For a brachytherapy source, "acceptance criteria" generally refer to design specifications, material properties, safety standards (e.g., leak integrity, dose uniformity, mechanical integrity), and performance characteristics (e.g., source strength accuracy, stability). The document asserts that the device is "substantially equivalent" to predicate devices, implying that it meets similar performance and safety criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This a 510(k) for a physical medical device (a brachytherapy source) and does not involve a "test set" in the context of data anlaysis or algorithm evaluation. Device performance is typically assessed through engineering tests, simulations, and often, phantom studies, but not with "data provenance" in the sense of clinical datasets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as there is no "ground truth for a test set" in this context. The safety and effectiveness of the device are assessed based on its physical properties and adherence to manufacturing and performance standards, likely evaluated by internal and external engineers/physicists.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable as there is no "test set" and no "adjudication method" in the context of expert review of clinical data.
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:
This is not applicable. The device is a physical brachytherapy source, not an AI or diagnostic imaging device that involves human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical brachytherapy source, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
As there is no "ground truth" in the typical sense of clinical data validation for an algorithm, this is not applicable. The "truth" here would relate to the physical and radiological properties of the source meeting design specifications and safety standards.
8. The sample size for the training set:
This information is not applicable as the device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
This information is not applicable as the device is not an AI algorithm requiring a training set.
Summary of what the document does provide regarding device characteristics and regulatory clearance:
- Device Name: Implant Sciences Corp. Model HDR-4140 169 Ytterbium Brachytherapy Source
- Intended Use: For the treatment of cancer by temporary interstitial, intracavitary, intraluminal, intraoperative, or surface irradiation. Can be used as primary treatment for various anatomical sites (cervix, vagina, endometrium, rectum, esophagus, bronchus, head and neck, bile duct, brain, skin, prostate, lung, pancreas, breast, sarcomas, and intraoperative radiation therapy). It may be used concurrently with or following other interventions like external beam radiation therapy, hyperthermia, or chemotherapy.
- Technological Characteristics: It is a doubly-encapsulated 169 Ytterbium Brachytherapy Source (containing solid radioactive 169 Ytterbium pellets in a plasma-welded titanium capsule, sealed in a stainless steel outer capsule attached to a cable).
- Comparison to Predicate Devices: The key difference from predicate devices is the use of 169 Ytterbium photons instead of 192 Iridium. The 510(k) submission states that the device is "substantially equivalent" to predicate high dose rate brachytherapy sources, indicating it meets similar safety and effectiveness standards, albeit with a different radioisotope.
- Regulatory Status: Cleared under 510(k) K042864, dated January 6, 2005, indicating substantial equivalence to predicate devices.
§ 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.