(17 days)
Proxcelan™ (Cesium-131) Implant Devices containing cesium-131 brachytherapy seeds are indicated for the treatment of malignant disease (e.g. head and neck, brain, breast, lung, prostate, eye, etc.) and may be used in surface, interstitial, and intracavity applications for tumors with known radiosensitivity. These devices may be used as a primary treatment or in conjunction with other treatment modalities, such as external beam radiation therapy, chemotherapy or as a treatment for residual disease after excision of primary tumors.
The Proxcelan (Cesium-131) Implant Devices are single use, prescription devices consisting of IsoRay Model CS-1 Brachytherapy Seeds that are combined with bioabsorbable spacers and preloaded into bioabsorbable hollow strands or 18 gauge brachytherapy needles for implant. The Implant Devices are designed to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for the treatment of malignant disease. These Implant Devices are described as follows: PL-1 Cs-131 Preloaded Strands, PL-2 - Cs131 Preloaded Strands in 18 Gauge Needles, PL-3 - Cs131 Preloaded 18 Gauge Needles.
The provided text is a 510(k) summary for the Proxcelan™ (Cesium-131) Implant Devices, primarily focusing on its substantial equivalence to a previously marketed device (K062384) and general safety and effectiveness.
It does NOT contain specific information about detailed acceptance criteria, a specific study proving device performance against those criteria, or the methodology for such a study (sample sizes, ground truth establishment, expert qualifications, adjudication, MRMC studies, or standalone performance).
The text primarily describes:
- Device Description: What the Proxcelan (Cesium-131) Implant Devices are (preloaded strands or needles with Cesium-131 seeds and bioabsorbable spacers).
- Intended Use/Indications for Use: Treatment of malignant disease in various body sites, used as primary treatment or in conjunction with other modalities.
- Technological Characteristics: Cesium-131 seeds, bioabsorbable spacers, preloaded into needles/strands. Mentions a change in copolymer formulation from the predicate device.
- Safety and Effectiveness (General Statement): States that "all finished products are tested and must meet all requires release specifications before distribution." This includes leak testing, external contamination, apparent activity, sterility, and labeling, defined by written and approved procedures conforming to product design specifications. It refers to a "Device Master Record" for details.
Based on the provided text, I cannot complete the requested information for acceptance criteria and the study that proves the device meets them because the document does not contain this level of detail.
However, I can extract what is explicitly stated regarding safety and effectiveness testing, which implies general acceptance criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (as stated in document) |
|---|---|
| General Requirement | "meet all requires release specifications before distribution" |
| Leak Testing | Tested and must meet specifications |
| External Contamination | Tested and must meet specifications |
| Apparent Activity | Tested and must meet specifications |
| Sterility | Tested and must meet specifications |
| Labeling | Tested and must meet specifications |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided in the text. The document only states "all finished products are tested," implying a manufacturing quality control process rather than a specific clinical or performance study with a defined test set sample size.
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 applicable / Not provided. The described testing relates to manufacturing quality control (e.g., leak testing, sterility), not clinical performance requiring expert ground truth for interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. Adjudication methods are typically for studies interpreting complex data, which is not described here.
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
- No. This device is a brachytherapy implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This device is a brachytherapy implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly stated for the "release specifications" testing. For manufacturing quality control, ground truth would likely be internal quality standards, calibrated measurement instruments, and predefined tolerances for physical and radioactive properties (e.g., a known standard for activity measurement, absence of microbial growth for sterility).
8. The sample size for the training set
- Not applicable / Not provided. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable / Not provided. This is not an AI/ML device.
§ 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.