(123 days)
MBI I-125 Brachytherapy Seeds with apparent activities between 3.7 MBq (0.1 mCi) to 37 MBq (1.0 mCi) are indicated for permanent interstitial treatment of tumors which are unresectable or residual after excision of the primary lesion, localized, slow growing, and exhibit low to moderate radiosensitivity. Intra abdominal, intrathoracic and superficial tumors may be treated with seeds containing apparent activities within this range. Tumors commonly treated are prostate (early stage), pancreas, head, neck, and lung.
MBI I-125 Brachytherapy Seeds containing apparent activities greater than 37 MBq (1.0 mCi) are indicated for temporary interstitial treatment of tumors which are unresectable or residual after excision of the primary lesion, localized, and exhibit moderate radiosensitivity. Temporary implants are indicated in breast, brain and eye tumors.
MBI I-125 Brachytherapy Seeds are indicated for treatment of residual tumors and recurrent tumors following external radiation therapy, hyperthermia, or chemotherapy or concurrent with these treatment modalities.
Each MBI I-125 Brachytherapy Seed external dimensions of 4.55 mm ± 0.35 mm in length and 0.865 mm ± 0.095 mm in diameter. The cylindrical metal casing is titanium having a wall thickness of 0.06 mm ± 0.02 mm laser welded at both ends. Both models: 125SL and 125SH have three to five silver spheres which are used to absorbed iodine-125 and provide X-ray contrast.
The provided text describes the K984446 Premarket Notification 510(k) Summary for the MBI I-125 Brachytherapy Seed. This document is a 510(k) summary, not a detailed study report. Therefore, it focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical or standalone performance studies with specific statistical acceptance criteria and results.
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) summary demonstrating substantial equivalence, formal acceptance criteria in a statistical sense (e.g., minimum sensitivity/specificity) are not explicitly stated for device performance in the same way they would be for a novel device. Instead, the acceptance criterion implicitly is "substantial equivalence" to the predicate device, Model 6711 by Amersham/Medi-Physics, Inc. (K914281), based on technological characteristics and non-clinical data.
The "reported device performance" is a comparison of key physical and radiation characteristics.
| Acceptance Criteria (Implied by Substantial Equivalence Goal) | Reported Device Performance (MBI I-125 Brachytherapy Seed) |
|---|---|
| Technological Characteristics: encapsulation material and sealing method to be similar. | Met: Both MBI I-125 (Models 125SL and 125SH) and Predicate Model 6711 encapsulate with titanium and seal by welding the ends closed. |
| Photon Emission Spectra: comparable spectral photon peaks. | Met: The emission spectra consisted of five energy peaks at 22.1, 25.5, 27.4, 31.4, 35.5 keV. This is stated to be consistent with the predicate device. |
| Total Radiation Fluence Distribution: comparable spatial radiation distribution. | Met: Total radiation fluence distribution is stated to be similar between MBI I-125 (Models 125SL and 125SH) and the predicate Model 6711, when compared to published data for Model 6711 (Ling, C.C., Yorke, E.D., Spiro, I.J., Kubiatowicz, D., Bennett, D .: Physical dosimetry of 1251 seeds of a new design for interstitial implant. Int. J. Radiation Oncology Biol. Phys., 9:1747-52, 1983). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Five I-125 seeds were analyzed for the total radiation fluence distribution. The emission spectra analysis was also performed on an unspecified, but likely small, number of seeds.
- Data Provenance: The data appears to be from non-clinical laboratory testing conducted by Mills Biopharmaceuticals, Inc. The country of origin for the testing facility/data is implied to be the United States (Oklahoma City, Oklahoma, where the company is located). The testing is prospective for the purpose of this submission, meaning it was conducted to support the 510(k) submission.
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. This is a non-clinical device, and the "ground truth" for the test set was established through physical measurements using scientific instruments (e.g., intrinsic Ge detector), not expert human interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no human adjudication for establishing "ground truth" from the device's physical and radioactive properties. The measurements are objective scientific 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
Not applicable. This document describes a physical brachytherapy seed, not an AI or imaging device involving human readers or interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device. The "performance" described is the physical and radiation characteristics of the brachytherapy seed itself. The device functions as intended by its physical properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical evaluation was established by objective physical measurements using scientific instrumentation (e.g., intrinsic Ge detector) and comparison to published scientific literature for the predicate device. For example, the total radiation fluence distribution data was compared to published data (Ling, C.C., et al., 1983) for the predicate Model 6711.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this 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.