(90 days)
The Implant Sciences 125 lodine Brachytherapy Seeds with activities from 0.1 to 5.0 mCi are indicated for temporary or permanent interstitial or intracavity implantation or surface application to treat selected localized tumors. They can be used either as primary treatment (such as for prostate cancer or unresectable tumors) or as treatment for residual disease after excision of primary or recurrent tumors. The 155 lodine Seeds may be used concurrently with or following treatment with other interventions, such as external beam therapy, hyperthermia or chemotherapy. Tumors of the head, neck, lung, pancreas, prostate and other accessible tumors are commonly treated.
The Implant Sciences 125 lodine (Model 3500) Brachytherapy Seeds consist of a laser welded titanium capsule containing a silica capillary tube that serves as a substrate for the radioactive iodine source. The tube is positioned around a silver radiopaque x-ray marker that identifies the source location and orientation. The seeds are provided non-sterile and must be sterilized prior to use.
Here's a breakdown of the acceptance criteria and study information for the Implant Sciences "I-plant" 125 Iodine Brachytherapy Seeds (Model 3500) based on the provided text:
Acceptance Criteria and Device Performance
The document does not explicitly state quantitative "acceptance criteria" for clinical performance that would typically be seen in studies evaluating diagnostic accuracy or prognostic prediction. Instead, the "acceptance criteria" are implied by the requirements of the ANSI Standard for Sealed Radioactive Sources (ANSI/HPS N43.6 - 1997) and the demonstration of substantial equivalence to predicate devices. The reported device performance is that the device meets these requirements and is consistent with or equivalent to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety testing per ANSI/HPS N43.6 - 1997 (including temperature resistance, external pressure resistance, impact resistance, vibration integrity, puncture resistance). | Results are consistent with predicate devices and satisfy performance requirements for temperature resistance, external pressure resistance, impact resistance, vibration integrity, and puncture resistance as specified by ANSI Standard N43.6-1997. Results confirm that the ISC 125 Iodine (Model 3500) Brachytherapy Seeds meet the requirements for radioactive sources in its class. |
| Radiation profile consistency with similar brachytherapy seeds. | Standardized studies describe the radiation profile of the sources, and these profiles are consistent with data generated from other Iodine-125 brachytherapy seeds with similar physical geometries. |
| Capsule leak testing compliance with ANSI standards. | Capsule leak testing was carried out in accordance with ANSI standards. The results support the equivalence of the ISC Model 3500 device to the predicate devices. |
| Material safety and history of use. | The materials from which the Implant Sciences device is fabricated have an established history of use in medical applications, and the specific materials used by Implant Sciences have been thoroughly tested in accordance with applicable guidelines. |
| Equivalence in design and function to predicate devices. | The device uses the same titanium capsule material and has the same physical dimensions (length and diameter) as predicate devices. The range of apparent activity levels is similar. The device is substantially equivalent in design and function to the specified predicate devices. |
Note: The "acceptance criteria" here are based on engineering and safety standards for the device itself, rather than a clinical performance metric like sensitivity or specificity for a diagnostic device.
Study Information
The provided text describes in vitro studies and comparisons to predicate devices, but not a clinical study with human subjects, a test set, or expert-established ground truth in the context of diagnostic or prognostic performance. The focus is on demonstrating physical and functional equivalence and safety according to engineering standards.
Here's what can be extracted based on the document:
-
Sample size used for the test set and the data provenance: Not applicable in the traditional sense of a clinical test set. The data provenance is related to in vitro studies and standardized tests performed by the manufacturer. The document doesn't specify sample sizes for these in vitro tests (e.g., how many seeds were tested for impact resistance).
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" here is compliance with engineering standards (ANSI/HPS N43.6 - 1997) and consistency with known properties of similar devices.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
-
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 device is a brachytherapy seed, not an AI-assisted diagnostic tool.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's evaluation is primarily adherence to established engineering and safety standards for sealed radioactive sources (ANSI/HPS N43.6 - 1997) and comparison to the known characteristics and performance of legally marketed predicate devices.
-
The sample size for the training set: Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.
-
How the ground truth for the training set was established: Not applicable.
§ 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.