(28 days)
TheraLoad™ is a sterile prostate-seeding kit containing TheraSeed® (Pd-103) or I-Seed (I-125) seeds and spacers custom loaded according to the treatment plan.
The brachytherapy source is intended to treat localized, unresectable turnors with low to moderate radiosensitivity. Tumors may be recurrent or residual following external beam or excision of primary tumor and may be superficial, intrathoracic (head, neck, lung), or intra-abdominal (pancreas, prostate).
TheraLoad™ is a sterile prostate-seeding kit containing TheraSeed® (Pd-103) or I-Seed (I-125) seeds and bioabsorbable spacers custom loaded according to the treatment plan.
The variable seed spacing available with TheraLoad™ allows the treating medical physicist to specify individual patient prescriptions. The customized order can contain a variable number of seeds and/or spacers (1-12 total components). The treating medical physicist determines the total number of active seeds required for each order.
The spacer material is biocompatible and commonly used in implantable medical devices.
Here's a summary of the acceptance criteria and the study information for the TheraLoad™ Custom Loaded Needles, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on design verification and validation testing to ensure compliance with device performance specifications and safety, as well as substantial equivalence to a predicate device. The acceptance criteria are largely defined by adherence to specific international and national standards related to sterilization, packaging, and microbiological methods. The 'reported device performance' is that the device met these standards and achieved functionality, safety, and substantial equivalence.
| Acceptance Criteria (Standards Adhered To) | Reported Device Performance |
|---|---|
| AAMI TIR 27:2001 (Sterilization of Healthcare Products Radiation - Sterilization - Substantiation of 25 kGy) | Results confirmed design inputs achieved |
| ANSI / AAMI / ISO 11137:1994 (Sterilization of Healthcare Products - Radiation Sterilization) | functionality, safety, and substantial equivalence to predicate device |
| EN 552:1994 (Sterilization of Medical Devices Validation and routine control of sterilization by irradiation) | |
| ANSI / AAMI / ISO 11737-1-1995 (Sterilization of medical devices - Microbiological methods - Part 1) | |
| ANSI / AAMI / ISO 11737-2-1997 (Sterilization of medical devices - Microbiological methods - Part 2) | |
| ISO 11607:2003 (Packaging for terminally sterilized medical devices) | |
| ASTM F1140-00 (Standard Test Methods for internal pressurization failure resistance) | |
| ASTM F1886-98 (Standard Test Method for determining integrity of seals by visual inspection) | |
| ASTM F1929-98 (Standard Test Method for detecting seal leaks by dye penetration) | |
| ASTM F2096-02 (Standard Test Method for detecting gross leaks by internal pressurization - Bubble Test) |
2. Sample size used for the test set and the data provenance:
This document describes a design verification and validation (V&V) study for a medical device. It does not provide specific sample sizes for individual tests. The focus is on demonstrating that the device meets engineering and safety specifications through adherence to recognized standards. The data provenance is implied to be internal testing conducted by Theragenics Corporation as part of their design control process. There is no mention of specific country of origin for test data or whether it was retrospective or prospective in the clinical sense, as this is a device design validation, not typically a clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The "ground truth" for this type of device (brachytherapy needles and spacers) is established by adherence to engineering specifications and international standards for sterilization, packaging, and material properties. It does not involve expert medical interpretation in the same way an AI diagnostic or prognostic device would. The "experts" involved would be engineers, microbiologists, and other technical specialists performing the V&V tests, but their number and specific qualifications are not detailed in this summary.
4. Adjudication method for the test set:
Not applicable. This is a design verification and validation study against established engineering and technical standards, not a clinical study requiring adjudication of expert opinions.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done. This device is a component for brachytherapy and its evaluation focuses on physical and biological safety, not on diagnostic performance or human-in-the-loop clinical effectiveness that would necessitate an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. The device itself is a physical medical product (custom-loaded needles), not a software algorithm or AI system.
7. The type of ground truth used:
The ground truth used for this device is based on engineering specifications, material science, and compliance with recognized international and national standards related to sterilization, packaging integrity, and biocompatibility. For example, for sterility, it relies on microbiological methods and a substantiated sterilization dose (25 kGy) according to AAMI TIR 27:2001 and ISO 11137:1994.
8. The sample size for the training set:
Not applicable. This device is not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established:
Not applicable. This device is not an AI/ML algorithm requiring a training set.
§ 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.