(28 days)
The VariSource Breast Template System is indicated for high-dose rate Brachytherapy irradiation of the breast or chest wall. The system offers a means of performing interstitial implants with a fixed geometry, for the treatment of breast carcinoma. A pair of a series of Templates are fixed in place relative to one another with the Breast Bridge. The Breast Bridge is also used to hold the Templates over the breast during needle insertion and can be adjusted, via a ratchet mechanism to achieve the required template spacing.
The Breast Bridge and Template System is designed to make implanting needles, particularly through the breast, in a fixed geometric pattern easily achievable. The design places templates with holes in a triangular pattern (Paris geometry) on either side of the breast. A ratchet mechanism holds these templates in place while needles are implanted through the Breast. The Needles are NOT part of this product. This product is simply a tool to make it easy to insert needles in a fixed pattern.
The provided document is a 510(k) Premarket Notification for the "VariSource Breast Template System". This type of document is for medical devices and focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through clinical studies in the same way an AI/ML device would.
Therefore, many of the requested categories for AI/ML device performance and study design are not applicable (N/A) to this 510(k) submission. There is no mention of an algorithm, AI, or machine learning in the document.
Here's the breakdown based on the information provided:
- A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document does not explicitly state "acceptance criteria" in terms of performance metrics like sensitivity, specificity, accuracy, etc. for an AI/ML system. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device, as per 21 CFR 807.92. The "acceptance" is that the device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to the predicate.
- Reported Device Performance: The document provides a "Specification Comparison Chart" (Tab G, not fully included in the snippets, but summarized in the "SDD FEATURE COMPARISON" table). This chart compares features of the new device (VariSource Breast Template System) to its predicate device (Applicators for Varian VariSource Remote High Dose Rate Afterloader – Interstitial Needle Applicator). Performance is primarily assessed through a comparison of technical characteristics and safety aspects, not through quantifiable performance metrics for an AI system. For example, it compares materials, sterilization methods, and anatomical sites.
| Feature | Varian Breast Bridge and Template System (Proposed Device) | Predicate Device |
|---|---|---|
| Intended use | HDR Brachytherapy | HDR Brachytherapy |
| Indications for use | For high-dose rate Brachytherapy irradiation of the breast or chest wall. Offers a means of performing interstitial implants with a fixed geometry for the treatment of breast carcinoma. A pair of templates are fixed relative to one another with the Breast Bridge, which also holds templates over the breast during needle insertion and can be adjusted via a ratchet mechanism to achieve required template spacing. | See above (implied same as new device for the relevant anatomical sites) |
| Design | Designed to make implanting needles, particularly through the breast, in a fixed geometric pattern easily achievable. Places templates with holes in a triangular pattern (Paris geometry) on either side of the breast. A ratchet mechanism holds these templates in place while needles are implanted through the Breast. Needles are NOT part of this product. This product is simply a tool to make it easy to insert needles in a fixed pattern. | Interstitial Needle Applicators (implies a more direct applicator for needles) |
| Materials | Stainless Steel ratchet, polycarbonate (USP class VI approved) templates | Stainless Steel |
| Performance | N/A (No specific performance data beyond design and material properties are provided as per 510(k) requirements for this type of device) | N/A |
| Sterility | Autoclave (Device not supplied sterile, validated for autoclave sterilization) | Autoclave (Predicate device's needles are supplied sterile via gamma radiation at 10⁻⁶ SAL) |
| Biocompatibility | Fully biocompatible Stainless Steel and Polycarbonate used. | Fully biocompatible Stainless Steel used. |
| Anatomical sites | Breast, Chest Wall | Breast, Chest Wall and others including Prostate. |
| Compatibility with other devices | Uses 18 gauge needles | Includes 18 gauge needles |
-
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. This is a mechanical device (template system), not an AI/ML algorithm. There is no "test set" in the context of evaluating algorithm performance. The evaluation is based on structural and functional comparison to a predicate device.
-
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)
- N/A. No ground truth establishment by experts for a test set is mentioned for this mechanical device.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No test set or adjudication method outlined for algorithm performance.
-
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
- N/A. This device is not an AI system. No MRMC study was performed or is applicable.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a mechanical device, not an algorithm.
-
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- N/A. Ground truth for algorithmic evaluation is not applicable here. The "truth" in this submission relates to the equivalence of the device's characteristics and safety profile to the predicate device.
-
The sample size for the training set
- N/A. There is no training set as this is not an AI/ML device.
-
How the ground truth for the training set was established
- N/A. No training set or ground truth establishment for a training set.
Summary of the Study/Evaluation:
The "study" in this 510(k) revolves around demonstrating substantial equivalence to a predicate device, not proving performance of an AI/ML system.
- Study Type: Substantial Equivalence Comparison (based on design, materials, intended use, and general safety/effectiveness characteristics).
- The manufacturer compares the "VariSource Breast Template System" to the "Applicators for Varian VariSource Remote High Dose Rate Afterloader – Interstitial Needle Applicator."
- The comparison focuses on technical characteristics, such as:
- Intended Use and Indications for Use (which are stated to be the same, allowing for fixed geometry interstitial implants for breast carcinoma).
- Design (the new device provides a fixed geometric pattern for needle insertion, unlike the predicate's direct needle applicators).
- Materials (both use stainless steel; the new device also uses USP class VI approved polycarbonate for templates).
- Sterility (the new device is autoclavable, the predicate's needles are gamma sterilized).
- Biocompatibility (both use biocompatible materials).
- Anatomical sites (breast and chest wall for both, predicate also prostate).
- Compatibility with other devices (both use/include 18 gauge needles).
The conclusion of the "study" (i.e., the basis for the FDA's clearance) is that the VariSource Breast Template System is substantially equivalent to the predicate device, meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.