(133 days)
The Titanium Fletcher-style Applicator Set - Defined Geometry is indicated for use for cancer treatment of the uterus, cervix, paracervix, endometrium and vagina using HDR or PDR brachytherapy.
The Smit Cervical Sleeves are indicated for use where any intrauterine tandem is used for HDR or PDR brachytherapy.
The Titanium Fletcher-style Applicator Set – Defined Geometry is intended for use for cancer treatment of the uterus, cervix, paracervix, endometrium and vagina when performing HDR or PDR brachytherapy.
The device does not contain or consist of software/firmware. The device does not contain any biologics or drug components. The device has patient-contacting materials. The device is designed for repeated use. No parts of the system are provided sterile. The device can be steam sterilized with common parameters using pre-vacuum sterilization.
The Titanium Fletcher-Style Applicator Set Defined Geometry includes patients whose cancer can be treated using HDR or PDR brachytherapy, as determined by the prescribing physician. The Titanium Fletcher-Style Applicator Set Defined Geometry is intended to be used in a healthcare or treatment facility by trained and qualified personnel.
This 510(k) submission is also inclusive of the Smit Cervical Sleeve which is an optional component that may be used with the Titanium Fletcher Style Applicator Set Defined Geometry but is not required to successfully perform the intended use.
The provided text describes a 510(k) premarket notification for a medical device, the "Titanium Fletcher-Style Applicator Set Defined Geometry" and "Smit Cervical Sleeves" by Varian Medical Systems, Inc. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that a new AI/software-based device meets specific acceptance criteria through a clinical study.
The acceptance criteria and study information requested in your prompt (e.g., sample size for test sets, data provenance, number of experts for ground truth, MRMC study, standalone performance, ground truth types for training/test sets) are highly relevant for AI-powered medical devices (software as a medical device - SaMD). However, this 510(k) submission is for a physical medical device used in brachytherapy, not an AI or software device.
Therefore, many of the specific questions in your prompt are not applicable to this non-AI medical device submission. The document details the device's technical specifications, intended use, indications for use, and a comparison to a predicate device to argue for substantial equivalence. The "performance testing" mentioned is primarily non-clinical (biocompatibility, MR compatibility, cleaning/sterilization, human factors, mechanical/acoustic testing), focusing on the device's physical properties and safety, not its diagnostic or therapeutic performance in a statistical sense that would require large clinical studies with ground truth derived from experts or pathology.
Here's a breakdown based on the provided text, addressing the points where information is available and noting where it's not applicable:
Acceptance Criteria and Device Performance (for a non-AI physical device)
The concept of "acceptance criteria" for this type of physical device is framed around demonstrating that its design and performance characteristics are equivalent to or do not raise new questions of safety and effectiveness compared to a legally marketed predicate device. The "performance" is primarily assessed through non-clinical laboratory testing to ensure physical integrity, material compatibility, and functionality within its intended use.
Table of Acceptance Criteria and Reported Device Performance (as inferred for a non-AI device through a 510(k))
| Acceptance Criteria Category (Inferred from 510(k) process for physical devices) | Specific Criteria (Implicit for Substantial Equivalence) | Reported Device Performance/Compliance |
|---|---|---|
| Intended Use & Indications for Use Equivalence | Device's intended use and indications for use are substantially similar to predicate, or differences do not raise new safety/effectiveness questions. Added paracervix. | Claimed: "Although this change adds an additional anatomical site, the manner in which the device is used is consistent with the anatomical area that was originally cleared and does not introduce an additional risk of being used in a generalized treatment application. The overall intended use to treat cancer with brachytherapy is unchanged." (p. 1 |
| Material Biocompatibility | Materials are biocompatible for patient contact. | Compliance: Meets ISO 10993-1 and applicable parts. |
| MR Compatibility | Device is safe for use in magnetic resonance environments. | Compliance: MR Conditional; complies with ASTM F2503-23. |
| Cleaning, Disinfection, and Sterilization (CDS) | Device can be effectively cleaned, disinfected, and sterilized; maintains integrity over specified cycles. | Demonstrated: Testing conducted to show effective sterilization and durability for specified cycles (e.g., sterilization cycle updated to 250 & 500 times from 100 & 500 times). |
| Human Factors/Usability | Device performs as intended for intended users, uses, and use environments. (Non-clinical validation) | Demonstrated: Human factors validation study conducted per IEC 62366. |
| Mechanical Integrity/Performance | Device maintains structural integrity and performs its mechanical functions as designed. | Demonstrated: Formal design validation testing, design verification testing, and design validation testing confirming performance as intended, in accordance with FDA QSR (21 CFR §820), ISO 13485, and ISO 14971. |
| Compatibility with Afterloaders | Device is compatible with specified brachytherapy afterloaders. | Confirmed: Compatible with GammaMedplus Series, VariSource Series, and addition of BRAVOS Afterloader System. |
| Safety Standards Compliance | Device conforms to relevant safety and performance consensus standards. | Compliance: Utilized FDA-recognized voluntary consensus standards including ISO 13485, ISO 14971, ISO 15223-1, ISO 20417, IEC 62366-1, ISO 11737-2, ISO 17664-1, ISO 11607-1, ISO 17665-1, various ISO 10993 parts, EN 60601-1, and EN 60601-2-17. (p. 10-11) |
Study Information (as applicable to a non-AI physical device 510(k) submission):
-
Sample size used for the test set and the data provenance:
- N/A (for clinical performance data): This is a submission for a physical device, not an AI/software device requiring a clinical test set for performance evaluation (e.g., diagnostic accuracy). The "testing" refers to non-clinical lab tests (biocompatibility, MR, mechanical, sterilization, human factors).
- For the non-clinical tests (e.g., sterilization cycles, human factors study), the sample size would be determined by the specific ISO/ASTM standards referenced, but typically isn't a large "test set" in the sense of clinical cases. The document does not specify these sample sizes.
- Data Provenance: Not applicable in the context of clinical data for a physical device. Testing is conducted in a laboratory environment, not on patient data from specific countries.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A: Ground truth established by medical experts is not listed as a component of this non-AI device's performance testing for 510(k) clearance. The device's "performance" is assessed through engineering testing against physical and safety standards and comparison to a predicate.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A: Not applicable as there is no clinical test set requiring expert adjudication for accuracy or 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:
- No: This is not an AI-powered device, so an MRMC study comparing human performance with and without AI assistance was not conducted.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A: This is a physical medical device, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A: "Ground truth" in the sense of clinical reference standards (pathology, expert consensus) is not applied to this type of 510(k) submission for a non-AI physical device. The "truth" or reference is established by engineering specifications, material standards, and functional test results (e.g., "does it sterilize correctly?", "is it MR compatible?").
-
The sample size for the training set:
- N/A: This is not a machine learning/AI device, so there is no training set in the AI sense.
-
How the ground truth for the training set was established:
- N/A: Not applicable.
In summary: The provided document is a 510(k) letter for a physical brachytherapy applicator set, demonstrating substantial equivalence to a predicate device. The regulatory pathway for such devices involves rigorous non-clinical testing (e.g., material testing, mechanical testing, sterilization validation) and a comparison of technical characteristics to a predicate, rather than large-scale clinical performance studies or AI-specific validation methods outlined in your prompt.
§ 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.