(112 days)
Nova Surface Applicator is indicated for and intended to be placed on the patient's skin to navigate an HDR radiation source during the treatment of various types of cancer using brachytherapy.
The device is for a single patient's use only and can be reused throughout the entirety of the treatment plan.
The device is designed by radiation therapy professionals using patient imaging data as input and must be verified and approved by the trained radiation therapy professional prior to use.
The device is restricted to sale by or on the order of a physician and is by prescription only.
Adaptiv's Nova Surface applicator is a 3D printed patient-matched radiation therapy accessory that expands the application of brachytherapy by providing a patient-specific fit and catheter trajectory design.
Patient imaging data from the treatment planning system (TPS) are used as inputs to generate digital design of the surface brachytherapy applicator by 3D Brachy Software Application (K213438), previously developed by Adaptiv. The resulting output Stereolithography (STL) file is compatible with the third-party 3D printers.
Nova Surface applicator navigates a radiation source toward tumors located closely to or on the surface of the body (e.g. skin cancers). It fits the patient's anatomy by means of a patient-specific contact surface ensuring that optimal dose is delivered to a target surface of the body. It accommodates catheter tunnels which guide the HDR brachytherapy radiation source according to the patient-specific design input chosen by users.
A surface brachytherapy applicator device is 3D printed by Stereolithography (SLA) technology using methacrylic resin.
It appears there might be a misunderstanding. The provided text is a 510(k) clearance letter and its associated summary for a medical device (Nova Surface Applicator). This document does not describe a study involving an AI algorithm or a multi-reader, multi-case (MRMC) comparative effectiveness study.
The device in question, the Nova Surface Applicator, is a 3D-printed accessory for brachytherapy that navigates a radiation source. The performance testing described is focused on the physical characteristics and accuracy of this manufactured device, not on the performance of a diagnostic AI algorithm.
Therefore, I cannot provide information on:
- Table of acceptance criteria and reported device performance for an AI algorithm: The criteria listed are for physical properties and fit, not for diagnostic accuracy (e.g., sensitivity, specificity).
- Sample size for test set and data provenance for an AI algorithm: There's no mention of a test set for an AI. The "worst-case samples" and "real patient datasets" refer to the physical testing of the applicator itself.
- Number of experts and their qualifications for ground truth establishment for an AI algorithm.
- Adjudication method for an AI algorithm test set.
- MRMC comparative effectiveness study or effect size of AI assistance.
- Standalone AI algorithm performance.
- Ground truth type for an AI algorithm.
- Sample size for the training set for an AI algorithm.
- How ground truth for the training set for an AI algorithm was established.
The document describes non-clinical performance testing for a physical medical device. Here's what can be extracted about the device's acceptance criteria and testing:
Device: Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA) - a 3D printed patient-matched radiation therapy accessory.
Purpose: To be placed on the patient's skin to navigate an HDR radiation source during the treatment of various types of cancer using brachytherapy.
Acceptance Criteria & Reported Device Performance (Based on Non-Clinical Tests):
| Acceptance Criteria Category | Specific Criteria/Test Description | Reported Device Performance/Conclusion |
|---|---|---|
| Post-production verification (Physical Inspection & Functional Tests) | - Look, feel, surface quality: Ensure acceptable physical appearance and tactile properties. | Demonstrated conformance to requirements. |
| - Inner structure consistency (mass consistency and dimensional fidelity): Verify that the internal structure of the 3D printed device is uniform and accurately reproduces the designed dimensions. | Demonstrated high printing accuracy of key functional features and functional key property (density of the material after printing) in conformance with performance requirements. | |
| - Functionality of catheter tunnel accessibility, orientation, inter-tunnel, and source-to-surface distances: Ensure that the tunnels for guiding the radiation source are correctly formed, accessible, oriented as designed, and maintain specified distances. | Demonstrated high printing accuracy of key functional features. | |
| - Labels legibility: Verify that all labels on the device are clear and readable. | Results not explicitly detailed for this point, but implied by overall positive conclusion. | |
| - Additional features functionality (dosimetry pockets and alignment guides): Ensure any other designed features perform as intended. | Results not explicitly detailed for this point, but implied by overall positive conclusion. | |
| Simulated performance testing (Spatial Fidelity & Fit) | - Evaluation of spatial fidelity and fit of patient-specific devices: Virtuallý positioning a CT scan of the device with respect to a DICOM-RT structure representing the patient's anatomy to ensure accurate fit and spatial relationship. This ensures the "patient-specific contact surface" provides enough accuracy to fit the patient's anatomy. | Demonstrated high accuracy in terms of spatial fidelity, providing a precise fit of the device on the patient's anatomy and successful delivery of radiation to the treatment target tissues. The technological and validation methods used are considered applicable to ensure product quality during the production process. Performance testing results demonstrate substantial equivalence to the predicate device and are considered evidence of overall safety and effectiveness. |
| Material & Manufacturing Process | - SLA technology and material compatibility: Ensure that Stereolithography (SLA) technology and methacrylic resin are suitable for manufacturing and do not negatively impact safety and effectiveness. | All tests verified that the chosen manufacturing technology performed as intended and did not affect the overall safety and effectiveness of the device, and are beneficial compared to the previously used technology (FDM and PLA for predicate). SLA offers high accuracy/tolerance, smoother surface finish, and transparency. |
Other Available Information from the Provided Text (NOT related to AI):
- Sample size used for the test set: The document states "The batch of the tests has been performed on worst-case samples as well as on the final device real patient datasets." No specific number for "worst-case samples" or "real patient datasets" is provided.
- Data provenance: Not explicitly stated for the "real patient datasets" (e.g., country of origin). The testing is described as non-clinical.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is a physical device test, not a diagnostic accuracy study. The device design process mentions it's "designed by radiation therapy professionals using patient imaging data as input and must be verified and approved by the trained radiation therapy professional prior to use." This refers to clinical use and design, not the test itself.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted, as this is not an AI diagnostic device.
- Standalone (i.e. algorithm only without human-in-the-loop performance): Not applicable, as this is a physical medical device, not an algorithm.
- The type of ground truth used: For the physical device testing, the "ground truth" seems to be the designed specifications and the expected physical and functional performance of the applicator. For the simulated performance, the "ground truth" is the patient's anatomy as represented by the DICOM-RT structure.
- The sample size for the training set: Not applicable; this device is manufactured from a design based on patient imaging data, not trained like a machine learning model.
- How the ground truth for the training set was established: Not applicable. The device is designed based on patient-specific imaging data as input into the Adaptiv's 3D Brachy Software Application.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.