(64 days)
The applicators will be used with the VariSource High Dose Rate Afterloaders to deliver brachytherapy treatment for gynecological and rectal applications. The applicators will be used in medical intracavitary for treatment of cancerous tumors.
The applicator sets in this submission are designed to be used with the VariSource High Dose Rate Afterloaders to deliver brachytherapy treatment for gynecological and rectal applications. The applicators will be used in medical intracavitary for treatment of cancerous tumors. The Intracavitary applicators are designed to be inserted into a body cavity. Six intracavitary applicator sets are included in this submission.
The provided text is a 510(k) Summary for Intracavitary Brachytherapy Applicators. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific performance acceptance criteria through a clinical study with detailed statistical outcomes.
Therefore, many of the requested details about acceptance criteria, specific study design, sample sizes, expert involvement, and ground truth establishment are not typically included or required in a 510(k) Summary for a device like this. The focus is on comparing the new device to an existing one regarding intended use and technological characteristics.
Here's an analysis based on the information available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the context of this 510(k) submission. A 510(k) for a device like these brachytherapy applicators does not typically establish performance acceptance criteria with numerical targets. Instead, the "performance" criteria are met by demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics (materials), and safety. The letter from the FDA confirms that the device was found substantially equivalent.
| Acceptance Criteria (Inferred from 510(k) Process) | Reported Device Performance (from text) |
|---|---|
| Substantial Equivalence to Predicate Device (K983436) in materials. | "The applicators are identical or equivalent to the predicate devices in materials." |
| Substantial Equivalence to Predicate Device in intended use (gynecological and rectal brachytherapy for cancerous tumors). | The intended uses described for each applicator (e.g., "treatment of cancerous gynological tumors", "treat cancer of the vagina or rectum") align with typical brachytherapy applications, implicitly similar to the predicate. |
2. Sample size used for the test set and the data provenance
Not applicable. This 510(k) summary does not describe a clinical performance study with a test set of data. The "test" for a 510(k) is the comparison of the device's characteristics to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No test set requiring expert ground truth establishment is described in this 510(k) summary.
4. Adjudication method for the test set
Not applicable. No test set or adjudication method is described.
5. 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 passive medical device (brachytherapy applicators), not an AI-powered diagnostic or interpretive system. No MRMC study was conducted or is relevant for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. There is no performance study where "ground truth" for a dataset would be established. The "truth" in a 510(k) is the demonstration that the new device is as safe and effective as the predicate device, primarily through comparison of design, materials, and intended use.
8. The sample size for the training set
Not applicable. This 510(k) summary does not describe an AI/ML algorithm or a training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set mentioned, no ground truth for it would be established.
§ 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.