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510(k) Data Aggregation
(414 days)
The CT/MR M.A.C Interstitial GYN Template is indicated for high dose rate irradiation of vaginal, endometrial and urethral cancers. It is intended to provide a needle guidance system for the introduction of needles and a vaginal obturator into the treatment site.
The CT/MR M.A.C. GYN Interstitial Template Set includes a labeled template, a slotted channel Vaginal Obturator, a set of intrauterine tubes in different angles, locking collets to accommodate both peripheral needle channels in the Template and needle channels in the central Vaginal Obturator, an Allen wrench to lock the intrauterine tube in the Obturator and a collet wrench to securely affix the needles by way of individual collets to both the Template and the vaginal obturator. The set features an Obturator - Template design with an optional intrauterine tube enabling complete or targeted treatment of the vagina, cervix, endometrium and parmetrium.
This is a 510(k) premarket notification for a medical device (CT/MR M.A.C. Interstitial GYN Template), not a study analyzing its performance against acceptance criteria in the manner typically seen for AI/ML devices or diagnostic tools. Therefore, much of the requested information (e.g., sample sizes, expert qualifications, ground truth methods, MRMC studies) is not applicable or cannot be extracted from this document.
However, I can extract information related to the device's technical specifications and non-clinical testing for compatibility.
Here's a summary of the available information and an explanation of the non-applicable sections based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
For a device like this, acceptance criteria primarily relate to its material properties, compatibility with other medical equipment (CT/MR), and functional design for its intended use (needle guidance system). The document reports the results of non-clinical testing to demonstrate these compatibilities.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| CT Compatibility: Minimal artifacts allowing for clinical use. | "CT compatibility testing has been performed and the results of the testing reveal very little artifacts and clinicians have certified that the CT images are not negatively impacted by artifacts due to the presence of the CT/MR M.A.C. Interstitial GYN Template and are of sufficient quality for use in the radiation therapy clinical workflow." |
| MR Compatibility (Displacement): Displacement force less than gravity. | "The calculated displacement force corresponded to an assumed displacement of 1 degree and the calculated force in all cases was less than that associated with gravity, in accordance with the relevant standard." |
| MR Compatibility (Torque): No significant torque effect. | "No torque effect was observed on the CT/MR M.A.C. Interstitial GYN Template with associated devices at approximate isocenter of the 3.0T magnet when the device was caused to rotate through three complete revolutions." |
| MR Compatibility (Image Artifacts): Limited image artifact extent. | "For image artifacts, the maximal extent of artifact associated with portions of the device expected to be within the body of the patient was 4.8cm on a 3.0T gradient-echo image. Observed artifacts were consistent with expectations due to the metallic construction." |
| MR Compatibility (Heating): Temperature rise within safe limits. | "Heating testing was performed using both the 1.5T and 3.0T scanners and the results of the testing indicate that with the application of a limitation to the Normal Operating Mode at a SAR of 1.0W/kg, the largest expected total temperature rise at the limiting field strength, with 15 minutes of scanning is less than 6°C. This level of heating is not expected to cause adverse effects. All comprehensive test data and results are on file." |
| Biocompatibility: No new issues; medical grade materials. | "No new issues of biocompatibility are raised with regard to the introduction of the CT/MR MAC Interstitial GYN Template. Medical grade materials are used in the manufacture of this device. However, biocompatibility testing has been performed on an applicator made from the same materials as the CT/MR MAC Interstitial GYN Template and considered a worst case scenario from device construction." (The document states no new issues, implying existing acceptance for these materials, and confirms testing was done.) |
| Manufacturing Standards: Compliance with GMP. | "This device is manufactured according to Good Manufacturing Practices (GMPs) as defined in 21CFR part 820." (This is a statement of compliance rather than a performance measurement). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and not provided in the document as it describes non-clinical engineering and materials testing for device compatibility rather than a clinical study evaluating diagnostic or interpretive performance. The testing was performed in a "non-clinical environment."
3. 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)
This information is not applicable and not provided. "Clinicians have certified that the CT images are not negatively impacted," but no specific number or qualifications are given, nor is it a "ground truth" establishment in the context of diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided.
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
This information is not applicable and not provided. This device is a physical medical instrument, not an AI/ML algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable and not provided. For non-clinical compatibility testing, "ground truth" would relate to precise measurements of physical properties (e.g., actual temperature rise, actual displacement force) against an expected standard, rather than clinical ground truth for a diagnostic outcome. The document states "All comprehensive test data and results are on file," implying these measurements were taken but not detailed here.
8. The sample size for the training set
This information is not applicable and not provided. This is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not applicable and not provided. This is not an AI/ML device.
In summary, the provided document details a 510(k) premarket notification for a physical medical device. The "study" refers to non-clinical compatibility testing (CT, MR, biocompatibility) rather than a clinical performance study with human subjects or an AI/ML model evaluation. Therefore, many of the typical acceptance criteria and study design elements requested would not be found in this type of submission.
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