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The Mick Radio-Nuclear Instruments, Inc. CT HDR Tandem/Ring Applicator with Rectal Retractor is indicated for High Dose Rate irradiation of the uterus and cervix. The modification that precipitated this Special 510(k) does not alter the indications for use.

The Mick Radio-Nuclear Instruments, Inc. CT HDR Tandem/Ring Applicator with Rectal Retractor is intended for use in Brachytherapy. It is indicated for use where high dose rate (HDR) irradiation of the uterus and cervix is an accepted clinical practice. The applicator is designed to be compatible with the sealed sources found in High Dose Rate After-Loaders and do not modify or change the source, source packaging or remote source positioning mechanisms found on these after-loaders.

The applicator presents a stable and flexible delivery system for the administration of high dose rate irradiation of cancers of the uterus and cervix. The applicator offers several treatment options by including three different angles of Rings (30°, 45° & 60°) and nine different Tandems. The Tandems are offered in complementary angles to the three rings and in three different Tandem lengths for each angle (2cm, 4cm & 6cm from the ring axis). In addition, there are two sizes of Build-Up Caps (5mm & 7.5mm) that affix to the Rings that offer shielding to patient tissue and a Rectal Retractor is included. The entire applicator system is housed in a specially designed Sterilization Cassette, meant for both storage and sterilization. This applicator has been cleared by FDA since 2003.

The modification presented in this Special 510(k) allows for the removal of the paddle portion of the Rectal Retractor from the Rectal Retractor assembly. This facilitates easier cleaning by the user to prevent potential build-up of soil in the paddle. There are no other impacts to the applicator system in this modification. The intended use is unchanged.

The modification to a two-piece Rectal Retractor design is controlled through the Mick Radio-Nuclear design controls and is manufactured onsite at Mick Radio-Nuclear Instruments, Inc. The two-piece Rectal Retractor design does not introduce any new risks or potential negative impacts to the overall performance of the applicator.

The provided document is a Special 510(k) Summary for a medical device (CT HDR Tandem/Ring Applicator with Rectal Retractor). This type of submission is for modifications to a legally marketed device that do not affect its intended use or fundamental scientific technology, and do not introduce new risks or alter performance.

Therefore, the document explicitly states that the in vitro and in vivo testing is "Not applicable to the modification for the device." This means there was no new study proving the device (or its modification) meets acceptance criteria in the traditional sense of clinical performance or diagnostic accuracy studies.

The acceptance criteria and performance are inherently assumed to be met via substantial equivalence to the predicate device because the modification is minor (a two-piece rectal retractor for easier cleaning) and does not impact performance.

Given this context, I cannot provide all the requested information, as a comprehensive performance study with specific acceptance criteria and detailed reporting on sensitivity, specificity, or similar metrics was not conducted or required for this type of submission.

Here's what can be extracted based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• None. As explicitly stated in the document: "In vitro Testing Not applicable to the modification for the device." and "In vivo Testing Not applicable for the modification for the device." This type of submission relies on design changes and substantial equivalence to a predicate device, not new performance studies.

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 or ground truth was established for a new performance study.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not Applicable. No test set was used.

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 mechanical applicator, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This device is a mechanical applicator; there is no algorithm for standalone performance testing in this context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not Applicable. No new performance study requiring ground truth was conducted. The ground truth for the predicate device's safety and effectiveness was established through its prior clearance (K030110), likely including clinical acceptance, material testing, and design validation appropriate for that time.

8. The sample size for the training set:

• Not Applicable. No training set was used, as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

• Not Applicable. No training set was used.

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The Mick Radio-Nuclear Instruments, Inc. CT HDR Tandem/Ring Applicator with Rectal Retractor is intended for use in Brachytherapy. The delivery of intra-cavitary radiation therapy requires not only proper visualization and localization of the applicator within the treatment volume, but precise dosimetry and a stable delivery system from which treatment can be administered. The Mick Radio-Nuclear CT HDR Tandem/Ring Applicator with Rectal Retractor meets these requirements.
The Mick Radio-Nuclear Instruments, Inc. CT HDR Tandem/Ring Applicator with Rectal Retractor is indicated for High Dose Rate irradiation of the uterus and cervix.

The Mick Radio-Nuclear Instruments, Inc. CT HDR Tandem/Ring Applicator with Rectal Retractor is intended for use in Brachytherapy. The delivery of intra-cavitary radiation therapy requires not only proper visualization and localization of the applicator within the treatment volume, but precise dosimetry and a stable delivery system from which treatment can be administered. The Mick Radio-Nuclear CT HDR Tandem/Ring Applicator with Rectal Retractor meets these requirements.

The provided document is a 510(k) premarket notification for a medical device (CT HDR Tandem/Ring Applicator with Rectal Retractor). It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily focuses on establishing substantial equivalence to a predicate device, which is a regulatory pathway for certain medical devices in the US. This pathway generally relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring new clinical studies to prove specific performance criteria.

Therefore, I cannot extract the requested information from this document. The sections you asked for, such as:

• A table of acceptance criteria and reported device performance
• Sample size and data provenance for a test set
• Number and qualifications of experts for ground truth
• Adjudication method
• MRMC comparative effectiveness study results
• Standalone algorithm performance
• Type of ground truth used
• Sample size for training set
• How ground truth for the training set was established

... are not present in this regulatory filing. This type of filing typically provides a summary of safety and effectiveness based on comparison to existing devices, design similarities, and sometimes bench testing, but not detailed clinical study reports with acceptance criteria and performance data in the way you've described for an AI/software-based device.

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