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The Intracavitary/Interstitial System is intended for cancer treatment of the uterus, cervix, and vagina using HDR or PDR brachytherapy.

The Intracavitary/Interstitial System is a device with two (2), hollow, open-ended catheters which connect to applicator sets with ovoids, ring caps or templates on the distal end.

The guide tubes extend outside of the patient. An interstitial needle is guided through the guide tube from outside the patient to an interstitial hole in the applicator. The proximal end of the guide tube contains a fixation mechanism for fixing the needle insertion depth between needle insertion and removal of the implant.

The Intracavitary/Interstitial System is intended to be used with the following required accessories: Plastic Needles (K120341) and Leak Stop Channel Markers (K152018).

I am sorry, but based on the provided FDA 510(k) clearance letter for the Intracavitary/Interstitial System (K250289), there is no information provided regarding acceptance criteria for device performance, nor is there a study described that proves the device meets such criteria in terms of clinical or algorithmic performance.

The document primarily focuses on:

• Administrative details of the 510(k) clearance: Device name, regulation number, product code, date of clearance, contact information.
• Device description and intended use: What the device is and what it's used for (brachytherapy for uterus, cervix, vagina).
• Comparison to a predicate device: Highlighting similarities in intended use, technological characteristics, materials, anatomical sites, MR compatibility, and use environment.
• Non-clinical performance testing: This section details engineering and safety tests like biocompatibility, cleaning/disinfection/sterilization, human factors, mechanical/acoustic, MR compatibility (physical properties under MR, not clinical performance), and electromagnetic compatibility (EMC). It also lists various consensus standards followed during design and evaluation.

Specifically, the document does NOT contain any of the following information requested in your prompt:

1. A table of acceptance criteria and reported device performance related to a clinical outcome or algorithmic performance metric. The "performance data" mentioned is exclusively for non-clinical, engineering, and safety assessments.
2. Sample size used for a test set or data provenance for any clinical performance evaluation. No clinical test set is described.
3. Number of experts, qualifications, or adjudication methods for establishing ground truth. This is relevant for studies involving human interpretation or AI performance assessment, which are not detailed here.
4. Multi-Reader Multi-Case (MRMC) comparative effectiveness study information or effect sizes.
5. Standalone (algorithm only) performance.
6. Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a clinical or AI performance study.
7. Sample size for a training set or how ground truth was established for a training set. These are relevant for AI/ML device submissions, but this document describes a physical medical device, not an AI algorithm for diagnosis or treatment planning.

Conclusion:

The provided 510(k) letter demonstrates that the Intracavitary/Interstitial System (a physical medical device) has undergone various engineering, safety, and compatibility tests to show it is as safe and effective as its predicate. However, it does not detail any clinical performance study, nor does it refer to an AI/ML component where acceptance criteria for diagnostic/prognostic accuracy or human-in-the-loop performance would be relevant. The performance data presented are purely non-clinical validation steps for a hardware device.

Therefore, I cannot populate the requested tables or provide details on the study proving the device meets performance criteria in the way you've outlined, as that information is not present in the given text.

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The Catheter Surface Flap Applicator Set is intended for use for skin cancer treatment using HDR or PDR brachytherapy.

The Catheter Surface Flap Applicator Set is an applicator for Brachytherapy is a form of radiotherapy using Gamma rays from a radioactive source placed at locations close to or within a tumor or other treatment area to a predefined treatment plan. The treatment plan defines the positions and times for the source to ensure the correct dose for the treatment area. The applicator acts to guide the radioactive source to the correct location or locations for treatment.

The key performance characteristics of this applicator set are as follows:

• Surface applicator intended for the treatment of skin cancers.
• A 10mm thick flap allowing for up to 38 channels spaced at 5 mm allows for a large uniform treatment.
• Hollow pattern design and semi translucent material provides good visibility of the treatment area.
• The material high flexibility allows the applicator to conform closely to complex patient anatomies such as when treating nose or ear lesions.
• Silicone material gives excellent biocompatibility and durability.
• Single patient multiple use.
• The Catheter Surface Flap is MR and CT compatible.
• Patient-contacting parts constructed of silicone and Polyvinylchloride; suitably for patient contact for a period up to 24 hours.

The fixation buttons are used for locking the mould probes in place after insertion in the catheter surface flap. Some of these are supplied in the fixation button kits but they are also available to be purchased separately as spares. As spares, they are packed in sterile pouches, with 10 pieces per pouch and sold as pack of 10 pouches respectively.

The provided text is a 510(k) summary for a medical device called the "Catheter Surface Flap Applicator Set (GM11011830)". This document is not a study proving a device meets acceptance criteria for an AI/ML algorithm. Instead, it's a submission to the FDA to demonstrate substantial equivalence to a predicate device, primarily focusing on materials, design, and intended use as an applicator for brachytherapy.

Therefore, I cannot extract the requested information because the document does not contain details about:

• Acceptance criteria for an AI/ML device's performance.
• A study involving a test set, training set, ground truth experts, or MRMC studies for an AI/ML algorithm.
• Any mention of AI or machine learning.

The document discusses non-clinical performance testing for a physical medical device, including biocompatibility, cleaning/disinfection/sterilization, human factors validation, and mechanical/acoustic testing. These are typical tests for a physical medical device, not an AI/ML software device.

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The GM Implant Tubes is indicated for use for irradiation treatments which require a flexible source guiding lumen including treatments of the head, neck, tongue, bladder, gynecology and prostate using HDR or PDR brachytherapy.

The Length Cutting Gauge in its variable length is indicated for use to cut implant tube or breast applicator treatment channels to the correct treatment length.

The GM Implant Tubes, listed in many of the submission document titles, is the family name covering the Flexible Interstitial Implant Tube Set and its required and optional components and the Length Cutting Gauge is an accessory component used with the Flexible Interstitial Implant Tube Set.

The Flexible Interstitial Implant Tube Set (GM11004680) from the GM Implant Tubes includes a variety of flexible implant tube lengths that create the optimal distance between the source and the layers of tissue to be treated. The implant tubes need to be cut down using the length cutting gauge to the required length. The set also includes a number of associated accessories for sterilization (K152018: Leak Stop Button, and Leak Stop Channel Marker Sets).

The provided document is a 510(k) Premarket Notification from Varian Medical Systems, Inc. for "GM Implant Tubes" and "Length Cutting Gauge." It describes the devices, their indications for use, comparison to a predicate device, and a summary of performance data.

However, the document does NOT contain information regarding:

• Specific acceptance criteria (numerical thresholds for performance metrics).
• Reported device performance against such criteria.
• The sample size used for a test set (as no studies evaluating algorithm performance are mentioned).
• Data provenance, number of experts, adjudication methods, or ground truth details for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Training set details (sample size, ground truth establishment) as the device does not employ machine learning or AI.

The document states, "GM Implant Tubes and Length Cutting Gauge do not contain or consist of software/firmware. The devices do not contain any biologics or drug components." Therefore, there is no AI algorithm to evaluate.

The performance data listed pertains to physical device attributes and safety, not algorithm performance. These include:

• Biocompatibility Testing (cytotoxicity, implantation, sensitization, toxicity)
• Sterilization Testing (suitability of design and material for use life and reprocessing cycles, validation/efficacy of cleaning, disinfection, sterilization cycles)
• CT Compatibility Test and Analysis
• Rationale MR Properties

Conclusion:

Based on the provided document, the devices ("GM Implant Tubes" and "Length Cutting Gauge") are purely mechanical/physical medical devices. They do not involve software, firmware, or artificial intelligence. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as they relate to AI/algorithm performance (e.g., sensitivity, specificity, F1-score with associated sample sizes, ground truth, experts, MRMC studies, standalone studies) are not applicable to this submission.

The "studies" conducted and mentioned in the document are non-clinical hardware tests to ensure physical safety, efficacy, and compatibility, such as biocompatibility, sterilization efficacy, and imaging compatibility.

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Heyman Packing Applicator Set is indicated for use for treating endometrial cancer using HDR or PDR brachytherapy.

The Heyman Packing Applicator Set consists of various sized Heyman-capsules which may be connected to compatible brachytherapy afterloaders via guide tubes. The set also includes a number of associated accessories for sterilization (Cleaning Cap, Leak Stop Button, and Leak Stop Channel Marker Sets). The Heyman Packing Applicator Set is intended for cancer treatment of the endometrium using HDR or PDR brachytherapy. The Heyman Packing Applicator Set is an applicator for intracavitary Brachytherapy. The applicator acts to quide the radioactive source to the correct location or locations for treatment.

This document is a 510(k) premarket notification for the Heyman Packing Applicator Set, not a study report that includes specific acceptance criteria and performance data in the format requested. The document outlines the device description, its indications for use, and a comparison to a predicate device. It also lists the non-clinical tests performed to support substantial equivalence.

Therefore, I cannot provide the requested table of acceptance criteria and reported device performance or details about a study proving the device meets those criteria, as this information is not present in the provided text.

Specifically:

1. A table of acceptance criteria and the reported device performance: This information is not provided. The document lists types of non-clinical tests (biocompatibility, sterilization, mechanical, MRI/CT compatibility, afterloader validation) that were performed, but does not detail the specific acceptance criteria for these tests nor the quantitative results that demonstrate meeting those criteria.
2. Sample size used for the test set and the data provenance: Not applicable, as this document describes non-clinical engineering and bench testing, not clinical studies involving test sets, human subjects, or data provenance in that sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set or human expert ground truth was established for this device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical test set or adjudication was performed.
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 medical applicator set, not an AI-assisted diagnostic or interpretation tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a physical applicator, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical ground truth was established for this non-clinical submission. The "ground truth" for the non-clinical tests would be the established scientific and engineering standards for biocompatibility, sterilization, and material compatibility.
8. The sample size for the training set: Not applicable, as this device does not involve a "training set" in the context of an algorithm or machine learning.
9. How the ground truth for the training set was established: Not applicable for the same reason as above.

In summary, the provided document is a regulatory submission for a physical medical device (applicator set) and details non-clinical testing for safety and effectiveness in demonstrating substantial equivalence to a predicate device. It does not contain the kind of clinical study or performance data that would involve acceptance criteria for diagnostic accuracy, expert evaluations, or AI performance metrics.

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