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The Mould Applicator Set is indicated for IORT, interstitial and intraluminal treatments of cancer and treatments of cancer or other superficial disease using HDR or PDR brachytherapy.

The Mould Applicator Set is an applicator for intraoperative, interstitial, intraluminal or surface brachytherapy. 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 Mould Applicator Set can be steam sterilized with common parameters using Pre-vacuum sterilization. The mould probes Ø 2.8mm (GM11002280), which are part of the set, have a maximum implantation time of up to 24 hours. According to ISO 10993-1 they are categorised as medical devices, external communicating with tissue/bone communicating and a limited contact duration (A). They can be steam sterilized and used 25 times. The mould probes Ø 1.8mm (GM11002290) have a maximum implantation time of up to 7 days. According to ISO 10993-1 they are categorised as a medical device, external communicating with tissue/bone communicating and prolonged contact duration (B). When steam sterilised, they are a single use product and can be used for IORT, interstitial and intraluminal treatments. If only disinfected the probe can be used up to 10 times for treatment of superficial diseases. The Mould Applicator Set is CT compatible. The Mould Applicator Set is MR conditional for 1.5 and 3 Tesla when the mandrins have been removed from the mould probes after insertion in the patient.

The provided document is a 510(k) Premarket Notification for a medical device called "Mould Applicator Set" manufactured by Varian Medical Systems, Inc. The document primarily focuses on establishing substantial equivalence to a predicate device (GammamedPlus HDR Afterloading System).

Based on the content, here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the tests performed within a section titled "Non Clinical Tests Bench Testing." The acceptance criteria are implied by statements such as "demonstrate that..." and "conformance to applicable requirements and specifications." The reported performance is the positive conclusion that all tests met these criteria.

2. Sample Size Used for the Test Set and Data Provenance:

The document explicitly states: "No clinical tests have been included in this pre-market submission." Therefore, there is no sample size for a test set of patient data, nor is there any provenance information for such data. The testing mentioned (bench testing) would have used physical samples of the device components. The number of such samples is not specified.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Since no clinical studies were performed, there was no expert review of patient data to establish ground truth in the context of diagnostic or treatment efficacy. The "experts" involved would have been the engineers and testers performing the bench tests, verifying compliance with technical standards and design specifications. Their specific number or qualifications are not detailed.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication was used. The bench testing would involve direct measurement and verification against predefined technical specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study was conducted. The document states, "No clinical tests have been included in this pre-market submission." Therefore, there is no information about the effect size of AI improving human readers' performance, as the device is a physical applicator and not an AI-assisted diagnostic or treatment planning tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. The device is a physical "Mould Applicator Set" for brachytherapy, not a software algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The device itself is designed to perform its function (guiding a radioactive source) without continuous human intervention during the source guidance, but it is always used by a human operator within a clinical workflow.

7. Type of Ground Truth Used:

For the non-clinical bench tests, the ground truth was based on engineering specifications, design requirements, and recognized industry standards (e.g., ISO 10993 for biocompatibility, IEC 62366 for usability, and internal Varian standards for accuracy and durability).

8. Sample Size for the Training Set:

Not applicable. The "Mould Applicator Set" is a physical medical device, not a machine learning or AI algorithm. Therefore, there is no concept of a "training set" in this context.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, for the same reason as point 8.

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The Intracavitary Mould Applicator Set is intended for use with Nucletron remote afterloading equipment for intracavitary rectal brachytherapy procedures. The applicator set provides a means of delivering the prescribed radiation dose to the treatment area.

The Nucletron Intracavitary Mould Applicator Set as described in this submission is designed for Intracavitary Brachytherapy procedures. The device consists of a disposable silicone cylinder, with eight radial placed catheters to the surface of the cylinder, which is inserted Intracavitary into the target volume, i.e. the rectum. The cylinder is fixated, by using an applicator introduction tool and the filling wires are removed, which protected the catheters from kinking during transport. In the center of the cylinder a central catheter can be placed. X-ray catheters or CT markers are inserted into the application. Radiographic images, planal images or transverse images of the target volume are taken to determine the precise position of the applicator. This information is then used for Brachytherapy treatment planning purposes. The Intracavitary Mould Applicator Set is a closed system to prevent the radioactive source from coming in contact with body fluids. The treatment catheter does not control the radioactive source. The afterloader is the treatment unit, it strictly provides a treatment path for the treatment source. The physicist and the clinical staff verify that the applicator is properly attached prior to treatment. For the first treatment the Intracavitary Mould Applicator Set is attached to the afterloader (treatment head), doing transfer tube. After the applicator is properly attached, a check cable run is performed to ensure that there are no obstructions, which will interest the transfer of the cable run. In a province of cable run, the radioactive source will be transferred into the applicator and the prescribed dose of radiation will be delivered. After the treatment is completed the Intracavitary Mould Applicator Set is removed from the patient. The device uses similar (implantable) materials as in the legally marketed predicate device cited the Freiburger Flap. The device uses similar implant techniques respect to the legally marketed predicate device cited the Miami Vaginal Applicator Set. The Intracavitary Mould Applicator Set is used as an accessory to the Nucletron microSelectron.

Here's an analysis based on the provided document, addressing your request for acceptance criteria and study information.

Important Note: The provided document is a 510(k) summary for a medical device (Intracavitary Mould Applicator Set) that demonstrates substantial equivalence to a predicate device. This type of submission generally does not include rigorous clinical studies with acceptance criteria, sample sizes, and expert ground truth establishment in the same way a de novo or PMA submission would. Instead, it focuses on demonstrating that the new device is as safe and effective as a previously cleared device. Therefore, many of your requested points will either be "Not Applicable" (N/A) or indicate that such detailed studies were not required for this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size: Not applicable. This 510(k) summary does not describe a formal "test set" or a clinical study that would have such a sample size. The substantial equivalence argument is based on comparison of design, materials, and intended use against a predicate device.
• Data Provenance: Not applicable for a traditional test set. The information provided is descriptive of the device and its relation to a predicate device, not data from a specific clinical evaluation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• Number of Experts: Not applicable. No formal ground truth establishment process for a test set is described in this 510(k) summary.
• Qualifications of Experts: N/A.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

• Adjudication Method: Not applicable. No test set requiring expert adjudication 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

• MRMC Study: No. This device is an accessory for brachytherapy and does not involve AI or human "readers" in the diagnostic sense.
• Effect Size: Not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance Study: No. This device is a physical applicator, not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: Not applicable for a formal study. The "ground truth" here is the prior FDA clearance of the predicate device (K953946), implying its safety and effectiveness have already been established. The new device is compared against this established benchmark.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth Establishment: Not applicable.

Summary of the K041715 Submission:

This 510(k) submission for the Nucletron Intracavitary Mould Applicator Set relies entirely on demonstrating substantial equivalence to a previously cleared predicate device (Nucletron's Miami Vaginal Applicator Set, K953946). The key argument is that the new device has:

• The same intended use.
• Similar technological characteristics (design, materials, operating principle).
• Raises no new questions of safety or effectiveness.

Therefore, the submission does not contain or require the types of detailed clinical performance studies (with acceptance criteria, sample sizes, expert ground truth, etc.) that would typically be associated with AI/ML devices or novel high-risk devices undergoing a De Novo or PMA pathway. The "acceptance criteria" are effectively satisfied by a successful argument for substantial equivalence, which the FDA concurred with, allowing the device to be marketed.

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