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2/3 Endometrial Applicator Sets: A manual radionuclide applicator system, a manually operated device intended to apply a radionuclide source into the body or to the surface of the body for radiation therapy.

Segmented Vaginal Applicator: The use of sealed Radioisotopes to treat tumors within the body has been documented and published since the turn of the century. Modem era Radiation Therapy has developed delivery systems using isotopes of Cesium, Iridium, Iodine, and Gold to name a few examples. Many tumors are now treated by internal exposure to radiation emitted from sealed radioactive sources.

Two common modalities of this are Low Dose Rate remote afterloading (Brachytherapy). One common use of Brachytherapy is in the treatment of cancer of the vaginal process. The system described in this 510(k) has been developed to function as an applicator for the positioning of sealed sources in the intracavitary treatment of the vagina.

HDR Miami Applicator: This applicator is designed as an accessory to the Varisource System (Varian Associates K952913) and the Gammamed System (K89113) which uses a single radioactive source of Iridium-192 to treat cancer in a wide range of body sites. The Miami Applicator is placed in the vicinity of the cervix via the vagina just as described for the predicate device (Nucletron Miami Vaginal Applicator, K953946) and different diameter sleeves and intrauterine tubes, can be optimized to best meet the clinical needs of the patient along with minimization of dose to the mucosa.

HDR Compatible Tandern and Ovoid Applicators: The applicators presented in this 510(k) notification have been developed to function as Applicators for the positioning of HDR Remote After-Loader sealed sources in the intra-cavitary treatment of cancer of the vagina and cervix.

CT Compatible F/S/D Applicators: CT Compatible F/S/D applicator is indicated for use in any case where high dose rate (HDR) radiation treatment of cancer in the cervix and uterus is an accepted clinical practice.

HDR CT Compatible Split Ring Applicator: The HDR CT Compatible Split Ring type applicator is indicated for use in any case where high dose rate (HDR) radiation treatment of cancer in the cervix and uterus is an accepted clinical practice.

CCT HDR Tandem Ring Applicator with Rectal Retractor: 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.

2/3 Channel Endometrial Applicator Sets: The 2/3 Channel Endometrial Applicator is designed for the treatment of the endometrium and cervix. The applicator set includes 3 intrauterine tubes that are available in 3 cm and 5 cm configurations. These intrauterine tubes can be assembled using only 2 or all 3 intrauterine tubes, depending on the patient requirements. The only change to the device will be the labeling that the device is now MR Conditional.

Henschke Applicator Set: The Henschke Applicator is based on "Henschke style" geometry for brachytherapy of the endometrium and cervix. This applicator is similar in design to the Fletcher Applicator with the exception of semispherical ovoids. These ovoids are ideal for patients with narrow vaginas due to their small size, the ovoid tube is closer to the surface on the side of the cervix while maintaining distance within the fornices. The tandem is inserted into the endometrium at a pre-determined depth and secured in place with the cervical stop. The only change to the device will be the labeling that the device is now MR Conditional.

Fletcher (FSD) Applicator Set: The Fletcher Applicators are based on "Fletcher style" geometry for brachytherapy of the endometrium and cervix. The ovoids are cylindrical to create equal spacing in the vaginal fornices for a symmetrical dose distribution in this area. The tandem is inserted to into the endometrium at a pre-determined depth and secured in place with the cervical stop. The only change to the device will be the labeling that the device is now MR Conditional.

Miami Applicator Set: The Miami Applicator is designed for treatment of the vagina and cervix and includes an intrauterine tube for the treatment of the endometrium, as required. The design incorporates 7 treatment channels around the periphery of the cylinder body and includes a center channel that can accommodate an intrauterine tube. The intrauterine tubes are available with either a 30° angled tip or in a straight (0° angle) configuration. A stump plug is provided to seal the end of the applicator when an intrauterine tube is not required. Build-up caps are available for the cylinder body to provide added spacing between the mucosa and radioactive source. This applicator provides additional treatment options, with the peripheral channels, to increase the dose to the target area while limiting the dose to normal tissue. The only change to the device will be the labeling that the device is now MR Conditional.

Ring & Tandem Applicator Sets: The Ring & Tandem Applicator is based on the Stockholm technique for brachytherapy of the endometrium and cervix. The applicator consists of a ring tube and intrauterine tube that, when combined, create a fixed geometry and form a 90° angle. Build up caps of different diameters are provided for the ring tube that provide additional spacing between the radioactive source and mucosa. Including the Vienna Ring and Tandem Accessory Kit. The only change to the device will be the labeling that the device is now MR Conditional.

Segmented Vaginal Applicator Set: The Segmented Vaginal Applicator is designed for treatment of the vagina and cervix and includes an intrauterine tube for the treatment of the endometrium, as required. The intrauterine tubes are available in different angles and lengths to meet anatomical requirements. The four individual segment design allows the applicator length to be adjustable based on the treatment volume. Additionally, the segments are available in different diameters to match the patient's anatomy. The only change to the device will be the labeling that the device is now MR Conditional.

Split Ring Applicator Sets: The Splicator's patented design combines the benefits of several other intracavitary applicators. The ring tubes can be configured as a closed/complete ring or separated/" split' into four different distances, symmetrically or asymmetrically with the spacing bracket. Build-up caps of different diameters fit over the ring tubes to provide additional tissue spacing distance between the radioactive source and the cervix. The only change to the device will be the labeling that the device is now MR Conditional.

Vienna System: The Mick Radio-Nuclear Instruments, Inc. Vienna System is intended to be used as an accessory to the Mick CT HDR Tandem I Ring Applicator and is indicated for High Dose Rate irradiation of the uterus and cervix. The Vienna System consists of perforated Build-Up Caps and complementary Needle Collectors which connect to the Mick CT HDR Tandem Ring Applicator. Pre-bent interstitial needles are intended to be used with the Vienna System but they are not manufactured by Mick Radio-Nuclear Instruments. Inc. and are not part of this submission.

Build-Up Caps: When used with the CT HDR Tandem/Ring Applicator, the Vienna Build-Up Caps enable the introduction of up to nine (9) interstitial needles around the circumference of the ring to enhance the standard HDR treatment. The Vienna System is not designed to be used with any Rectal Retractor due to the introduction of the interstitial needles.

Needle Collectors: When used in conjunction with the Vienna Build-Up Caps, the Needle Collectors will maintain and control the positioning of an array of up to nine (9) interstitial needles. The Needle Collectors are part of the Vienna System and as such, are not designed to be used with any Rectal Retractor.

The Vienna System is designed to be used as an accessory with the Applicator and this does not alter the indications for use and is MR Conditional.

The provided text describes a Special 510(k) Premarket Notification for various radionuclide applicator systems. The core purpose of this submission is to add MR Conditional labeling to existing devices, meaning the devices are safe for use in specific MR environments. The letter explicitly states that there have been no changes to the devices themselves or their intended use, only to their labeling.

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context are related to demonstrating that the existing devices are indeed MR Conditional and comply with relevant safety standards for MR environments, specifically regarding radiofrequency-induced heating.

Based on the provided information, here's an analysis to address your request:

Acceptance Criteria and Study to Prove MR-Conditional Status

The primary acceptance criteria for this submission is to demonstrate that the various applicator sets are "MR Conditional" as per relevant standards (which are not explicitly detailed in the document but implied by the testing). This typically means ensuring that the device does not pose a safety hazard (e.g., excessive heating, significant artifact, or device malfunction) when exposed to a specified MR environment.

The study that proves the device meets the acceptance criteria for MR Conditional labeling is "Computational Modeling of Mick Radio-Nuclear Instruments HDR Brachytherapy Intracavitary Applicators for Radiofrequency-Induced Heating Evaluation Final Report."

Here's how the information provided aligns with your specific points:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: This was a computational modeling study, not a study involving a "test set" of patients or physical devices in the traditional sense for performance evaluation (e.g., clinical images). The "sample size" would refer to the computational models of the various applicator sets. The document references the "GYN 1 Applicator Family" and "GYN II Applicator Family" as the devices being re-labeled, which includes multiple distinct applicators (e.g., CT/MR Fletcher, CT/MR Henschke FSD, CT/MR Split Ring, CT/MR Segmented Vaginal, CT/MR Miami, CT/MR 2/3 Channel Endometrial, CT/MR Ring & Tandem). Each of these would have been computationally modeled.
• Data Provenance: The study was a "Computational Modeling" study which is a form of in silico (computer simulation) analysis. The document does not specify the country of origin of the modeling data or if it was retrospective/prospective in a clinical sense. Given it's a 510(k) submission to the FDA, the assessment was likely conducted to meet US regulatory requirements.

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 was a computational modeling study for MR safety, not a study relying on expert human readers to establish ground truth for clinical diagnostic purposes. Therefore, the concept of "experts establishing ground truth for the test set" (e.g., radiologists) is not applicable here. MR safety testing (including computational modeling) is typically conducted by engineers and physicists specializing in MR compatibility, following established standards (e.g., ASTM, ISO). The document does not specify the number or qualifications of the individuals who performed or validated the computational modeling.

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

• Not applicable. As noted, this was a computational modeling study focused on MR safety (RF-induced heating). Adjudication methods like 2+1 or 3+1 are used in clinical image interpretation studies where human reviewers disagree on findings.

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

• No. This was a submission for MR Conditional labeling of medical devices (applicators), not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI performance metrics are not relevant to this submission.

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

• Not applicable as this is not an algorithm/AI device. The "standalone" performance here relates to the inherent physical properties of the device in an MR environment, specifically its heating characteristics, which was assessed via computational modeling.

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

• The "ground truth" for MR Conditional status in a computational modeling study is derived from established physics principles of electromagnetic interaction with materials, validated computational methods, and adherence to relevant international standards for MR safety testing (e.g., ASTM F2182 for RF-induced heating, ISO/TS 10974). The "Final Report" of the computational modeling likely presents this "ground truth" in terms of calculated temperature increases within the simulated device and surrounding tissue.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of this device and its assessment for MR Conditional labeling. This is not a machine learning or AI device.

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

• Not applicable for the same reason as point 8.

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Luneray is intended for interstitial brachytherapy of soft tissue that allows the insertion of this flexible applicator, e.g .:

• Abdominal structures / organs (e.g. urinary . bladder)
• Head and neck (e.g. ear, lip, nose, tongue, oral . mucosa)
• Skin (e.g. keloids) .
• Soft tissue sarcoma .
  Luneray enables minimally invasive procedures to be performed both manually and laparoscopically.

Luneray is a pre-assembled, sterile needle-catheter combination for interstitial brachytherapy treatments. The needle is inserted into the tissue and pulls the catheter through the tissue. After insertion the needle is removed from the catheter by cutting it off the catheter.
Radiation treatment planning can be based on X-ray and CT images. X-ray markers shall be used during the imaging procedure, to enable catheter reconstruction in the planning software.
The applicator is connected to a Nucletron brachytherapy afterloader for radiation treatment.

I am sorry, but the provided text does not contain the specific information required to complete your request. The document is a 510(k) summary for a medical device (Luneray) and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than detailing the acceptance criteria and study proving performance as typically found in clinical trials or performance verification reports.

The document discusses:

• Device description and indications for use.
• Comparison to predicate devices.
• Summary of testing: It mentions "Sterilization, Shelf Life, Biocompatibility, Functional verification testing and testing to Standards" and states that "Performance testing was performed at a hospital site, under clinical conditions and with the involvement of clinical personnel but excluding the delivery of treatment of patients." It also says, "Experienced users reviewed the device design and executed validation tests."

However, it does not provide:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, or details on ground truth establishment for specific performance metrics.
• Number/qualifications of experts for ground truth.
• Adjudication methods.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance, as the device is a physical medical instrument, not an AI algorithm.
• Sample size for training sets, as concept of training sets is not applicable to a physical medical device.

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The Vienna Ring CT/MR Applicator is intended for use with Nucletron remote afterloading equipment for gynaecological brachytherapy procedures.

The Vienna Ring CT/MR Applicator is based on the Ring CT/MR Applicator set enhanced with the addition of nine guide holes in the ring tube (seven holes for part number 189.699). These guide holes allow placement of interstitial titanium needles using the ring tube as a needle template while still maintaining the treatment on the dose distribution. The addition of interstitial needles makes it possible to achieve asymmetric dose distributions around the ring and are parallel to the tandem. The applicator is fully CT/MR compatible. Its design uses composite fiber tubing, to eliminate distortion on CT or MR imaging. Interstitial needles can be used for treatment of carcinoma where no lumen or cavity is available. The Titanium Needles are fully CT/MR compatible and can be used in order to have minimal artifacts on the acquired images.

This document is a 510(k) premarket notification for a medical device (Vienna Ring CT/MR Applicator). It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria, study design, or performance metrics that would be used to "prove the device meets the acceptance criteria."

The 510(k) submission process is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, not necessarily on presenting raw performance data or clinical study results in the same way a PMA or de novo submission might.

Therefore, I cannot fulfill your request for the tables and information about study design, sample sizes, ground truth establishment, or expert adjudication, as this information is not present in the provided text.

The document mainly includes:

• Device Identification: Name, classification, and manufacturing information.
• Predicate Device: Identification of the legally marketed device to which the new device claims substantial equivalence.
• Description of Modifications: Details how the new device differs from the predicate.
• Intended Use Statement: Clarifies the medical purpose of the device.
• FDA Clearance Letter: Official communication from the FDA confirming clearance.

To answer your request, a document detailing the verification and validation testing for this device would be needed.

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The MicroSelectron V3 is intended to enable an operator to apply, by remote control, a radionuclide source into the body (including Interstitial, Intracavitary, Intraluminal, Bronchial, Endovascular and Intra-operative) or to the surface of the body for radiation therapy.

The MicroSelectron V3 delivers a radiation dose distribution conforming to treatment data, which is either, manually entered at the workstation or imported from a treatment planning system. For a treatment, a source and applicator are minimally required. Treatment can be administered via up to 30 applicators connected to 30 channels in the treatment unit. The dose distributions are achieved by sequentially letting the source dwell in required positions within the applicators. The required dose distribution can be delivered according to two principles: The "high dose rate brachytherapy" principle (HDR) and The "pulsed dose rate brachytherapy" principle (PDR). The MicroSelectron V3 consists of the following main components: Treatment Unit (TU), Treatment Control Panel (TCP), Treatment Control Station (TCS), Remote Control Unit (RCU) (optional for HDR), and Nurse Station Display (Optional).

The provided text is a 510(k) Summary for the MicroSelectron V3, a remote-controlled radionuclide applicator system. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical validation studies for AI/ML-enabled devices.

The MicroSelectron V3 is a hardware device for brachytherapy and not an AI/ML-enabled medical device. Therefore, the questions regarding acceptance criteria, performance metrics, sample sizes, ground truth establishment, expert adjudication, and comparative effectiveness studies are not applicable in the context of this document.

This 510(k) submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (MicroSelectron PDR, K041933) based on technological considerations, intended use, and modifications to existing functionalities rather than on performance metrics derived from a study designed to meet specific acceptance criteria for diagnostic or predictive accuracy.

Therefore, I cannot extract the requested information from the provided text.

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The Accu-Source™ remote control high dose rate afterloading brachytherapy system is intended for the treatment of cancer and other lesions by intracavitary, interstitial, intralumenal, intraoperative, endobronchial and surface applicator irradiation treatments.

The Accu-Source™ is a remote afterloading system for High Dose Rate Brachytherapy. The system is designed to deliver a predetermined dose of radiation to organs and tissue via a radioactive source. The ACCU-SOURCE™ system includes an operator console and a remote afterloading device. The ACCU-SOURCE™ system has a tungsten shielded storage safe which houses a radioactive source when the system is not in use. There are encoders and motors used in conjunction with electronic circuitry that drive the source and keep track of its position. A battery is used for back-up power and an uninterruptible power supply is also integrated into the ACCU-SOURCE™ system to charge the battery backup subsystem.

The provided document is a 510(k) summary for a medical device called Accu-Source™, a Remote Control High Dose Rate Afterloading Brachytherapy Device. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific acceptance criteria through a formal clinical study with performance metrics as one might see in a de novo or PMA submission.

Therefore, the document does not contain the acceptance criteria and study details as requested in the input prompt (e.g., sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a diagnostic device).

Instead, it focuses on demonstrating that the Accu-Source™ device is substantially equivalent to a legally marketed predicate device (Nucletron MicroSelectron HDR Version 2). This is done through a comparison of technical specifications, intended use, and general features.

Here's a breakdown of what can be extracted based on the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated as "acceptance criteria" in the context of a performance study. However, the implicit acceptance criteria for a 510(k) submission are that the new device is as safe and effective as a predicate device and does not raise new questions of safety or effectiveness. This is demonstrated by showing similar specifications and performance characteristics to the predicate.
• Reported Device Performance: The document provides a comparison table of technical specifications between the Accu-Source™ and its predicate, the Nucletron MicroSelectron HDR Version 2. This table highlights features, intended use, and various physical and operational parameters. The "performance" here is described by these specifications, rather than quantitative metrics from a clinical study.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not Applicable: The document does not describe a clinical performance study with a test set of data. It is a comparison of technical specifications against 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 clinical performance study or ground truth establishment is described for a test set.

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

• Not Applicable: No clinical performance study or 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:

• Not Applicable: This device is a remote afterloading brachytherapy system, not an AI-assisted diagnostic tool involving human readers.

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

• Not Applicable: This device is a physical brachytherapy system, not solely an algorithm. Its performance is demonstrated through its physical and operational specifications.

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

• Not Applicable: The concept of "ground truth" for a performance study is not relevant in this 510(k) submission, which focuses on substantial equivalence based on technical specifications and safety features.

8. The sample size for the training set:

• Not Applicable: No machine learning or algorithm development with a training set is described.

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

• Not Applicable: No machine learning or algorithm development with a training set is described.

In summary: The provided 510(k) summary for the Accu-Source™ device establishes substantial equivalence by comparing its technical specifications and intended use to a predicate device, rather than through a detailed clinical or diagnostic performance study that would typically involve acceptance criteria, test/training sets, expert ground truth, or MRMC studies.

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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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Nucletron Intracavitary Applicator Sets: Vacinal CT/MR. Standard CT/MR. Ring CT/MR and Fletcher-Williamson are intended for use with the Nucletron remote afterloading equipment, mHDR, mHDR-Classic and mPDR, for intracavitary brachytherapy. The applicators provide a means of delivering the prescribed radiation dose to the treatment area. The applicator is a closed system to prevent the radioactive source from coming in contact with body fluids.

The Nucletron Intracavitary Applicator Sets: Vaginal CT/MR, Standard CT/MR, Ring CT/MR and Fletcher-Williamson, as described in this submission are designed as accessories to the Nucletron remote afterloading equipment: mHDR, mHDR-Classic and mPDR, for intracavitary brachytherapy procedures. Standard CT/MR, Ring CT/MR and Fletcher-Williamson Applicator Sets can be used for gynecological treatment of the cervix and endometrium. The Vaginal CT/MR can be used for treatment of the vagina, rectum and endometrium.

The Nucletron Intracavitary Applicator Sets are inserted into the body and immobilized. Radiographic images, planar films or transverse slices, i.e. CT, MR are obtained to determine the precise location of the applicator within the body. This information is then used for brachytherapy treatment planning purposes. When the treatment planning is completed the applicator is then attached to the Nucletron remote afterloading equipment (treatment head): mHDR, mHDR-Classic and mPDR, by the Nucletron transfer tubes. These transfer tubes lock into the open end of the applicator and the remote afterloading equipment (treatment head) prior to treatment. When the applicator is properly attached, a check cable run is performed to ensure that the applicator is properly attached and that there are no obstructions which will interrupt treatment. After the check cable run, the radioactive source will step through the applicator to deliver that prescribed dose of radiation. When the treatment is complete, the applicator is detached from the transfer tube and remote afterloading equipment. The applicator is then removed from the patient. The applicator is a closed system to prevent the radioactive source from coming in contact with body fluids. The applicator does not control the treatment unit; it strictly provides a treatment path for the radioactive source. The Nucletron remote afterloading system and the clinical staff verify that the applicator is properly attached prior to treatment

The provided text is a Premarket Notification (510(k) submission) for Nucletron Intracavitary Applicator Sets. This document is a regulatory submission for medical devices and does not contain information regarding studies that establish acceptance criteria or device performance metrics for diagnostic algorithms or AI models.

The document states that the Nucletron Intracavitary Applicator Sets are substantially equivalent to legally marketed predicate devices (K953946) and combine their functionality, components, and design while incorporating a new material. This substantial equivalence is the basis for their clearance, rather than extensive performance studies often associated with novel AI devices.

Therefore, I cannot provide the requested information from the given text as it pertains to a different type of device and regulatory pathway. There is no information about acceptance criteria, device performance, sample sizes, ground truth establishment, or human-in-the-loop studies.

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Remote Afterloading Brachytherapy Unit for interstitial, intracavitary, intraluminal, including bronchial, endovascular (PARIS IDE), intraoperative and surface applicator treatments.

The Treatment Control Station (TCS) described in this submission is a software and hardware package which replaces the current Treatment Control Unit (TCU) for the microSelectron-HDR classic. The TCS is windows based software and runs on a PC based computer system. TCS will allow the user to program a treatment and monitor a treatment in progress. TCS will come together with a Treatment Control Panel, which takes care of the secondary timing and providing hardware independent "Start", "Interrupt" button and source location indicators. The TCS user obtains authorization for parts of the functionality depending on the user name and password. Treatment data can either be entered manually, based on a standard plan, based on a previously fraction or Imported from the Nucletron Treatment Planning System (PLATO). Prior and after treatment completion an extensive report is generated providing full details of how the patient will be and is treated.

The provided text describes a Premarket Notification (510(k)) for the Nucletron microSelectron-HDR classic with TCS (Treatment Control Station). This submission focuses on software and hardware upgrades to an existing remote afterloading brachytherapy system.

Based on the provided document, the submission is a 510(k) for device approval, which primarily demonstrates substantial equivalence to predicate devices. It does not contain information about a dedicated clinical study with specific acceptance criteria, performance metrics, ground truth establishment, or human reader effectiveness as would typically be found for novel diagnostic AI devices.

The document states that "Our Device is substantially equivalent to the legally marketed predicate devices cited in the table below," implying that performance is assumed to be similar to legally marketed devices rather than being proven through a separate study with specific acceptance criteria.

Therefore, many of the requested details are not present in this type of regulatory submission. I will answer based on the information available and note where information is not provided.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

No explicit acceptance criteria or reported device performance metrics (e.g., accuracy, sensitivity, specificity for diagnostic devices) are provided in this regulatory submission. The submission is focused on demonstrating "substantial equivalence" to existing, legally marketed devices for a software and hardware upgrade. The "performance" being assessed here is the device's ability to fulfill its intended use in a similar manner to its predicate.

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 provided. This type of 510(k) submission for a software/hardware upgrade to a therapeutic device often relies on engineering verification and validation, rather than a clinical "test set" with patient data in the way a diagnostic AI device would.

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 provided. As there's no mention of a clinical "test set" involving patient data and diagnostic outcomes, the concept of establishing ground truth by medical experts in this context is not applicable from the provided text.

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

This information is not provided, as there is no described test set or ground truth establishment by experts in the document.

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This device is a treatment control station for brachytherapy, not a diagnostic AI device intended to assist human readers in image interpretation. Therefore, this type of study would not be relevant in this context.

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

This information is not provided, and the concept of "standalone performance" for a treatment control station (which is inherently a human-in-the-loop system) would not directly apply. The TCS is an interface and control system for a medical device, requiring operator input and monitoring.

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

This information is not provided. The regulatory submission focuses on the technical specifications and safety/effectiveness equivalence to predicate devices, rather than clinical performance against a medical ground truth (like pathology or outcomes data). The "ground truth" in this context would likely relate to the correct and safe execution of treatment plans and control of the brachytherapy unit, which would be assessed through engineering and software validation.

8. The sample size for the training set

This information is not provided. The device is a software and hardware upgrade to control a therapeutic device. It is not an AI/ML model that would have a traditional "training set" of data in the sense of learning from patient images or diagnostic outcomes.

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

This information is not provided, as there is no traditional "training set" described for a machine learning model.

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