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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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The Standard Catheter Set is indicated for use to provide access to tumor sites for treatment of any case where high dose rate irradiation is an accepted clinical practice.

The Standard Catheter Set (AL1311XXXX) is designed as an applicator for intraluminal Brachytherapy. The Standard Catheters are 4.7 French (1.6 mm in diameter) PTFE (Polytetrafluroethalene) catheters, which are supplied in nominal lengths of 100cm and 150cm with either a metal tip or plastic tip. The catheters can be readily inserted into small lumen. The metal tip catheter is sealed at the distal end with a small tungsten pluq for easy visualization under fluoroscopy. The distal end of the plastic catheter is tightly sealed to prevent body fluids from entering the lumen or extension of the source wire beyond the tip. The catheters are shipped with a pin plug in the open end to keep the lumen clean and to keep the opening round. The applicator acts to guide the radioactive source to the correct location or locations for treatment.

The provided document describes a 510(k) premarket notification for the "Standard Catheter Set" by Varian Medical Systems, Inc. This submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance data.

Here's a breakdown of the acceptance criteria and study information, based on the provided text:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in a quantitative sense for clinical or algorithm performance. Instead, it details various non-clinical tests conducted to support substantial equivalence and safety. The acceptance criteria are implicitly met by successfully passing these tests, indicating the device performs as intended and is safe.

Specific quantitative thresholds for "acceptance" (e.g., maximum allowable cytotoxic response, specific log reduction in microbial load) are not detailed in this summary document but would have been part of the full test reports referenced. The general statement is that the results support the safety and effectiveness and that the device performs as well as or better than the predicate device.

Study Details

The provided document describes the evaluation of a medical device (Standard Catheter Set), not an AI algorithm. Therefore, many of the typical AI-specific questions are not applicable.

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

   • Test Set Sample Size: Not applicable. The studies described are non-clinical, involving physical device testing (biocompatibility, sterilization, mechanical properties) rather than a "test set" of patient data for an algorithm.
   • Data Provenance: Not applicable in the context of patient data. The tests were performed in a laboratory/testing environment on device samples.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable as there is no "test set" of patient data requiring expert ground truth or an AI algorithm being evaluated. The evaluations were performed by laboratories/personnel competent in the specific types of non-clinical tests (e.g., biocompatibility specialists, sterilization validation experts).

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

   • Not applicable. This is not a study involving human reader interpretation or annotation of data.

4. 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 is a medical device (catheter) submission, not an AI or software product.

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

   • No. This is a medical device (catheter) submission, not an AI or software product. The document explicitly states: "This item is not applicable to the subject device; the device does not contain or consist of software/firmware." (page 9)

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

   • Not applicable in the context of an AI algorithm. For non-clinical tests, "ground truth" would correspond to established scientific principles, regulatory standards (e.g., ISO 10993-1 for biocompatibility), and established test methods, with results assessed against predefined acceptance criteria from these standards.

7. The sample size for the training set:

   • Not applicable. This is not an AI or software product.

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

   • Not applicable. This is not an AI or software product.

In summary, the provided information pertains to the premarket notification of a physical medical device (Standard Catheter Set) and its equivalence to a predicate device, focusing on non-clinical performance data to establish safety and effectiveness. It does not involve AI or clinical performance studies with patient data, hence many of the requested AI-specific details are not applicable.

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The Varian Remote High Dose Rate Afterloader system, including the applicators and accessories included in this notification, is a device intended to be used by properly trained and licensed medical personnel to provide radiation brachytherapy with a high specific activity radioisotope source to reduce the exposure times required to achieve a prescribed dose. Remote operation of the Afterloader eliminates the necessity of hand placement of radioactive sources on or within the body of a patient. The radioactive source is Iridium-192, encapsulated in the end of a wire stored in the Afterloader and mechanically driven from it to a precisely described position for a specified dwell time during treatments the wire is retracted into the Afterloader so that the source end resides in a tungsten-shielded safe to limit personnel exposures to an acceptable, safe level. The Afterloader contains a radiation detector which signals whenever the source is not in the safe.

The Interstitial Needles are used with Varian High Dose Rate Afterloaders.

The device is a family of closed-ended, interstitial needles and associated obturators to be used in conjunction with a high dose rate (HDR) brachytherapy afterloading device. The needles are available in either 17 gauge O.D. or 18 gauge O.D. and in lengths of 113mm, 200mm, 250mm, and 320mm. The associated obturators are inserted into needles to stiffen the needles during implantation of the needles into the patient and to stiffen the needles between radiation therapy fractions. The obturators are available in lengths of 113mm, 200mm, 250mm, and 320mm. The needles are provided unsterile with instructions for steam sterilization and have been qualified for 25 uses. The obturators are provided unsterile with instructions for steam sterilization and have been qualified for 100 uses.

The provided text is a 510(k) summary for Varian Interstitial Needles. It describes the device, its intended use, and its classification, but 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 medical devices. This pathway often relies on demonstrating that the new device has the same intended use and similar technological characteristics as an already legally marketed device, rather than requiring extensive clinical performance studies to prove specific acceptance criteria.

Therefore, I cannot populate the table or answer the questions as the requested information is not present in the provided text.

Here's a breakdown of why the information isn't available:

• Acceptance Criteria & Device Performance: These are usually defined in testing protocols and reports for performance validation. The 510(k) summary provided here is a high-level regulatory document, not a detailed test report.
• Sample Size, Data Provenance, Expert Ground Truth, Adjudication, MRMC, Standalone Performance, Ground Truth Type, Training Set Sample Size, Training Set Ground Truth: All these items relate to the specifics of a performance study, which is not detailed or even referenced as existing in this 510(k) summary. The document states a "Substantial Equivalence Comparison Chart provides a comparison of the technological characteristics to those of the predicate device" is in Tab 7 of the submission, but this chart's content is not provided. This chart is likely comparing specifications, materials, and design, not clinical performance metrics.

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This applicator is designed as an accessory to the Varisource System (Varian Associates K952913) and the Gammamed System (K891131/A) 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 interuterine tubes, can be optimized to best meet the clinical needs of the patient along with minimization of dose to the mucosa.

The Mick Radio-Nuclear Instruments, Inc. HDR Miami Applicator 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 HDR Miami Applicator meets these requirements.

This document describes a 510(k) premarket notification for the "HDR Miami Applicator." The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process primarily relies on comparing the new device's design, materials, intended use, and performance characteristics to those of the predicate device, rather than requiring extensive clinical studies to prove effectiveness from scratch.

Therefore, the provided document does not contain the detailed information typically found in a study demonstrating device performance against specific acceptance criteria. It focuses on asserting substantial equivalence.

Here's an analysis based on the provided text, highlighting what is not available and what can be inferred:

Acceptance Criteria and Device Performance

Since this is a 510(k) submission, the "acceptance criteria" are not detailed in terms of quantitative performance metrics, but rather the device's characteristics being "substantially equivalent" to the predicate. The "reported device performance" is essentially that it functions similarly to the predicate.

Study Details (Information Not Provided in this Document for Performance Testing)

The document is a 510(k) premarket notification, which is a regulatory submission focused on demonstrating substantial equivalence to a predicate device. It does not present a study with detailed performance data against specific acceptance criteria in the manner one might expect for a novel device requiring a PMA, or a device with new technological characteristics.

Here's why the requested study details are largely absent:

1. Sample sizes used for the test set and the data provenance: Not applicable for a substantial equivalence claim based on design/material similarity. No clinical test set data is presented.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is discussed.
3. Adjudication method: Not applicable.
4. 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 physical applicator for radiotherapy, not an AI-assisted diagnostic or therapeutic tool.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. As above, this is a physical medical device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this type of submission. The "ground truth" for the 510(k) is the established safety and effectiveness of the predicate device.
7. The sample size for the training set: Not applicable. There is no mention of a training set as this is not an AI/machine learning device.
8. How the ground truth for the training set was established: Not applicable.

Summary of What the Document Conveys:

• Device Name: HDR Miami Applicator
• Intended Use: Used in brachytherapy to deliver intra-cavitary radiation therapy, specifically placed in the vicinity of the cervix via the vagina, similar to the predicate device. It is an accessory to the Varisource and Gammamed systems.
• Predicate Device: Nucletron Miami Vaginal Applicator (K953946)
• Demonstration of Acceptance/Compliance: The manufacturer asserts that the device is "substantially equivalent" to the predicate device because it is "similar in design and construction, utilizes the identical materials, and has the same intended use and performance characteristics." They also state, "No new issues of safety or effectiveness are introduced by using this device." The FDA agreed with this assessment, hence the 510(k) clearance.
• Regulatory Context: This is a Class II device (21 CFR 892.5700 - Remote controlled radio-nuclide applicator system). No specific performance standards have been established by the FDA for this type of device under Section 514 of the Food, Drug, and Cosmetic Act.

In essence, the "study" for this device's acceptance criterion is the comparison to the predicate device, and the "proof" is the detailed submission to the FDA outlining these similarities, which the FDA then reviewed and cleared. Performance is inferred to be equal to the predicate without independent, novel clinical studies.

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The use of sealed Radioisotopes to treat tumors within the body has been documented and published since the turn of the century. Modern era Radiation Therapy has developed delivery systems using isotopes of Cesium, Iridium, Iodine, and Gold to name a few examples. Many tumors now are treated by internal exposure to radiation emitted from sealed radioactive sources. Two common modalities for this are Low Dose Rate and High Dose Rate remote afterloading (Brachytherapy). One common application of Brachytherapy is in the treatment of cancer of the cervix. This applicator is designed as an accessory to the Varisource System (Varian Associates K952913) and the Gammamed System (K891131/A) which uses a single radioactive source of Iridium-192 to treat cancer in a wide range of body sites. The HDR Tandem/Ring Applicator with Rectal Retractor is placed in the vicinity of the vagina just as described for the predicate device (Nucletron Ring Applicator, K953946) and with a rectal retractor and varying intrauterine tube length diameters, clinical needs can be best optimized along with minimization of dose to the rectum.

The Mick Radio-Nuclear Instruments, Inc.. 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 HDR Tandem/Ring Applicator with Rectal Retractor meets these requirements.

This document is a 510(k) premarket notification for a medical device, the "HDR Tandem/Ring Applicator with Rectal Retractor," from Mick Radio-Nuclear Instruments, Inc. It addresses the device's substantial equivalence to predicate devices, not an AI/ML device or a study proving acceptance criteria in the typical sense of diagnostic accuracy or performance metrics.

Therefore, the requested information for acceptance criteria and a study proving the device meets them, including sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable to this submission.

This 510(k) summary focuses on demonstrating that the new device is as safe and effective as previously cleared (predicate) devices, primarily through comparison of design, materials, intended use, and performance characteristics. It does not involve a clinical study with performance metrics as one would find for an AI/ML diagnostic or predictive device. The "performance characteristics" mentioned are in the context of the device's physical and functional attributes for brachytherapy application, not in terms of AI model performance.

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The Mick Radio-Nuclear Instruments, Inc. HDR Contour TP Template and Implant Accessories are intended for use in Brachytherapy. The delivery of radiation therapy to the Prostate via High Dose Rate Remote Afterloading (HDR) requires not only proper visualization and localization of the treatment volume. but precise dosimetry and then a stable delivery system from which treatment can be administered. The Mick Radio-Nuclear "HDR Contour TP Template and Implant Accessories are designed to act as accessories to commercially available HDR Systems (Varian K952913; Gammamed K891131/A: Nucletron K852842). By providing a template that can be attached to the patient perineum as described in the currently cleared H.A.M. Applicator (Mick Radio-Nuclear Instruments K961601), and hold multiple HDR needles in a pre-defined array for treatment delivery, again as cleared in the H.A.M. Applicator (Mick Radio-Nuclear Instruments K961601) the Contour TP Template System provides a system for needle placement in the use of HDR for radiotherapy treatments of the Prostate.

The Mick Radio-Nuclear Instruments, Inc. HDR Contour TP Template and Implant Accessories are designed to act as accessories to commercially available HDR Systems (Varian K952913; Gammamed K891131/A: Nucletron K852842). By providing a template that can be attached to the patient perineum as described in the currently cleared H.A.M. Applicator (Mick Radio-Nuclear Instruments K961601), and hold multiple HDR needles in a pre-defined array for treatment delivery, again as cleared in the H.A.M. Applicator (Mick Radio-Nuclear Instruments K961601) the Contour TP Template System provides a system for needle placement in the use of HDR for radiotherapy treatments of the Prostate.

The provided document is a 510(k) premarket notification for a medical device: the "HDR Contour TP Template and Implant Accessories." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets acceptance criteria through detailed performance studies.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC comparative effectiveness studies.

Here's why and what information is available:

• 510(k) Submissions and Performance Studies: For Class II devices like this one, a 510(k) typically demonstrates substantial equivalence by showing the new device is as safe and effective as a predicate device. This is often achieved by comparing design, materials, intended use, and performance characteristics to existing, cleared devices. Full-scale clinical trials or extensive performance studies with detailed acceptance criteria and statistical analysis are generally not required for a 510(k) unless the device introduces new technology, new indications for use, or raises new safety/effectiveness concerns.
• "Performance Standards": The document explicitly states: "Performance standards for applicators for remote controlled afterloading brachytherapy have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act." This confirms that formal, regulator-defined performance standards with specific acceptance criteria are not applicable here.
• "Summary of Substantial Equivalence": The document states: "This device is similar in design and construction, utilizes the identical materials, and has the same intended use and performance characteristics to the predicate devices. No new issues of safety or effectiveness are introduced by using this device." This is the core argument for clearance, not a report of specific test results against defined acceptance criteria.

Information that is present in the document but does not address your specific questions:

• Device Name: HDR Contour TP Template and Implant Accessories
• Intended Use: For use in Brachytherapy, specifically for "delivery of radiation therapy to the Prostate via High Dose Rate Remote Afterloading (HDR)." It acts as an accessory to commercially available HDR Systems, holding multiple HDR needles in a pre-defined array for treatment delivery.
• Predicate Devices: A list of predicate templates, needles, and applicators (e.g., Syed/Neblett Prostate Template, Mick 200-TP and Mick TP Needle, H.A.M. Applicator).
• Classification: Class II device (21 CFR 892.5700).

In summary, none of the requested information regarding acceptance criteria, device performance results, study details (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone performance, training set details) can be extracted from the provided 510(k) document because such detailed studies are not typically part of a substantial equivalence demonstration for this type of device.

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To provide an enclosed coupling between a Remote High Dose Rate Afterloader and patient needles and/or other devices to apply a radionuclide source into the body or to the surface of the body for radiation therapy. Single Use Device. Do not re-clean, re-sterilize device. Any reprocessing may result in changes in the physical characteristics of the device. Do not counter accepted clinical practice or institution guidelines.

The AOS Universal Connecting Guide Tube coupling catheters are substantial equivalence to Varian Coupling catheter (K952913), and Omnitron International Coupling catheter (K881665). Construction and materials are the same for all referenced devices. All devices are listed as single use, provided as non sterile.

This document is a "Summary & Certification" for a medical device called the "AOS Universal Connecting Guide Tube." It appears to be a submission to a regulatory body (likely the FDA in the US, given the "K" numbers for predicate devices). It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and detailed performance metrics as one might find for a novel diagnostic or AI-powered device.

Therefore, many of the requested points cannot be directly addressed from the provided text. I will answer what is available and indicate where information is not present.

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

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

This document does not describe a study with a test set of data. It is a declaration of substantial equivalence based on comparison to existing predicate devices, primarily in terms of construction, materials, indications for use, and manufacturing. No sample size, data provenance, or study type (retrospective/prospective) for a performance test is mentioned.

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)

Not applicable. No test set requiring expert-established ground truth is described.

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

Not applicable. No test set requiring 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 is not a study of an AI or diagnostic device; it is a regulatory submission for a physical medical device (coupling tube) demonstrating substantial equivalence.

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

Not applicable. This is not an algorithmic device.

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

The "ground truth" here is the established safety and efficacy of the predicate devices. The document asserts that the new device shares the same "construction and materials" and "indications" as these devices, leading to the conclusion of "equivalent in safety and efficacy." There is no other empirical ground truth established by a study within this document.

8. The sample size for the training set

Not applicable. No training set is mentioned as this is not a machine learning or AI device.

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

Not applicable. No training set and thus no ground truth for a training set is mentioned.

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