Search Results

The intended use of the MICK Valencia Applicator is to facilitate the placement of a radioactive source near the target area on intact skin for remote afterloading brachytherapy treatment.

The Mick Valencia Applicator is used for remote afterloading treatment on intact skin/surface. The applicator with associated plastic cap is placed onto the patient, locked into position, and connected to the remote afterloading equipment (via transfer tube) to facilitate the brachytherapy treatment in accordance with the physician approved treatment parameters. The radioactive source travels from the machine into the applicator and deliver the desired dose distribution to the defined treatment volume. When the treatment is completed, the source returns to the machine. The applicator is disconnected from the treatment unit and removed from the patient.

The applicator does not control the treatment unit, it strictly provides a treatment path for the radioactive source. The Mick Valencia applicator is temporarily placed during the treatments designed as a closed system to prevent the radioactive source from coming in contact with bodily fluids.

The device is the same as the legally marketed device cited, both in design and materials.

The provided document (K230155) is a 510(k) premarket notification for the Mick Valencia Applicator Set. It does not contain information about a study proving device performance against acceptance criteria in the way one would expect for an AI/ML medical device.

This document describes a medical device used for brachytherapy, which is a physical applicator for radioactive sources. The determination of substantial equivalence for this type of device relies on demonstrating that its design, materials, and intended use are similar to a legally marketed predicate device, and that it performs similarly. The "non-clinical tests" mentioned are bench tests for connection compatibility, not performance trials for diagnostic accuracy or clinical outcomes.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details because the document does not report on a study that would typically have such components. There is no mention of a "device" in the context of an AI/ML algorithm that would require ground truth, expert consensus, MRMC studies, or training/test sets.

Here's why the requested information cannot be extracted:

• No AI/ML Component: The device, the Mick Valencia Applicator Set, is a physical medical instrument (an applicator for a radioactive source). It's not an AI or software device.
• Substantial Equivalence, Not Performance Study: The entire submission is built around demonstrating "substantial equivalence" to a predicate device (Nucletron/Elekta Valencia Skin Applicator K073107). This is a comparative assessment, not an independent performance study of a novel device
• No "Ground Truth" or "Experts": For a physical applicator, "ground truth" and "experts" in the context of diagnostic performance (e.g., radiologists interpreting images) are not relevant. The "ground truth" for this device's function would be its physical specifications and compatibility with afterloaders, which are verified through engineering tests and comparison to the predicate.
• No "Training/Test Sets": These concepts apply to machine learning models, which are absent here.
• No "MRMC Study": A Multiple Reader Multiple Case study is for evaluating human interpretation with and without AI assistance, which is not applicable to a physical brachytherapy applicator.

The document states:

• "Non-clinical testing is performed on the Mick Valencia Applicator connection to the transfer tube (the transfer tubes are supplied by the Afterloader manufacturer). These are bench top tests, performed on every applicator produced."
• "The Mick Valencia Applicator Sets are substantially equivalent in design, manufacture, construction and materials and have the same intended use and performance characteristics to the predicate device."

These statements indicate that the "proof" of the device meeting its acceptance criteria (which are implicitly its functional specifications, material properties, and compatibility) comes from bench testing and the demonstration of substantial equivalence to a device already on the market. There's no performance study in the sense of a clinical trial or algorithm validation study described.

Ask a specific question about this device

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.

Ask a specific question about this device

The CT/MR M.A.C Interstitial GYN Template is indicated for high dose rate irradiation of vaginal, endometrial and urethral cancers. It is intended to provide a needle guidance system for the introduction of needles and a vaginal obturator into the treatment site.

The CT/MR M.A.C. GYN Interstitial Template Set includes a labeled template, a slotted channel Vaginal Obturator, a set of intrauterine tubes in different angles, locking collets to accommodate both peripheral needle channels in the Template and needle channels in the central Vaginal Obturator, an Allen wrench to lock the intrauterine tube in the Obturator and a collet wrench to securely affix the needles by way of individual collets to both the Template and the vaginal obturator. The set features an Obturator - Template design with an optional intrauterine tube enabling complete or targeted treatment of the vagina, cervix, endometrium and parmetrium.

This is a 510(k) premarket notification for a medical device (CT/MR M.A.C. Interstitial GYN Template), not a study analyzing its performance against acceptance criteria in the manner typically seen for AI/ML devices or diagnostic tools. Therefore, much of the requested information (e.g., sample sizes, expert qualifications, ground truth methods, MRMC studies) is not applicable or cannot be extracted from this document.

However, I can extract information related to the device's technical specifications and non-clinical testing for compatibility.

Here's a summary of the available information and an explanation of the non-applicable sections based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For a device like this, acceptance criteria primarily relate to its material properties, compatibility with other medical equipment (CT/MR), and functional design for its intended use (needle guidance system). The document reports the results of non-clinical testing to demonstrate these compatibilities.

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 applicable and not provided in the document as it describes non-clinical engineering and materials testing for device compatibility rather than a clinical study evaluating diagnostic or interpretive performance. The testing was performed in a "non-clinical environment."

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 applicable and not provided. "Clinicians have certified that the CT images are not negatively impacted," but no specific number or qualifications are given, nor is it a "ground truth" establishment in the context of diagnostic accuracy.

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

This information is not applicable and not provided.

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

This information is not applicable and not provided. This device is a physical medical instrument, not an AI/ML algorithm.

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

This information is not applicable and not provided. This is not an algorithm.

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

This information is not applicable and not provided. For non-clinical compatibility testing, "ground truth" would relate to precise measurements of physical properties (e.g., actual temperature rise, actual displacement force) against an expected standard, rather than clinical ground truth for a diagnostic outcome. The document states "All comprehensive test data and results are on file," implying these measurements were taken but not detailed here.

8. The sample size for the training set

This information is not applicable and not provided. This is not an AI/ML device.

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

This information is not applicable and not provided. This is not an AI/ML device.

In summary, the provided document details a 510(k) premarket notification for a physical medical device. The "study" refers to non-clinical compatibility testing (CT, MR, biocompatibility) rather than a clinical performance study with human subjects or an AI/ML model evaluation. Therefore, many of the typical acceptance criteria and study design elements requested would not be found in this type of submission.

Ask a specific question about this device

The Nfick Radio-Nuclear Instruments, Inc. Vienna System is intended to be used as an accessory to the Nfick CT HDR Tandem / Ring Applicator and is indicated for High Dose Rate irradiation of the vierus and cervix.

The Vienna System consists of perforated Build-Up Caps and complementary Needle Collectors which connect to the Nfick CT HDR Tandem / Ring Applicator. The Vienna System is comprised of two sizes of Build-Up Caps, both 5.0mm & 7.5mm, to replicate the original Build-Up Caps in the applicator set and complementary Needle Collectors. The system is designed to utilize implanted rigid interstitial needles that are commercially available and must be purchased separately. The Vienna System is not designed to be used in conjunction with any type of Rectal Retractor. The Vienna Build-Up Caps have nine pre-drilled holes in the circumference of the Build-Up ring to accept separate interstitial needles for a wider dose distribution during treatment. One size Vienna Build- Up Cap can accommodate all three angles of Rings and Tandems. Needle Collectors are offered as part of the system and are used to "collect", stabilize and protect interstitial needles inserted through the Vienna Build-Up Cap. The Needle Collector is offered in three different angles (30°, 45° & 60°) and all have nine channels oriented to the pre-drilled hole positions in the Vienna Build-Up Cap.

The information provided is for a 510(k) premarket notification for the Vienna System, an accessory to a remote controlled radionuclide applicator system used in brachytherapy. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than detailed performance studies with acceptance criteria in the context of diagnostic accuracy.

Therefore, many of the requested points regarding acceptance criteria, study design, and performance metrics for an AI/device algorithm are not applicable to this type of regulatory submission. The document emphasizes mechanical design, material equivalence, and intended use as the basis for clearance.

Here's a breakdown of the relevant information from the provided text in relation to your request:

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

• Acceptance Criteria: Not explicitly stated as quantitative performance metrics for a diagnostic or AI device. The acceptance criteria for this 510(k) submission are based on demonstrating substantial equivalence to predicate devices in terms of design, construction, materials, intended use, and performance characteristics (which are mechanical/functional in nature, not diagnostic accuracy). The core "acceptance" is that "No new issues of safety or effectiveness are introduced by using this device."
• Reported Device Performance: No quantitative performance metrics (ee.g., sensitivity, specificity, accuracy) are reported because the device is an accessory for brachytherapy application, not a diagnostic or AI-driven decision support system. The performance is inferred by its equivalence to predicate devices and its ability to function as intended without altering the indication of use of the main applicator.

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

• Not applicable. This submission does not involve a "test set" in the context of evaluating a diagnostic algorithm's performance on patient data. It's a review of a medical device accessory's design and materials.

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. There is no "ground truth" establishment in the context of diagnostic assessment for this submission.

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

• Not applicable. No test set or adjudication for diagnostic outcomes.

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 an AI-assisted diagnostic device, so no MRMC study or AI improvement metrics are relevant.

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

• Not applicable. This is not an algorithm.

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

• Not applicable. No ground truth for diagnostic purposes is used. The "ground truth" in this context is the established safety and effectiveness of the existing predicate devices.

8. The sample size for the training set

• Not applicable. This is not an AI algorithm requiring a training set.

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

• Not applicable. No training set for an AI algorithm.

Summary of Relevant Information from the Document:

• Device Name: Vienna System
• Regulatory Class: II (21 CFR 892.5700)
• Product Code: JAQ
• Intended Use: As an accessory to the Mick CT HDR Tandem/Ring Applicator for High Dose Rate irradiation of the uterus and cervix. It enhances the standard HDR treatment by enabling the introduction of up to nine interstitial needles.
• Key Argument for Clearance: Substantial Equivalence to predicate devices (K030110, K122840, K080934).
• Basis for Substantial Equivalence:
  • Similar in design and construction.
  • Utilizes the same materials (Acetal for Build-Up Cap, Titanium for Colpostat/Tandem material).
  • Has the same intended use and performance characteristics (mechanical/functional).
  • Crucially, "No new issues of safety or effectiveness are introduced by using this device."
• Manufacturing: According to Good Manufacturing Practices (GMPs) as defined in 21 CFR part 820.
• Biocompatibility: No new issues raised regarding materials.
• Performance Testing: "Performance Test Results or In vitro Testing / In vivo Testing are not applicable to the Vienna System" because no new issues of safety or effectiveness are raised and the fundamental scientific technology is unchanged from the predicate devices.

Ask a specific question about this device

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

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

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

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

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

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

• Not Applicable. No test set or ground truth was established for a new performance study.

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

• Not Applicable. No test set was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. This device is a mechanical applicator, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.

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

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

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

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

8. The sample size for the training set:

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

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

• Not Applicable. No training set was used.

Ask a specific question about this device

The HDR CT Compatible Split Ring type applicator is indicated for use in any case where high dose rate Brachytherapy treatment of the cervix or uterus is an accepted clinical practice.

The HDR CT Compatible Split Ring Applicator presented in this 510(k) notification has been developed to function for the positioning of HDR Remote After-Loader sealed sources in the treatment of cancer of the cervix or uterus. The design of these systems is similar to that of the predicate devices listed below. The delivery of radiation therapy via high dose rate Brachytherapy treatment of the cervix or uterus requires not only a stable system for precise dosimetry but also a reproducible and predictable geometry for positioning of the radioactive source under remote control. The HDR CT Compatible Split Ring Applicator is designed to act as such a device.

The provided document K063382 is a 510(k) Pre-Market Notification for a medical device called the "HDR CT Compatible Split Ring Applicator." This type of submission focuses on demonstrating substantial equivalence to pre-existing devices, rather than a clinical study proving its performance against detailed acceptance criteria in the way an AI/software device would. Therefore, much of the requested information (like sample size, ground truth, expert opinions, MRMC studies) is not applicable to this document.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not specify quantitative "acceptance criteria" or report "device performance" in terms of metrics like sensitivity, specificity, accuracy, or similar for a clinical study. The acceptance criteria for this type of submission are primarily demonstrating substantial equivalence to predicate devices based on design, materials, intended use, and performance characteristics.

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

• Not Applicable. This submission does not involve a "test set" or a clinical study with data from patients. It's a regulatory submission for a physical medical device based on its design and comparison to existing, already-approved devices.

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

• Not Applicable. No ground truth for a test set was established as no clinical test set was used for performance evaluation in this 510(k) submission.

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

• Not Applicable. No test set or adjudication method was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. This is a physical medical device, not an AI or software device. Therefore, no MRMC study involving human readers and AI assistance was conducted.

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• Not Applicable. No ground truth in the context of clinical data or diagnostics was established for this submission. The "ground truth" for the submission itself is the FDA's determination of substantial equivalence based on the provided engineering and manufacturing data.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is a physical medical device submission, not a machine learning model.

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

• Not Applicable. No training set was used.

Ask a specific question about this device

The 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.

The CT Compatible F/S/D Applicator presented in this 510(k) notification has been developed to function for the positioning of HDR Remote After-Loader sealed sources in the treatment of cancer of the cervix or uterus. The design of these systems is the similar to that of the predicate devices listed below. The delivery of radiation therapy via high dose rate Brachytherapy treatment of the cervix or uterus requires not only a stable system for precise dosimetry but also a reproducible and predictable geometry for positioning of the radioactive source under remote control. The CT Compatible F/S/D Applicator is designed to act as such a device.

This 510(k) submission (K063381) for the CT Compatible F/S/D Applicator does not contain a study demonstrating specific device performance against acceptance criteria. Instead, it relies on a declaration of substantial equivalence to existing predicate devices. Consequently, many of the requested sections regarding performance studies cannot be filled as the information is not present in the provided text.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

No specific acceptance criteria or quantitative device performance data are provided in this 510(k) submission. The submission focuses on demonstrating substantial equivalence to predicate devices rather than providing a performance study with defined criteria. The rationale for approval is based on similarity in design, construction, materials, intended use, and performance characteristics compared to the predicate devices.

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

Not applicable. No test set or performance study is detailed in the provided document.

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

Not applicable. No test set requiring ground truth establishment is detailed.

4. Adjudication Method for the Test Set

Not applicable. No test set or adjudication process is mentioned.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The submission does not describe any human-in-the-loop studies or comparisons of human reader performance with or without AI assistance. The device in question is an applicator for radiation treatment, not an AI-driven diagnostic or interpretative tool.

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

Not applicable. The CT Compatible F/S/D Applicator is a physical medical device (an applicator for remote-controlled radionuclide delivery), not an algorithm or software requiring standalone performance evaluation.

7. The Type of Ground Truth Used

Not applicable. As there is no performance study or AI component, the concept of "ground truth" as it relates to expert consensus, pathology, or outcomes data for performance evaluation is not relevant to this submission.

8. The Sample Size for the Training Set

Not applicable. The device is a physical medical instrument, not a machine learning model. Therefore, there is no "training set."

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

Not applicable. There is no training set for this device.

In summary, the provided 510(k) K063381 for the CT Compatible F/S/D Applicator does not include a performance study with acceptance criteria. The approval is based on substantial equivalence to predicate devices, asserting that the new device shares similar design, construction, materials, intended use, and performance characteristics, without introducing new issues of safety or effectiveness.

Ask a specific question about this device

The Mick HDR IORT Shielded Applicator presented in this 510(k) notification has been developed to function as accessories/applicators for the positioning of HDR Remote After-Loader scaled sources in the superficial or interoperative treatment of cancer.
The Mick HDR IORT Shielded Applicator presented in this 510(k) notification has been developed to function as accessories/applicator for the positioning of HDR Remote After-Loader sealed sources during intraoperative procedures or externally on the patient surface.

The Mick HDR IORT Shielded Applicator presented in this 510(k) notification have been developed to function as accessories/applicators for the positioning of HDR Remote After-Loader scaled sources in the superficial or interoperative treatment of cancer. The design of these systems is the similar to that of the predicate devices listed below. The delivery of radiation therapy via high dose rate Brachytherapy for superficial or interoperative treatment requires not only a stable system for precise dosimetry but also a reproducible and predictable geometry for positioning of the radioactive source under remote control. The Mick HDR IORT Shielded Applicator is designed to act as such a device.

This 510(k) submission for the Mick HDR IORT Shielded Applicator does not contain a study that proves the device meets specific acceptance criteria in the way described in your request (e.g., involving AI performance, human reader improvement, or detailed statistical analysis of performance metrics).

Instead, this document is a premarket notification (510(k)) based on substantial equivalence to previously approved devices. This means the manufacturer is asserting that their new device is as safe and effective as existing legally marketed predicate devices, and therefore does not require a new premarket approval (PMA). The "study" here is essentially the comparison to predicate devices, demonstrating that the new device shares similar design, materials, intended use, and performance characteristics, and introduces no new issues of safety or effectiveness.

Here's how to interpret the provided information in the context of your questions:

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

• Acceptance Criteria: The primary acceptance criterion for a 510(k) submission based on substantial equivalence is that the device is as safe and effective as a legally marketed predicate device and does not raise new questions of safety or effectiveness. This is not quantified with specific performance metrics in the way you might see for an AI algorithm study.
• Reported Device Performance: 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."
  • The device is designed to function as "accessories/applicators for the positioning of HDR Remote After-Loader scaled sources in the superficial or interoperative treatment of cancer" and provides "a reproducible and predictable geometry for positioning of the radioactive source under remote control."

Since this is a substantial equivalence determination and not a performance study comparing the device to specific clinical outcomes or statistical thresholds, a table like the one you requested cannot be populated from this document. The performance is implicitly "equivalent to predicate devices."

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

• N/A. No "test set" in the sense of a dataset for evaluating an AI algorithm or a clinical trial for performance metrics is described. The evaluation is based on engineering design, material equivalence, and intended use comparison to predicate devices.

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

• N/A. Ground truth for a test set is not applicable here as there is no such test set or performance study described. The "ground truth" for this submission is that predicate devices are already considered safe and effective by the FDA.

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

• N/A. No adjudication method is described because there is no test set or performance study.

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 document describes a medical device (a radionuclide applicator system), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human readers and AI assistance is entirely irrelevant and not mentioned.

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

• N/A. This is a hardware medical device, not an algorithm.

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

• The "ground truth" here is the established safety and effectiveness of the predicate devices, as determined by their prior FDA clearance (K-numbers). The current device's safety and effectiveness are established by demonstrating its substantial equivalence to these predicates in terms of design, materials, and intended use.

8. The sample size for the training set

• N/A. As this is not an AI/machine learning device, there is no concept of a "training set."

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

• N/A. Not applicable for the reasons stated above.

In summary: This document is a regulatory submission demonstrating substantial equivalence for a physical medical device. It does not involve performance studies or evaluations in the manner typically associated with AI or diagnostic imaging devices where your requested criteria would be relevant. The "study" is the comparison to predicate devices.

Ask a specific question about this device

The Mick HDR Interstitial Implant Accessories (consisting of needles, catheters, and fixation buttons) presented in this 510(k) notification have been developed to function as accessories/applicators for the positioning of HDR Remote After-Loader sealed sources in the interstitial treatment of cancer of the oral cavity, oropharyngeal tumors, head and neck and soft tissue sarcomas.

The Mick HDR Interstitial Implant Accessories (consisting of needles, catheters, and fixation buttons) presented in this 510(k) notification have been developed to function as accessories/applicators for the positioning of HDR Remote After-Loader sealed sources in the interstitial treatment of cancer of the oral cavity, oropharyngeal tumors, head and neck and soft tissue sarcomas. The design of these systems is the similar to that of the predicate devices listed below. The delivery of radiation therapy via high dose rate Brachytherapy requires the ability to guide and position the radioactive source under remote control so that the sealed source is contained within the treatment volume providing precise dosimetry and then a stable delivery system from which treatment can be administered. The Mick HDR Interstitial Implant Accessories are designed to act as such.

This 510(k) submission (K051423) for the Mick HDR Interstitial Implant Accessories does not contain a detailed study with acceptance criteria and device performance results.

Instead, the submission relies on demonstrating substantial equivalence to existing predicate devices. This means the manufacturer is asserting that their new device is as safe and effective as devices already legally marketed, primarily because it shares similar design, construction, materials, intended use, and performance characteristics.

Therefore, many of the requested elements for a detailed study report are not present in this document. Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance

Study Information (Not Applicable or Not Provided in this Document)

The 510(k) submission for the Mick HDR Interstitial Implant Accessories details a substantial equivalence (SE) determination, not a standalone clinical or performance study with the specific elements requested. The FDA determined the device was substantially equivalent to predicate devices (K890341, K811279 for Mick Radio-Nuclear Instruments, Inc., and K933400 for Best Medical Industries).

Here's a breakdown of the requested information based on the provided document:

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

   • N/A. No specific "test set" or clinical study data is presented in this 510(k) summary. The demonstration of substantial equivalence relies on similarity to predicate devices rather than new performance data.

2. 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):

   • N/A. No de novo ground truth establishment for a specific test set is described.

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

   • N/A. No adjudication method is described as there is no specific test set or clinical study.

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:

   • N/A. This device is an accessory for brachytherapy, not an AI-driven diagnostic or imaging device. Therefore, an MRMC study related to AI assistance is irrelevant and not performed.

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

   • N/A. This device is not an algorithm; it is a physical medical accessory. Standalone algorithm performance is not applicable.

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

   • N/A. The "ground truth" here is essentially the established safety and effectiveness of the predicate devices, which are already legally marketed. The submission argues that the new device is fundamentally the same and therefore shares that "ground truth."

7. The sample size for the training set:

   • N/A. No training set for an algorithm is applicable or described.

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

   • N/A. Not applicable, as there is no training set for an algorithm.

In summary: This 510(k) document is a regulatory submission focused on demonstrating substantial equivalence, not a detailed report of a performance study for a novel device with specific acceptance criteria that require extensive new testing and data collection. The "proof" that the device meets acceptance criteria stems from its demonstrated similarity to already approved devices.

Ask a specific question about this device

The applicators presented in this 510(k) notification have been developed to function as Remote After-Loader sealed sources in the intracavitary treatment of cancer of the vagina and cervix.

The Mick Radio-Nuclear Instruments, Inc. HDR compatible Tandem and Ovoid Applicators are intended for use in HDR Brachytherapy as described for the predicate device (Cervix Applicator, Varian Medical Systems, K033371). The design of these systems is the similar to that of the predicate devices listed below. The delivery of radiation therapy to cervix via high dose rate Brachytherapy requires the ability to properly link the applicator to the HDR unit so that the radioactive source can be remotely positioned in the applicator along with the ability to properly localize the sealed sources at the treatment volume providing precise dosimetry and then a stable delivery system from which treatment can be administered. The Mick Radio-Nuclear HDR compatible Tandem and Ovoid Applicators are designed to act as such a device and utilize the same design as previously cleared for other applicators manufactured by Mick Radio-Nuclear Instruments (Vaginal Applicator Set, Shielded, K001544, HDR Tandem/Ring Applicator with Rectal Retractor, K011657).

The provided document is a 510(k) premarket notification for a medical device (HDR Compatible Tandem and Ovoid Applicators), which primarily focuses on demonstrating substantial equivalence to existing predicate devices rather than proving performance against specific acceptance criteria through a detailed study.

Therefore, many of the requested items related to a performance study will not be present in this type of document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria or provide a study with reported device performance in the way a clinical trial or performance verification study would. The acceptance is based on the device being "substantially equivalent" to predicate devices.

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

No test set or associated data provenance is described in this 510(k) submission. The submission relies on design and material similarities to predicate devices, not on new clinical performance data for this specific device.

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

Not applicable. No ground truth establishment activity is described for a test set.

4. Adjudication Method for the Test Set:

Not applicable. No test set requiring adjudication is described.

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

No MRMC comparative effectiveness study was done or reported in this 510(k) submission.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This device is a physical medical instrument, not an algorithm, so a standalone algorithm performance study is not relevant here.

7. Type of Ground Truth Used:

Not applicable. The document assesses the device's technical and safety characteristics in comparison to established predicate devices, not against a new ground truth established for a separate performance study.

8. Sample Size for the Training Set:

Not applicable. As this is a physical medical device, not an AI/ML algorithm, the concept of a "training set" is not relevant.

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

Not applicable for the same reasons as #8.

Summary of Device and Approval Basis:

The document describes the Mick Radio-Nuclear Instruments, Inc. HDR Compatible Tandem and Ovoid Applicators. This device is intended for use in High Dose Rate (HDR) Brachytherapy for the intracavitary treatment of cancer of the vagina and cervix.

The study that proves the device meets (or rather, is acceptable for marketing) is the 510(k) substantial equivalence submission (K040704).

• Basis for Acceptance: The FDA determined the device is "substantially equivalent" to legally marketed predicate devices. This means that, based on the information provided, the new device has similar intended use, design, construction, materials, and performance characteristics to previously cleared devices.
• Predicate Devices:
  • Henschke Applicator; Mick Radio-Nuclear Instruments, Inc. (K871217)
  • Hilaris/Nori Applicator; Mick Radio-Nuclear Instruments, Inc. (K891377)
  • Cervix Applicator; Varian Medical Systems, Inc. (K033371)
  • Vaginal Applicator Set, Shielded, Mick Radio-Nuclear Instruments (K001544)
  • HDR Tandem/Ring Applicator with Rectal Retractor, Mick Radio-Nuclear Instruments (K011657)
• Key Argument for Equivalence: "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."

In essence, this 510(k) does not present a new clinical study with specific performance metrics and acceptance criteria for this device. Instead, it argues that because the device is sufficiently similar to already approved and marketed devices, it can be presumed to be safe and effective.

Ask a specific question about this device