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LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source with individual activity up to 20 mCi (740 MBq), is indicated for episcleral brachytherapy of tumors and benign growths. The Model 1 source is intended for use within a manual brachytherapy system.

LV Liberty Vision Model 1 90Yttrium Brachytherapy Source is a singly-encapsulated 99Yttrium Brachytherapy Source. It consists of a titanium capsule containing a solid radioactive 99Yttrium element. The radioactive element is hermetically sealed in the titanium capsule and, in use, will be attached to a manual radionuclide applicator system (21 CFR 892.5650).

The provided document is a 510(k) summary for the LV Liberty Vision Model 1 90Yttrium Brachytherapy Source. It describes the device, its intended use, and a comparison to a legally marketed predicate device (K163572), also the LV Liberty Vision Model 1 90Yttrium Brachytherapy Source. This submission focuses on demonstrating substantial equivalence to an existing device rather than establishing novel performance metrics through clinical trials or standalone AI studies.

Here's an analysis based on your requested information:

1. Table of acceptance criteria and reported device performance

The document does not specify general "acceptance criteria" in the sense of performance targets for a new AI/diagnostic device. Instead, it demonstrates equivalence to a predicate device through physical and dosimetric characteristics.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the "acceptance criteria" (defined here as demonstrating substantial equivalence to the predicate device) is documented through nonclinical physical testing and dosimetric analysis.

• Physical Testing: Prototype sources of the LV Liberty Vision Model 1 90Yttrium Brachytherapy Source were subjected to tests specified in American National Standard (ANSI) N43.6 and International Organization for Standardization (ISO) Standard 2919. The results "equaled or exceeded the requirements corresponding to a classification of C53211," which is the requirement for brachytherapy sources. This was deemed equivalent to the physical testing of the predicate device (K163572).
• Dosimetry: The dose distribution around the new device was calculated by Monte Carlo simulation. This was stated to be "similar to the dosimetry of the predicate device."

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

• Test Set Sample Size: The document refers to testing of "prototype sources." It does not specify a numerical sample size but implies a sufficient number of prototypes were tested to satisfy the standards.
• Data Provenance: Not explicitly stated, however, the testing standards (ANSI and ISO) are international. The company is based in Portsmouth, New Hampshire, USA. The testing would have been conducted to demonstrate compliance with US FDA requirements. The data is prospective in the sense that physical and dosimetric measurements/simulations were performed on the prototypes or models of this specific device to demonstrate its properties.

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 is not applicable as the study involves physical and dosimetric testing against established engineering standards (ANSI, ISO) and computational simulations (Monte Carlo), not clinical data requiring expert human interpretation for ground truth.

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

This is not applicable for physical and dosimetric testing. Adjudication methods are typically relevant for clinical studies where human expert consensus is used to establish ground truth for image or diagnostic interpretations.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a brachytherapy source, a physical medical device, not an AI or diagnostic software 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

No, a standalone (algorithm only) performance study was not done. As stated above, this is a physical medical device, not an algorithm or AI.

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

For the physical testing and dosimetry, the "ground truth" is based on:

• Established Engineering Standards: ANSI N43.6 and ISO 2919 provide objective pass/fail criteria and specifications for brachytherapy sources.
• Physics Principles and Computational Models: Monte Carlo simulations for dosimetry are based on established physics principles to calculate dose distribution.

8. The sample size for the training set

This is not applicable. There is no training set mentioned or implied as this is not an AI/machine learning device.

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

This is not applicable as there is no training set.

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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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LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source with individual activity up to 20 mCi (740 MBq), is indicated for episcleral brachytherapy of tumors and benign growths. The Model 1 source is intended for use within a manual brachytherapy system.

LV Liberty Vision Model 1 ®Yttrium Brachytherapy Source is a singly-encapsulated ®º (ttrium Brachytherapy Source. It consists of a titanium capsule containing a solid radioactive ®Yttrium element. The radioactive element is hermetically sealed in the titanium capsule and, in use, will be attached to a manual radionuclide applicator system (21 CFR 892.5650).

The provided text describes the LV Liberty Vision Model 1 90Yttrium Brachytherapy Source and its substantial equivalence to a predicate device, rather than providing a detailed study that proves the device meets specific acceptance criteria in the format requested. The document focuses on comparing the new device's technological characteristics and performance to a legally marketed predicate device (Salutaris Medical Devices, Inc. Smd Sr90-1 Radionuclide Brachytherapy Source).

However, I can extract the information provided about the nonclinical tests and their outcomes, which serve as the basis for the device's acceptance.

Here's the information based on the provided document:

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

The document does not explicitly state "acceptance criteria" in a quantitative table with pass/fail thresholds for clinical performance metrics (like sensitivity, specificity, etc.) that would typically be associated with AI/medical image analysis devices. Instead, it demonstrates equivalence to a predicate device through nonclinical (physical and dosimetry) testing and technological characteristics.

The qualitative "acceptance criteria" are implied by meeting or exceeding the standards relevant to brachytherapy sources and demonstrating comparable dosimetry and safety characteristics to the predicate.

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

• Sample Size: The document does not refer to a "test set" in the context of clinical data for performance evaluation in the way AI devices are typically evaluated. The "tests" mentioned are nonclinical physical and dosimetry tests. For physical testing, "Prototype sources were subjected to the tests." The exact number of prototypes isn't specified, but it's likely a small number of physical samples for laboratory testing.
• Data Provenance: Not applicable for nonclinical physical and dosimetry testing.

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

Not applicable. Ground truth for clinical cases or image interpretations is not relevant to the nonclinical physical and dosimetry testing performed for this brachytherapy source.

4. Adjudication method for the test set

Not applicable. No expert adjudication process for clinical ground truth is described.

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

Not applicable. This device is a brachytherapy source, not an AI software or a device that assists human readers in interpretation.

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

Not applicable. This is not an algorithm-based device. The "performance" relates to the physical and dosimetric properties of the radioactive source itself.

7. The type of ground truth used

For physical testing, the "ground truth" would be the direct measurement of physical properties and verification against defined engineering standards (ANSI N43.6 and ISO 2919).
For dosimetry, the "ground truth" is established through Monte Carlo simulation, which is a widely accepted method for calculating dose distribution in radiophysics.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for this type of medical device evaluation.

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

Not applicable.

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This device is indicated for use in adult males with known or suspected prostate cancer.

The Stepping Unit holds an ultrasound imaging probe and facilitates manual linear and rotational positioning of the probe. The Stepping Unit consists of a Cradle designed to hold a specific ultrasound probe and a Carriage that moves longitudinally along the Stepping Unit. A Grid Platform connected at one end of the Stepper provides support for the Disposable Template Grid. The Stepping Unit connects to the Stabilizer.

The Stabilizer provides a base for the Stepping Unit and offers fixation and support during insertion and final placement of the ultrasound imaging probe. On certain models, a fine tune mechanism is used to micro-adjust the probe or instrument to the ideal orientation. The Stabilizer mounts to an operating room table or is supported by a floor stand.

The Disposable Template Grid is a single-use, sterile grid that consists of rows and columns of holes (channels) spaced 5mm apart. These channels are labeled and provide placement of needles in predefined areas of the prostate.

Here's a summary of the acceptance criteria and study information for the CIVCO Medical Instruments Co., Inc. devices, based on the provided text:

Acceptance Criteria and Device Performance

Since this is a 510(k) submission for substantial equivalence for a medical device (specifically a stepping unit, stabilizer, and disposable template grid used in prostate procedures), the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are generally focused on demonstrating that the new/modified device is as safe and effective as a legally marketed predicate device. The evidence provided is primarily through:

• Comparison to Predicate Devices: Showing similarity in technological characteristics and intended use.
• Literature Review: For expanding indications of use for existing devices.
• Verification and Validation Testing: Specifically for the new EX3 Stepper, confirming its new features meet specifications and do not compromise overall safety/effectiveness.

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

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

• Sample Size for Test Set: Not explicitly stated. The verification and validation testing for the EX3 Stepper (longitudinal movement, encoder reporting, electrical safety, and compatibility with treatment planning software) would have involved specific test units, but the number of units tested is not detailed in this summary.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not explicitly stated. The verification and validation testing would have been conducted internally or by a contracted lab, likely in the US (where CIVCO is headquartered). This would be prospective testing on the physical device. The literature review for expanded indications of use would involve published, likely retrospective or prospective, clinical data (of various origins) that has already been peer-reviewed and published.

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

• This type of information is generally not applicable or explicitly stated for a 510(k) submission concerning a mechanical device like a stepping unit. The "ground truth" for mechanical function, electrical safety, or general utility for specific surgical procedures isn't typically established by expert consensus in the same way as an AI diagnostic algorithm's output would be. Instead, the "ground truth" here is the established safety and efficacy of the predicate device, engineering specifications, and universally accepted standards (e.g., IEC 60601-1 for electrical safety).
• For the validation with "treatment planning software," it implies functionality was checked against expected outputs, likely by engineers or possibly clinical users, but no explicit "expert" review process is described for establishing a ground truth.

4. Adjudication Method for the Test Set

• Not applicable/mentioned. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies, especially for evaluating diagnostic accuracy where there might be disagreements among human readers or between AI and human readers. This submission focuses on the mechanical and electrical performance of hardware, not diagnostic interpretation.

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, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This study type is highly specific to evaluating the clinical impact of AI-assisted diagnostic tools on human performance, which is not the subject of this 510(k) submission. This device is a mechanical accessory (stepping unit, stabilizer, template grid) used during procedures, not an AI diagnostic tool.

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

• Not applicable. This device is a mechanical accessory, not an algorithm or AI system. The EX3 Stepper has "firmware in the encoders report position," which is a functional component, but not a standalone algorithm in the typical sense of AI. Its performance (accuracy of position reporting) was verified.

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

• For EX3 Stepper's new features (encoders, continuous movement, electrical safety): The "ground truth" would be established engineering specifications, measurable physical properties, and adherence to recognized electrical safety standards (IEC 60601-1 and IEC 60601-1-1). For compatibility with treatment planning software, the ground truth would be the expected data output/interaction defined by the software's specifications.
• For expanded indications of use of existing devices: The "ground truth" for safety and effectiveness in cryotherapy, transperineal template-guided biopsy, and fiducial marker placement was established through a literature review. This means previously published clinical studies and outcomes data effectively served as a form of "ground truth" demonstration of safe and effective use.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device that requires a training set. The firmware on the EX3 Stepper's encoders is for reporting position, not for learning or prediction from data.

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

• Not applicable, as there is no training set for this device.

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RIC Conformal Source Model 100 Brachytherapy Source, containing 32Phosphorus with activity up to 200 mCi is indicated for treatment on the surface of tumors. It can be used either as primary surface application to treat intact tumors or as treatment after excision of primary or recurrent tumors. It can be used concurrently with or following treatment with other interventions, such as external beam therapy. Chordomas, chondrosarcomas, soft tissue sarcomas, skin cancers and other treatable tumors could be commonly treated by the RIC Conformal Source, containing 32Phosphorus.

RIC Conformal Source Model 100 Brachytherapy Source is designed for use in medical Brachytherapy applications. The capacity of each source is up to 200 millicuries of 32Phosphorus. The physician could prescribe a physical size up to 50mm by 100mm. This RIC Conformal Source is a flat flexible planar radioactive 32Phosphorus polymeric film that could be made conformal to different surface geometries such as flat, concave or convex semi-cvlindrical shapes through the use of an appropriately shaped shield / holder or by placement on an area to be treated and made conformal by the weight of a flexible compliant media. At the option of the prescribing physician, the RIC Conformal Source could be attached to a manual radionuclide applicator (available from RI Consultants, Class I device, 892.5650) to facilitate handling and to provide shielding to the clinician. The RIC Conformal Source consists of 32Phosphorus chemically bound to the biocompatible polymeric film. The polymeric film thickness is 0.3mm (0.012 inch) to 0.7 mm (0.028 inch). The 32Phosphorus polymeric film is then coated with a flexible biocompatible silicone coating which is about 0.01 mm (0.0005 inch) thick. The 32Phosphorus is chemically bonded to the polymer molecule and is an integral part of the film.

The provided text is a 510(k) summary for the RIC Conformal Source Model 100 Brachytherapy Source, a medical device. It describes the device, its intended use, and its similarities to legally marketed predicate devices.

However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. The 510(k) summary is primarily focused on demonstrating substantial equivalence to a predicate device, as required for FDA clearance, rather than presenting detailed performance study data.

Therefore, I cannot provide the requested table and study details from the given text.

To address your request, I would need a document specifically detailing the performance studies conducted for the RIC Conformal Source Model 100 Brachytherapy Source, including information such as:

• Clinical trial reports or validation studies: These would contain the acceptance criteria and performance metrics.
• Study protocols: These would outline the methodology, sample sizes, and ground truth establishment.
• Statistical analysis plans: These often detail how performance metrics are calculated and compared.

Without such information, any attempt to provide the requested details would be speculative and not based on the provided document.

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The Mick Radio-Nuclear Instruments, Inc. Segmented Vaginal Applicators are intended for use in Brachytherapy. 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.

The Mick Radio-Nuclear Segmented Vaginal Applicator meets these requirements by providing an system that can be adjusted in length and diameter to meet the dimensions of the treatment volume and by utilizing radio opaque markers for visualization.

This submission K993472 is for a Segmented Vaginal Applicator, which is a medical device used in brachytherapy. The submission asserts substantial equivalence to a predicate device and does not involve a study to demonstrate performance against specific acceptance criteria.

Therefore, most of the requested information cannot be extracted from the provided text as the application did not involve a performance study with acceptance criteria.

Here's what can be stated based on the given document:

1. A table of acceptance criteria and the reported device performance: Not applicable. The submission asserts substantial equivalence based on design, construction, materials, intended use, and performance characteristics being similar to a predicate device, rather than providing specific performance metrics against pre-defined acceptance criteria for a new study.

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. No test set or data provenance is mentioned as this was not a clinical performance study.

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 ground truth establishment for a test set is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set adjudication is mentioned.

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 an applicator for radiation therapy, not an AI-assisted diagnostic tool.

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 a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth was established for a performance study. The "ground truth" for this submission is the established safety and effectiveness of the predicate device to which it claims substantial equivalence.

8. The sample size for the training set: Not applicable. This device is not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

The core argument for the device's marketability lies in its substantial equivalence to a previously cleared device, not in a new performance study with specific acceptance criteria. 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."

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A single patient use disposable device to hold radioactive seeds, in magazine fashion, in the MICK radionuclear 200-TP applicator. This device performs the same function as the reusable magazines sold by Mick Radionuclear Instruments, Inc.

A single patient use disposable device to hold radioactive seeds, in magazine fashion, in the MICK radionuclear 200-TP applicator.

The provided documents are a 510(k) clearance letter from the FDA and an "Indications For Use" statement for the NIT Radionuclide Seed Magazine.

These documents do not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device evaluations.

The FDA clearance is for a physical medical device (radionuclide seed magazine) under the traditional 510(k) pathway, which focuses on substantial equivalence to a predicate device rather than performance metrics from AI/ML models.

Therefore, I cannot fulfill your request for information about acceptance criteria, study details, training/test set specifics, or MRMC studies, as none of this information is present in the provided text.

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The N.T., Inc. Radionuclide Seed Applicator is a manually operated device intended to apply a radionuclide source into the body for radiation therapy. This device is typically used in the transperineal approach for radionuclide seed application in the prostate.

The N.T., Inc. Radionuclide Seed Applicator is a manually operated device intended to apply a radionuclide source into the body for radiation therapy.

This looks like a 510(k) clearance letter from the FDA for a medical device called the "NIT Radionuclide Seed Applicator." This type of document declares that a device is "substantially equivalent" to a legally marketed predicate device, meaning it's considered safe and effective for its indicated use.

However, a 510(k) clearance letter does not typically contain detailed acceptance criteria or a study outlining specific performance metrics, sample sizes, ground truth establishment, or expert qualifications in the way you've described for an AI/CADe device.

The questions you've asked are highly relevant for the evaluation and clearance of AI-powered medical devices (often referred to as AI/CADx or AI/CADe). These types of devices typically undergo rigorous performance studies to demonstrate their efficacy, and the information you requested would be standard in their regulatory submissions and subsequent clearance documents.

Therefore, based solely on the provided text, I cannot answer the questions regarding acceptance criteria and the detailed study information. The document is a regulatory approval for a physical, manually operated medical device (a radionuclide seed applicator), not an AI-driven diagnostic or assistive technology.

To answer your questions, I would need a different type of document, specifically a regulatory submission summary or a published study for an AI/CADe device.

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The intended use of the Worldwide Medical Technologies Seed Implant Needle is to introduce radionuclide seeds of I-125 or Pd-103 (purchased by the user directly from another manufacturer) into the body for radiation therapy. This device is typically used in the transperineal approach for radionuclide seed application in the prostate.

Worldwide Medical Technologies Seed Implant Needle Set

The provided documents are a 510(k) premarket notification letter from the FDA and an "Indications For Use" statement for the "Worldwide Medical Technologies Seed Implant Needle Set." These documents relate to the regulatory clearance of a medical device and do not contain information about acceptance criteria, device performance studies, or clinical trial data.

Therefore, I cannot extract the requested information (table of acceptance criteria and reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from these documents.

The documents primarily confirm that the device is "substantially equivalent" to predicate devices, allowing it to be marketed. They do not detail the specific studies or data used to establish device performance against defined criteria.

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The Precision Stepper and Needle Guide is intended for use with a rectal probe in ultrasound-guided prostate brachytherapy (transperineal radioactive seed implantation), and prostate gland voluming. The Precision Stepper and Needle Guide system is an accessory to an ultrasound system used for these medical procedures in a clinical setting.

Condition to be screened, monitored, treated or diagnosed. Prostate gland voluming and treatment of prostate cancer by transperineal brachytherapy

Physiological purpose. The Precision Stepper provides equipment support and quidance for a rectal probe. When used with its Needle Guide, an ultrasonic imaging system, and a rectal probe, the Precision Stepper and Needle Guide System is an accessory to clinical procedures for prostate gland voluming and ultrasound-guided radioactive seed implantation.

The Precision Stepper and Needle Guide is a manually operated medical device used to provide mechanical support for the application of a radionuclide source into the prostate in the course of a brachytherapy procedure in a clinical setting. The Stepper guides and secures a rectal probe which is used for imaging of the prostate. The Stepper moves the transducer in precise increments, or steps. When used in conjunction with the Stepper, the Needle Guide is used to aid the clinician in guiding needles through a template into the prostate. Under the guidance of the ultrasound probe, these needles are used to implant radioactive seeds that irradiate the prostate in cancer therapy.

The provided text is related to a 510(k) premarket notification for a medical device called the "Northwest Radiation Therapy Products Precision Stepper and Needle Guide." It describes the device, its intended use, and its comparison to predicate devices, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically expected for an AI/software as a medical device (SaMD) submission.

This document is for a physical medical device with no software component or energy source. The "Testing" section concisely states that the device "has been subject to extensive inspection and testing to verify that the device meets all its physical and performance specifications." It then mentions that "Test results are maintained in the design history file and/or device history files for this device." However, it does not provide details about these tests, their acceptance criteria, or the study design/results.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a detailed study as requested in your prompt based on the provided text. The requested information (sample sizes, ground truth establishment, MRMC studies, standalone performance, etc.) are commonly associated with performance evaluations of AI algorithms or software, which is not applicable to this physical, manually operated device.

The document essentially claims substantial equivalence to predicate devices (CIVCO Seed Implant Needle Guide K875241 and CIVCO Ultra-Step Stepper K871413) based on similar materials, design, principle of operation, and technology, and confirms manufacturing in accordance with U.S. Quality System Regulation (21 CFR 820).

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