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SagiNova® is a family of Eckert & Ziegler BEBIG HDR afterloading systems that are intended to apply brachytherapy treatment to specific body sites (interstitial, intracavitary, intraluminal, and intra-operative or skin surface) with a remote controlled radioactive source. The systems are intended to be used by medical professionals trained in radiation oncology.

The SagiNova "HDR afterloading systems are computer controlled medical devices that provide high dose rate brachytherapy treatment by sending a radioactive source into an anatomical site, through an applicator, to deliver a physician prescribed dose.

The SagiNova HDR afterloading system includes the following models:

SagiNova®: Safe shielding suitable for a Co-60 or Ir-192 Source, Contains 25 channels
SagiNova® S: Safe shielding suitable for a Co-60 or Ir-192 Source, Contains 5 channels
SagiNova® Ir: Safe shielding suitable for a Ir 192 Source, Contains 25 channels
SagiNova® Ir-S: Safe shielding suitable for a Ir 192 Source, Contains 5 channels

These afterloading systems include the same treatment unit, applicators, and accessories. They differ in the type of radioactive source that can be accommodated within the shielded safe of the treatment unit and the number of allowed treatment channels.

• The SagiNova and SagiNova Sare capable of accommodating a Co-60 or Ir-192 radioactive . source due to the tungsten and lead safe that is incorporated within the treatment unit. These sources (Co-60 and Ir-192) are nearly identical in construction and clinical performance but differ in half life (Co-60 = 1953.2 days, Ir-192=73.4 days) and maximum activity (Co-60 = 2.2 Ci, Ir-192=13Ci).
• 0 The SagiNova Ir and SagiNova Ir-S can only accommodate an Ir-192, 13 Ci radioactive source within the lead safe that is incorporated in the treatment unit.

The number of treatment channels does not interfere with the performance of the device or the size of the implant that can be treated, but strictly limits the number of channels that can be connected at one time. This difference was designed to provide the user with a system that meets their specific clinical requirements. For standard HDR brachytherapy, e.g. GYN treatment, the 5 channel systems (SagiNova S and SagiNova Ir-S) are sufficient. While clinics that routinely perform more complex HDR brachytherapy implants, e.g. interstitial treatment, the 25 channel systems (SagiNova "Ir) are required.

The applicators and accessories are interchangeable between all SagiNova "models and are based on clinically accepted designs required for HDR remote afterloading brachytherapy treatment. The range of applicators includes:

• Intracavitary GYN applicators for the treatment of the vagina, cervix and endometrium including o tandem and ovoid, ring applicators and vaginal cylinders.
• . Interstitial applicators for the treatment of breast, prostate, and soft tissue including templates, needles and flexible catheters.
• 0 Intraluminal applicators for the treatment of esophagus, lung, nasopharynx including molds, catheters and bougie tubes
• o Intraoperative applicators for the treatment of tumor beds include needles, catheters, and molds
• 0 Surface applicators for the treatment of skin surface and mucosa including flexible molds.

The applicators are available for different imaging modalities including CT/MR and X-ray imaging. The applicators are securely connected to the SagiNova with specially designed transfer tubes or connectors. The transfer tube designs are based on the type of applicator to be connected to the treatment unit, e.g. "Easy Click" transfer tubes for plastic needles and catheters, Transfer Tubes for GYN applicators and metal needles and connectors for universal applicators.

The different components of the SagiNova HDR remote afterloading system work together to provide safe and effective HDR brachytherapy treatment to physician prescribed treatment areas.

The provided text describes the SagiNova® HDR Afterloading System, a medical device for brachytherapy treatment. The document focuses on regulatory approval (510(k)) and demonstrates substantial equivalence to predicate devices through non-clinical testing. It explicitly states that clinical testing was not required.

Therefore, the following information regarding acceptance criteria and a study to prove the device meets these criteria can be extracted, with some items explicitly stated as not applicable or not performed:

1. Table of Acceptance Criteria and Reported Device Performance

• IEC 60601-2-17 (Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment)
• IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance)
• IEC 60601-2 (Likely referring to a specific part of the IEC 60601- series, general safety for medical electrical equipment)
• IEC 60601-1-6 (Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability)
• IEC 60601-8 (Likely referring to a specific part of the IEC 60601- series) | "Confirmed that the product requirements, identified control measures from the risk management process and requirements from the appropriate standards were met." |
  | Software Testing | Design and functionality testing in accordance with:
• Product specifications
• Risk control measures
• Usability requirements | "Confirmed that the product requirements, identified control measures from the risk management process and requirements from the appropriate standards were met." |
  | Radioactive Sources | - Source integrity (Co-60 and Ir-192 sources)
• Weld connections for both sources
• Durability: 100,000 source transfers with Co-60 source (in SagiNova and SagiNova S)
• Durability: 25,000 source transfers with Ir-192 source (in SagiNova, SagiNova Ir, and SagiNova Ir-S)
• Compliance with ISO 2919 (Radiation protection - Sealed radioactive sources - General requirements and classification) | "Confirmed the source integrity and all weld connections for both sources, including 100,000 source transfers with the Co-60 source... and 25,000 source transfers with the Ir 192 source..." |
  | Applicators | - Design and functionality testing (in accordance with applicator specifications and risk control measures)
• Biocompatibility of materials (ISO 10993-5, ISO 10993-6, ISO 10993-9, ISO 10993-13, ISO 10993-7)
• MR Testing (ASTM 2052-6, F2213-06e1, F2119-07, F2182-11a, ASTM F2503-13)
• Sterilization testing for EtO (ISO 11135)
• Sterilization testing for steam sterilization (ISO 17665-1) | "Performed in accordance with the applicator specifications and risk control measures with additional testing performed for; biocompatibility... MR Testing... and sterilization testing..." |
  | Overall Performance | Meeting defined functional requirements, applicable recognized standards, and clinical expectations. Performance comparable to legally marketed predicate devices. | "Confirmed that the product meets the defined functional requirements, the applicable recognized standards and clinical expectations. These results were the same if not better than performed for the predicate devices and confirms that the device is safe and effective for clinical use." |

2. Sample size used for the test set and the data provenance
The document describes non-clinical testing rather than a study with a test set of data. The testing involved specific hardware components, software, radioactive sources, and applicators.

• Sample size for hardware/software/applicator testing: Not explicitly stated as a "sample size" in the conventional statistical sense, but rather a comprehensive suite of tests on the device and its components.
• Sample size for source durability: 100,000 source transfers for Co-60 and 25,000 for Ir-192.
• Data provenance: Internal testing by Eckert & Ziegler BEBIG GmbH and external test laboratories. Country of origin for the testing is primarily Germany, as the company is based in Berlin, Germany. The testing described is prospective, in that it was conducted specifically to validate the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the study described is a non-clinical device validation study, not a study evaluating expert performance or diagnostic accuracy. "Ground truth" in this context refers to the defined engineering specifications and regulatory standards.

4. Adjudication method for the test set
Not applicable. The testing involved verifying compliance with established engineering specifications and international standards, not subjective evaluation requiring adjudication.

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 MRMC comparative effectiveness study was performed. The device is an HDR afterloading system, not an AI-powered diagnostic or decision support tool for human readers. Clinical testing was explicitly stated as not required.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is a device that autonomously performs brachytherapy based on physician-prescribed dose plans. The "standalone" performance was verified through comprehensive hardware and software testing to ensure it operates according to specifications without human intervention during the treatment delivery phase. There is no "algorithm only" performance reported in the context of diagnostic accuracy, but the device's functional algorithms were tested.

7. The type of ground truth used
The "ground truth" for this device validation (non-clinical testing) was based on:

• Engineering specifications and product requirements.
• Established international standards (e.g., IEC 60601 series, ISO 2919, ISO 10993 series, ISO 11135, ISO 17665-1, ASTM standards for MR compatibility).
• Risk management processes.
• "Clinical expectations," although clinical trials were not performed.

8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not a machine learning or AI algorithm development study.

9. How the ground truth for the training set was established
Not applicable, as there was no training set.

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

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

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

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

Here's why and what information is available:

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

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

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

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

Ask a specific question about this device