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The UNIQUE is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

The Varian UNIQUE is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

The UNIQUE is a radiotherapy treatment unit. The equipment consists of a gantry, couch, stand and control console. The device is permanently installed. The radiotherapy treatment beam is generated by a linear accelerator assembly consisting of an electron gun, waveguide and collimator.

An extensive system of interlocks is designed to prevent or terminate beam-on unless essential treatment parameters are in place and system operating conditions relevant to safe operation are correct.

The changes to the UNIQUE establish motion zone rules, which limit the motions of couch and gantry that can be initiated or directed from outside the treatment room. The purpose of the zone rules is to increase patient safety by reducing the possibility of collision between the gantry and the patient.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Varian UNIQUE device:

The provided document (K132705) is a 510(k) summary for a medical linear accelerator, the Varian UNIQUE. It focuses on demonstrating substantial equivalence to a predicate device (UNIQUE K101751) due to specific changes primarily related to enhanced patient safety features concerning gantry and couch motion.

Key takeaway: This document describes a modification to an existing medical device where the primary focus is on safety features (motion zone rules and interlocks). It is not a study demonstrating the diagnostic or therapeutic performance of an AI-powered device, but rather a verification and validation of engineering changes to a linear accelerator.

Therefore, many of the requested elements (like AI-specific performance, MRMC studies, expert ground truth for imaging, training set details) are not applicable to this type of submission.

Acceptance Criteria and Reported Device Performance

Study Details (as applicable to this type of device modification)

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

   • This document does not describe a "test set" in the context of imaging data or a diagnostic algorithm.
   • The "test set" for this modification would refer to testing of the device's hardware and software functionalities.
   • Provenance: Not specified, but generally, Varian Medical Systems, Inc. is a U.S.-based company, and such engineering tests are typically conducted internally at their facilities.
   • Retrospective/Prospective: The testing described (Verification and Validation) is inherent to the product development lifecycle and would be considered prospective in relation to the design changes.

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)

   • Not applicable in the sense of medical image interpretation.
   • Ground Truth: For device functionality, the "ground truth" is defined by the design input requirements and technical specifications for the motion zone rules and interlocks.
   • Experts: "Qualified personnel" performed the validation testing. These would be engineers, QA specialists, and potentially clinical representatives experienced with linear accelerators, but not radiologists establishing ground truth for disease.

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

   • Not applicable as this is not an imaging or diagnostic study requiring expert consensus. The testing would follow engineering test protocols.

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

   • No, an MRMC comparative effectiveness study was not done.
   • The device is a medical linear accelerator; it does not involve human readers interpreting images with or without AI assistance for diagnostic purposes. The changes are to hardware/software interlocks for patient safety during treatment delivery.

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

   • The device itself (the linear accelerator) operates in conjunction with human operators (radiotherapy technologists, dosimetrists, radiation oncologists). The "motion zone rules" and "interlocks" are algorithmic components within the device's software that automatically prevent unsafe operations.
   • Standalone testing of these sub-systems (e.g., verifying the interlock logic in isolation) would have been part of the verification process, but not as a standalone AI diagnostic tool.

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

   • The ground truth for this type of device modification is established by engineering design specifications, safety standards, and validated functional requirements. For example, the ground truth for the expanded "collision protection" is that the gantry should not collide with the couch in specified scenarios, regardless of imaging arm position, and the system correctly prevents such collisions.

7. The sample size for the training set

   • Not applicable. This is not an AI/machine learning model where a "training set" is used to develop an algorithm for diagnosis or prediction. The changes are deterministic software and hardware logic.

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

   • Not applicable, as there is no "training set" in the AI/ML sense.

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Geratherm UniqueTemp® is a thermal regulating system for adult patients in order to prevent hypothermia in the operating theater. It is suitable for pre-, intra- and post-operative use. The device is not life-supporting. It is intended for use by appropriately trained healthcare professionals in clinical environments.

Geratherm UniqueTemp® has been developed for the prevention of hypothermia. The Geratherm warming blankets can be used for covering the patient in various ways without restricting the surgical area and provide active warming to the patient. All the blankets can be freely combined. The flexibility of the blankets makes it possible to warm the patient, even if complicated positioning on the operating table is required. After being placed over the patient, Geratherm UniqueTemp® can itself be covered with surgical drapes. Geratherm UniqueTemp® is suitable for use with adult patients of all sizes. The blankets should not be used for children. Geratherm UniqueTemp® is intended to be used during lengthy operations as well as by hypothermic patients. The device is not life-supporting. Geratherm UniqueTemp® should be operated only by qualified medical professionals. The Geratherm UniqueTemp9 consists of the following components: Control unit, Holding claw, Mains cable, Arm/shoulder blanket, Reusable cover for arm/shoulder blanket, Torso blanket, Reusable cover for torso blanket, Leg blankets, Reusable cover for leg blankets, Connecting cable, Body temperature sensor. The Controller is made of anodized aluminum (colorless or black); furthermore, the control unit has a glass screen. All blankets and covers have a PU coated material. The connecting cable is made of silicone.

The provided text describes the Geratherm UniqueTemp® Patient Warming System and its 510(k) summary. However, it does not contain specific acceptance criteria, a detailed study protocol for performance, or quantitative results that would allow for the direct completion of the requested table and study details.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Hot Dog Patient Warming System K052392) through comparisons of intended use, indications for use, safety characteristics, and compliance with various international standards.

Therefore, I cannot extract the specific acceptance criteria and detailed study information as requested.

However, I can summarize what is available in the document regarding performance and regulatory compliance:

Summary of Device Performance Information from the Document:

The document states:

• "The presented data which was conducted using the Geratherm UniqueTemp®, in comparison to the predicate device, shows that the product is safe and effective for its intended use." - This is a general claim rather than specific performance metrics.
• "Both devices are similar regarding the performance characteristics and reach a similar maximum temperature of 42°C and 43°C respectively." - This indicates a performance characteristic (maximum temperature) but does not provide acceptance criteria or a study comparing the devices' ability to maintain a target temperature or prevent hypothermia.
• "The product components which are covered by this 510(k) premarket notification have been successfully tested for biocompatibility, electromagnetic compatibility, functionality and safety according to international standards." - This refers to testing against general standards, not specific clinical performance criteria.
• The device meets the requirements of Council Directive 93/42 EEC on Medical Devices and specific IEC standards (60601-1, 60601-1-2, and 80601-2-35). These standards cover general safety, electromagnetic compatibility, and particular requirements for heating devices, implying compliance with their respective criteria, but the document doesn't detail what these criteria are or the specific test results.

In the absence of the requested data, I will present the information that can be inferred or directly stated from the provided text, and explicitly note where the requested information is not available.

1. Table of Acceptance Criteria and 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: Not specified. The document refers to "presented data" and "successful testing" but does not provide details on the number of subjects (if clinical) or units (if bench testing) used in performance tests.
• Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the tests were retrospective or prospective. Given the manufacturer is German and the correspondent is also in Germany, it's plausible testing was conducted in Europe, but this is not explicitly stated.

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

• Not Applicable. This type of information (expert consensus for ground truth) is typically relevant for diagnostic devices or those involving interpretation of medical images/data. The Geratherm UniqueTemp® is a patient warming system, where "ground truth" would likely refer to objective physical measurements (e.g., temperature) or established safety standards, rather than expert interpretation.

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

• Not Applicable. Adjudication methods are typically used in studies where multiple human readers assess a case and their discrepancies need to be resolved to establish ground truth (e.g., in diagnostic imaging studies). This is not relevant for a patient warming device.

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 type of study is entirely irrelevant for a patient warming device. An MRMC study is designed for diagnostic systems that involve human interpretation, often assisted by AI. The Geratherm UniqueTemp® is a therapeutic device that performs a function directly.

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

• Yes, implicitly. The "Non-Clinical Performance Data" section and the statement "The product components... have been successfully tested for biocompatibility, electromagnetic compatibility, functionality and safety according to international standards" indicate that testing of the device's technical performance and safety characteristics was done in a standalone manner, without explicit human interaction being part of the primary performance measurement (other than operation). The device's function (heating) is inherently "standalone" in its operation once set.

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

• Known Standards and Objective Measurements. For a device like a warming system, "ground truth" would be established by:
  • Compliance with International Standards: The document explicitly states compliance with IEC 60601-1 (general safety), IEC 60601-1-2 (EMC), and IEC 80601-2-35 (specific heating device requirements). These standards define objective performance and safety criteria.
  • Objective Physical Measurements: Testing would involve measuring temperature output, power consumption, safety cut-offs, material properties, etc., against predefined specifications derived from product design and regulatory requirements.
  • Comparison to Predicate Device: The concept of "substantial equivalence" means the new device's performance is compared to a legally marketed predicate device, implying the predicate device's performance serves as a benchmark for effectiveness and safety.

8. The sample size for the training set

• Not Applicable/Not Provided. The concept of a "training set" typically applies to AI/machine learning algorithms. The Geratherm UniqueTemp® is not described as an AI-powered device. Therefore, there is no training set in that context. If "training set" refers to developmental or internal testing, that information is not provided.

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

• Not Applicable. (See point 8).

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