(27 days)
The INTRABEAM® System is intended to be used for radiation therapy treatment. The INTRABEAM® System is indicated for radiation therapy treatments. The INTRABEAM® Spherical Applicators are indicated for use with the INTRABEAM® System to deliver a prescribed dose of radiation to the treatment margin or tumor bed during intracavity or intraoperative radiotherapy treatments.
The INTRABEAM® System described in this Special 510(k) is a modification and enhancement of the PRS400 System cleared under K980526 and K992577. The INTRABEAM® System consists of the PRS500 Control Console, the XRS 4, the Workstation Software, the User Terminal, the verification accessories, and the treatment accessories. The PRS500 Control Console provides all low-level operational control and safety functions of this System. The User Terminal with Workstation Software is the primary interface between the System and the user. The Software provides the high level control and display functions of the System. With the INTRABEAM® System, the radiologist, physicist, or technologist uses the Workstation Software on the User Terminal to set up the PRS500 Control Console (perform the pre-treatment verification and treatment planning), perform the treatment to completion, log all procedure variables and events, and after completion of the treatment, save and/or print treatment and performance data.
The provided document is a 510(k) summary for the Carl Zeiss Surgical GmbH INTRABEAM® System. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics. The document focuses on regulatory compliance and technical equivalence rather than clinical performance data.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a clinical performance study cannot be fully provided from the given text alone.
Here's an breakdown of what can be inferred from the provided text, and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as performance metrics in a clinical context. The document mentions "systematically tested to demonstrate that the modifications did not adversely affect safety and effectiveness." This implies internal engineering and regulatory compliance criteria were met, but these are not clinical performance acceptance criteria (e.g., sensitivity, specificity, accuracy).
- Reported Device Performance: No clinical performance data (like accuracy, sensitivity, specificity) is provided for the INTRABEAM® System or its comparison to the predicate in a clinical setting. The "performance" mentioned refers to engineering and safety performance.
2. Sample Size for the Test Set and Data Provenance:
- Sample Size: Not applicable in a clinical sense. The testing described (functionality, safety, electrical safety, EMC, environmental, mechanical stress, validation testing) refers to engineering and regulatory tests, not a patient-based test set for clinical performance evaluation.
- Data Provenance: Not applicable. The "testing" refers to internal company testing, not data generated from patient studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable. Ground truth, in the context of clinical performance evaluation, would be established by medical experts reviewing patient data (e.g., imaging, pathology). This type of clinical expert review or ground truth establishment is not mentioned as part of the described testing.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. As there is no clinical test set with medical outcomes being evaluated, no adjudication method is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was an MRMC study done? No, the document does not indicate that a MRMC comparative effectiveness study was performed. The focus is on the substantial equivalence of the modified device to the predicate device based on technological characteristics and safety/effectiveness testing.
- Effect size of improvement with AI vs. without AI assistance: Not applicable. This device is an X-ray radiation therapy control unit, not an AI-assisted diagnostic or interpretation tool for human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Was a standalone study done? Not in the sense of an "algorithm only" performance study. The "systematic testing" includes "functionality (integration testing of hardware, firmware, and accessories), safety, electrical safety, electromagnetic compatibility, environmental testing, mechanical stress testing, and validation testing." This represents standalone engineering performance, but not standalone clinical performance in isolation from a human operator. The device itself is an integrated system with controls for a human user.
7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):
- Type of Ground Truth: Not applicable in a clinical performance sense. For the engineering and regulatory tests, "ground truth" would be established by design specifications and regulatory standards (e.g., electrical safety standards, electromagnetic compatibility limits, mechanical stress tolerances).
8. Sample Size for the Training Set:
- Sample Size: Not applicable. The INTRABEAM® System is a piece of medical hardware and software, not an AI/ML algorithm that requires a "training set" of data in the typical sense. Its functionality is based on programmed controls and physics principles, not learned patterns from a dataset.
9. How the Ground Truth for the Training Set Was Established:
- How Ground Truth Established: Not applicable. As there's no training set for an AI/ML algorithm, there's no ground truth established for it.
In summary, the provided 510(k) summary primarily addresses the regulatory approval process for a modified medical device, focusing on its substantial equivalence to a predicate device through engineering and safety testing. It does not contain information about clinical performance studies with acceptance criteria, human reader evaluations, or AI/ML algorithm training and validation common in submissions for diagnostic or AI-powered devices.
§ 892.5900 X-ray radiation therapy system.
(a)
Identification. An x-ray radiation therapy system is a device intended to produce and control x-rays used for radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II.