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The INTRABEAM 600 is indicated for radiation therapy treatments.

The INTRABEAM Spherical Applicators are indicated for use with the INTRABEAM 600 to deliver a prescribed dose of radiation to the treatment margin or tumor bed during intracavity and intraoperative radiotherapy treatments.

The INTRABEAM Spherical Applicators used with the INTRABEAM 600 are able to deliver a prescribed dose of intraoperative radiation in conjunction with whole breast irradiation, based upon the medical judgment of the physician. The safety and effectiveness of the INTRABEAM 600 as a replacement for whole breast irradiation in the treatment of breast cancer has not been established.

The Needle Applicator set (comprising the Needle Applicator and guide shafts) is intended for use in combination with the INTRABEAM 600 to intraoperatively administer radiation to tissue including irraciation of intracranial tumors.

The INTRABEAM Flat Applicator is intended to supply a specified radiation dose during applications in combination with the INTRABEAM 600,

• during intraoperative radiotherapy, on a surgically exposed surface or in a tumor bed.
• during treatment of tumors on the body surface.

The INTRABEAM Flat Applicator is designed to deliver a flat radiation field at a distance of 5mm from its circular application surface in water.

The INTRABEAM Surface Applicator is intended to supply a specified radiation dose during applications in combination with the INTRABEAM 600.

• during intraoperative radiotherapy, on a surgically exposed surface or in a tumor bed.
• during treatment of tumors on the body surface.

The INTRABEAM Surface Applicator is designed to deliver a flat radiation field directly at the applicator's surface.

The INTRABEAM 600 is a radiation therapy device intended for targeted treatments of selected lesions for minimally invasive, intraoperative, interstitial, intracavity and contact radiation therapy of tumors or tumor beds within the body of cancer patients. By applying the radiation source in conjunction with various applicators, a prescribed dose of low energy radiation can be delivered to the target volume. The delivery of the radiation dose is controlled via the integrated control unit and software.

The INTRABEAM 600 is provided as a mobile workstation. Like the previously cleared versions of the INTRABEAM system, the INTRABEAM 600 provides several tools for Quality Assurance of radiation delivery, which are intended to verify the proper functioning of the radiotherapy treatment system.

The main components of the INTRABEAM 600 system are:

• INTRABEAM Workplace mobile cart containing the following:
  • Control Console 600 (CC600)
  • Computer with Software Version 4.0
  • Touchscreen monitor, keyboard and mouse
  • Dosimeter (UNIDOS E)
  • V-guide
• XRS 4 X-ray Source
• Quality Assurance Tools: PAICH, PDA, and Ionization Chamber with Ionization Chamber Holder
• radiance Third party treatment planning simulation software

The applicators used with the INTRABEAM 600 are identical to the applicators cleared in previous 510(k)s.

This document is a 510(k) premarket notification for the INTRABEAM 600, a radiation therapy system. It focuses on demonstrating substantial equivalence to a predicate device rather than defining acceptance criteria and presenting a study to prove they are met in the traditional sense of a clinical trial for a novel device.

The "acceptance criteria" here are essentially compliance with safety and performance standards for an X-ray radiation therapy system, and the "study" is a series of engineering tests and comparisons to a previously cleared device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not specify a "sample size" in terms of patients or a clinical dataset for a performance study. The testing described is primarily focused on engineering compliance verification and validation of the device itself (electrical safety, EMC, software, etc.).
• Data Provenance: Not applicable in the context of clinical data provenance. The data comes from internal engineering tests conducted by Carl Zeiss Meditec AG, likely at their facilities in Germany, as the applicant is based there. These are premarket tests, so they are not retrospective or prospective in the clinical sense.

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

• This information is not provided. The "ground truth" for the engineering tests would be the specifications and standards themselves (e.g., IEC standards, internal design requirements). The engineers conducting and verifying these tests would be the "experts," qualified in electrical engineering, software engineering, medical device safety, etc., but their specific number and qualifications are not detailed.

4. Adjudication method for the test set:

• Not applicable. The tests are compliance checks against objective standards and functional requirements. There's no subjective interpretation or "adjudication" in the clinical sense.

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 study was done. This device is an X-ray radiation therapy system, not an AI-powered diagnostic or decision support tool. It does not involve "human readers" interpreting images with or without AI assistance. The "radiance" software mentioned is a treatment planning simulation software, not an AI for image interpretation.

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

• This concept is not directly applicable to the INTRABEAM 600. It's a medical device that delivers radiation, not an algorithm that performs a diagnostic task. Its "performance" is about its physical and software functionality according to specifications and safety standards. The software verification and validation are essentially "standalone" checks of the software's functional correctness.

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

• The "ground truth" for this PMA is primarily:
  • International and national medical device safety and performance standards: e.g., IEC 60601 series.
  • Internal design specifications and requirements: for system functionality, electrical safety, software behavior, etc.
  • The predicate device (INTRABEAM System K051055): for demonstrating substantial equivalence in terms of intended use, indications, and technological characteristics.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a "training set" in the context of learning from data. The software within the device is designed and developed based on established engineering principles and programming, not trained on a dataset.

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

• Not applicable, as there is no "training set" for an AI/machine learning algorithm.

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