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The INTRABEAM is intended for use in radiotherapy treatments.
The INTRABEAM SMART Spherical Applicator is used with the INTRABEAM to deliver a prescribed dose of intraoperative radiation to the treatment margin or tumor bed during intracavity and intraoperative radiotherapy treatments.
The safety and effectiveness of the INTRABEAM as a replacement for whole breast irradiation in the treast cancer has not been established.
The INTRABEM Needle Applicator (comprising the Needle Applicator and guide shafts) is intended for use in combination with the INTRABEAM to intraoperatively administer radiation to tissue including irradiation of intracranial tumors.
The INTRABEAM SMART Stand is designed as an instrument support and positioning unit for the INTRABEAM.
The INTRABEAM Spherical Sizer Set shall support the doctor (surgeon and/or radiation oncologist) in assessing which spherical-shaped applicator shall be used for the radiation therapy procedure, involving INTRABEAM.

The INTRABEAM 700 is a radiation therapy device intended for targeted treatments of selected lessions for minimally invasive, intraoperative, interstital, 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 700 is provided as a mobile workstation. Like the previously cleared versions of the INTRABEAM system, the INTRABEAM 700 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 700 system are:

• INTRABEAM Workplace - mobile cart containing the following:
  • Control Console 700 (CC700)
  • Computer with Software Version 5.0
  • Touchscreen monitor and mouse
  • UNIDOS Romeo Electrometer
  • 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 INTRABEAM SMART Stand is connected to the INTRABEAM 700 and is used to mount the X-ray generator (XRS 4) and the necessary applicator, in order to deliver the prescribed radiation dose at the target site.
  The INTRABEAM Spherical Applicator is a sterile disposable product that shall be placed in contact with the tumor mass and/or tumor resection cavity to deliver a prescribed dose of intraoperative radiation.
  The INTRABEAM Spherical Sizer Set is a sterile disposable product that shall be placed in contact with body part and/or tumor mass to help support the doctor (surgeon and/or radiation oncologist) in assessing which spherical-shaped applicator shall be used for the radiation therapy procedure, involving INTRABEAM.
  The INTRABEAM Needle Applicator has not been updated since the last clearance, K162568.

The provided document is a 510(k) Premarket Notification from the FDA, which assesses the substantial equivalence of a new medical device (INTRABEAM 700) to a legally marketed predicate device (INTRABEAM 600). The document focuses on regulatory compliance, safety, and performance testing to demonstrate equivalence, rather than providing details of a clinical study designed to prove the device meets specific acceptance criteria in a clinical setting with human subjects.

Therefore, the document does not contain the information requested regarding acceptance criteria and the specifics of a study proving the device meets those criteria, particularly in the context of AI assistance or human reader performance. The "Performance Testing - Bench" section describes non-clinical system testing, software verification, and compliance with various IEC standards (EMC, Electrical, Mechanical, Thermal Safety, Radiation Safety, Usability/Human Factors), which are important for device safety and functionality but are not clinical performance "acceptance criteria" as would be evaluated in a multi-reader multi-case (MRMC) study or a standalone AI performance study.

The document primarily relies on demonstrating substantial equivalence to a predicate device through:

• Identical or equivalent indications for use.
• Similar technological characteristics.
• Compliance with relevant safety and performance standards (e.g., IEC 60601-series).

In summary, none of the requested information regarding acceptance criteria for clinical performance, test set sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone AI performance, or training set details are present in the provided text. The document focuses on bench testing and regulatory compliance, not clinical efficacy or AI performance metrics.

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The Needle Applicator set (comprising the Needle Applicator and guide shaft) is indicated for use in combination with the INTRABEAM® System to intraoperatively administer radiation to tissue including irradiation of intracranial tumors.

The proposed device is a modification of the INTRABEAM® System with Balloon Applicator, K090584, incorporating a Needle Applicator and guide shafts that are used to open a tract for the positioning of the applicator for irradiation of turnors. The INTRABEAM® System that will be used with the new Needle Applicator accessory was most recently described in K090584. There are no modifications to the INTRABEAM® System hardware or software. The INTRABEAM® Core System consists of the following components: PRS500 Control Console, XRS4 X-ray source, User terminal. Components of the Needle Applicator set are as follows: 1) Inner Sterile Packaging, 2) 5 cm guide shaft, 3) 6 cm guide shaft, 4) Needle Applicator. The physical design of the Needle Applicator consists of a polycarbonate case which fits over the probe of the XRS 4 X-ray source, a stainless steel shaft, and a polyetherimide tip for the Applicator. The guide shafts are stainless steel.

The provided text describes a 510(k) summary for the Carl Zeiss INTRABEAM® System with Needle Applicator. This document focuses on the non-clinical performance testing conducted to demonstrate substantial equivalence to predicate devices, rather than a study typically associated with AI/ML device approval which would include extensive clinical performance criteria and human reader studies.

Therefore, many of the requested categories related to clinical study design, AI performance, ground truth establishment for a training set, and expert adjudication are not applicable or not explicitly detailed in the provided content. This document primarily addresses the safety and functional performance of the hardware modification (Needle Applicator) to an existing radiation therapy system.

Here's an attempt to populate the requested table and information based on the provided text, indicating "Not Applicable" or "Not Specified" where the information is not present or not relevant to this type of submission.

Acceptance Criteria and Reported Device Performance

2. Dosimetry equivalence to the PRS400 with the XRS probe (with sheath).
3. Isotropy of tested units meets criteria. | 1. Five samples inspected visually before/after sterilization and accelerated aging. All applicators passed tests, were fully functional, and met engineering specifications.
4. Dose depth curves of Needle Applicators matched those of the bare probe with sheath.
5. Isotropy of tested units met the passing criteria. All criteria met. |
   | Biocompatibility Testing | 1. Cytotoxicity (L 929 cell cultures, quantitative proliferation).
6. Chemical Analysis (GC-FID, quantification of organic/inorganic leachables). | 1. Needle Applicator and Guide shaft: "No relevant effects observed in comparison to controls."
7. Needle Applicator: "No relevant effects observed in comparison to controls." All criteria met. |
   | Overall Conformity | Fulfills prospectively defined design and performance specifications as basis for substantial equivalence to predicate devices. | Based on the non-clinical testing, the Carl Zeiss INTRABEAM® Needle Applicator is substantially equivalent to the cited predicate devices and fulfills prospectively defined design and performance specifications. This led to a substantial equivalence determination by the FDA in 2012. All key criteria met for regulatory approval based on non-clinical data. |

Study Details

1. Sample size used for the Test Set and Data Provenance:

   • Sterilization Validation: Not explicitly stated for specific test runs, but the methodology (VDmax 25) implies a statistically relevant sample size for microbial testing.
   • Performance Testing (Functionality/Aging): 5 samples (Needle Applicators) were subjected to visual inspection, sterilization, and accelerated aging.
   • Performance Testing (Dosimetry): Not explicitly stated, but "tested units" implies multiple devices.
   • Biocompatibility Testing: Not explicitly stated, likely follows standardized protocols requiring specific sample sizes for each test type.
   • Data Provenance: The testing was conducted internally by Carl Zeiss Meditec AG, likely in Germany (country of manufacturer) or its affiliates. This is retrospective data for the submission, based on laboratory testing.

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

   • Not applicable in the context of this submission. The "ground truth" here refers to objective measurements (e.g., sterilization levels, dose depth curves, cytotoxicity assays) against engineering specifications and industry standards, not expert clinical interpretation of medical images or patient data.

3. Adjudication Method for the test set:

   • Not applicable. Performance was assessed against objective, predefined physical and chemical standards, not through adjudication of subjective interpretations.

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:

   • Not applicable. This is not an AI/ML device, and no clinical studies involving human readers or comparative effectiveness were conducted for this submission ("No clinical testing was conducted to support this submission").

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

   • Not applicable. This is a hardware modification for a radiation therapy system, not an algorithm or AI.

6. The type of ground truth used:

   • Objective physical and chemical measurements/standards:
     • Sterilization Assurance Level (SAL) of 10⁻⁶
     • Engineering specifications for functionality
     • Dosimetry measurements (dose depth curves, isotropy data) compared to bare probe with sheath
     • Standardized biocompatibility test results (cytotoxicity, chemical analysis) compared to controls.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device requiring a training set.

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

   • Not applicable.

Summary of Device and Study Context:

This 510(k) submission (K110590) is for a hardware accessory (Needle Applicator) to an existing X-ray radiation therapy system (INTRABEAM® System). The purpose of the submission is to demonstrate that the new accessory is substantially equivalent to previously cleared predicate devices. The "study" described is a series of non-clinical, laboratory-based tests (sterilization, performance/aging, biocompatibility) designed to ensure the safety, functionality, and compatibility of the Needle Applicator with the existing system and regulatory standards. It does not involve patient data, clinical trials, or AI/ML components, hence many of the specific questions are not relevant in this context.

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