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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

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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