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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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The Carl Zeiss Surgical INFRARED 800 with the FLOW 800 option is a surgical microscope accessory used in viewing and visual assessment of intra-operative blood flow in the cerebral vascular area including, but not limited to, assessing cerebral aneurysm and vessel branch occlusion, as well as patency of very small perforating vessels. It also aids in the real-time visualization of blood flow and visual assessment of vessel types before and after Arteriovenous Malformation (AVM) surgery. Likewise, INFRARED 800 with the FLOW 800 option used during fluorescence guided surgery aids in the visual assessment of intra-operative blood flow as well as vessel patency in bypass surgical procedures in neurosurgery, plastic and reconstructive procedures and coronary artery bypass graft surgery.

INFRARED 800 with the FLOW 800 option is an accessory to the OPMI Pentero surgical microscope for visualizing blood flow intraoperatively. INFRARED 800 allows the surgical microscope to produce light to illuminate the fluorescence properties of the Indocyanine Green (ICG) dye and to detect the emitted fluorescent signal to examine the human vascular system during surgery. FLOW 800 provides the surgeon with a processing mode that allows convenient handling and visualization of the INFRARED 800 video data.

The provided 510(k) summary for the INFRARED 800 with FLOW 800 option does not contain explicit acceptance criteria or a dedicated study section detailing the device's performance against such criteria.

Instead, it relies on a "Substantial Equivalence" claim based on comparison to predicate devices and a review of existing clinical literature. This type of submission generally does not include a specific "acceptance criteria" table or a detailed "device performance" study as you might find for novel devices or those with specific quantitative performance claims.

However, I can extract information related to the device's clinical evaluation and training data based on the provided text.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, the document does not present a table of explicit acceptance criteria or a dedicated study with quantified device performance metrics against those criteria. The submission is a substantial equivalence claim, meaning the device is considered safe and effective because it is similar to already legally marketed devices.

The "performance" is implicitly demonstrated through:

• Technological Comparison: The device utilizes similar technology (surgical microscope, ICG dye, CCD cameras, real-time visualization of images) to the predicate devices (Leica FL800, Novadaq SPY Intra Operative Imaging System).
• Clinical Literature Review: The submission points to peer-reviewed medical literature demonstrating the use and effectiveness of the INFRARED 800 accessory with Indocyanine Green (ICG) angiography in hundreds of patients for various surgeries.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document states that the INFRARED 800 accessory with ICG angiography "has been used in hundreds of patients." This suggests the "test set" for the clinical literature review encompasses a large, but unspecified, number of patients.
• Data Provenance: The data comes from "clinical literature that discusses the relevant studies," which are described as "peer-reviewed medical literature." This indicates the data is retrospective, collected from previously published studies. The countries of origin are not specified, but peer-reviewed medical literature generally implies multinational sources.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not specify a number of experts or their qualifications for establishing ground truth within the context of a dedicated "test set" for this submission. The "ground truth" implicitly comes from the diagnostic and surgical outcomes reported in the peer-reviewed clinical literature that informed the substantial equivalence claim. These outcomes would have been determined by the operating surgeons and medical professionals involved in those published studies (e.g., neurosurgeons, plastic surgeons, cardiac surgeons).

4. Adjudication Method for the Test Set

No explicit adjudication method is described, as there wasn't a specific, controlled "test set" created for this 510(k) submission. The clinical evidence is derived from existing published studies, where the outcomes and diagnoses within those studies would have been adjudicated according to the standard practices of the respective clinical research teams.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No MRMC comparative effectiveness study is mentioned in the provided text. The submission focuses on the device's equivalence to existing technology and its utility as demonstrated in clinical literature, not on assessing the improvement of human readers with AI assistance (which is not relevant for this type of imaging device).

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

This device is not an algorithm, but rather a surgical microscope accessory that aids in viewing and visual assessment by a human surgeon. Therefore, a "standalone algorithm-only" performance study is not applicable and was not conducted. The "performance" is inherently human-in-the-loop.

7. The Type of Ground Truth Used

The ground truth is based on expert clinical observation and surgical outcomes reported in peer-reviewed medical literature. This includes:

• Assessment of closure/remnants of cerebral aneurysms
• Patency of vessels (including small perforating vessels)
• Real-time visualization of blood flow and vessel types in AVMs
• Assessment of patency in anastomosed vessels during bypass or free flap surgery

This is essentially "outcomes data" and "expert clinical consensus/observation" derived from actual surgical procedures.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of device development or algorithm training. Since this is a hardware accessory for visualization, and not an AI/ML algorithm that requires training, the concept of a "training set" as typically understood in AI is not applicable. The device's design and functionality would be based on general engineering principles and medical knowledge related to fluorescence imaging.

9. How the Ground Truth for the Training Set was Established

As there is no mention of a "training set" in the context of algorithm development, there is no description of how ground truth for such a set was established.

In summary: The 510(k) submission for the INFRARED 800 with FLOW 800 option relies on a substantial equivalence pathway. It demonstrates this by comparing its technological features to legally marketed predicate devices and by referencing a body of existing clinical literature that documents the use and effectiveness of the INFRARED 800 accessory in "hundreds of patients." It does not present novel performance data against specific acceptance criteria, nor does it involve AI algorithms with distinct training and test sets in the modern sense.

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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® Balloon Applicator together with the INTRABEAM® System is intended to deliver intracavitary or interstitial radiation to the surgical margins following lumpectomy for breast cancer.

The safety and effectiveness of the INTRABEAM® System as a replacement for whole breast irradiation in the treatment of breast cancer has not yet been established.

Not Found

This document is a 510(k) clearance letter from the FDA for the Carl Zeiss INTRABEAM® System. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in terms of diagnostic or clinical accuracy (like sensitivity, specificity, etc.) for a medical imaging or AI device.

Instead, this document focuses on:

• Regulatory clearance: Stating that the device is substantially equivalent to legally marketed predicate devices.
• Intended Use: Defining the radiotherapy treatments for which the device is indicated.
• Limitations and Warnings: Explicitly stating that the "safety and effectiveness of the Carl Zeiss INTRABEAM® System with Balloon Applicators for breast brachytherapy as a replacement for whole breast irradiation in the treatment of breast cancer has not been established," and requiring this warning to be in the labeling.

Therefore, I cannot provide the requested information about acceptance criteria and a performance study based on the provided text. The traditional "acceptance criteria" and "study that proves the device meets the acceptance criteria" as typically described for diagnostic AI/imaging devices (e.g., sensitivity, specificity, F1 score) are not present in this regulatory clearance letter. The "acceptance" here relates to regulatory clearance based on substantial equivalence, not a direct performance study like those for AI algorithms.

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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.

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