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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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The Photon Radiosurgery System (PRS) is indicated for radiation therapy treatments.

The PRS Spherical Applicators are indicated for use with the Photon Radiosurgery System (PRS) to deliver a prescribed dose of radiation to the treatment margin or turnor bed during intracavity or intraoperative radiotherapy treatments.

The Photoelectron Corporation Photon Radiosurgery System (PRS) is a miniature, high-dose rate, low energy X-ray source that emits X-ray radiation from the tip of a 3 mm diameter probe. The original PRS Model was cleared for marketing in the 510(k) K964947. The PRS was subsequently modified and cleared for marketing in 510(k) K980526 (PRS400). The PRS was cleared by these 510(k)s for the irradiation of intracranial tumors.

Since the currently cleared PRS400 is restricted to treatment of intracranial tumors, Photoelectron Corporation is also proposing in this 510(k) to modify the PRS indications for use to permit use of the PRS to irradiate tumors other than at intracranial locations.

This 510(k) is also being submitted to add the use of PRS Spherical Applicators to the PRS System. The Spherical Applicators will permit the PRS to be used for intracavitary or intraoperative radiation therapy. In addition, two accessories for use with the Spherical Applicators are also being added to the PRS: the Radiation Shields, which protect surrounding tissue and/or organs from radiation, and the PRS Interface Adapters, which provide a means for connecting the PRS X-ray Source (XRS), and the Spherical Applicators to various commercially available surgical support systems for non-stereotactic applications.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Photon Radiosurgery System (PRS):

Overall Assessment:

The provided document (K992577) is a 510(k) premarket notification for the Photoelectron Corporation's Photon Radiosurgery System (PRS). This document seeks to expand the indications for use of an already cleared device and introduce new accessories. A 510(k) typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical trial data or detailed performance acceptance criteria in the same way a PMA (Premarket Approval) might.

As such, the document does not describe traditional clinical acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device. Instead, it focuses on dosimetry data to demonstrate the performance of the new applicators and substantial equivalence to existing radiation therapy devices.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the acceptance criteria are implicitly tied to the dosimetry data demonstrating the performance of the Spherical Applicators. There are no explicit, quantifiable acceptance criteria (e.g., minimum accuracy, sensitivity, specificity) for a diagnostic outcome, as this is a therapeutic device.

Note: The document provides no specific numerical values or detailed results of the dosimetry data beyond this statement.

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

• Sample Size: Not applicable in the traditional sense of a patient test set for an AI/ML diagnostic. The "test set" here refers to the physical characterization of the device through dosimetry. The document does not specify how many tests or measurements were conducted for the dosimetry data.
• Data Provenance: Not applicable. This is not patient-derived data but rather engineering and physics characterization of the device.

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

Not applicable. The ground truth for dosimetry measurements is derived from physical measurement techniques, not expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication needed for physical dosimetry measurements.

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

No, an MRMC comparative effectiveness study was not done. This device is a radiation therapy system, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images.

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

This question is not directly applicable. The device itself is a standalone therapeutic system. The "performance" being evaluated is its ability to deliver radiation, not an algorithm's diagnostic output. The dosimetry data is a measure of the device's standalone performance in terms of radiation delivery characteristics.

7. The Type of Ground Truth Used

The ground truth used for the evaluation mentioned (dosimetry) is based on physical measurements and scientific principles related to radiation dose distribution. This is a form of objective, empirical data to characterize the device's output.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML system trained on a dataset.

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

Not applicable. This device is not an AI/ML system.

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