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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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EquiDose™ Solid State Diode Detectors are intended to be used for the collection of radiation beam data from radiation therapy treatment machines in air, water, or in other suitable material. The data acquired with this type of detector can be used to compile radiation beam data over time as part of a quality assurance program, to verify treatment machine energy and output, and to measure therapeutic doses delivered to patients during treatment.

The EquilDose™ Solid State Diode Detector is intended to be used for the collection of radiation beam data from radiation-producing machines.

MasTek's EquiDose™ Solid State Diode Detectors are classical solid state diode detectors used for verification measurements in radiation therapy. All of the diodes share the same design, manufacturing process, are made of the same materials and they are all waterproof. With the exception of their higher input impedance and standard 2 meter cable length, the EquiDose™ Solid State Diode Detectors are exactly the same as the predicate ISORAD™ Solid State Diode Detectors.

EquiDose™ Solid State Diode Detectors, when connected to an appropriate electrometer like the PTW-UNIDOS, K951764, are used to collect and verify beam data from radiation therapy treatment machines and to verify therapeutic amounts of radiation delivered during treatments.

The provided text is a 510(k) submission for the EquiDose™ Solid State Diode Detectors. It does not contain acceptance criteria or the results of a study designed to prove the device meets specific performance metrics. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (ISORAD™ Solid State Diode Detectors, K912250).

The core of the submission states:

• "The indications for use are exactly the same as the predicate devices..."
• "The designs are exactly the same."
• "The manufacturing and testing, process and procedures are exactly the same."
• "The materials used are the same as in the predicate devices."
• "The specifications are the same as the predicate devices."
• "The indications for use, design, materials, manufacturing, and specifications of the EquiDose™ Solid State Diode Detectors do not raise any issues with regard to safety and effectiveness. MasTek D.E.M., Inc. considers all of these solid state diode detectors equivalent to the predicate devices for radiation therapy beam data measurements."

This means that instead of conducting a new study with defined acceptance criteria for the EquiDose™ device itself, the manufacturer is relying on the previous clearance of the predicate device (ISORAD™) and asserting that the EquiDose™ device is essentially identical in all relevant aspects that would impact safety and effectiveness.

Therefore, I cannot populate the requested table or answer the specific questions about standalone studies, MRMC studies, sample sizes, or ground truth establishment for the EquiDose™ device's performance, as this information is not present in the provided 510(k) summary. The submission's approach is to demonstrate equivalence, not to re-prove performance against new criteria.

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The PTW T31006 and T31007 Pinpoint type ionization chambers are intended to be used for the collection of beam data in water, air, or other suitable solid state phantom material from radiation therapy treatment machines. This data is used to completely document the beam characteristics of treatment machines and to establish and maintain an on going treatment machine quality assurance program.

The PTW T31006 and T31007 are classical waterproof ionization chambers that differ only in the lengths of their respective active volumes. The T31006 is a 0.015 cc ionization chamber with a 5 mm active length and the T31007 is a 0.005 cc ionization chamber with a 2 mm active length. Both chamber volumes are open to the atmosphere, they are waterproof, and they are vented via their connectors. These chambers are constructed of precisely the same materials, are available with a 1 m or 10 m cable for connection to an electrometer, and may be terminated in a variety of standard electrometer connectors (BNT, TNC, PTW M, or BNC banana.

Here's an analysis of the provided text regarding the PTW T31006 and T31007 Pinpoint type ionization chambers for their acceptance criteria and study information:

This submission is a 510(k) Premarket Notification for ionization chambers, which are measurement devices. As such, the concept of "device performance" in terms of clinical outcomes or diagnostic accuracy doesn't directly apply in the same way it would to an imaging or therapeutic device for patients. Instead, the "performance" here relates to their measurement accuracy, precision, and adherence to established specifications compared to predicate devices.

The document primarily demonstrates substantial equivalence to predicate devices rather than a standalone clinical study. Therefore, many of the requested fields regarding a clinical study will not be explicitly present.

Acceptance Criteria and Reported Device Performance

1. A table of acceptance criteria and the reported device performance

Explanation of "Acceptance Criteria" for this device:

Since this is a 510(k) submission for a measurement device, the "acceptance criteria" are implicitly defined by demonstrating substantial equivalence to already cleared predicate devices. The primary acceptance criterion is that the new devices do not raise new questions of safety or effectiveness and are equivalent in indications for use, technological characteristics, and performance to the predicate devices. The study, in this context, is the comparison to the predicate device and the assertion of equivalence.

Study Information (Based on 510(k) Submission)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• The document does not describe a traditional clinical study with a "test set" of patient data.
• The "test" here involves the characterization and comparison of the new devices (PTW T31006 and T31007) against the predicate devices (PTW T31002 and T31003) and their known specifications. The sample size would refer to the number of units tested, but this information is not provided in the summary.
• Data provenance (country of origin, retrospective/prospective) is not applicable or stated for this type of submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This is not a diagnostic device requiring expert interpretation or ground truth establishment in a clinical context. The "ground truth" for an ionization chamber's performance would be its physical measurement accuracy against traceable standards, which is not detailed in this summary, but would be part of the internal manufacturing and testing processes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No clinical adjudication method is described. The "adjudication" is internal to the manufacturer's quality control and testing processes demonstrating adherence to specifications and equivalence.

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

• Not applicable. This is not a diagnostic or AI-assisted device.

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

• Not applicable. This is a passive measurement device, not an algorithm. Its operation is standalone in the sense that it collects data without human interpretation during the collection, but the interpretation of the collected data is done by humans.

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

• For a measurement device like an ionization chamber, the "ground truth" would typically be established by comparison to primary or secondary standards in a metrology laboratory, ensuring the device accurately measures radiation dose. This is not explicitly detailed in the 510(k) summary but is implied by the assertion of "specifications are the same as the predicate devices" and "routinely measure, record, and document therapeutic amounts of ionizing radiation with an exceptionally high degree of accuracy and precision."

8. The sample size for the training set

• Not applicable. There is no machine learning or AI algorithm involved, so no training set.

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

• Not applicable. No training set.

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The PTW T30004, T30005, T30001 and T30002 0.6 cc Farmer type ionization chambers are intended to be used for the collection of beam data in water, air, or other suitable solid state phantom material from radiation therapy treatment machines. This data is used to completely document the beam characteristics of treatment machines and to establish and maintain an on going treatment machine quality assurance program.

The PTW T30004 and T30005 are classical 0.6 cc Farmer type ionization chambers. These chambers differ only in the type of material their respected thimbles are made of. The T30004 has a graphite thimble and an aluminum stem and the T30005 has a solid water thimble and an aluminum stem. The chambers can be thimble vented, which is not waterproof, or connector vented, which is water proof. Both chambers offer 1 or 10 meter cables for connection to an electrometer, and a variety of standard electrometer connectors (BNT, TNC, M, BNC banana). The connector vented version of the PTW T30001 and T30002 Farmer type ionization chambers are simply a waterproof version of the thimble vented chambers that were cleared to market by the FDA under K951764. The Farmer type ionization chamber, when connected to an appropriate electrometer like the PTW-UNYODS. K951764, is used to collect beam data from radiation therapy treatment machines.

I am sorry, but the provided text does not contain the necessary information to generate a table of acceptance criteria and reported device performance or to describe a study proving the device meets acceptance criteria.

The document is a 510(k) submission summary for PTW 0.6 cc Ionization Chambers. It focuses on demonstrating substantial equivalence to predicate devices (K951764) rather than presenting a performance study with acceptance criteria.

Specifically, the document states:

• "The indications for use are exactly the same as the predicate devices..."
• "The designs are exactly the same."
• "The manufacturing and testing, process and procedures are exactly the same."
• "The specifications are the same as the predicate devices."

This indicates that the submission relies on the existing clearance of the predicate device and asserts that the new devices are essentially the same, rather than providing new performance data against specific acceptance criteria.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Details of a study proving the device meets acceptance criteria, including sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information.

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