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This instrument is intended for the purpose of calibrating and measuring the ionizing radiation outputs from medical therapy machines.

The Model 580-006 Radiation Therapy Ionization Chamber is modeled after the traditional 0.6cm Farmer-type chamber used for absolute dosimetry measurements of medical linear accelerators and 900 machines. Each chamber includes an energy response chart, a PMMA 600 buildup cap, a convenient low noise one meter cable with triaxial BNC connector and a custom carrying case.

The provided document is a 510(k) Premarket Notification Summary for a medical device, the Model 580-006 Radiation Therapy Ionization Chamber. This type of document is for demonstrating substantial equivalence to a predicate device, not for a study proving device performance against acceptance criteria in the way a clinical trial or AI algorithm validation would.

Therefore, many of the requested categories (such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone performance for AI, and ground truth establishment for training) are not applicable to this type of regulatory submission for a physical medical device like an ionization chamber. The "study" here is essentially the comparison of specifications and characteristics to a predicate device.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not present or not applicable to this type of device submission:

Acceptance Criteria and Device Performance Study Summary

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

The document provides a "Specification Comparison Table" where the new device (Model 580-006) specifications are presented alongside the predicate device (Model 500-6) specifications. In the context of a 510(k) submission, the "acceptance criteria" are generally that the new device's specifications and performance fall within an acceptable range, demonstrating substantial equivalence to the predicate device, or that any differences do not raise new questions of safety or effectiveness. The table below presents the new device's specifications as its "reported performance" and the predicate device's specifications as the "benchmark" for substantial equivalence.

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The Nuclear Associates VacuDAP - Model 2000, 2001 is intended to measure the radiation output of diagnostic X-ray generating machines during imaging of patients in both radiography and fluoroscopy. The instrument measures and displays Dose Area Product, a parameter that can be related to patient dose by a Medical Physicist. The Dose Area Product measurement includes the influence of dose rate, screening time and used field quantity variables. The instrument accumulates Dose Area Product values until manually reset by the user.

The basic unit VacuDAP 2000 consists of the square ionization chamber and the chamber electronics including the high voltage generation, amplifier, microcontroller and a 8-digit display. These components are designed as a compact unit. The VacuDAP 2001 is completed display. These control (terminal) which makes it possible to operate from everywhere. Optional a printer is available. The X-ray generates an electric charge in the ionization chamber which is measured by the electronic evaluator as chamber current. The microcontroller calculate the dose area product and dose area product rate including the factor of the chamber. The results are transmitted to the serial interface on request of the terminal microcontroller. The measuring operation is working irrespective of the data displayed and is cumulating until the electronic evaluator is reset.

The provided documentation for the Victoreen VacuDAP, Models 2000 and 2001, is a Premarket Notification [510k] Summary. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results to meet specific acceptance criteria through rigorous performance evaluation.

Therefore, the document does not contain the detailed information required to fill out all sections of your request regarding a study proving the device meets acceptance criteria. Here's what can be extracted and what is missing:

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

The document provides a "Specification Comparison Table" that lists key features and their performance for both the new device (VacuDAP Model 2000, 2001) and the predicate device (Dose Area Product Meter, Model 07-205). These specifications are implicitly the "acceptance criteria" for demonstrating substantial equivalence, where the new device's performance needs to be comparable or better than the predicate.

Assessment of Performance against Criteria:
The new device (VacuDAP) meets or exceeds the predicate device's performance for several key parameters:

• System accuracy: Max. ± 20% is comparable to "better than ± 20%".
• Dap range and rate: The new device has a significantly wider range and higher rate capability.
• Light Transmission: The new device has higher light transmission.
• Al equivalent/filter effects: The new device has a lower filter effect (0.4mm vs 0.5mm).
• Energy Range: The new device has a wider energy range (50 to 200kV vs 50 to 150kV).
• Sensitivity: A direct numerical comparison is difficult due to different units ($As/Gycm^2$ vs $Gycm^2 S^{-1}$), but the text mentions the new device has "a higher sensitivity".

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 provide any details on a specific test set, its sample size, or data provenance. The calibration section mentions that "The measuring results have been compared against a reference instrument calibrated by the Physikalisch-Technische Bundesanstalt, Braunschweig (Germany)." This implies some form of testing or comparison was done, likely in Germany, but no specifics about the dataset are given.

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)

This information is not provided in the document, as it's not a clinical study involving human interpretation of medical images or data requiring expert consensus. The device measures physical parameters (Dose Area Product). The "reference instrument calibrated by the Physikalisch-Technische Bundesanstalt" served as the ground truth.

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

This information is not applicable and not provided as there is no human interpretation or subjective assessment that would require an adjudication method.

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

This is not applicable as the VacuDAP is a device for measuring radiation output and is not an AI-assisted diagnostic tool that would involve human readers or image interpretation.

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

A "standalone" performance evaluation was implicitly performed during factory calibration. The document states: "Factory calibration of the product is limited to calibration of the ionization chamber with a radiation source. The measuring results have been compared against a reference instrument calibrated by the Physikalisch-Technische Bundesanstalt, Braunschweig (Germany)." This describes the device's performance in measuring known radiation outputs against a traceable standard, which is essentially a standalone performance assessment for a measurement device. However, specific performance metrics from this calibration (e.g., accuracy, precision) beyond the "max. ± 20%" system accuracy are not detailed in the summary.

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

The ground truth for evaluating the VacuDAP's performance was established using a reference instrument calibrated by the Physikalisch-Technische Bundesanstalt, Braunschweig (Germany). This represents a highly accurate and traceable physical standard for dose area product measurement.

8. The sample size for the training set

This information is not applicable and not provided. The VacuDAP is a physical measurement device, not a machine learning or AI algorithm that requires a training set.

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

This information is not applicable and not provided, as there is no training set for this type of device.

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Model 37-185 is used to provide a means of scanning the light field and radiation field generated by radiation therapy machines and presents this data for quality control purposes only. Sequential scans of the light field and the radiation field provides information as to whether the cross hairs in the light field are in the center of the radiation field (per TG-40), the coincidence of the light field to the radiation field, and beam flatness and symmetry. These data aid in the determination of the therapy machine's performance characteristics.

The product consists of two main parts; the readout module, and the scanner (data acquisition) module. The readout module is located outside the treatment room while the scanner is positioned on the treatment couch in such a manner as to allow the detectors to transverse the radiation beam as determined by the operator. The readout and the scanner are connected via a single 25 meter (75 foot) shielded cable.

The readout contains a LCD (Liquid Crystal Display) and 8 softkeys providing the operator interface. The readout also includes the microprocessor system, memory, printer interface and computer interface. Connections are provided for the power supply, parallel printer, computer RS-232 interface and the scanner cable.

The scanner module contains a stepper motor and a transport mechanism that moves a light detecting diode and a radiation detecting diode 50 cm, in a straight line to obtain a beam or light field profile during a measurement cycle. There is a fixed radiation detecting diode located in the center of the scanner which acts as a reference to null out any fluctuations in the amplitude of the radiation beam (as a function of time). The stepper motor controller and detector pre-amplifiers are also housed in the scanner assembly. The product includes a separate leveling mechanism to level the scanner module and rotate it 90 degrees.

The provided text describes the Victoreen Model 37-185, a device used for quality control of radiation therapy machines. However, it does not contain detailed information about acceptance criteria, a specific study that proves the device meets those criteria, or the methodology of such a study. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria.

Therefore, I cannot directly answer most of your numbered points from the provided input. The information necessary to fill out a table of acceptance criteria and device performance, details about sample size, expert qualifications, ground truth, or MRMC studies is not present.

However, I can extract the available information:

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

• Acceptance Criteria: Not explicitly stated in the provided text. The document refers to "quality control purposes only" and obtaining information "as to whether the cross hairs in the light field are in the center of the radiation field (per TG-40), the coincidence of the light field to the radiation field, and beam flatness and symmetry." However, specific numerical or qualitative criteria for these measurements are not provided.
• Reported Device Performance: Not explicitly stated in the provided text as a quantifiable study result. The device's function is described: "provides a means of scanning the light field and radiation field... and presents this data." The implication is that it accurately performs these scans, but no performance metrics are given.

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

• Not provided.

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 provided.

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

• Not provided.

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

• No MRMC study is mentioned. This device is a quality control tool for radiation therapy machines, not an AI-assisted diagnostic or treatment planning system involving human readers in the context of interpreting patient data.

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

• The device itself functions as a standalone measurement tool, providing data for quality control. It's not an "algorithm only" in the modern AI sense, but rather a sensor system. The document does not describe a performance study for its standalone accuracy against a gold standard.

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

• Not provided. For a device measuring radiation and light fields, the ground truth would likely be established by conventional, highly accurate physical measurement tools, but this is not detailed.

8. The sample size for the training set

• Not applicable/Not provided. This device is a measurement tool, not a machine learning model that typically requires a training set in the AI context.

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

• Not applicable/Not provided. (See point 8)

Summary of available information related to performance/validation (from the 510(k) context):

The document states:

• The device is "substantially equivalent" to a predicate device (Beam Scan, Model 37-201, 510(k) #K853671A). This implies that its safety and effectiveness are similar to a device already on the market without the need for new extensive clinical trials for performance.
• Intended Use: "quality control purposes only."
• Functions: "scanning the light field and radiation field generated by radiation therapy machines and presents this data." It provides information on "whether the cross hairs in the light field are in the center of the radiation field (per TG-40), the coincidence of the light field to the radiation field, and beam flatness and symmetry."
• The device "does not involve patient contact nor is it used to evaluate patient treatment planning. The patient is not in the room while this product is in use." This context suggests that the primary validation would be technical accuracy and reliability of its measurements rather than direct patient outcome studies.

In conclusion, the provided 510(k) summary focuses on regulatory approval through substantial equivalence and describes the device's function and intended use. It does not contain the detailed performance study information with explicit acceptance criteria, sample sizes, and ground truth methodologies that you requested. Such details would typically be found in a more comprehensive testing report, which is not part of this 510(k) summary.

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This device provides integrated dose and dose rate readout capabilities for radiation sensing diodes when used for patient dose verification or quality assurance in radiation therapy. The diodes produce a current directly proportional to the ionizing radiation to which they are exposed. The diodes are connected to this readout device. The purpose of the combination of the diodes and this product are to measure ionizing radiation independently at various points of interest. The VeriDose V is intended for use by persons responsible for the proper interpretation of its readings and observing the appropiate safety procedures in the presence of radiation.

The Veridose V (Five) - Model Number 37-705 is used to provide integrated dose and dose rate readout capabilities for radiation sensing diodes when used for patient dose verification or quality assurance in radiation therapy.

The product is a five channel diode dosimeter. The device will measure and display real time dose rate or integrated dose on up to 5 diodes simultaneously. The features include a keyboard, an ON / OFF switch, a power input connector (12VDC), 5 BNC connectors for diode inputs, a RS-232 connector, and a parallel printer port connector. Up to 21 sets of calibration data can be acquired, stored, and selected for use. Calibration and patient data is transmitted to a printer or the RS-232 port.

The provided text describes a medical device called "Veridose V (five), Model number 37-705," which is a five-channel diode dosimeter. It measures and displays real-time dose rate or integrated dose using radiation-sensing diodes for patient dose verification or quality assurance in radiation therapy.

However, the document is a Premarket Notification [510(k)] Summary, which is a submission to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of document does not typically contain detailed studies with acceptance criteria, sample sizes, expert ground truth, or adjudication methods in the way that would be found in a clinical trial report or a comprehensive validation study.

Instead, the document focuses on comparing the new device's specifications to those of a predicate device to establish substantial equivalence.

Based on the provided information, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a comparison table between the "Veridose V" and its predicate device ("Model 526"). While it doesn't explicitly state "acceptance criteria," the comparison implies that the Veridose V should meet or exceed the performance of the predicate device for various specifications.

Study Proving Acceptance Criteria:

The document explicitly states: "The VeriDose V and the predicate device are technologically the same. Both are based on a multi-channel electrometer designed to measure the charge provided by a variety of diode detectors. Both devices convert this charge to a dose or dose rate value."

Further, it asserts, "These differences [referring to the VeriDose V having more channels and an RS232 interface], while providing additional capability, do not degrade performance of the device."

The "study" proving the device meets the (implied) acceptance criteria is the demonstration of substantial equivalence to the predicate device, Model 526 (K912249/A). This is a regulatory pathway, not a detailed technical performance study in the way one might expect for a new diagnostic or AI device. The comparison table itself serves as the primary evidence provided in this document to show how the VeriDose V meets or exceeds the predicate's performance.

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

• Sample Size for Test Set: This information is not provided in the document. The filing focuses on a comparison of specifications and intended use, not a clinical or performance study with a 'test set' of data.
• Data Provenance: This information is not provided. The document describes the device's technical specifications and how it compares to a predicate, not where performance data was collected.

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

• This information is not applicable and not provided. The device is a measurement tool (dosimeter), not an interpretive device like an AI for image analysis where expert ground truth is typically established for a test set. The factory calibration procedure is described, but it doesn't involve multiple experts establishing ground truth for performance testing.

4. Adjudication Method for the Test Set:

• This information is not applicable and not provided. As explained above, this isn't a study involving human interpretation that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

• This information is not applicable and not provided. MRMC studies are typically for evaluating the impact of AI on human reader performance in diagnostic tasks. The VeriDose V is a direct measurement device and does not involve human interpretation in the same way.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• This information is not directly applicable in the context of an "algorithm-only" study for an AI device. The VeriDose V itself is a standalone device that performs measurements. Its performance is characterized by its accuracy, reproducibility, and other specifications listed in the table, independently of human interpretation of the raw electrical signals from the diodes. The "study" done is the establishment of its specifications and comparison to the predicate.

7. The Type of Ground Truth Used:

• For the device's inherent function, the ground truth is established through physical standards and calibration. The document mentions: "Factory calibration of the product is limited to calibration of each of the five channels with a current source to a nominal 2 nC = 1 cGy." For user calibration, "The diodes are exposed to a known quantity of radiation and the charge acquired. The actual radiation exposure will be entered by the user." This indicates that a known, precisely measured radiation exposure acts as the "ground truth" for calibration.

8. The Sample Size for the Training Set:

• This information is not applicable and not provided. These terms (training set, test set, validation set) are typically used for machine learning or AI models. The VeriDose V is an electronic measurement device; it is not "trained" on data in that sense.

9. How the Ground Truth for the Training Set Was Established:

• This information is not applicable and not provided, for the same reasons as #8.

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These diodes are used to provide dose verification and quality assurance for paţients undergoing radiation therapy.

The product consists of a waterproof color coded molded plastic hemisphere containing the appropriate buildup material and a radiation sensitive diode attached to a coaxial cable. A BNC connector is supplied for connection to a readout device.

Here's an analysis of the provided text, focusing on acceptance criteria and the study that proves the device meets them:

The provided document is a 510(k) Premarket Notification summary for the Victoreen VeriDose Diodes. This type of regulatory submission is primarily focused on demonstrating substantial equivalence to a predicate device, rather than proving efficacy or meeting specific, independently established acceptance criteria through a comprehensive clinical study.

Therefore, the information presented does not include a detailed study proving the device meets explicit acceptance criteria in the way a clinical trial or performance study for an AI/software device would. Instead, the document lists general specifications that characterize the device's performance, implying these specifications are comparable to or meet the expected performance for such a device, and are substantially equivalent to the predicate device.

Let's break down what is available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for a physical medical device (radiation detector), the "acceptance criteria" are implied by the listed general specifications of the device, which are then compared to the predicate device (ISORAD Photon Detectors) for substantial equivalence. "Reported device performance" refers to these established specifications.

Regarding the "Study that proves the device meets the acceptance criteria":

The provided document is a 510(k) summary from 1996. For physical, non-software/AI medical devices, the demonstration of "acceptance criteria" and "proof" typically comes from bench testing and engineering validation comparing the new device's specifications to those of a predicate device, and ensuring it meets its own design specifications. The document summarizes these characteristics, implying that the necessary testing was performed to establish these specifications. However, it does not describe the detailed study methodologies or results.

Based on the prompt's request for information commonly associated with AI/software device studies, much of that information is not applicable or not provided in this type of regulatory submission for a physical device from that era.

Here's an attempt to address the remaining points, noting where information is absent or irrelevant:

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

• Not applicable / not provided. This device is a physical radiation detector. "Test set" and "data provenance" as understood for AI/software are not relevant here. The "testing" would involve characterizing the diode's physical and electrical properties in a laboratory setting, likely under controlled radiation fields, rather than with a "data set."

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 / not provided. As a physical sensor, there is no "ground truth" established by human experts in the way an AI algorithm needs it for image interpretation. The "truth" in this context would be physical measurements from calibrated radiation sources and established dosimetry standards.

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

• Not applicable / not provided. Adjudication methods are used in cases where human interpretation is part of establishing ground truth (e.g., for medical images). This is not relevant for a physical radiation detection device.

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

• No, not applicable. MRMC studies and the concept of "human readers improving with AI" are specific to AI-assisted diagnostic or interpretive tools. This device is a sensor used by medical professionals, not an interpretive AI.

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

• Standalone performance (algorithm only) is not applicable. The device itself is a "standalone" physical sensor. Its performance is based on its physical properties and electrical output, not on an algorithm. It requires a human operator and an "appropriate display device" to interpret its readings.

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

• The "ground truth" for evaluating this device would be physical dosimetry standards and measurements obtained from highly calibrated and traceable radiation sources (e.g., using primary or secondary standard electrometers and ionization chambers). It would involve comparing the diode's output to these established physical standards under controlled laboratory conditions. This is implied by the specification data, but not explicitly documented as a "ground truth" method.

8. The sample size for the training set

• Not applicable. This device is a physical sensor, not an AI/ML algorithm that requires a training set.

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

• Not applicable. No training set is involved.

In summary, the provided document is a regulatory submission for a physical medical device (radiation detector) from the 1990s. The concept of "acceptance criteria" is largely met by demonstrating that the device's technical specifications are suitable for its intended use and are substantially equivalent to a predicate device. The detailed study methodologies for establishing these specifications are not included in this type of summary document, and many of the specific questions related to AI/software performance studies are not applicable to this device.

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The Prone Breast Positioning Board, model number 37-018 is to be used as a positioning device in patient set-up for primary breast irradiation.

The Prone Breast Positioning Board is a linear accelerator couch-mounted platform which enables the breast to hang in a comfortable, gravity-dependent fashion for treatment with opposed tangential photon beams.

The provided document, K971382, describes a Premarket Notification [510(k)] for the "Prone Breast Positioning Board, Model #37-018." This submission primarily focuses on establishing substantial equivalence to a predicate device, rather than proving a novel device meets specific performance acceptance criteria through an independent study.

Therefore, many of the requested elements for describing acceptance criteria and a study proving a device meets them are not applicable (N/A) in the context of this 510(k) submission. This is because the 510(k) pathway is designed to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and technological characteristics, or different technological characteristics that do not raise new questions of safety and effectiveness. It does not typically require extensive novel clinical studies with predefined acceptance criteria in the same way a Premarket Approval (PMA) pathway might.

However, based on the information provided, we can extract details related to the comparison performed to establish substantial equivalence.

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

Since this is a 510(k) submission for substantial equivalence, the "acceptance criteria" are implicitly tied to demonstrating that the new device is as safe and effective as the predicate device. The performance is reported through a comparative analysis rather than meeting predefined quantitative metrics for a new claim.

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

• Test Set Sample Size: The document explicitly mentions "Two sample treatment plans (exhibits F and G) labeled 'Jones, Pearl' are attached." This indicates a sample size of one patient with two treatment plans (prone and supine for comparison) were used for the non-clinical performance data portion.
  • For the clinical study/test data, the submission references two external articles (Exhibits "H" and "I"). The sample sizes for these articles are not provided in this 510(k) document.
• Data Provenance:
  • The "Jones, Pearl" treatment plans are presented as internal data to the submission, likely from the manufacturer or an affiliated institution. Country of origin is not explicitly stated but implied to be the US, given the submission to the FDA. The nature (retrospective/prospective) of these specific plans is not stated.
  • The external articles (Exhibits "H" and "I") would have their own data provenance, which is not detailed in this 510(k) summary. One article is from "The Official Journal," suggesting a peer-reviewed publication.

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

• For the "Jones, Pearl" sample treatment plans: The creation and interpretation of these treatment plans would typically be performed by medical physicists and/or radiation oncologists. The document references the expertise of the authors of the referenced articles ("Thomas E. Merchant, D.O., and Beryl McCormick, M.D."). These are medical doctors, likely radiation oncologists, but the exact number of experts involved in the "ground truth" for the submitted sample plans is not specified.
• For the referenced articles (Exhibits H and I): The ground truth would be established by the authors and peer reviewers of those respective studies, whose qualifications are not detailed in this 510(k) summary.

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

• None explicitly stated for the "Jones, Pearl" treatment plans. It appears to be an internal comparison exercise rather than a multi-reader, adjudicated study.
• The referenced articles (Exhibits H and I) would have their own research methodologies which are not detailed here.

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:

• No MRMC comparative effectiveness study was done. This device is a physical positioning board, not an AI-assisted diagnostic or therapeutic tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

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

• Not applicable. This is a physical medical device (breast positioning board), not a software algorithm.

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

• For the "Jones, Pearl" sample treatment plans: The "ground truth" for demonstrating dosimetric advantages is based on medical physics calculations and interpretation of dose distributions, which represents an expert-driven simulation and analysis, possibly reflecting accepted clinical practice for judging treatment plan quality.
• For the referenced articles: The ground truth would be based on the methodologies specific to those studies (e.g., clinical outcomes, dosimetric measurements, simulated patient data), but this is not specified within the 510(k) document.

8. The sample size for the training set:

• Not applicable. This submission focuses on demonstrating substantial equivalence of a physical device. There is no AI algorithm being "trained" in this context. The "training data" for the concept of prone breast positioning would be general medical knowledge and the body of scientific literature, implicitly represented by the referenced articles.

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

• Not applicable. As above, there is no discrete "training set" in the AI sense for this physical device. The information supporting the benefits of prone breast positioning is derived from established medical literature and clinical understanding, as evidenced by the cited articles.

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