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IDENTIFY is indicated for adult patients undergoing radiotherapy treatment simulation and/or delivery. IDENTIFY is indicated for positioning of patients, and for monitoring patient motion including respiratory patterns. It allows for data output to radiotherapy devices to synchronize image acquisition or treatment delivery with the acquired motion information.

IDENTIFY is a system for motion monitoring during radiotherapy treatment simulation and delivery. It incorporates patient safety, quality, and workflow efficiency. Its high precision SGRT cameras support proper patient positioning and enable to monitor the patient's respiratory motion and to detect intra-fraction patient position changes during the treatment.

The provided text does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets these criteria with reported performance metrics. The document is primarily a 510(k) summary for the IDENTIFY (4.0) device, outlining its intended use, description, and non-clinical testing for substantial equivalence to a predicate device.

Therefore, I cannot fulfill all parts of your request. I can, however, extract information about what non-clinical testing was conducted, which suggests certain underlying acceptance criteria related to safety, effectiveness, and performance against standards.

Here's what can be inferred and stated based on the provided text:

Acceptance Criteria and Study Information (Based on Inferred Information from Non-Clinical Testing Section):

The document does not present a table of explicit acceptance criteria with reported device performance in the format requested. Instead, it describes general compliance with standards and internal testing to ensure safety, effectiveness, and performance.

Inferred Acceptance Criteria from Non-Clinical Testing:

While not explicitly listed as a table of "acceptance criteria," the non-clinical testing section implies the device needed to meet the following:

• Conformance to Applicable Requirements Specifications: The device must meet its defined functional and performance specifications.
• Hazard Safeguards Functioning Properly: Safety mechanisms must work as intended.
• Software Compliance: Adherence to FDA's "Content of Premarket Submissions for Device Software Functions" guidance, specifically for a "major" level of concern.
• Electrical Safety: Compliance with IEC 60601-1 standards.
• Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2 standard.
• Quality Management System: Adherence to ISO 13485.
• Risk Management: Adherence to ISO 14971.
• No Unresolved Anomalies: No Discrepancy Reports (DRs) with "Safety Intolerable" or "Customer Intolerable" priority remaining.
• Performance at least as well as Predicate Device: The device performs comparably in terms of safety and effectiveness to the IDENTIFY (K230576).

Reported Device Performance:

The document states: "Test results showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly." And "The outcome was that the product conformed to the defined user needs and intended uses and that there were no DRs (discrepancy reports/Unresolved Anomalies) remaining which had a priority of Safety Intolerable or Customer Intolerable (applicable to the US)."

Missing Information:

The document does not provide the following details that would be typically found in a clinical study report or a more detailed performance evaluation:

• A specific table of quantitative acceptance criteria and corresponding numerical performance results.
• Details on a specific "study" with a test set, sample sizes for test or training sets, data provenance, expert qualifications, or ground truth establishment methods for a clinical or performance evaluation.
• Information on MRMC studies or a human-in-the-loop effect size.
• Information on standalone algorithm performance.

Summary of Available Information from the Text:

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

   • Acceptance Criteria (Inferred): Conformance to requirements, proper functioning of hazard safeguards, compliance with specific software guidances (FDA Software Functions guidance, "major" level of concern), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), Quality Management (ISO 13485), Risk Management (ISO 14971), and absence of critical unresolved anomalies (Safety Intolerable or Customer Intolerable DRs). Performance at least as well as the predicate device.
   • Reported Device Performance: "Test results showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly." "The outcome was that the product conformed to the defined user needs and intended uses and that there were no DRs (discrepancy reports/Unresolved Anomalies) remaining which had a priority of Safety Intolerable or Customer Intolerable (applicable to the US)."

2. Sample sizes used for the test set and the data provenance:

   • Not provided. The document refers to "hardware and software verification and validation testing" but does not specify sample sizes for a test set of patient data or data provenance (e.g., country of origin, retrospective/prospective). This often implies bench testing and software verification without a dedicated clinical performance study.

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

   • Not provided. This information would be relevant for a clinical performance study using expert labels, which isn't detailed here.

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:

   • Not provided. The document focuses on the device's own performance and substantial equivalence, not an MRMC study with human readers.

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

   • The "Non-clinical Testing" section refers to "hardware and software verification and validation testing," implying performance of the device's functions, which would be "standalone" in nature. However, specific metrics or a dedicated "standalone study" in terms of clinical performance are not detailed. It's more about technical compliance.

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

   • Not specified as a formal ground truth for a clinical dataset. The "ground truth" for the non-clinical testing likely refers to engineering specifications, established safety standards, and validated software requirements.

8. The sample size for the training set:

   • Not provided. Training set information is relevant for AI/ML devices, but IDENTIFY is described as a "system for motion monitoring," not explicitly an AI/ML diagnostic or predictive device in the traditional sense that would require a large training dataset with labeled ground truth of patient outcomes.

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

   • Not applicable/Not provided. As above, a specific training set with associated ground truth is not detailed, as this appears to be a traditional medical device verification and validation rather than an AI/ML model for clinical decision support.

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IDENTIFY is indicated for adult patients undergoing radiotherapy treatment simulation and/or delivery. IDENTIFY is indicated for positioning of patients, and for montoring patient motion including respiratory patterns. It allows for data output to radiotherapy devices to synchronize image acquisition or treatment delivery with the acquired motion information.

IDENTIFY is a system for motion monitoring during radiotherapy treatment simulation and delivery. It incorporates patient safety, quality, and workflow efficiency. Its high precision SGRT cameras support proper patient positioning and enable to monitor the patient's respiratory motion and to detect intra-fraction patient position changes during the treatment.

This FDA 510(k) summary for Varian Medical Systems Inc.'s IDENTIFY device mentions non-clinical testing for hardware and software verification and validation, electrical safety, and electromagnetic compatibility. However, it does not include a study specifically demonstrating device performance against pre-defined acceptance criteria for its intended use (patient positioning and motion monitoring, including respiratory patterns).

The document focuses on conformance to regulatory standards and a conclusion that the product conformed to defined user needs and intended uses, and is considered safe and effective. It explicitly states: "The Verification and Validation demonstrates that the device is as safe and effective as the predicate." This implies that the validation activities were largely focused on ensuring the new device performs at least as well as its predicate and meets safety standards, rather than proving performance against specific quantitative metrics for its core functionality in a study format.

Therefore, many of the requested sections regarding a specific performance study (e.g., sample size, ground truth establishment, MRMC study, standalone performance) cannot be answered from the provided text.

Here's a breakdown of what can and cannot be extracted from the provided text:

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

The document does not provide a table of acceptance criteria for device performance (e.g., accuracy of positioning, respiratory motion tracking accuracy, beam-hold trigger accuracy) nor does it report specific quantitative performance metrics for these functions. It states that "Test results showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly," but does not detail what these requirements or results were in measurable terms related to the device's clinical indications.

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 in the document.

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 in the document.

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

Not provided in the document.

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 provided in the document. The device is not described as an AI-assisted diagnostic tool that would typically involve human readers. Its primary function is motion monitoring and synchronization with treatment delivery.

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

A standalone performance study against specific clinical metrics for motion tracking or positioning accuracy is not described in the provided text. The non-clinical testing mentions "hardware and software verification and validation testing," which would imply testing the algorithm, but the specifics of such testing in terms of clinical performance metrics are absent.

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

Not provided in the document.

8. The sample size for the training set

Not applicable, as this document does not describe a machine learning model's training phase for a diagnostic or predictive task. The device is for motion monitoring and synchronization, not typically modeled through a "training set" in the sense of supervised learning for image interpretation.

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

Not applicable, as a training set for machine learning is not discussed.

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IDENTIFY is indicated for patient and accessory identification, positioning and tracking for imaging and radiation therapy treatments.

Identify is used for patient-setup, guidance and to monitor a patient before and during radiation treatment. The system consists of cameras, software, PC workstations, RFID kit, Interlock unit, calibration tools, Palm scan unit, RFID tags and optical markers, network components and cabling and handheld controllers.

The provided text is a 510(k) summary for the Varian Medical Systems "Identify" device. It focuses on regulatory compliance, non-clinical testing, and an argument for substantial equivalence to a predicate device. Critically, it does not include details on acceptance criteria and a study proving the device meets those criteria, especially in the context of clinical performance or the improvement of human readers with AI assistance.

The "Identify" device, as described, is for patient and accessory identification, positioning, and tracking for imaging and radiation therapy. The description of its components (cameras, software, RFID, optical markers) suggests it's a patient localization and monitoring system, not primarily an AI-driven image analysis tool for diagnosis or decision support.

Therefore, I cannot extract the requested information regarding:

• A table of acceptance criteria and reported device performance: This document does not specify quantitative performance metrics or acceptance criteria for accuracy, precision, or other operational parameters of the "Identify" system. It mentions conformance to standards and "no DRs remaining which had a priority of Safety Intolerable or Customer Intolerable," which are general quality and safety statements, not specific performance criteria.
• Sample size and data provenance for a test set: No test set is described in terms of patient data or clinical cases. The testing seems to be focused on hardware/software verification and standard compliance.
• Number of experts and qualifications for ground truth establishment: Not applicable, as there's no mention of a human-read test set or ground truth established by experts.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: No such study is mentioned. The device's function as described (patient tracking) does not lend itself to an MRMC study comparing human reader performance with and without AI assistance in the diagnostic sense.
• Standalone (algorithm only) performance: No such
  performance metrics are provided for an AI algorithm. The device is a system.
• Type of ground truth used: Not clearly defined in the context of clinical performance data.
• Sample size for the training set: Not applicable, as there's no mention of a machine learning model training set with clinical data.
• How the ground truth for the training set was established: Not applicable.

Summary of available information related to testing:

• Non-clinical Testing: Hardware and software verification and validation testing were conducted according to FDA Quality System Regulation (21 CFR §820), ISO 13485, ISO 14971, and other FDA-recognized consensus standards (IEC 62304, ISO 15223-1, IEC 60601-1, IEC 60601-1-2, IEC 61217, AAMI RT2, IEC 62366-1).
• Software Level of Concern: "Major," indicating that a failure could result in serious injury or death.
• Electrical Safety and EMC: Complies with IEC 60601-1 and IEC 60601-1-2.
• Conclusion: "The outcome was that the product conformed to the defined user needs and intended uses and that there were no DRs (discrepancy reports/Unresolved Anomalies) remaining which had a priority of Safety Intolerable or Customer Intolerable (applicable to the US)."

This document describes a device approval process based on substantial equivalence, primarily supported by adherence to recognized standards and internal V&V testing, rather than a clinical performance study with defined acceptance criteria and human-in-the-loop evaluations typically seen for AI-diagnostic devices.

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IDENTIFY is indicated for patient and accessory identification, positioning and tracking for imaging and radiation therapy treatments.

Identify is used for patient-setup, guidance and to monitor a patient before and during radiation treatment. The system consists of cameras, software, PC workstations, RFID kit, Interlock unit, calibration tools, Palm scan unit, RFID tags and optical markers, network components and cabling and handheld controllers.

This document is a 510(k) Premarket Notification for the IDENTIFY device from Varian Medical Systems, referencing K192968. It details the device's indications for use, its description, and its claim of substantial equivalence to a predicate device (IDENTIFY K190137) based on non-clinical testing.

Unfortunately, the provided text does not contain the detailed acceptance criteria or the specific study that proves the device meets these criteria in the format requested. The document primarily focuses on regulatory compliance, product description, and a general statement about non-clinical testing outcomes.

Specifically, the following information is missing from the provided text:

• A table of acceptance criteria and reported device performance. The document states "Test results showed conformance to applicable requirements specifications" but does not define these specifications or provide quantitative results.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method.
• MRMC comparative effectiveness study details.
• Standalone performance details.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document states:
"Hardware and software verification and validation testing was conducted according to the FDA Quality System Regulation (21 CFR §820), ISO 13485 quality Management System standard, ISO 14971 Risk Management Standard and the other FDA recognized consensus standards listed below. Test results showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly."

And:
"The outcome was that the product conformed to the defined user needs and intended uses and that there were no DRs (discrepancy reports/Unresolved Anomalies) remaining which had a priority of Safety Intolerable or Customer Intolerable. Varian therefore considers Identify to be safe and to perform at least as well as the predicate device."

These are general statements about the completion and success of V&V testing, but they do not provide the granular data requested in your prompt regarding specific acceptance criteria and detailed study results. The submission relies on demonstrating conformity to standards and the absence of critical discrepancies, rather than presenting a detailed performance study with quantitative acceptance metrics.

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IDENTIFY is indicated for patient and accessory identification, positioning and tracking for imaging and radiation therapy treatments.

Identify is used for patient-setup, guidance and to monitor a patient before and during radiation treatment. The system consists of cameras, software, PC workstations, RFID kit, Interlock unit, calibration tools, Palm scan unit, RFID tags and optical markers, network components and cabling and handheld controllers.

The provided text is a 510(k) summary for Varian Medical Systems' "Identify" device. It outlines the device's intended use, classification, and non-clinical testing. However, it does not contain a detailed study report that includes specific acceptance criteria and device performance metrics, sample sizes, ground truth establishment methods, or any information regarding multi-reader multi-case comparative effectiveness studies.

The document focuses on demonstrating substantial equivalence to a predicate device (Identify K112692) through compliance with various quality and safety standards.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or other specific study details based on the information given. The text explicitly states:

• "Non-clinical Testing Hardware and software verification and validation testing was conducted according to the FDA Quality System Regulation (21 CFR §820), ISO 13485 quality Management System standard, ISO 14971 Risk Management Standard and the other FDA recognized consensus standards listed below. Test results showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly."
• "The outcome was that the product conformed to the defined uses and that there were no DRs (discrepancy reports/Unresolved Anomalies) remaining which had a priority of Safety Intolerable or Customer Intolerable."

This indicates that internal verification and validation testing was performed to affirm compliance with regulations and standards, but it does not detail a study designed to measure performance against specific clinical or technical acceptance criteria with quantified results. The document emphasizes "conformance to applicable requirements specifications" rather than presenting specific performance metrics.

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The intended use of the device is to identify the patient specific accessories and to aid in the positioning of a patient during radiation therapy.

The intended use of the device is to identify the patient specific accessories and to guide the positioning of patients and accessories for radiotherapy procedures. The system uses optical tracking of optical markers and RFID tracking of RFID tags as the method of identifying the patient and the accessories. The system consists of an optical tracking system with optical markers and RFID tracking system including RFID tags, a RFID identification system, a computer workstation, an interlock unit, a handheld controller, Wireless LAN access points, a video camera and calibration tools.

ldentify displays position and identification information during radio therapy treatment to the user.

The system uses optical tracking of retro reflective disk markers to find the position of the patient and radiotherapy equipment and radio frequency identification (RFID) to obtain identification information from the patient and radiotherapy equipment.

The system consists of a PC, a graphical user interface, a NDI Polaris 3D tracking system, a video camera and a RFID reader.

The provided text does not contain information about specific acceptance criteria or a study designed to prove the device meets such criteria. The document is a 510(k) summary for the "Identify" system, primarily focusing on its substantial equivalence to a predicate device.

Instead, the document describes the device, its intended use, and argues for its safety and effectiveness based on similarity to an existing device and compliance with general safety standards. There is no mention of a particular study with a defined test set, ground truth, expert involvement, or statistical analysis to demonstrate performance against specific quantitative acceptance criteria.

Therefore, I cannot provide the requested table or details about a study for this device based on the given information.

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