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The device is indicated to aid in supporting adult and adolescent patients undergoing radiation therapy of the breast and chest region including electron, photon, and proton treatments. Device is also used to position the patient during image acquisition to support treatment planning including in Computed Tomography (CT) and Magnetic Resonance (MR) imaging systems. The device is not intended for use with patients under 12 years of age.

The Breastboard and Overhead Arm Positioner are used to position the patient during external beam radiation therapy. The Breastboard is comprised of a Base, Back Support, and Bottom Stop. The Base serves as the foundation of the assembly and provides a mounting surface for the Back Support, Angle Supports, and the Bottom Stop. The inferior end of the Back Support is mounted to the Base while the superior end of the Back Support is raised/lowered as needed for patient setup using Low Angle Supports. The Bottom Stop is located near the inferior end of the Base and prevents the patient from sliding down the Board. The Low Angle Support is used to position the Back Support at 5°, 7.5°, 10°, 12.5°, and 15° angles. Features on the High Angle Support receive the cutouts on the Low Angle Support and hold the angular position of the Support. The High Angle Support is used to position the Back Support at 17.5°, 20°, 22.5°, and 25° angles. Features on the Base receive the cutouts on the High Angle Support and hold the angular position of the Support. A Lock provides a method of locking the Back Support to the Base at 0° to facilitate easier handling and storage of the Breastboard. The Overhead Arm Positioner provides support for the patient's arms above the head and is attached to the Back Support via a locking assembly. The Overhead Arm Positioner adjusts longitudinally on the Back Support to accommodate a variety of patient sizes. A Hand Grip is mounted on the Overhead Arm Positioner and the location of the Hand Grip is adjustable longitudinally. A Head Support rests on a recessed area of the Overhead Arm Positioner and provides a cushion for positioning of the head of the patient. The Head Support can also be mounted directly on the Breastboard. A Thermoplastic Frame may also be mounted to the Overhead Arm Positioner to enable attachment of a thermoplastic mask for additional patient support. The Breastboard and Overhead Arm Positioner can also be used for supporting and elevating patients undergoing treatment who cannot lay down flat on the table due to their habitus. The Breastboard and Overhead Arm Positioner are reusable devices that are provided nonsterile.

This document is a 510(k) premarket notification for a medical device called the C-Qual M Breastboard and Monarch Overhead Arm Positioner. The notification seeks to add MR (Magnetic Resonance) compatibility to the device's indications for use.

Based on the provided text, there is no study conducted to demonstrate the performance of a device that relies on algorithms or AI assistance, nor is there a study involving human readers or experts to establish ground truth for such a device. The device in question is a physical positioning and immobilization device used in radiation therapy and imaging.

Therefore, many of the typical acceptance criteria and study components requested in your prompt (such as algorithm performance, human-in-the-loop studies, multi-reader multi-case studies, and ground truth establishment for diagnostic/interpretive tasks) are not applicable to this specific device submission.

The "acceptance criteria" for this device relate to its physical safety and compatibility in an MR environment, not to the performance of a diagnostic algorithm.

Here's how to address your points based on the provided document:

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

The acceptance criteria and performance for this physical device are focused on MR safety and biocompatibility, as no AI/algorithmic performance is being evaluated.

Explanation: The device "passed" criteria for magnetically induced torque and displacement force, indicating it is safe for use in 1.5 T and 3.0 T MR fields under these aspects. Image artifact was observed, but this is reported as a known characteristic, and users are informed. Biocompatibility testing confirmed the materials are safe for patient contact under the specified use conditions.

2. Sample size used for the test set and the data provenance

As this is a physical device undergoing safety and compatibility testing (rather than an AI/algorithmic performance study), the concept of a "test set" in the context of data points (like images or patient cases) and "data provenance" (country of origin, retrospective/prospective) is not directly applicable.

Instead, the "test set" would refer to the physical device units that underwent testing. The document does not specify the exact number of units tested for MR safety or biocompatibility. However, it states the "device was tested," implying a sufficient number of samples were used to ensure representativeness for regulatory purposes. The testing was conducted in accordance with ASTM and ISO standards, which define the methodologies and often the minimum number of samples.

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

Not applicable. The ground truth for this device's safety and compatibility is established through standardized physical testing protocols (ASTM F2052-15, F2213-06, F2119-07 for MR safety; ISO 10993 standards for biocompatibility), not through expert consensus or interpretation of medical images. Engineering and materials science experts would conduct and interpret these tests, but their role is not that of clinical "ground truth" adjudicators in the typical sense of a diagnostic AI study.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic accuracy, where disagreements among human readers or ground truth establishment require a pre-defined resolution process. Since this submission concerns physical device safety and compatibility, such methods are not relevant.

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 device is a passive physical support and positioning system; it does not involve AI, human readers, or diagnostic interpretation. Therefore, an MRMC study is irrelevant.

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

Not applicable. This is not an algorithmic device.

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

The "ground truth" for this device's acceptance is based on:

• Scientific and Engineering Standards: Compliance with recognized international standards (ASTM and ISO) for MR safety and biocompatibility.
• Physical Measurements and Observations: Direct measurement of torque, displacement, and visual assessment of image artifact under controlled MR conditions. Laboratory testing for biocompatibility.

8. The sample size for the training set

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

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

Not applicable. No training set exists for this device.

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The device is indicated to assist in the proper positioning of patients for radiation therapy including electron, photon and proton treatments, and simulation including CT and MR image acquisition.

The Respiratory Plate with Cushion and Respiratory Belt are components of a modularbased patient positioning system that indexes directly to a treatment or simulation couch.

The Respiratory Plate is comprised of a compression plate, mount, index screw, and screw wheel. Rotation of the screw wheel lowers and raises the compression plate. The mount is attached to the positioning system bridge using pins, and the bridge is indexed to the system platform using a clamping mechanism. A Cushion is mounted on the compression plate via pocket features on the Cushion. The Cushion is comprised of three compartments of beads plus an air chamber. The Cushion is inflated with air to the desired pressure using a hand-held pump accessory with reference pressure qauge.

The Respiratory Belt is comprised of a central air chamber with indexing scale. Velcro straps, hand pump, pressure gauge, and clamps. The Velcro straps allow the Belt to be tightened or loosened around the patient. The Belt is inflated using a hand pump and the pressure is monitored with a reference pressure gauge. Clamps are used to attach the Velcro straps to the positioning system platform.

The Respiratory Plate with Cushion and Respiratory Belt are reusable devices that are provided non-sterile and are manufactured of non-magnetic materials with the exception of the pressure gauge. The devices are used in a healthcare facility/hospital.

The provided document describes a 510(k) premarket notification for the CIVCO Medical Solutions Body Pro-Lok™ Respiratory Plate with Cushion and Body Pro-Lok™ Respiratory Belt. The document focuses on demonstrating substantial equivalence to a predicate device and addresses safety and effectiveness through non-clinical testing.

Based on the provided text, the device is a patient positioning system intended to assist in radiation therapy and imaging. The acceptance criteria and the "study" that proves the device meets them are related to non-clinical testing for safety and compatibility rather than clinical performance or diagnostic accuracy. Therefore, many of the typical questions regarding AI/algorithm performance, ground truth, and expert consensus are not directly applicable to this type of device submission.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are implicit in the ASTM standards cited, which dictate passing or failing tests for specific physical properties. The reported performance is whether the device passed or no artifact was observed.

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

• Sample Size: Not explicitly stated as a number of devices. The "test set" would be the submitted physical devices themselves, or representative samples, used for the non-clinical testing.
• Data Provenance: The testing was non-clinical (laboratory/bench testing) conducted in accordance with referenced ASTM and ISO standards. Country of origin of the data is not specified beyond the compliance with international standards. The testing is prospective in the sense that it was conducted specifically for this submission.

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

• Not applicable. This is a non-clinical device safety and compatibility testing, not a diagnostic or AI performance study requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

• Not applicable. This involves objective physical testing according to standards, where results are measured against defined pass/fail criteria, not subjective interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• Not applicable. This is a non-clinical device submission for a patient positioning system, not an AI or diagnostic imaging device.

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

• Not applicable. This device is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• For the non-clinical tests (RF heating, torque, displacement, image artifact, biocompatibility), the "ground truth" is defined by the objective physical measurements and established pass/fail criteria of the referenced ASTM and ISO standards. For example, a temperature increase above a certain threshold would be a "fail".

8. The Sample Size for the Training Set

• Not applicable. This is a physical device submission, not an AI or machine learning product that requires a training set.

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

• Not applicable. As above, this is a physical device.

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The device is intended to be used for immobilization, positioning and re-positioning during Stereotactic Radiotherapy (SRT) and Stereotactic Radiosurgery (SRS) in all parts of the brain, head, and neck during external beam radiation therapy. The device is also used to immobilize and position the head during image acquisition to support treatment planning including in Computed Tomography (CT) and Magnetic Resonance (MR) imaging systems.

The Head Immobilization System is intended for head and neck immobilization. The device is used as an aid in positioning and re-positioning of the patient during diagnostic and therapeutic treatments including radiation therapy. The fundamental component of the system is the trUpoint ARCH™ comprised of an arch, frame arm, bite assembly arm, and nasion assembly arm. A nasion cushion and bite cup also comprise the system. A storage plate is used to store the trUpoint ARCH™ and a Base Lock Replacement Kit is available to replace the base lock in the trUpoint ARCH™. Accessories to the proposed device that are manufactured by CIVCO Medical Solutions include the individual head support, thermoplastic mask, and baseplate. Accessories to the proposed device that not manufactured by CIVCO Medical Solutions include a bite tray, impression putty, and putty dispenser. The proposed devices are sold non-sterile. The nasion cushion and bite cup are single patient use devices whereas the trUpoint ARCH™ may be reused for multiple patients. The proposed devices are non-implanted devices that are large in size and manufactured of non-magnetic and plastic materials.

Here's a breakdown of the acceptance criteria and study information for the CIVCO Medical Solutions trUpoint ARCH™ Head Immobilization System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating the device's safety and compatibility in an MR environment and its efficacy in patient immobilization.

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

• MR Safety/Compatibility Testing: Not explicitly stated, but implies a sufficient number of devices were tested to meet ASTM standards.
• Immobilization Efficacy Data (Zurich White Paper):
  • Sample Size: Not explicitly stated in the provided text. It mentions data was "collected by the University Hospital Zurich" and analyzed in a "white paper."
  • Data Provenance: Prospective (implied, as it was "collected by the University Hospital Zurich") from Switzerland. "Zurich's data" is referenced, indicating real-world patient data likely collected at an academic institution.

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

• MR Safety/Compatibility Testing: Not applicable. Ground truth for these tests is based on established engineering and materials science standards (ASTM).
• Immobilization Efficacy Data: Not specified. The "ground truth" for intrafraction immobilization (within 1 mm) and interfraction shifts (equivalence to competitor) would likely be derived from high-resolution imaging modalities (e.g., CT, MR) and established clinical protocols for assessing patient movement during radiation therapy. The expertise would be in radiation oncology, medical physics, and imaging sciences, typically associated with a university hospital setting performing such studies.

4. Adjudication Method for the Test Set

• MR Safety/Compatibility Testing: Not applicable. Automated measurements and compliance with engineering specifications are the primary evaluators.
• Immobilization Efficacy Data: Not explicitly stated. For a study conducted at a university hospital, it would typically follow established clinical research protocols, potentially involving independent review of imaging data by medical physicists or radiation oncologists if subjective assessments were part of the data collection (though the metrics mentioned seem objective).

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 device is a physical head immobilization system, not an AI-powered diagnostic or treatment planning tool that would involve human readers interpreting images with or without AI assistance.

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

Not applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

• MR Safety/Compatibility: Engineering specifications and established ASTM standards for material properties and interaction with MR fields.
• Immobilization Efficacy (Zurich Data): Objective measurements from imaging data (e.g., CT, daily image matching) to quantify patient movement and shifts during diagnostic and therapeutic procedures. This would fall under outcomes data in the sense of measured performance related to the device's function.

8. The Sample Size for the Training Set

• Not applicable. This is a physical device, not a machine learning algorithm requiring a training set.

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

• Not applicable. This is a physical device.

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CIVCO Patient Positioning Devices are used to aid in the support and positioning of patients during MR, radiological, and other procedures.

CIVCO Patient Support Devices have been used for many years and were previously cleared under 510(k)'s for use in radiological and other medical procedures. This 510(k) is to have these Class II products cleared for use in an MR environment. Various sizes and shapes of patient positioning devices are offered in order to install on a specific system which the device is used on and/or the body region to be positioned. Devices are sold non-sterile and may be re-used for multiple patient or single patient use if set-up for a single patient.

This document describes the 510(k) submission for CIVCO MR & Radiological Patient Positioning Devices, which seeks to clear existing Class II patient positioning devices for use in an MR environment. The submission focuses on demonstrating substantial equivalence to previously cleared devices.

Here's an analysis of the provided text with respect to acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

   The document doesn't explicitly define "acceptance criteria" in a quantitative, objective manner (e.g., a specific numerical threshold for performance metrics). Instead, it relies on demonstrating substantial equivalence to predicate devices by showing that the proposed device has equivalent intended uses, manufacturing, quality systems, device body contacting category, and safety parameters. The "reported device performance" is essentially the claim of "Same" or "Equivalent" to the predicate for these parameters, with specific testing conducted for MR compatibility and biocompatibility.

   Parameter	Acceptance Criteria (Implied)	Reported Device Performance
   Intended Use / Indications for Use	Must be equivalent to predicate device for safety & effectiveness.	CIVCO Patient Positioning Devices are used to aid in the support and positioning of patients during MR, radiological, and other procedures. (Expanded from predicate's "radiological and other procedures" to include MR, but still for support and positioning).
   Manufacturing	Must be the same or demonstrably equivalent.	Same (Machined, injection molded, formed, assembled, painted).
   Quality Systems	Must be the same or demonstrably equivalent.	Same (FDA/QSR cGMP 21CFR Part 820. ISO 9001 / ISO 13485).
   Device Body Contact Category	Must be the same or demonstrably equivalent.	Same (Surface devices, intact skin; limited contact duration (< 24 hours)).
   Safety (Biocompatibility)	Must meet established safety standards.	Testing in accordance with ISO 10993-Part 1 Biological Evaluation of Medical Devices, FDA Blue Book Memorandum #G95-1, and FDA-Good Laboratory Practices (GLP). (Implicitly, the device meets these standards as part of the "Same" claim for safety characteristics).
   Safety (MR Environment)	Must be safe for use in MR environments.	Products have been tested to demonstrate that they can be safely used in both radiological and in MR environments. All products in this submission are non-metallic and marked as MR safe with the exception of the Clam-Lok Cushion (MR conditional labeling). This directly addresses the main difference from the predicate (MR compatibility).
   Effect on Safety & Effectiveness (Changes)	Changes in design, materials, or labeling should not affect safety and effectiveness.	Changes have been determined to not have the potential to affect the safety and effectiveness of the device. (Stated in the "Substantial Equivalence Summary" section).

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

   The document does not specify a "test set" in the context of an algorithm or AI model performing a task on data. This is a submission for physical medical devices. The "testing" mentioned refers to physical property testing (e.g., biocompatibility and MR compatibility) of the device materials and design.

   • Data Provenance: Not applicable in the sense of patient data. The provenance for the physical testing would be the raw materials and finished products from the manufacturer (CIVCO).
   • Sample Size: Not explicitly stated for specific material or product tests. However, the nature of these tests typically involves a representative sample of materials or devices to ensure compliance with standards.

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

   Not applicable. This is not an AI/algorithm-based diagnostic device where expert ground truth is typically established for image or data interpretation. The "ground truth" here is compliance with established physical and biological safety standards for medical devices and MR compatibility.

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

   Not applicable. This is not a study involving human readers or interpretation of diagnostic output 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:

   Not applicable. This document pertains to physical patient positioning devices, not an AI or algorithm that assists human readers.

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

   Not applicable. This is not an AI algorithm.

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

   The "ground truth" for this device's acceptance is based on adherence to established international and national standards for medical device safety and performance, specifically:

   • ISO 10993-Part 1 Biological Evaluation of Medical Devices: For biocompatibility.
   • FDA Blue Book Memorandum #G95-1: For biocompatibility guidance.
   • FDA-Good Laboratory Practices (GLP): For the conduct of non-clinical laboratory studies.
   • MR compatibility standards: Although not explicitly named, the testing "to ensure these differences have no effect on safety and effectiveness of the device" in an MR environment implies adherence to recognized MR safety standards.
   • Predicate Device Equivalence: The ultimate ground truth for this submission is demonstrating that the device is substantially equivalent to legally marketed predicate devices, in terms of safety and effectiveness.

8. The sample size for the training set:

   Not applicable. This is not an AI/machine learning device that uses a "training set."

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

   Not applicable. As there is no training set, there is no ground truth established for one.

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Patient Positioning Devices are used to aid in the support and positioning of patients during an MRI.

The CIVCO Patient Support Devices have been used for many years and were previously cleared under 510(k)'s. This 510(k) is to have these identical Class II products cleared for use in an MRI environment.

This 510(k) pertains to MRI Patient Positioning Devices, which are Class II devices intended to support and position patients during an MRI. The submission is for identical products previously cleared under other 510(k)s, now seeking clearance for use in an MRI environment.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

Key Finding: The provided document does not contain information about specific acceptance criteria or a study that proves the device meets those criteria, particularly in the context of performance metrics or clinical outcomes. This submission is a 510(k) Premarket Notification for Substantial Equivalence, which primarily focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive clinical performance studies.

The document highlights the device's classification as Class II and its regulatory pathway via substantial equivalence to previously cleared predicate devices. The FDA's letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices." This implies that the acceptance criteria are met by demonstrating equivalence to existing products, rather than through novel performance testing.

Therefore, many of the requested details about acceptance criteria and study particulars are not present in this type of submission.

Here's a breakdown based on the available information:

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

   • Acceptance Criteria: The primary acceptance criterion for this 510(k) is substantial equivalence to predicate devices in terms of intended use, design, materials, and safety for use in an MRI environment. The document implies that the device is identical to previously cleared devices but is now seeking specific clearance for MRI compatibility.
   • Reported Device Performance: The document does not provide quantifiable performance metrics or a study demonstrating specific device performance against a set of numerical acceptance criteria. The "performance" is implicitly demonstrated through the device's classification as "identical Class II products cleared for use in an MRI environment" (implying safety and functionality within that environment, likely based on material compatibility and design).

   Acceptance Criteria	Reported Device Performance
   Substantial equivalence to predicate devices for intended use and safety in MRI environment.	The device (MRI Patient Positioning Devices) is deemed substantially equivalent to the listed predicate devices (e.g., K950866 MEDTEC Inc, Hip Fix; K080072 CIVCO Medical Solutions, MRI Patient Positioning Devices; K060737 SINMED Positioning Devices; K973842 MEDTEC Inc, Carbon Fiber Conformal Couch Top). The FDA's letter explicitly states a finding of substantial equivalence based on the provided 510(k) premarket notification. The devices are described as "identical Class II products cleared for use in an MRI environment," suggesting that their design, materials, and functionality are consistent with existing, cleared MRI-compatible positioning devices, thereby meeting the safety and efficacy standards for their intended use in MRI.
   Compliance with general controls and relevant special controls (if any) for Class II devices.	The FDA letter reminds the submitter of compliance with general controls provisions of the Act (annual registration, listing, good manufacturing practice, labeling, prohibitions against misbranding and adulteration) and potential additional controls for Class II devices. The act of receiving the 510(k) clearance implies that the information submitted satisfies these regulatory requirements for market entry.

2. Sample size used for the test set and the data provenance: Not applicable. This 510(k) submission does not describe a test set or data provenance for a clinical performance study. The substantial equivalence is based on comparing the new device's characteristics to cleared predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no mention of a test set requiring expert-established ground truth in this submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication is described.

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 device is a passive patient positioning device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. This submission does not involve ground truth determination for performance evaluation. The "ground truth" equivalent would be the established safety and efficacy profiles of the predicate devices.

8. The sample size for the training set: Not applicable. This device is not an AI/machine learning product and does not involve a training set.

9. How the ground truth for the training set was established: Not applicable. As above, no training set is involved.

In summary: This 510(k) submission is for a medical device that demonstrates substantial equivalence to existing products. The information provided does not detail clinical performance studies with specific acceptance criteria, test sets, or ground truth establishment typically associated with novel or high-risk devices or software. The "acceptance" is the FDA's determination of substantial equivalence, allowing the device to be marketed.

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The intended use of the MED-TEC, INC. Carbon Fiber Breast Board is to support and aid in positioning a patient during radiologic and other medical procedures.

Carbon Fiber Breast Board

I am sorry, but based on the provided documents, I cannot extract the information required to describe the acceptance criteria and the study proving the device meets them. The documents are a 510(k) clearance letter and an Indications for Use statement for a "Carbon Fiber Breast Board." These documents confirm the regulatory clearance of the device but do not contain detailed study information such as:

• Acceptance criteria: There's no mention of specific performance metrics or thresholds the device needed to meet.
• Reported device performance: No data on the device's performance is provided.
• Study details: Information regarding sample sizes, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth establishment, or training set sizes is absent.

The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance study results against predefined acceptance criteria for a novel device.

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The intended use of this device is to sheild healthy tissue from radiation. The MED-TEC, INC. MT-MX3 thermoplastic shield MATRIX operates in the same manner as other personnel protective shields. or The intended use of the MED-TEC, INC. MT-MX3 MATRIX thermoplastic shield is to shield healthy tissue from radiation.

MED-TEC, INC. has a Personnel Protective Shield System to be manufactured by MED-TEC, INC.

I am sorry, but the provided text from the FDA 510(k) letter and the indications for use document for the Med-Tec Corporation Matrix MT-MX3 device does not contain the kind of detailed information requested about acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert qualifications.

The documents indicate that the Matrix MT-MX3 is a "Personnel Protective Shield System" (thermoplastic shield) intended to "shield healthy tissue from radiation." The 510(k) letter confirms that the device is substantially equivalent to legally marketed predicate devices.

However, a 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, not necessarily on a de novo clinical study with pre-defined acceptance criteria for performance metrics in the same way a novel AI or diagnostic device might. The provided documents are administrative and regulatory approvals, not clinical study reports.

Therefore, I cannot fulfill your request for the specific details about acceptance criteria and the study proving the device meets them based on the given information.

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The intended use of the MED-TEC, INC. Carbon Fiber Conformal Couch Top is to support and aid in positioning a patient during radiologic and other medical procedures.

MED-TEC, INC. has a Table, Radiographic, Stationary Top System to be manufactured by MED-TEC, INC. The MED-TEC, INC. Carbon Fiber Conformal Couch Top operates in the same manner as an ordinary couch.

This document is a 510(k) premarket notification for a "Carbon Fiber Conformal Couch Top." It is a regulatory approval letter from the FDA, and as such, it does not contain the detailed technical study information requested. The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can proceed to market.

Therefore, most of the requested information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not available in the provided text.

Here's what can be inferred from the document:

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

• Acceptance Criteria: Not explicitly stated as this is a regulatory approval letter rather than a technical report. However, the FDA's acceptance of substantial equivalence implies that the device met certain safety and effectiveness benchmarks comparable to predicate devices.
• Reported Device Performance: Not explicitly stated with specific metrics. The letter implies that the device operates "in the same manner as an ordinary couch" and is intended "to support and aid in positioning a patient during radiologic and other medical procedures."

Remaining information (2-9) is not available within the provided FDA letter. The letter is a formal notification of approval based on a submission, not the submission itself or a summary of its technical data.

To provide the requested details, a different type of document, such as the actual 510(k) submission summary or a scientific study report, would be necessary.

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