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Device is intended to be used for instrument placement to access anatomical structures under transrectal ultrasound guidance.

• . Prostate - Biopsy and minimally invasive puncture
• . Surgical (Prostate) - Biopsy and minimally invasive puncture

The TP Pivot Pro™ needle guide is a tool for performing freehanded transperineal prostate biopsies, taking advantage of the transperineal path to sample regions of the prostate including the difficult to reach anterior zone. Used in conjunction with an ultrasound probe, users visualize suspect target areas of the prostate, plan and position an access site, and obtain specimens from a precise point in the prostate.

The FDA Summary for the TP Pivot Pro™ Needle Guide (K233109) does not include specific acceptance criteria or detailed study results in the format typically used for performance claims of diagnostic or AI-powered devices. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive performance data like clinical trials.

The information provided describes non-clinical tests to ensure design functionality and biocompatibility. Here's a breakdown based on your request, with missing information noted:

1. Table of Acceptance Criteria and Reported Device Performance

(Note: The acceptance criteria for the design specification tests are not quantified in this summary, but are described in terms of meeting established requirements for adequate function and integrity.)

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

• Test Set Sample Size: Not explicitly stated for any of the non-clinical tests. The document mentions "Simulated use evaluations were performed by customers," but the number of customers/evaluations is not specified.
• Data Provenance: The biocompatibility tests are conducted in accordance with ISO standards, implying laboratory testing. The design specification tests and simulated usability testing are described as "tested internally" or "performed by customers," suggesting in-house and potentially external user tests, respectively. No information on country of origin for test data or whether it was retrospective/prospective is provided.

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

• Not applicable / Not provided. The document describes non-clinical engineering and usability tests. There is no mention of "ground truth" in the clinical sense (e.g., disease diagnosis) or involvement of experts for establishing clinical ground truth for the performance evaluations described. The "customers" in simulated usability testing are users, not necessarily experts establishing ground truth for a diagnostic outcome.

4. Adjudication Method for the Test Set

• Not applicable / Not provided. Since there is no clinical "ground truth" determination described, no adjudication method like 2+1 or 3+1 is relevant for the reported tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. This device is a mechanical needle guide, not an AI-powered diagnostic system or imaging device, so such a study comparing human reader performance with and without AI assistance is not relevant or described.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone performance study was not done. This device is a mechanical needle guide, not an algorithm or AI system.

7. Type of Ground Truth Used

• Not a clinical ground truth. For the biocompatibility tests, ground truth is based on established ISO standards. For the design specification tests, ground truth refers to the engineering requirements and functional specifications (e.g., "adequately attaches," "not damaged," "meets established requirements"). For simulated usability testing, ground truth is conformity to user needs.

8. Sample Size for the Training Set

• Not applicable / Not provided. This device is a mechanical device, not an AI or machine learning model, so there is no concept of a "training set" in the context of algorithm development.

9. How Ground Truth for the Training Set Was Established

• Not applicable / Not provided. As there is no training set for an algorithm, there is no ground truth establishment for a training set.

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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 Envision cover and Envision pad are intended as a microbial barrier between the patient and medical imaging electronics.

The Envision cover and Envision pad are used, without the need for ultrasound coupling gel, in adult and pediatric patients, for diagnostic ultrasound imaging, in sterile fields, that currently use an ultrasound coupling gel or fluid alone or in combination with a protective transducer cover, including ultrasound guided venous access, ultrasound imaging over surgical wounds, during transcutaneous biopsy; for intraoperative, endocavity, or transcutaneous imaging procedures; or to enhance acoustic coupling to difficult geometries.

The Envision Ultrasound pad and Envision Ultrasound cover (Envision) are microbial barriers for use during ultrasound procedures. The Envision device contains a coating that facilitates the acoustic coupling between the patient and ultrasound equipment without the need for traditionally ultrasound gel. This enables the clean transmission of sound waves between the transducer and patient without the mess of gels.

The Envision Ultrasound pad is comprised of four layers. The first layer is a crack and peel release liner that is removed by the customer to expose the adhesive layer (second layer) that sticks to the patient or the transducer within the cover. The third layer is a film carrier layer to hold the adhesive and coating layers together. The final layer is the coating layer, which is the acoustic couplant layer and is activated by using hydrating media, such as saline.

The Envision pad is sold as both a standalone pad and also sold as an integrated ultrasound cover (cover). The cover is a traditional CIVCO ultrasound cover, where one end of the cover is cut out, and the Envision pad, cut down to size, is sealed to the cover at the location of the cut out.

The document describes the Envision™ Ultrasound Cover and Pad, a device intended as a microbial barrier and acoustic coupler for ultrasound procedures. This device is compared to a predicate device (CIVCO General Purpose Transducer Cover K970513) and a reference device (EcoVue® Sterile and Non-Sterile Ultrasound Gels K181363).

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by comparison to the predicate or reference device, or through meeting specific standards (e.g., ISO, ASTM). The "Reported Device Performance" column reflects the results of the non-clinical tests.

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

The document does not specify exact sample sizes for the test sets in most non-clinical studies. For example, it states "The Envision pad's ability to withstand viral penetration was performed to evaluate the barrier performance... in accordance with ASTM F1671-13," without detailing the number of samples tested under this standard. Similarly, for acoustic properties, specific sample sizes are not provided.

The data provenance is from non-clinical bench testing performed by the manufacturer (CIVCO Medical Instruments Co., Inc.). There is no mention of patient data (prospective or retrospective) or country of origin for such data, as this is a device clearance based on engineering and material performance.

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

This information is not applicable as the evaluation is based on non-clinical, objective measurements and compliance with established standards, rather than expert interpretation of medical images or conditions.

4. Adjudication method for the test set

This information is not applicable as the evaluation is based on non-clinical, objective measurements and compliance with established standards, not on subjective expert consensus.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an ultrasound cover and pad, not an AI-powered diagnostic system. Clinical tests were explicitly stated as "not required to demonstrate substantial equivalence."

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

No, a standalone performance study in the context of an algorithm or AI was not done. This device is a physical accessory for ultrasound, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is established by:

• Established standards and regulations: Such as ISO 10993 for biocompatibility, ASTM F1671-13 for viral penetration, ISO 11135 for sterilization, ASTM F1980-16 for accelerated aging, ISO 11607-2 and ISTA 2A for packaging.
• Direct measurement and comparison: For acoustic properties (impedance, sound velocity, density, pH) where the Envision device's physical properties are directly measured and compared against established ranges from a reference device (EcoVue® Sterile and Non-Sterile Ultrasound Gels).
• Functional tests: Water leak testing, rehydration testing, and simulated use testing to ensure the device performs its intended functions.

8. The sample size for the training set

This information is not applicable as this is not an AI/machine learning device. There is no concept of a "training set" for the Envision Ultrasound Cover and Pad.

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

This information is not applicable as this is not an AI/machine learning device.

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1. Solstice™ SRS Immobilization System (when used with customizable cushion):

The device is indicated to position and/or immobilize adult and pediatric patients undergoing radiation therapy of the head, brain, and neck, including Stereotactic Radiosurgery (SRS), Stereotactic Radiotherapy (SRT), Surface Guided Radiation Therapy (SGRT) and electron, photon treatments. The device is also used during image acquisition. including Computed Tomography (CT), to support treatment planning.

2. Solstice™ SRS Immobilization System (when used with headrest):

The device is indicated to position and/or immobilize adult and pediatic patients undergoing radiation therapy of the head, brain, and neck, including Surface Guided Radiation Therapy (SGRT) and electron, photon, and proton treatments. The device is also used during image acquisition, including Computed Tomography (CT), to support treatment planning.

3. Solstat™ Immobilization System & Solstice™ Thermoplastic Mask:

The device is indicated to position and/or immobilize adult and pediatic patients undergoing radiation therapy of the head, brain, and neck, including Surface Guided Radiation Therapy (SGRT) and electron, photon, and proton treatments. The device is also used during image acquisition, including Computed Tomography (CT) Magnetic Resonance (MR) Imaging, to support treatment planning.

The Tilting Head Fixation (Solstice) device is comprised of a baseplate and bowl with a locking lever. The bowl is permanently attached to the baseplate and the locking level allows the bowl to be tilted up to 10º in relation to the baseplate at infinite intervals. The baseplate is attached to the treatment or simulation couch top or overlay by pins. When used with customizable cushion and thermoplastic mask, the system can immobilize the patient to under 1 millimeters. The provider can correct the patient position for simulation and treatments by tilting the device.

The Static Head Fixation (Solstat) device is comprised of a baseplate and bowl with a locking lever. The bowl is permanently attached to the baseplate and cannot be tilted. The baseplate is attached to the treatment or simulation couch top or overlay by pins. When used with customizable cushion and thermoplastic mask, the system can reproduce the patient position to under 3 millimeters within a treatment cycle.

The Open-Face Thermoplastic mask is comprised of a thermoplastic mask bonded with a frame. The frame has five swivel clamps that allow secure attachment onto either the Solstice or Solstat device. When heated, the thermoplastic mask can be formed around the patient anatomy and allows the Region of Interest (ROI) to be capture by camera systems, allowing Surface Guided Radiation Therapy to occur via camera systems. The same mask will be used throughout the course of the treatment. The Open-Face style mask is ideal for Surface Guided Radiation Therapy (SGRT) via camera systems.

The Solstice Immobilization device and Solstat Immobilization device are reusable devices that are provided non-sterile. Solstat and Solstice thermoplastic are single-patient reusable and is provided non-sterile and manufactured of non-magnetic materials. The devices are used in a healthcare facility/hospital. All devices are intended to be used on adult and pediatric patients.

The provided text describes premarket notification K182079 for the Solstice™ SRS Immobilization System/Solstat™ Immobilization System/Solstice™ Thermoplastic Mask. It does not contain information about a study proving the device meets acceptance criteria in the manner requested, particularly regarding clinical effectiveness studies involving human readers or expert consensus on ground truth.

However, it does provide acceptance criteria related to device performance in terms of patient immobilization accuracy, which is substantiated by non-clinical testing.

Here's an attempt to extract and frame the available information in the requested format, clearly stating where information is "Not Applicable" or "Not Provided" based on the document:

Device: Solstice™ SRS Immobilization System / Solstat™ Immobilization System / Solstice™ Thermoplastic Mask

Purpose of Testing (Non-Clinical): To substantiate the immobilization performance for Stereotactic Radiosurgery (SRS) and Stereotactic Radiotherapy (SRT), and suitability for Surface Guided Radiation Therapy (SGRT) and MRI compatibility.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for the non-clinical tests. The data points presented for the Solstice device are statistical confidence intervals (99.73% and 95.45%), but the raw number of measurements or repetitions for these tests is not provided.
• Data Provenance: Non-clinical testing data; likely internal laboratory testing (MEDTEC Inc. dba CIVCO MEDICAL SOLUTIONS). The country of origin and whether it was retrospective or prospective is not specified, but non-clinical tests are generally prospective.

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

• Not Applicable / Not Provided. The "ground truth" for these performance claims appears to be derived from physical measurements using camera systems (e.g., VisionRT's AlignRT system) and standard test methods (e.g., ASTM F2119-07 for MR safety), rather than human expert interpretation of medical images.

4. Adjudication Method for the Test Set

• Not Applicable / Not Provided. This concept (2+1, 3+1, none) typically applies to human reader studies where expert disagreement on ground truth needs resolution. Here, it's about physical performance measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. An MRMC study was not conducted as this is a device for patient immobilization and positioning, not an AI image analysis device requiring human-in-the-loop performance evaluation.

6. Standalone (Algorithm Only) Performance

• Not Applicable. The device itself is a physical immobilization system. The "performance" relates to its mechanical stability and ability to maintain patient position, measured non-clinically. It does not employ an algorithm in the sense of AI for diagnostic or clinical decision support.

7. Type of Ground Truth Used

• Physical Measurements and Standard Test Methods.
  • For Solstice: Intrafraction movement measured by camera systems (e.g., VisionRT's AlignRT system).
  • For Solstat MRI safety: Compliance with ASTM F2119-07.

8. Sample Size for the Training Set

• Not Applicable / Not Provided. There is no "training set" in the context of this physical device's non-clinical performance evaluation. This concept is relevant for machine learning models.

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

• Not Applicable / Not Provided. See point 8.

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General Positioning Devices: The device is indicated to aid in supporting and positioning adult and pediatric patients undergoing radiation therapy including electron, photon treatments. The device is also used during image acquisition to support treatment planning. Devices include Couchtops, Cushions, Cushions, and Accessories. The following are other positioning devices:

Head. Neck. and Shoulders Device is indicated to aid in supporting, positioning, and/or immobilization of adult and pediatric patients undergoing radiation therapy of the head, brain, neck, and spine including radiosurgery and electron, photon, and proton treatments. The device is also used during image acquisition to support treatment planning. Devices include Overlays, Extensions, Thermoplastic Masks, and Cushions.

Support Garments: The device is indicated to aid in supporting adolescents undergoing radiation therapy including electron, photon treatments. The device is also used during image acquisition to support treatment planning. The device is not intended for use with patients under 12 years of age.

Breast Positioning Devices: The device is indicated to aid in supporting adult and adolescent patients undergoing radiation therapy of the breast and chest region including electron, photon treatments. The device is also used during image acquisition to support treatment planning. The device is not intended for use with patients under 12 years of age.

The CIVCO Positioning and Immobilization devices have been used for many years and were previously cleared under other 510(k) is to have these identical Class II products cleared for use in Proton Therapy environment.

The Head, Neck, and Shoulder Devices are used to treat cancer of the head, neck, brain and spine. Organs that are located in these anatomical regions are applicable.

The General Positioning Devices are used to treat cancer of the spine, thorax, breast, abdomen, pelvis and prostate. Organs that are located in these anatomical regions are applicable.

The Support Garments are used to treat cancer of the breast, thorax and abdominal area. Organs that are located in these anatomical regions are applicable.

The Breast Positioning Devices are used to treat cancer of the breast, thorax and abdominal area. Organs that are located in these anatomical regions are applicable.

The devices are intended for therapeutic treatment (including proton, photon, and electron beam therapy) and diagnostics (including CT and MR as indicated). The devices will be used in a variety of types of external beam radiation therapy including Intensity Modulated Proton Therapy (IMPT), Intensity Modulated Radiation Therapy (IMRT), Pencil Beam Proton Therapy (PBPT), Image Guided Radiation Therapy (IGRT), Volumetric Modulated Arc Therapy (VMAT), Stereotactic Radiosurgery (SRS), Stereotactic Radiotherapy (SRT), Stereotactic Body Radiation Therapy (SBRT), and Craniospinal Treatment.

The intended users of the devices are radiation oncology therapists, medical physicists, and oncologists. The provider selects the appropriate equipment based on a patient's individual clinical goals and unique constraints.

Thermoplastic mask, AccuForm Cushion, and Support Garment devices are single patient use. All devices are non-powered and static.

The subject devices are reusable or disposable as provided in product labeling, provided non-sterile, and are used in a healthcare facility/hospital. The devices are labeled for MR safety, as applicable.

This document is a 510(k) Pre-market Notification for medical devices, specifically Proton Positioning and Immobilization Devices. It is a submission to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, primarily for the modified intended use/indications for use to include proton treatment and pediatric/adolescent use.

The document does not describe a study involving an algorithm or artificial intelligence (AI) with acceptance criteria in the traditional sense of a computer-aided diagnosis (CAD) or AI-driven diagnostic device. Instead, it describes non-clinical performance testing for physical medical devices. Therefore, many of the requested details about acceptance criteria, ground truth establishment, expert consensus, and multi-reader multi-case (MRMC) studies are not applicable to this type of device submission.

Here's an interpretation of the relevant information provided, framed as closely as possible to your request for acceptance criteria and study proof for a medical device:

Device Type: Physical Medical Devices (Positioning and Immobilization for Radiation Therapy)
Purpose of Submission: To expand the Indications for Use of existing, previously cleared devices to include proton treatment and pediatric/adolescent use.

1. Table of "Acceptance Criteria" (Performance Goals) and Reported Device Performance

Given that this is a 510(k) for physical positioning devices, the "acceptance criteria" are not quantitative performance metrics like sensitivity/specificity for an AI algorithm. Instead, they are functional performance goals related to the physical interaction with the proton beam and patient. The "reported device performance" is the confirmation that these functional goals are met.

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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 provide physicians with a tool for electromagnetic (EM) tracking of instruments with respect to pre-acquired or real-time data. The device is intended for use in Magnetic Resonance Imaging (MRI) and ultrasound (US) environments.

The proposed device contains multiple fluid-filled cavities that serve as registration points (markers) in MR. Adhesive tape on the bottom of the proposed device is used to secure the device to the patient. Skin marking areas allow for repositioning in both MR and ultrasound environments. The device also provides a connection point for an electromagnetic sensor accessory. The proposed device is provided non-sterile, is intended for single patient use, and is manufactured of non-magnetic materials. The proposed device enables automatic or manual image fusion of real-time ultrasound to previously acquired MR data sets. The proposed device may also be used to aid in image fusion of real-time ultrasound to previously acquired ultrasound data sets.

The provided document (K143396) describes the omniTRAX™ Active Patient Tracker, which is an active fiducial marker. The document focuses on demonstrating substantial equivalence to a predicate device, particularly regarding its safety and compatibility for use in Magnetic Resonance (MR) environments, as well as its intended use in ultrasound (US) environments for electromagnetic (EM) tracking.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily focused on safety and compatibility in MR environments, rather than performance metrics like sensitivity, specificity, or accuracy, which are typical for diagnostic AI devices. The device's performance is reported in terms of passing these safety tests.

• RF Heating (ASTM F2182-11a): The device must not pose an unacceptable risk of heating when exposed to Radiofrequency fields in an MRI scanner.
• Magnetic Induced Torque (ASTM F2052-06): The device must not experience significant torque (rotational force) when subjected to the magnetic field of an MRI scanner, which could cause movement and potential injury.
• Magnetically Induced Displacement Force (ASTM F2213-06): The device must not experience significant translational force (pulling or pushing) when subjected to the magnetic field gradient of an MRI scanner, which could cause it to move or become dislodged.
• Magnetic Field Interactions (ASTM F2119-07 - modified): Although specifically for implants, modifications were made for external use, implying assessment of interactions with the magnetic field. The acceptance criterion would be that the device does not show adverse interactions. | - RF Heating: "The devices passed the acceptance criteria for RF heating."
• Magnetic Induced Torque: "The devices passed the acceptance criteria for... magnetic induced torque."
• Magnetically Induced Displacement Force: "The devices passed the acceptance criteria for... magnetically induced displacement force."
• Magnetic Field Interactions (modified F2119-07): "The devices passed the acceptance criteria for... [other aspects related to magnetic field interactions]." (Implied from the general statement, as F2119-07 covers this broader category).
• Localized Image Artifact: While not an "acceptance criterion" in the sense of a pass/fail for safety, the document notes that "Localized image artifact was observed" and that "information regarding location and size of the artifacts has been included in the Instructions for Use," indicating this was an expected outcome that needed to be addressed through labeling rather than eliminated. |
  | Biocompatibility | Compliance with ISO 10993 standards for biological evaluation of medical devices (for skin contact):
• Cytotoxicity (ISO 10993-5:2009/(R) 2014): Materials should not be toxic to cells.
• Sensitization & Irritation (ISO 10993-10:2010): Materials should not cause allergic reactions or skin irritation. The device is intended for "limited contact duration (

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The Protura Couch Software is intended to interface between record and verify systems, linear accelerator (Linac) software systems, Linac safeguard systems, and/or image guidance systems and the Protura Couch. The Protura Couch Software is also capable of operating the Protura Couch (6 Degree Axis Couch).

The proposed device, the Protura Couch Software 1.3.0 (Part No. MT6XSM1.3.0), is patient positioning software used in radiation treatments in conjunction with an Image Guided Radiation Therapy (IGRT) system. The Protura Couch Software interfaces with the Couch Hardware (K031866) and is intended to position the patient after diagnostic decisions have been made based on results from an IGRT system. The Protura Couch Software allows the user to control patient positioning with six degrees of freedom from outside of the treatment room. The Protura Couch Software also includes the ability to interface with record and verify systems, Linac software systems, Linac safeguard systems, and/or image guidance systems.

The provided document is a 510(k) summary for the Protura Couch Software 1.3.0, a patient positioning software used in radiation treatments. It states that non-clinical performance testing was conducted, but no clinical testing was performed. Therefore, it does not contain the specific information required to complete a table of acceptance criteria and reported device performance based on a study, nor does it provide details about patient data, expert reviews, or comparative effectiveness studies.

However, based on the information provided, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists "Non-Clinical Performance Data" areas tested and states "All testing confirmed that the Protura Couch Software 1.3.0 is safe and effective for its intended use." However, it does not provide specific acceptance criteria (e.g., numerical thresholds, error limits) or quantitative results of the device's performance against such criteria.

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

• Sample Size: Not applicable. No clinical testing with patient data was performed. The testing described is non-clinical performance testing of the software and hardware interfaces.
• Data Provenance: Not applicable, as no patient data was used.

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

• Number of Experts: Not applicable. No clinical testing or expert review of patient data was conducted.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. No clinical testing or expert review requiring adjudication was conducted.

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

• MRMC Study: No. The document explicitly states: "No clinical testing was performed in the evaluation of this medical device." Therefore, no MRMC study, human reader improvement analysis, or AI assistance effect size was reported.

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

• Standalone Performance: The non-clinical performance testing focused on the device's functionality, interfacing, and mechanical aspects. While this could be considered a form of "standalone" testing for the software's operational characteristics, it's not in the context of diagnostic or interpretive performance where "standalone" typically refers to an AI algorithm's accuracy in analysis without human input. The document describes testing of the software's technical operation (e.g., couch movement, interfacing), not its interpretation of data.

7. The Type of Ground Truth Used:

• Ground Truth: For the non-clinical performance tests, the "ground truth" would have been established by engineering specifications, calibration standards, and expected operational parameters for the couch movement, interface communication, and alignment accuracy. For example, for "Movement of the Protura Couch," the ground truth would be the programmed movement patterns and expected physical responses of the couch hardware. For "Couch Pedestal and Isocenter Alignment," it would be the precise physical alignment specifications.

8. The Sample Size for the Training Set:

• Sample Size: Not applicable. This device is software that controls a medical device (a radiation therapy couch). It is not an AI/ML algorithm that requires a training set in the typical sense (i.e., for learning from data to perform a diagnostic or predictive task). The software is programmed based on engineering principles and specifications, not trained on a dataset of patient cases.

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

• Ground Truth for Training Set: Not applicable, as there is no "training set" in the context of an AI/ML algorithm for this device. The software functions based on its coded logic and interface protocols, not on learned patterns from a dataset.

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The Protura Couch Software is interface between a record and verify system, linear accelerator (Linac) software, Linac safeguard systems, and/or image guidance systems and the Protura Couch. The Protura Couch Software is also capable of operating the Protura Couch (6 Degree Axis Couch).

The proposed device, the Protura Couch Software (MT6XSMEU), is patient positioning software used in radiation treatments in conjunction with an Image Guided Radiation Therapy (IGRT) system. The Protura Couch Software interfaces with the Protura Couch Hardware (K031866) and is intended to position the patient after diagnostic decisions have been made based on results from an IGRT system. The Protura Couch Software allows the user to control patient positioning with six degrees of freedom from outside of the treatment room. The Protura Couch Software also includes the ability to interface with a record and verify system, Linac software, Linac safeguard systems, and/or image guidance systems.

The provided text describes a 510(k) summary for the Protura Couch Software (device name: MT6XSMEU) by MED-TEC, Inc. d/b/a CIVCO Medical Solutions. This software is designed for patient positioning in radiation therapy.

Here's an analysis of the acceptance criteria and study information, based solely on the provided document:

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

The document does not explicitly state quantitative acceptance criteria in a table format. Instead, it describes performance testing conducted. The reported device performance is that "All testing confirmed that the Protura Couch Software is safe and effective for its intended use" and that it is "substantially equivalent to the predicate device in regards to safety, effectiveness, and performance."

The characteristics tested include:

• Movement of the Protura Couch
• Interfacing with External Systems
• Couch Pedestal and Isocenter Alignment
• Patient Record Handling

Without specific numerical targets for these characteristics, a precise table of acceptance criteria and reported performance cannot be generated. The document indicates these tests were performed and passed.

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 specify a sample size for the test set. It mentions "non-clinical performance testing" but does not detail the number of test cases, simulated patients, or data points used. Data provenance is also not mentioned, as no clinical data or data from human subjects was used for testing.

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 applicable and hence not provided. As the testing was "non-clinical" and involved evaluating software functionality and interface, there was no need for experts to establish ground truth in the context of medical image interpretation or patient outcomes.

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

This information is not applicable and hence not provided. The non-clinical performance data described does not involve expert adjudication as it pertains to software functionality and system interfaces, not diagnostic or prognostic outcomes requiring consensus.

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 was performed or is mentioned. The device is software for controlling a radiation therapy couch, not an AI for image interpretation or diagnosis that would typically be evaluated with human readers.

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

Yes, based on the description, the performance testing appears to be a standalone evaluation of the software's functionality and its ability to interface with other systems and control the couch. The "non-clinical performance data" section describes testing conducted on the software itself and its interactions, without human-in-the-loop performance being a primary evaluation point for its safety and effectiveness.

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

The concept of "ground truth" as typically applied in AI/clinical studies (e.g., expert consensus for diagnosis, pathological findings) is not relevant here. For this device (software controlling a medical couch), the "ground truth" would be the expected functional behavior and precise physical movements of the couch, as defined by engineering specifications and safety standards. The testing verified that the software met these operational specifications.

8. The sample size for the training set

This information is not applicable and not provided. The Protura Couch Software is described as an interface and control system, programmed in C#. It is not an AI/machine learning model that typically requires a distinct "training set" in the sense of labeled data for learning.

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

This information is not applicable and not provided, for the same reasons as in point 8.

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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.

The MR & Radiological Patient Positioning devices are used to aid in patient positioning and immobilization during radiotherapy procedures. The following models of the Patient Positioning Devices are included in this submission: . Bellyboard 126000 Bellyboard, which includes the following: 301101 Bellyboard Cushion o SBRT Accessories MTSBRT011 SBRT Patient Transfer System, which includes the following: MTSBRT012 Gurney Plate Assembly MTSBRT032 Transfer System Trans Slot MTSBRT033 Transfer System Longitudinal Slot MTSBRT014 Ski Assembly 20-CFHN-017 Type-S Strap Devices are sold non-sterile and may be reused for multiple patient or single patient use if set-up for a single patient. The proposed devices are non-implanted devices i that are large in size and manufactured of non-magnetic and plastic materials.

The provided text describes the regulatory submission for CIVCO MR & Radiological Patient Positioning Devices and their testing for MR compatibility. It is a 510(k) summary, not a study report for a novel AI device with specific performance metrics like those typically found in clinical trials. Therefore, much of the requested information (e.g., sample size for test/training sets, number of experts for ground truth, MRMC study details) is not applicable or cannot be extracted directly from this document.

However, I can extract the acceptance criteria and reported device performance related to MR compatibility, as well as general information about the testing.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated as a number of patient cases or device units tested in a clinical performance manner. The testing was non-clinical and focused on the device itself for MR compatibility.
• Data Provenance: The testing was non-clinical, involving direct device testing following ASTM standards. It is not patient or country-specific data but rather laboratory/device performance data. Therefore, it's neither retrospective nor prospective in the typical clinical study sense.

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

• Not applicable. This was non-clinical engineering and materials testing for MR compatibility, not a study requiring expert clinical assessment for ground truth.

4. Adjudication Method for the Test Set

• Not applicable. This was non-clinical engineering and materials testing, not a study requiring adjudication of expert interpretations.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission concerns MR compatibility of patient positioning devices, not diagnostic or AI performance with human readers.

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

• Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

• The "ground truth" here is objective physical measurements and observations against established engineering standards (ASTM F2182-9, F2119-07, F2052-06, F2213-06) for MR compatibility, along with biocompatibility testing results.

8. The Sample Size for the Training Set

• Not applicable. This document does not describe an AI/machine learning study with training sets.

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

• Not applicable. This document does not describe an AI/machine learning study.

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