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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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This device provides physicians with a tool for performing needle/instrument guided procedures with the use of diagnostic ultrasound endocavity transducers.
Transvaginal - Diagnostic ultrasound needle / instrument quided procedures such as tissue biopsy. fluid aspiration, catheter placement, treatment, and oocyte retrieval.
Transrectal - Diagnostic ultrasound needle / instrument guided procedures such as tissue biopsy, fluid aspiration, catheter placement, treatment.

The VitroPRO disposable endocavity needle guides are devices used to direct needles or instruments along a fixed path to a target location with an ultrasound traducer. They are provided in a variety of sizes to fit different equipment and situations. They can be utilized for various types of procedures from tissue biopsy and fluid aspirations to instrument placements and oocyte harvesting.

The FDA 510(k) summary for the VitroPRO device (K231783) outlines the acceptance criteria and the study performed to demonstrate the device meets these criteria, specifically in relation to the added indication for oocyte retrieval.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not specify the exact sample size for the MEA and LAL tests. For the MEA, it mentions "One-cell mouse embryos" were incubated, implying a certain number of embryos were used, but the precise count is not provided. For LAL, it refers to "EU/device," meaning a certain number of devices were tested, but the exact quantity is not stated.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given it's a premarket notification for an FDA submission, the studies would typically be prospective and conducted under controlled laboratory conditions to demonstrate safety and effectiveness for regulatory clearance in the US.

3. Number of Experts and Qualifications for Ground Truth:

• This device is a medical instrument (needle guide) and not an AI or diagnostic imaging device that requires interpretation by human experts (e.g., radiologists) for ground truth establishment.
• The ground truth for the performance tests (MEA and LAL) is established through standardized laboratory assays with objective, measurable endpoints (e.g., percentage of blastocyst development, endotoxin units). Therefore, no "experts" in the sense of clinical reviewers (like radiologists) were utilized to establish ground truth for this type of testing.

4. Adjudication Method:

• Not applicable as the tests are laboratory-based assays with objective measurements, not subjective evaluations requiring adjudication.

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

• No, an MRMC study was not done. This device is a passive medical instrument (needle guide) and not a diagnostic imaging or AI-powered device that aids human interpretation, which would typically necessitate an MRMC study to evaluate improved reader performance.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

• Not applicable. This is not an algorithm or AI device. The tests performed (MEA and LAL) evaluate the biological safety and pyrogenicity of the device material, which are inherent properties of the device itself.

7. Type of Ground Truth Used:

• The ground truth used is based on objective laboratory assay results against predefined biological and chemical thresholds.
  • For MEA: The objective metric is the percentage of embryos developed to the expanded blastocyst stage, compared to a control group.
  • For LAL: The objective metric is the endotoxin units (EU) per device.

8. Sample Size for the Training Set:

• Not applicable. This device is not an AI or machine learning model that requires a training set.

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

• Not applicable, as there is no training set for this type of device.

In summary, the VitroPRO device demonstrates its safety and effectiveness for the expanded indication of oocyte retrieval through established biological and chemical material compatibility tests (MEA and LAL), rather than clinical performance studies involving human readers or AI algorithms. The acceptance criteria are objective thresholds for these laboratory tests.

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This device provides physicians with a tool for performing needle/instrument guided procedures with the use of diagnostic ultrasound endocavity transducers.

• Transvaginal Diagnostic ultrasound needle / instrument guided procedures such as tissue biopsy fluid aspiration, catheter placement, treatment, and oocyte retrieval.
• Transrectal Diagnostic ultrasound needle / instrument guided procedures such as tissue biopsy, fluid aspiration, catheter placement, treatment.

The disposable endocavity needle guides are devices used to direct needles or instruments along a fixed path to a target location with an ultrasound traducer. They are provided in a variety of sizes to fit different equipment and situations. They can be utilized for various types of procedures from tissue biopsy and fluid aspirations to instrument placements and oocyte harvesting.

The provided text describes a 510(k) summary for the VitroPRO, a disposable endocavity needle guide. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive performance studies with acceptance criteria based on human-in-the-loop and algorithm-only performance metrics typical for AI/ML devices. Therefore, much of the requested information regarding AI/ML study design, such as MRMC studies, effect sizes, training set details, and ground truth establishment methods for AI, is not applicable or present in this specific document, as the VitroPRO is a mechanical device, not an AI/ML diagnostic tool.

However, based on the information provided, here's what can be extracted and presented to align with the prompt, focusing on the available non-clinical test data which serves as the "study" proving the device meets its "acceptance criteria" for substantial equivalence.

Device Name: VitroPRO / Disposable Endocavity Needle Guide (K222052)
Device Type: Mechanical Accessory (Needle Guide), not an AI/ML diagnostic device.

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this device are implicitly tied to demonstrating the same safety and effectiveness as the predicate device, K970514, through non-clinical performance testing. The "reported device performance" refers to the results of these non-clinical tests.

Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

• Cytotoxicity (ISO 10993-5): Met.
• Sensitization (ISO 10993-10): Met.
• Irritation (ISO 10993-10): Met.
  (Note: "Not labeled non-pyrogenic" compared to predicate's "non-pyrogenic" but deemed not to affect safety/effectiveness given the application). |
  | Cover Breach and Probe Damage: Device attachment to ultrasound cover/probe does not cause damage. | Water leak testing demonstrated material attachment of needle guide to cover did not cause damage to cover or probe. |
  | Retention and Movement: Minimum force required to dislodge the guide from the transducer. | Force testing demonstrated a minimum force of 8N would not cause the guide to dislodge. |
  | Needle Drag: Force required to pass a cannula through the guide is below a specified threshold, preventing binding. | Force testing demonstrated binding would not occur and force was less than a 1.5N threshold. |
  | Needle Path Verification: Needle path falls within design tolerances. | Needle guides were tested on test fixtures to ensure needle path falls within the design tolerances specified for the design. |
  | Usability: Design conforms to user needs and intended use. | Simulated use evaluations were performed by customers to ensure the design of the needle guide conforms to the user needs and intended use. (Details on specific metrics or acceptance thresholds for usability are not provided beyond general conformance). |

Study Details (Non-Clinical Performance Testing)

Given that this is a mechanical device submission, the "study" refers to non-clinical performance testing rather than clinical trials or AI/ML specific studies.

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

   • Sample Size: Not explicitly stated as a numerical 'sample size' in the context of distinct cases or images like an AI dataset. Instead, the tests involved physical samples of the VitroPRO device and its components. For instance:
     • Biocompatibility: Samples of materials used in the device.
     • Cover breach/probe damage, Retention/movement, Needle drag, Needle path verification: Likely multiple physical units of the device tested under controlled conditions.
   • Data Provenance: The data comes from internal non-clinical performance testing conducted by CIVCO Medical Instruments Co., Inc. The country of origin of the data would be the US, as the company is based in Kalona, IA. The data is prospective in the sense that these tests were performed specifically for this 510(k) submission to demonstrate performance.

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

   • Not applicable in the context of establishing "ground truth" for diagnostic interpretation in the way it is used for AI/ML or image analysis. These tests are engineering performance validations, where "ground truth" is established by physical measurement standards and engineering specifications rather than expert interpretation of medical data.
   • For "Simulated Usability Testing," it states "customers" performed evaluations. The number and specific qualifications (beyond being target users/clinicians) are not detailed.

3. Adjudication Method for the Test Set:

   • Not applicable. Adjudication methods like "2+1" or "3+1" are used for resolving disagreements among human reviewers (e.g., radiologists) in diagnostic studies, especially for establishing ground truth from image interpretations. For mechanical performance testing, results are typically objective measurements against predefined engineering specifications.

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

   • No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for evaluating the impact of AI on human reader performance for diagnostic tasks. As the VitroPRO is a mechanical needle guide and not an AI/ML diagnostic tool, an MRMC study is not relevant or required for its clearance.
   • Therefore, there is no effect size reported for human readers improving with or without AI assistance.

5. If a Standalone (algorithm only without human-in-the-loop performance) was done:

   • No, a standalone assessment was not done. This type of assessment is for AI/ML algorithms operating independently. The VitroPRO is a mechanical device, not an algorithm.

6. The Type of Ground Truth Used:

   • For the non-clinical performance tests, "ground truth" refers to engineering specifications, physical measurements, and well-defined pass/fail criteria established through standard testing methodologies (e.g., ISO, internal engineering standards).
   • For Biocompatibility: Adherence to ISO 10993 standards and a "bio-response" indicating safety.
   • For Mechanical Tests (e.g., Retention, Needle Drag, Needle Path): Measured forces, paths, or absence of damage against predefined numerical thresholds and design specifications.
   • For Usability: User feedback and confirmation that the design meets user needs, although specific metrics are not detailed.

7. The Sample Size for the Training Set:

   • Not applicable. There is no "training set" as this is not an AI/ML device.

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

   • Not applicable. There is no "training set."

In summary, the provided document is a 510(k) summary for a mechanical medical device, not an AI/ML-driven diagnostic tool. Therefore, the "acceptance criteria" and "study" are defined by non-clinical engineering and biocompatibility testing designed to demonstrate substantial equivalence to a predicate device, rather than the complex clinical or artificial intelligence performance metrics often associated with AI/ML systems.

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The cover is intended as a microbial barrier between the patient and medical imaging equipment.

The transducer covers are used for all body sizes in sterile and non-sterile fields and for the following applications.

• · Abdominal Diagnostic imaging and minimally invasive puncture procedures.
• · Small Parts Diagnostic imaging and minimally invasive puncture procedures.
• · Regional Anesthesia Minimally invasive puncture procedures.
• · Vascular Access Vessel identification and catheter placement.
• · Surgical Diagnostic imaging and puncture procedures.
• · Transesophageal Diagnostic imaging and monitoring of heart chamber, valves and vessels.
• · Transrectal Diagnostic imaging and minimally invasive puncture procedures.
• · Transvaginal Diagnostic imaging and minimally invasive puncture procedures

When conducting an ultrasound procedure, place an appropriate amount of gel inside cover and/or on transducer face.

The CIV-Clear cover is a microbial barrier for use during ultrasound procedures. The cover is offered in sterile and non-sterile configurations in a variety of sizes to function with different equipment. The material has been tested and proven to be a viral barrier for microbes 27 nanometers and larger in size.

This FDA 510(k) summary describes the CIV-Clear cover, a microbial barrier for ultrasound procedures. The document aims to demonstrate its substantial equivalence to a legally marketed predicate device.

Here's the breakdown of acceptance criteria and the supporting study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a separate "test set" in the context of clinical or large-scale performance data in the typical sense of AI/diagnostic device studies. The testing described is primarily non-clinical, involving material science, biological, and engineering tests. For these tests, sample sizes would be determined by the specific ASTM and ISO standards followed, but these are not explicitly stated in the document.

The data provenance is from laboratory testing and engineering evaluations conducted by or for CIVCO Medical Instruments Co., Inc. It is not patient data (retrospective or prospective). The document does not mention any country of origin for the data other than the manufacturer's location (Kalona, IA, USA).

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

This section is not applicable as the described studies are non-clinical, focusing on device properties and safety rather than diagnostic accuracy involving expert interpretation of medical images or patient outcomes. Ground truth in this context refers to the defined parameters of the relevant ISO/ASTM standards.

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

This is not applicable as the described studies are non-clinical and do not involve human interpretation or adjudication of diagnostic outputs.

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 such study was done or reported. The device is a physical barrier (ultrasound cover), not an AI-powered diagnostic tool.

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

This is not applicable as the device is not an algorithm or AI system. It is a physical medical device.

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

The "ground truth" for the non-clinical tests is based on the established parameters and requirements of the referenced industry standards (e.g., ASTM F1671-13 for viral penetration, ISO 10993 for biocompatibility, ISO 11135 for sterilization, ASTM F1980-16 for accelerated aging, ISO 11607-2 and ISTA 3A for packaging). For acoustic performance, the ground truth is the measured physical properties compared against established ranges or predicate device performance.

8. The sample size for the training set

This is not applicable as no AI model or "training set" is mentioned or relevant to this physical device.

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

This is not applicable for the same reason as point 8.

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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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For the ASTRA TEE® -

The ASTRA TEE® automated reprocessor facilitates high-level disinfection and rinsing of 1 or 2 transesophageal ultrasound probes using FDA cleared and Civco Medical Solutions approved high-level liquid disinfectants.

For the ASTRA VR™ -

The ASTRA VR™ automated reprocessor facilitates high-level disinfection and rinsing of 1 or 2 endovaginal/endorectal ultrasound probes using FDA cleared and Civco Medical Solutions approved high-level liquid disinfectants.

The ASTRA Product Family of automated reprocessors are floor standing electromechanical lab equipment that facilitate high-level liquid disinfection of ultrasound probes that have been enzymatically pre-cleaned.

The provided document is a 510(k) Pre-Market Notification for medical devices (ASTRA TEE® Transesophageal Probe Reprocessor and ASTRA VR™ Endovaginal/Endorectal Probe Reprocessor). It outlines the device description, intended use, and a comparison to predicate devices, focusing on demonstrating substantial equivalence. The document primarily discusses the device's technical specifications and the testing conducted to ensure its safety and effectiveness in controlling high-level disinfection processes.

Unfortunately, the provided document does not contain the specific details required to answer all parts of your request about acceptance criteria met by a "device" in the context of an AI/human-in-the-loop study. The device in question here is an automated reprocessor for ultrasound probes, not an AI-powered diagnostic tool, and the performance criteria are related to disinfection efficacy, not diagnostic accuracy.

Therefore, I cannot populate most of the requested table and details, as they pertain to performance metrics and study designs common for AI-based diagnostic devices (e.g., sensitivity, specificity, reader performance studies, expert adjudication for ground truth).

However, I can extract the information relevant to the device's operational performance and the studies conducted to support its substantial equivalence.

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

What can be extracted:

• Acceptance Criteria (Performance Attributes): The core performance attribute for this device is its ability to "control the HLD temperature, soak time, and rinse cycle to facilitate ≥6 Log reduction of M. terrae using Metricide OPA Plus, Cidex OPA, and Resert XL." This is the primary functional performance claim.
• Study That Proves the Device Meets Acceptance Criteria:
  • Performance Testing Summary:
    • "The ASTRA system maintains time and temperature required for disinfection as per HLD manufacturers' specifications."
    • "The ASTRA system passed Safety and EMC testing."
    • "The ASTRA system passed Simulated use and Residual testing."
    • "The ASTRA system passed In-use testing."
  • Efficacy (Disinfection and Residual testing): "Pass as per simulated use (6log reduction of M. terrae), In-use Testing (complete kill) and residual testing (ISO10993-5 cytotoxic effect of

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The system provides guidance for precise instrument placement of common interventional devices by positioning the device relative to the ultrasound transducer and the resulting a diagnostic or therapeutic procedure. This guidance system is intended for use with pediatric and adult patients.

The ultrasound guidance system is used during diagnostic or therapeutic procedures to assist the clinician in placing an interventional device in a targeted anatomical location. The quidance system consists of a quide, gauge inserts, and may include a bracket. The guide attaches to the OEM ultrasound transducer via a VerzaLink™ locating feature either on the customized bracket (Figure 1) or on the OEM ultrasound transducer housing (Figure 2). The guide is secured to the locating feature using a locking mechanism. The angle of the quide adjusts within a 37° range by moving the angle selector grip proximally or distally on the quide. The angle is secured into place at the desired position using a locking mechanism. The guide receives the gauge inserts. The gauge inserts are provided on a gauge insert tree in sizes ranging from 12F to 25G. Rotation of a quick-release tab on the gauge insert enables the guide and OEM ultrasound transducer to be removed while leaving the interventional instrument in place. The guide and gauge inserts are provided sterile, and are intended for single-use. The bracket is provided non-sterile and is reusable.

The provided text describes a 510(k) premarket notification for the "Verza™ Guidance System." This document is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing rather than presenting a clinical study with detailed performance metrics and ground truth establishment for an AI algorithm.

Therefore, many of the requested elements for an AI study (like sample size for test/training sets, ground truth details, expert qualifications, or MRMC studies) are not applicable or extractable from this type of document.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes non-clinical testing to confirm the safety and effectiveness of design modifications. The acceptance criteria were implicit in demonstrating that these modifications did not diminish safety and effectiveness. The reported performance is a statement of compliance rather than quantitative metrics.

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

• Sample Size: Not specified. The testing described is non-clinical/engineering verification of device function and safety features, not a clinical study on a patient cohort or a dataset for an AI algorithm.
• Data Provenance: Not applicable in the context of an AI study. The testing refers to physical device functionality checks in a lab setting. "Clinical images were provided with the submission; these images were not necessary to establish substantial equivalence based on the modifications to the predicate device, but they provide further evidence in addition to the test performance data to show that the complete ultrasound guidance system works as intended." This suggests some informal use of clinical images for demonstration, but not as a formal test set for performance evaluation in the AI sense.

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

Not applicable. This is a physical device, not an AI algorithm requiring expert-annotated ground truth.

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

Not applicable. This is a physical device, not an AI algorithm requiring adjudication of ground truth labels.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

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

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

Not applicable. This is a physical guidance system, not a standalone AI algorithm.

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

Not applicable. The "ground truth" for this device would be its mechanical and material properties meeting specifications and performing its intended function (guidance of instruments) in simulated or actual usage scenarios.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning.

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

Not applicable.

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