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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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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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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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This device is indicated for use in adult males with known or suspected prostate cancer.

The Stepping Unit holds an ultrasound imaging probe and facilitates manual linear and rotational positioning of the probe. The Stepping Unit consists of a Cradle designed to hold a specific ultrasound probe and a Carriage that moves longitudinally along the Stepping Unit. A Grid Platform connected at one end of the Stepper provides support for the Disposable Template Grid. The Stepping Unit connects to the Stabilizer.

The Stabilizer provides a base for the Stepping Unit and offers fixation and support during insertion and final placement of the ultrasound imaging probe. On certain models, a fine tune mechanism is used to micro-adjust the probe or instrument to the ideal orientation. The Stabilizer mounts to an operating room table or is supported by a floor stand.

The Disposable Template Grid is a single-use, sterile grid that consists of rows and columns of holes (channels) spaced 5mm apart. These channels are labeled and provide placement of needles in predefined areas of the prostate.

Here's a summary of the acceptance criteria and study information for the CIVCO Medical Instruments Co., Inc. devices, based on the provided text:

Acceptance Criteria and Device Performance

Since this is a 510(k) submission for substantial equivalence for a medical device (specifically a stepping unit, stabilizer, and disposable template grid used in prostate procedures), the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are generally focused on demonstrating that the new/modified device is as safe and effective as a legally marketed predicate device. The evidence provided is primarily through:

• Comparison to Predicate Devices: Showing similarity in technological characteristics and intended use.
• Literature Review: For expanding indications of use for existing devices.
• Verification and Validation Testing: Specifically for the new EX3 Stepper, confirming its new features meet specifications and do not compromise overall safety/effectiveness.

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

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

• Sample Size for Test Set: Not explicitly stated. The verification and validation testing for the EX3 Stepper (longitudinal movement, encoder reporting, electrical safety, and compatibility with treatment planning software) would have involved specific test units, but the number of units tested is not detailed in this summary.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not explicitly stated. The verification and validation testing would have been conducted internally or by a contracted lab, likely in the US (where CIVCO is headquartered). This would be prospective testing on the physical device. The literature review for expanded indications of use would involve published, likely retrospective or prospective, clinical data (of various origins) that has already been peer-reviewed and published.

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

• This type of information is generally not applicable or explicitly stated for a 510(k) submission concerning a mechanical device like a stepping unit. The "ground truth" for mechanical function, electrical safety, or general utility for specific surgical procedures isn't typically established by expert consensus in the same way as an AI diagnostic algorithm's output would be. Instead, the "ground truth" here is the established safety and efficacy of the predicate device, engineering specifications, and universally accepted standards (e.g., IEC 60601-1 for electrical safety).
• For the validation with "treatment planning software," it implies functionality was checked against expected outputs, likely by engineers or possibly clinical users, but no explicit "expert" review process is described for establishing a ground truth.

4. Adjudication Method for the Test Set

• Not applicable/mentioned. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies, especially for evaluating diagnostic accuracy where there might be disagreements among human readers or between AI and human readers. This submission focuses on the mechanical and electrical performance of hardware, not diagnostic interpretation.

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 study type is highly specific to evaluating the clinical impact of AI-assisted diagnostic tools on human performance, which is not the subject of this 510(k) submission. This device is a mechanical accessory (stepping unit, stabilizer, template grid) used during procedures, not an AI diagnostic tool.

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

• Not applicable. This device is a mechanical accessory, not an algorithm or AI system. The EX3 Stepper has "firmware in the encoders report position," which is a functional component, but not a standalone algorithm in the typical sense of AI. Its performance (accuracy of position reporting) was verified.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• For EX3 Stepper's new features (encoders, continuous movement, electrical safety): The "ground truth" would be established engineering specifications, measurable physical properties, and adherence to recognized electrical safety standards (IEC 60601-1 and IEC 60601-1-1). For compatibility with treatment planning software, the ground truth would be the expected data output/interaction defined by the software's specifications.
• For expanded indications of use of existing devices: The "ground truth" for safety and effectiveness in cryotherapy, transperineal template-guided biopsy, and fiducial marker placement was established through a literature review. This means previously published clinical studies and outcomes data effectively served as a form of "ground truth" demonstration of safe and effective use.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device that requires a training set. The firmware on the EX3 Stepper's encoders is for reporting position, not for learning or prediction from data.

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

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

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Protective cover or sheath placed over diagnostic ultrasound transducer / probe / scanhead instruments. The cover allows use of the transducer in scanning and needle guided procedures for body surface, endocavity, central nervous system, and intra-operative diagnostic ultrasound, while helping to prevent transfer of microorqanisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the transducer. The cover also provides a means for maintenance of a sterile field. The cover is single use patient / procedure, nonpyrogenic, and disposable.

The Non-Pyrogenic Ultrasound Transducer Cover provides a thin, conformal covering to fit a variety of ultrasound transducer geometries. The cover is made of polyurethane, polyethylene, and/or synthetic polyisoprene materials. The cover is manufactured as either a one-or two-piece design that helps prevent the transmission of pathogens as the ultrasound transducer is reused from one patient to another. The Non-Pyrogenic Ultrasound Transducer Cover is provided sterile and is single patient / procedure and disposable.

Ultrasound imaging is not impaired by use of the cover as it is intended. As adequate coupling between the cover and the transducer is required, the Non-Pvrogenic Ultrasound Transducer Cover is utilized by applying sterile saline or other non-pyrogenic coupling media onto the transducer face or into the closed end of cover, inserting the ultrasound transducer into the closed end of cover, and unrolling the cover over the length of the transducer as desired. The open end is secured with elastic bands and nylon clips as necessary. The removal process is accomplished by pulling the cover off the transducer in a reverse method from the application.

It seems there's a misunderstanding about the nature of the provided document. This document is a 510(k) Premarket Notification Summary for a medical device (Non-Pyrogenic Ultrasound Transducer Cover), not a study report demonstrating the performance of an AI algorithm or a diagnostic device that outputs specific measurements.

Therefore, the requested information about acceptance criteria for an AI device, sample sizes for test/training sets, expert ground truth, MRMC studies, or standalone algorithm performance, does not apply to this document.

This document is primarily concerned with demonstrating substantial equivalence of a physical medical device (transducer cover) to previously cleared predicate devices, and justifying an expanded indication for use (central nervous system and non-pyrogenic claim) through specific non-clinical tests.

However, I can extract the information that is relevant to the document concerning the device's safety and effectiveness for its intended use based on the non-pyrogenic and implantation claims.

Here's an interpretation based on the document's content, focusing on what could be considered acceptance criteria and how the device met them, with caveats that this is not an AI device:

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

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

• Sample Size for testing: The document does not specify the exact sample size (number of units tested) for the endotoxin or implant testing. It states "test data" was used.
• Data Provenance: The tests were conducted to support a 510(k) submission to the US FDA, implying the data would adhere to relevant US regulatory standards. However, the country of origin of the actual testing facilities or samples is not specified in this summary. The testing appears to be prospective laboratory testing of the device itself.

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 concept is not applicable as this is a physical medical device undergoing non-clinical laboratory testing, not a diagnostic device requiring expert interpretation of results for ground truth.

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

Not applicable. The testing methods (USP and ISO 10993-06) involve objective laboratory measurements, not subjective interpretation requiring adjudication among experts.

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 not an AI diagnostic device.

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

Not applicable. This is not an AI algorithm.

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

The "ground truth" here would be the objective measurements obtained from standardized laboratory tests:

• For pyrogenicity: Detection of bacterial endotoxins below a specified limit as defined by USP and USP.
• For biocompatibility: Observation of local tissue reactions after implantation in muscle, evaluated against criteria defined by ISO 10993-06.

8. The sample size for the training set

Not applicable. This device does not have a "training set" as it is not an AI/machine learning model.

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

Not applicable.

In summary: The provided document is a regulatory submission for a physical medical device. It details non-clinical testing to demonstrate the safety and effectiveness of a transducer cover for expanded indications, specifically regarding its non-pyrogenic nature and biocompatibility for central nervous system use. The "acceptance criteria" and "device performance" in this context refer to the successful completion and results of these specific laboratory tests against established standards.

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

The Civco Patient Support Devices have been used for many years and were previously cleared under 510(k)'s before the classification was reduced to Class I exempt. This 510(k) is to have these identical Class I products cleared for use in an MRI environment.

This 510(k) submission (K080072) is for "MRI Patient Positioning Devices" and focuses on demonstrating substantial equivalence to previously cleared devices. The core of the submission revolves around proving the safety and effectiveness of these devices for use in an MRI environment, as they were previously Class I exempt and are now being cleared for MRI use.

The document does not provide a typical "study" with specific acceptance criteria and reported device performance in the way one might expect for an AI/software device or a diagnostic device. Instead, the "study" is a series of tests to ensure MRI compatibility and safety.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The document does not specify a "test set" in the context of data for an algorithm. Instead, it refers to the physical devices themselves. The sample size would be the number of physical MRI Patient Positioning Devices tested for MRI compatibility. This number is not disclosed in the provided text.
Data provenance (country of origin, retrospective/prospective) is not applicable here as it's not a data-driven study.

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

Not applicable. "Ground truth" in the context of device performance for physical products like patient positioning devices (especially for MRI compatibility) typically involves engineering tests, material compatibility assessments, and MRI safety protocols, rather than expert interpretation of data.

4. Adjudication Method for the Test Set

Not applicable. There's no interpretive test set requiring adjudication.

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

Not applicable. This is not a diagnostic device or an AI assistant for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

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

7. Type of Ground Truth Used

The "ground truth" for the device's main claim (MRI safety) would be established through:

• Engineering Standards and Test Results: Compliance with recognized MRI safety standards (e.g., ASTM F2503 for "MR Safe," "MR Conditional," "MR Unsafe"). These standards outline specific tests for magnetic attraction, RF-induced heating, image artifact, etc.
• Material Compatibility: Assessment of the materials used in the devices for their magnetic properties and potential for heating in an MRI environment.
• Regulatory Compliance: Meeting the requirements of the FDA for safe medical devices.

The document only states "These products have been tested to demonstrate that they can be safely used in an MRI environment," implying these types of tests were performed.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable.

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Protective cover or sheath is placed over an ultrasound transducer / probes / scanbead instruments. The cover allows use of the transdacer in Naming and intra-operative uitesound, while helping to proven transfer of microorganisms, body fluids, and and intra-operative uitesound, while helping to proven during rease of the tearile and non-sterile covers). The cover also provides a means for maintenance of a sterile fold (sterile covers only). non-sterile covers). The cover also provides a modis for manished sterile and non-sterile, single use patient / procedure, disposable.

The Synthetic Polyisoprene Ultrasound Transducer Cover provides a thin, conformal covering to fit various and specific ultrasound transducer geometries. The cover is manufactured as either a one-or two-piece design that provides a covering that helps prevent the transmission of pathogens as the ultrasound transducer is reused from one patient to another. The cover material is polyisoprene synthetic rubber similar to that of non-latex medical examination / surgical gloves. Various sizes and shapes of covers are offered in order to customize the fit to specific transducer geometries. Product categories / models include: General Purpose Synthetic Polyisoprene Transducer Covers (sterile and non-sterile) Endocavity Synthetic Polyisoprene Transducer Covers (sterile and non-sterile) Surgi-Tip™ Intraoperative* Synthetic Polyisoprene Transducer Covers (sterile) *Polyethylene cord cover w/ Synthetic Polyisoprene tip Covers are packaged in both sterile and non-sterile "procedure kit" form for single patient / procedure, disposable use. Cover kits are supplied with fasteners, and with or without coupling gel packet. Transducer covers are also combined with disposable needle guide devices into custom kits that CIVCO builds for ultrasound OEMs and end users.

The provided text describes a 510(k) submission for a Synthetic Polyisoprene Ultrasound Transducer Cover, arguing for its substantial equivalence to a legally marketed predicate device, the CIVCO NeoFlex™ Ultrasound Transducer Cover (K991236).

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets for performance metrics (e.g., "tear strength > X MPa"). Instead, the criteria are qualitative and comparative, demonstrating that the new device performs "effectively similar" to the predicate device in key areas.

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