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The Resilience Fully Covered Esophageal Stent System is intended for maintaining esophageal luminal patency in patients with esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and for occlusion of esophageal fistulae.

The MERIT ENDOTEK® Resilience™ Fully Covered Esophageal Stent System is a through-the-scope system comprised of two components: the radiopaque self-expanding nitinol stent and the delivery system. The stent is completely covered with a biocompatible silicone membrane. Stent expansion results from the physical properties of the metal and the proprietary geometry. The stent is designed with unique geometrical features at the distal and proximal ends to anchor the stent and resist migration. The proximal and distal ends of the stent are threaded with suture intended for use in repositioning and removal of the stent.

The stents come in nine (9) sizes, comprising all combinations of three lengths (5cm, 6cm, and 7cm) and three midbody diameters (14mm, 17mm, and 20mm). The midbody lengths are 1cm, 2cm, and 3cm with the flared ends comprising the remaining length. The ends of the stents are larger in diameter than the midbody.

There is one 10.5Fr delivery system used to deploy all 9 stents.

The provided FDA 510(k) clearance letter and summary for the Resilience Fully Covered Esophageal Stent System describes non-clinical testing to demonstrate substantial equivalence to a predicate device. However, it does not include information about clinical studies involving human readers or AI algorithms. The clearance is based on the device itself (the stent system), not an AI algorithm performing diagnosis or analysis.

Therefore, many of the requested points, especially those pertaining to AI performance, human reader studies, and ground truth establishment for AI, cannot be answered from the provided text.

Here's an analysis based on the information provided, focusing on the device's non-clinical testing:

Acceptance Criteria and Reported Device Performance (Non-Clinical)

The study described is a series of non-clinical, in-vitro tests on the mechanical and material properties of the Resilience Fully Covered Esophageal Stent System and its delivery system.

Information Not Found in the Provided Text:

Since this is a clearance for a medical device (esophageal stent) and not an AI/software device, the following points related to AI studies are not applicable or not present in the provided document.

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

   • This device clearance is based on non-clinical, in-vitro testing. It does not utilize "test sets" in the context of clinical data for AI analysis. The "test sets" here refer to batches of manufactured stents and delivery systems for mechanical and material property evaluation. Specific sample sizes for each non-clinical test are not detailed in this summary, but the summary states "all of the above testing passed the predetermined specifications" and "All design validation requirements were met."

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 as this is not an AI/software clearance based on expert-labeled clinical data. Ground truth for non-clinical device testing is typically based on engineering specifications and direct physical measurements/observations.

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

   • Not applicable.

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-assisted device.

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

   • Not applicable.

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

   • For the non-clinical testing, the "ground truth" or "reference standard" would be the pre-defined engineering specifications and performance criteria derived from established medical device standards and the predicate device's performance benchmarks. For biocompatibility, the ground truth is compliance with ISO 10993-1.

8. The sample size for the training set:

   • Not applicable, as this is not an AI/software device. There is no "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 CT/MR Tandem and Ovoid Set is indicated for use for cancer treatment of the uterus, cervix, paracervix, endometrium, and vagina using HDR Brachytherapy.

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This FDA clearance letter describes a new device, the "CT/MR Tandem and Ovoid Set," but it does not describe a study involving AI or software performance evaluation. The document focuses on the substantial equivalence of this physical medical device (an applicator for brachytherapy) to a predicate device, primarily through mechanical, material, and compatibility testing.

Therefore, I cannot extract information related to acceptance criteria for AI model performance or a study proving that an AI device meets acceptance criteria, as the provided text doesn't contain such a study.

The document discusses:

• Biocompatibility Testing: Ensuring the materials are safe for patient contact.
• Magnetic Resonance Testing (MR): Confirming the device is MR safe/compatible.
• Cleaning, Disinfection, and Sterilization Testing: Verifying the device can be properly cleaned and sterilized for repeated use.
• Human Factors Validation Study: To ensure the device is user-friendly and performs as intended for its users and environment.
• Mechanical and Acoustic Testing: To demonstrate the device performs as intended and meets design specifications.

These tests are for the physical device's safety and effectiveness, not for an AI algorithm's diagnostic or predictive performance.

Therefore, I cannot fill in the requested table and details for AI-related performance.

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The Merit Prelude Wave Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries, including but not limited to the radial artery, while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.

The access needle with inner metal needle and outer plastic cannula is used to gain access to the vein or artery for placement of guidewires.

The Prelude Wave™ Hydrophilic Sheath Introducer consists of a sheath introducer with compatible vessel dilator that snaps securely into the sheath introducer hub. The sheath hub contains an integral hemostasis valve. The sheath tubing is coated with a hydrophilic coating. A sidearm is affixed to the sheath hub and has a 3-way stopcock at its proximal end. The Prelude Wave™ Hydrophilic Sheath Introducer is available in 11cm and 23cm lengths, (French sizes 4F, 5F, 6F and 7F) and is designed to accept 0.018", 0.021" and 0.025" diameter guidewires. The Prelude Wave™ Hydrophilic Sheath Introducer is marketed with any of the following components, depending on the product configuration: guidewire, metal access needle, access needle with inner metal needle and outer plastic cannula and SnapFix™ securement device.

The provided FDA 510(k) clearance letter and summary for the Prelude Wave Hydrophilic Sheath Introducer (K250909) do not contain the specific information requested in the prompt regarding acceptance criteria, device performance, sample sizes for training and testing, expert qualifications, or detailed descriptions of ground truth establishment for an AI/ML medical device.

This document describes a traditional medical device (a catheter introducer), not an AI/ML-based device. Therefore, the types of studies and acceptance criteria typically associated with AI/ML device clearance (as outlined in your prompt questions) are not applicable here.

The document primarily focuses on:

• Substantial Equivalence: Demonstrating that the new device is as safe and effective as a legally marketed predicate device (Prelude IDEAL Hydrophilic Sheath Introducer, K173750). This is a common pathway for traditional medical devices.
• Performance Testing: Verification and validation studies to ensure the device meets its specifications and performs as intended, based on established international standards (ISO 10555-1, EN ISO 11070, ISO 10993-1, ISO 14971). These tests are standard for physical medical devices and include mechanical, functional, and biocompatibility assessments.
• Design Changes: Highlighting minor design modifications from the predicate, such as sheath material, sheath/dilator tip fit, and inclusion of an adhesive fixation device.

Therefore, I cannot populate the table or answer the specific questions about AI/ML device study parameters (like MRMC, standalone AI performance, expert labeling, training data) based on the provided text. The provided text simply does not contain this information because it's a submission for a physical medical device, not an AI software.

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The Titanium Flexible Geometry FSD Applicator Set with the optional interstitial ovoids is intended for cancer treatment of the uterus, cervix, paracervix, endometrium and vaqina, with intracavitary or with a combination of intracavitary and interstitial HDR brachytherapy.

The Titanium Flexible Geometry FSD Applicator Set with the optional interstitial ovoids is intended for cancer treatment of the uterus, cervix, paracervix, endometrium and vagina, with intracavitary or with a combination of intracavitary and interstitial HDR brachytherapy.

The device does not contain or consist of software/firmware. The device does not contain any biologics or drug components. The device has patient-contacting materials. The device is designed for repeated use. No parts of the system are provided sterile. The device can be steam sterilized with common parameters using pre-vacuum sterilization.

The intended patient population includes adult female patients whose cancer can be treated using HDR brachytherapy, as determined by the prescribing physician. The subject device is intended to be used in a healthcare or treatment facility by trained and qualified personnel.

The key performance characteristics of this applicator set are as follows:

• . The ability to customize the relative depth of the tandem and ovoids, as well as adapt to different anatomies with three tandem angles (15°, 30°, 45°) and a movable cervical stop.
• 3.5 mm diameter intrauterine tandems allow for easy insertion into the cervical channel helping provide maximum patient comfort.
• The tandems and the pivot assembly are made from strong, lightweight titanium.
• Four different ovoid sizes to allow for varying anatomy.
• . Channel marking on the intrauterine tandems and colpostat tandems for easy identification.
• . Ability to image the patient using CT imaging.
• Ability to image the patient using MR imaging.
• Optional interstitial ovoids for more complex cases with guide tubes to allow for the needles to be preloaded outside of the patient and locked into place.
• . Compatible with cervical sleeves to allow easy multiple fraction and help provide maximum patient comfort and eliminate the risk of perforation.
• Can be manually or machine cleaned, disinfected and steam sterilizable.
• Can be securely connected to the BRAVOS Afterloader System and GammaMedeplus iX series afterloader.
• Suitable for patient contact for a period of less than 30 days

This document is a 510(k) Premarket Notification for the Titanium Flexible Geometry FSD Applicator Set (GM11013400). It does not describe an AI/ML powered device. The information provided focuses on the substantial equivalence to a predicate device through non-clinical performance testing. Therefore, many of the requested categories related to AI/ML device studies (such as MRMC studies, standalone algorithm performance, AI training/test sets, expert ground truth establishment, etc.) are not applicable to this submission.

Here is the information that can be extracted relevant to the performance and acceptance criteria for this medical device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. This submission concerns a physical medical device (applicator set), not an AI/ML model for data-driven analysis. Performance testing likely involved physical prototypes or units, but specific "sample sizes" in the context of data analysis are not presented.
• Data Provenance: Not applicable in the context of clinical data used for AI/ML development. The testing described is non-clinical (biocompatibility, MR compatibility, cleaning/sterilization, mechanical, human factors).

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

• Not applicable. Ground truth as typically defined for AI/ML (e.g., expert labels on medical images) is not relevant for the type of device and testing described. The "ground truth" for this device's performance is established by objective engineering and safety standards.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication is typically for resolving discrepancies in expert labels for AI/ML ground truth.

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. This is not an AI-powered device.

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

• No. This is not an AI-powered device.

7. The Type of Ground Truth Used

• The ground truth for this device's performance is based on objective engineering standards, regulatory requirements, and validated test methods. This includes:
  • Compliance with ISO 10993 for biocompatibility.
  • Compliance with ASTM standards for MR compatibility.
  • Demonstrated effectiveness for cleaning, disinfection, and sterilization.
  • Usability verification through human factors studies (IEC 62366).
  • Verification and validation against design specifications and risk management (21 CFR §820, ISO 13485, ISO 14971).

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

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

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

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

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

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

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

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

Inferred Acceptance Criteria from Non-Clinical Testing:

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

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

Reported Device Performance:

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

Missing Information:

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

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

Summary of Available Information from the Text:

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

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

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

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

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

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

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

   • Not provided.

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

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

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

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

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

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

8. The sample size for the training set:

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

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

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

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The Babyroo TN300 is an open care radiant warmer that provides a controlled source of heat and regulation of skin temperature for neonates and infants. The optional integrated resuscitation module provides emergency respiratory support administered by clinicians and includes the functionality of suction. Additionally, the device provides weighing (optional) and pulse oximetry (optional) of neonates and infants. The device is designed for use with a body weight up to 10 kg (22 lb).

The device is indicated for thermoregulation, skin temperature regulation, weighing (optional), pulse oximetry (optional), and resuscitation (optional) of neonates and infants.

The purpose of this premarket notification is to activate, for the US market, existing optional functionality which enables the display of SpO2 information by the subject Babyroo TN300 via its graphical user interface (GUI). The SpO2 display functionality is facilitated through connection with existing, cleared pulse oximetry accessories which generate the SpO2 information that is displayed on the subject Babyroo TN300 GUI.

As originally cleared under K230278:
The Babyroo TN300 is an open care infant radiant warmer that provides controlled source heat and skin temperature display for use with neonates and infants. The device can be configured for either labor and delivery or the newborn intensive care unit (NICU) and can be used for intra hospital transfer. Warming therapy is interrupted during intra hospital transfer and patient is not supplied with heat.

The Babyroo TN300 device is offered with a fixed height or adjustable height trolley configuration and provides two heat sources for infant warming: a radiant warmer and an optional heating plate with conductive gel mattress. The device's bed can be tilted up to 15° in Trendelenburg and reverse Trendelenburg directions and the design of the device is intended to facilitate uniform heat distribution over the entire mattress surface across the range of bed tilt angulation. An optional removable canopy is available for intra-hospital transfer.

Infant warming is facilitated via three (3) available thermorequlation modes:

• Manual mode
• Skin temperature mode
• Kangaroo mode

The Babyroo TN300 is available with an optional Resuscitation module. The optional Resuscitation module is pneumatically powered, can be connected to central gas supplies or gas cylinders, and provides emergency resuscitation and suction to the patient. The optional Resuscitation module includes adjustment for gas flow, peak inspiratory pressure, O2 concentration, and suction functionality and is available in three (3) variants:

• Resuscitation module with gas mixer and AutoBreath®.
• Resuscitation module with gas mixer.
• Resuscitation with O2 only.

The optional AutoBreath® function facilitates pneumatically driven, automatic respiratory rate and positive end-expiratory pressure control.

The Babyroo TN300 can be configured to include an optional integrated electronic scale, as well as, optional heated gel mattress, optional integrated single or dual storage drawers, optional gas cylinder holders, and optional x-ray tray.

The provided text describes a 510(k) premarket notification for a modification to the Babyroo TN300 infant warmer device. The modification involves activating existing optional software functionality to display SpO2 information generated by existing, cleared pulse oximetry accessories. The core device functions for warming, resuscitation, and weighing remain unchanged from the predicate device (K230278).

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

Key Takeaway: The submission focuses on demonstrating substantial equivalence for the new functionality (SpO2 display and associated alarms) by relying on existing clearances of the core device and the OEM pulse oximetry accessories, in conjunction with specific non-clinical verification testing of the integrated system. No new clinical studies were performed.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a modification (enabling SpO2 display), the acceptance criteria primarily revolve around demonstrating that the new functionality performs as expected and does not introduce new safety or effectiveness concerns, especially concerning the integration with existing, cleared pulse oximetry technology. The performance is assessed by confirming conformity to relevant standards and effective data transfer.

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

The document explicitly states: "No human clinical data are included in support of substantial equivalence." This means there isn't a "test set" in the traditional sense of patient data.

The testing relied on non-clinical performance testing:

• Sample Size: Not numerical. The testing involved the Babyroo TN300 device itself, presumably one or more units, integrated with the specific OEM Masimo SET® pulse oximetry accessories. The "sample" here refers to the actual device and integrated components under test in a laboratory/engineering setting.
• Data Provenance: The data comes from laboratory/engineering testing performed by the manufacturer (Draeger Medical Systems, Inc.). It is implicitly prospective in the sense that the testing was conducted specifically for this 510(k) submission to demonstrate the safety and effectiveness of the new functionality. No geographic origin for the test data is specified, but it would typically be conducted at the manufacturer's R&D facilities.

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

Since no human clinical data or expert evaluations of images/readings were used for the test set (as this is a device modification for display of existing, cleared parameters), there were:

• Number of Experts: N/A.
• Qualifications of Experts: N/A.

The acceptance criteria were demonstrated through objective non-clinical performance testing against recognized standards (e.g., ISO 80601-2-61) and internal verification activities. The "ground truth" for the SpO2 display functionality would be the accurate and reliable transmission and display of the SpO2 and pulse rate data generated by the cleared OEM pulse oximetry accessories themselves, as validated in the OEM integration testing.

4. Adjudication Method for the Test Set

• Adjudication Method: N/A. As no human interpretation of data (e.g., images, vital signs patterns) was involved in a "test set" requiring ground truth establishment through expert consensus or adjudication, this is not applicable. The performance was verified through direct measurements and compliance with technical standards.

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

• MRMC Study: No. The document explicitly states: "No human clinical data are included in support of substantial equivalence." This type of study is typically performed to evaluate diagnostic accuracy or human performance with AI assistance, neither of which is the primary focus of this specific device modification (which is display of a physiological parameter).
• Effect Size of Human Readers Improvement with AI vs Without AI Assistance: N/A, as no MRMC study was conducted.

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

• Standalone Study: Yes, in a practical sense, the "OEM Integration Validation" is a form of standalone testing. This is described as validating "the effective transfer of pulse oximetry signals generated by a clinical simulator through the cleared OEM Masimo SET® pulse oximetry technology board to the subject Babyroo TN300 device's display." This tests the algorithm's ability (within the Babyroo TN300's software) to receive, process, and display the SpO2 data accurately from the source. The "algorithm" here isn't a complex diagnostic AI but rather the software logic for data handling and display.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for validating the SpO2 display functionality was the known, simulated pulse oximetry signals generated by a "clinical simulator" and then interpreted by the already cleared OEM Masimo SET® pulse oximetry technology board. The test ensured that the Babyroo TN300 accurately displayed what the cleared OEM technology was reporting. Essentially, the ground truth was the output of the "cleared OEM Masimo SET® pulse oximetry technology," and the new device's display was compared directly to that expected output.

8. The Sample Size for the Training Set

• Training Set Sample Size: N/A. This device modification does not involve a machine learning or AI algorithm that requires a "training set" in the traditional sense. The software functionality being activated is to display existing, cleared data.

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

• Ground Truth for Training Set: N/A, as no training set was used.

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Embozene Color-Advanced Microspheres are intended for embolization of arteriovenous malformations and hypervascular tumors, including uterine fibroids (UFE) and hepatoma, and for embolization of prostatic arteries (PAE) for symptomatic benign prostatic hyperplasia (BPH). The device is not intended for neurovascular use.

Embozene Color-Advanced Microspheres (hereafter may be referenced as Embozene Microspheres or Embozene) are spherical, tightly calibrated, biocompatible, non-resorbable, hydrogel microspheres coated with an inorganic perfluorinated polymer shell (Polyzene-F). The microspheres are suspended in liquid and then injected into the bloodstream to permanently occlude blood vessels. They are used to stop bleeding when the underlying lesion is not likely to heal or block arteries supplying a tumor to cause tumor necrosis and/or shrinkage. Embozene Color-Advanced Microspheres are sterile, single use devices and are supplied in pre-filled 20 ml syringes containing 2ml of microspheres in approximately 7 ml of transport solution. The Embozene Microspheres are available in 40-1300 µm sizes.

The provided text is a 510(k) Premarket Notification from the FDA regarding "Embozene Color-Advanced Microspheres". This submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing efficacy study data with acceptance criteria for a new device.

Therefore, the document does not contain the requested information regarding specific acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The submission confirms that:

• The device is "substantially equivalent" to a legally marketed predicate device (K180102).
• The substantial equivalence is based on the devices having "the same indications for use and the same technological characteristics."
• The only change in the subject device is an "updated syringe due to end of life of the previously used syringe."
• Non-clinical testing (mechanical performance, biocompatibility, sterility, packaging, and shelf-life) was conducted to ensure the updated device meets the specifications of the predicate device.

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The Ventrax™ Delivery System is intended to provide a pathway through which devices are introduced within the chambers and coronary vasculature of the heart.

The Ventrax™ Delivery System is designed to provide a conduit to deliver diagnostic and therapeutic catheters to specific heart chambers and locations. It provides support for positioning and maintaining the position of catheters at specific locations in the heart. The sheath may be used for percutaneous entry. The system consists of four components: a sheath, a pigtail dilator, a straight dilator and a J-tipped Amplatz guidewire.

VENTRAX™ DELIVERY SYSTEM COMPONENTS
A. 8.5F Guiding Sheath Introducer: provides a conduit to deliver diagnostic and therapeutic catheters to specific heart chambers and locations. The sheath has an integrated valve to restrict blood loss, and a sideport for flushing and withdrawing blood.
B. Mating Pigtail Dilator: designed to conform to the sheath introducer inner diameter, has a tapered tip, has a pigtail at the distal end to assist aortic valve crossing, has an integrated valve to restrict blood loss, and has a sideport for flushing.
C. Mating Straight Dilator: designed to conform to the sheath introducer inner diameter and has a tapered tip. Usage of this straight dilator is optional. This straight dilator is intended to be used only when access is unsuccessful after using the mating pigtail dilator.
D. 0.035" X 220cm J-tipped Amplatz guidewire: provide path for sheath and dilator advancement.

This looks like a 510(k) summary for a medical device called the Ventrax™ Delivery System. However, this submission does not contain information about software with AI/ML components. The document focuses on the substantial equivalence of the Ventrax Delivery System to a previously cleared predicate device with respect to its physical design, materials, and mechanical performance. There is no mention of accepting criteria related to AI/ML device performance, or any studies designed to prove AI/ML performance.

Therefore, I cannot provide an answer based on the prompt's request for acceptance criteria and study details related to AI/ML. The provided text does not contain any of that information.

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The Merit Micro Ace™ Gold Advanced Micro Access System is intended for percutaneous placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guidewire into the vascular system.

The Merit Micro Ace™ Gold Advanced Micro Access System (hereafter referred to as Micro Ace™ Gold) provides access to the vascular system and facilitates the placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guide wires. The system is available in 4 French and 5 French sizes – and includes the coaxial introducer-dilator pair, a 21 gauge needle and a 0.018” (0.46mm) guide wire.

The introducer-dilator assembly that is included in each kit is 10 cm effective length. The system will be offered with optional guidewires: Some catalog codes will include a nitinol wire with platinum guidewire tips; Some catalog codes will be offered with a stainless steel wire with platinum guidewire tips.

The provided text is a 510(k) summary for the Merit Micro Ace™ Gold Advanced Micro Access System. It describes the device, its intended use, comparison to a predicate device, and the safety and performance testing conducted.

However, this document does not describe a study proving a device meets acceptance criteria related to an AI/Software as a Medical Device (SaMD) product. Instead, it pertains to a physical medical device (vessel dilator for percutaneous catheterization) and describes the verification and validation tests for its physical characteristics and biocompatibility.

Therefore, many of the requested items, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)," "number of experts used to establish ground truth," and "sample size for training set," are not applicable to this type of device and review.

The document focuses on demonstrating substantial equivalence to a predicate device through physical and material property testing, rather than performance of an AI algorithm based on data analysis.

Given this, I will answer the applicable questions based on the provided text, and explicitly state when a question is not applicable.

Acceptance Criteria and Device Performance (for a physical medical device):

The document lists "Design Verification Studies" and "Design Validation Studies" as evidence that the device meets "pre-established performance criteria" and addresses "unacceptable risks." The acceptance criteria are implicitly the successful completion of these tests as per relevant international standards.

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

The document broadly states: "All tested samples met pre-established performance criteria and were deemed acceptable." It does not provide a quantitative table of specific acceptance criteria values and the measured performance results for each test. Instead, it lists the types of tests performed.

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

• Sample Size: The document states that "The tests were performed on both 4F and 5F Micro Ace™ Gold products." It also mentions "All samples were manufactured in accordance with existing and validated processes, and when sterile, are representative of product that Merit Medical intends to commercialize." It does not specify the exact number of samples per test for the test set.
• Data Provenance: The data provenance is from internal testing conducted by Merit Medical Systems, Inc. The document does not specify country of origin for the data (beyond the company's location in South Jordan, Utah, USA), nor does it classify the study as retrospective or prospective in the context of clinical data, as this is a device verification/validation study.

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

• Not Applicable in the context of AI/SaMD ground truth establishment.
• For the "Clinician feedback following assessment of design changes" in the Design Validation Studies, the specific number and qualifications of clinicians are not provided. This feedback typically informs the practical usability and design, rather than establishing a 'ground truth' for an AI algorithm.

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

• Not Applicable. This concept is relevant for reconciling discrepancies in expert annotations for AI ground truth, which is not what this document describes.

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. This type of study is for evaluating the impact of AI on human reader performance, and is not applicable to a physical vessel dilator device.

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

• No. This applies to AI/SaMD performance, which is not the subject of this submission.

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

• Not Applicable in the sense of 'ground truth' for AI performance. The "ground truth" for this device's performance is defined by its compliance with engineering specifications, industry standards (ISO 10555-1, EN ISO 11070 2014/A1:2018, ISO 10993-1, ISO 14971), and successful completion of pre-established physical, mechanical, and biocompatibility criteria.

8. The sample size for the training set:

• Not Applicable. This document describes a physical medical device, not an AI algorithm requiring a training set.

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

• Not Applicable. As above, this document does not describe an AI algorithm or its training set.

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