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The HeroTracker Sense Device (HTS) is an add-on device which is attached by patients on a metered-dose inhaler (MDI).

HTS is intended for single-patient multiple use in the home environment as an electronic data capture accessory for monitoring and recording actuation, inhaler shake, inhaler orientation, inhalation coordination, and inspiratory strength and duration for prescribed inhaler usage.

HTS may be used in the following applications: in clinical practice or clinical trials, where specialists, general practitioners, nurses and educators need to know if a patient has used their prescribed medication or assess inhaler technique.

HTS is designed to work only with the MDI and medication indicated on the HTS label.

HTS is not intended to indicate the remaining quantity of medication in an inhaler and does not include a dose counting function.

HTS is not intended to provide spirometry measurements.

HTS is intended to be used by Metered Dose Inhaler (MDI) users aged 12 years and over.

The HeroTracker Sense (HTS) is a nebulizer accessory. It is an add-on device which is attached by patients on a metered dose inhaler (MDI) and is used to record and analyze data related to medication actuation and technique of use for prescribed inhaler usage. Data is transferred to a mobile application with appropriate settings and is displayed to end users.

The provided FDA 510(k) Clearance Letter for HeroTracker Sense (HTS) does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a study proving the device meets those criteria. The document primarily focuses on demonstrating substantial equivalence to a predicate device based on non-clinical performance data.

Here's a breakdown of what can be gleaned from the document and what information is missing:

Missing Information: The document explicitly states "No clinical data was necessary to determine the substantial equivalence of this device." This means there was likely no "performance study" in the traditional sense, with a clinical test set, ground truth experts, adjudication, or MRMC studies. The acceptance criteria for performance would have been established and demonstrated through non-clinical testing.

Therefore, many of the sections you requested (e.g., sample size for test set, number of experts, adjudication, MRMC, specific effect sizes, ground truth type for test set the training set) cannot be answered from the provided text.

Inference from Document's Purpose: The 510(k) process for this device relies heavily on demonstrating that the HeroTracker Sense (HTS) functions similarly to its predicate device (Hailie® Sensor NF0110) and that any differences do not raise new questions of safety or effectiveness. The performance validation would have been against defined specifications for each function, likely derived from the predicate device's capabilities and internal design requirements.

Acceptance Criteria and Device Performance (Based on available non-clinical data)

Since clinical data was not required, the "acceptance criteria" for the device would be met by passing the non-clinical performance and safety tests. The "reported device performance" is essentially that it "passed" these tests and met its internal specifications.

Table of Acceptance Criteria and Reported Device Performance (Inferred from Non-Clinical Testing):

Study Details (Based on available information and limitations)

Given the explicit statement that "No clinical data was necessary to determine the substantial equivalence of this device," the following sections reflect this limitation. The "study" refers to the non-clinical verification and validation activities.

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

   • (Provided above, based on non-clinical testing outcomes).

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

   • Test Set Sample Size: Not applicable in the context of a clinical test set. For non-clinical performance testing (e.g., electrical safety, software validation, sensor accuracy), the sample sizes would refer to the number of devices or test iterations used. This specific detail is not provided in the document.
   • Data Provenance: Not applicable in the sense of patient data. The tests were performed in a lab or testing facility environment.

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

   • Not applicable. No clinical ground truth experts were used as no clinical data was required. Ground truth for non-clinical performance (e.g., whether a sensor accurately detects an actuation) would be established by validated test methods and reference standards, not human expert consensus.

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

   • Not applicable. There was no human expert adjudication as no clinical test set with subjective interpretations was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No. The document explicitly states "No clinical data was necessary." Therefore, no MRMC study comparing human readers with and without AI assistance was performed.

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

   • Yes, implicitly. The "Performance Testing" section confirms that the device was "verified to meet specifications" and its "correct functionality and compatibility" was verified. This implies standalone performance testing of the device's ability to record and analyze data from the MDI. The "algorithm" itself (which processes sensor data to identify events like actuation, shake, etc.) would have been validated against controlled physical actions.

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

   • Instrumental/Physical Ground Truth: For the non-clinical performance tests, the "ground truth" would be established by controlled physical inputs and reference measurements. For example:
     • For "actuation," the ground truth would be a definitively measured actuation event.
     • For "inhaler shake," the ground truth would be a quantitatively measured shaking motion.
     • For software functionality, the ground truth would be predefined correct outputs for given inputs.

8. The sample size for the training set:

   • Not applicable / Not specified. This device is an electronic data capture accessory. While it uses sensors and potentially algorithms to interpret movements, the document doesn't indicate that it employs machine learning or AI that would require a "training set" in the typical sense (e.g., for image classification or complex pattern recognition). Its function seems to be based on pre-defined thresholds and sensor data processing rather than adaptive learning from a large training dataset. If any "calibration" or initial parameter setting was done, the size of that dataset is not provided.

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

   • Not applicable. As no training set is indicated.

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The HeRO Graft is indicated for end stage renal disease patients on hemodialysis who have exhausted all other access options. These catheter-dependent patients are readily identified using the KDOQI guidelines as patients who:
• Have become catheter-dependent or who are approaching catheter-dependency (i.e., have exhausted all other access options, such as arteriovenous fistulas and grafts).
• Are not candidates for upper extremity fistulas or grafts due to poor venous outflow as determined by a history of previous access failures or venography.
• Are failing fistulas or grafts due to poor venous outflow as determined by access failure or venography (e.g. fistula/graft salvage).
• Have poor remaining venous access sites for creation of a fistula or graft as determined by ultrasound or venography.
• Have a compromised central venous system or central venous stenosis (CVS) as determined by a history of previous access failures, symptomatic CVS (i.e., via arm, neck, or face swelling) or venography.
• Are receiving inadequate dialysis clearance (i.e., low Kt/V) via catheters. KDOQI guidelines recommend a minimum Kt/V of 1.4.

The HeRO Graft is a non-autogenous (i.e., synthetic) vascular graft prosthesis which provides arterial venous access with continuous outflow into the central venous system. The HeRO Graft is composed of the following components: (1) Venous Outflow Component (VOC) with delivery stylet, (2) Arterial Graft Component (AGC) or HeRO Adapter with Support Seal (used in conjunction with commercial vascular grafts), and (3) Accessory Component Kit (ACK). The VOC consists of a radiopaque silicone base tube, a nitinol braid (imparts kink and crush resistance), a distal radiopaque marker band, and an outer silicone elastomer encapsulation layer. During surgery, the VOC is cut to length for the patient anatomy and then advanced over the barbs of the AGC Connector or HeRO Adapter. The AGC is a conventional ePTFE vascular graft with a guideline and beading near the custom titanium alloy connector to provide kink resistance. As an alternative to the AGC, the titanium alloy HeRO Adapter with Support Seal allow the clinician to choose one of the commercially available 6mm ID vascular grafts qualified for use with the HeRO Graft. The HeRO Graft Accessory Component Kit is intended to aid in the implantation of the HeRO Graft and contains instruments including, introducers, dilators, hemostasis valve with stopcock, disposable clamp, and hemostasis plug.
The HeRO Graft is a fully subcutaneous surgical implant single-use device provided sterile via ethylene oxide for long-term (>30 day) use.

The document provided does not contain information related to an AI/ML powered device, so there is no data to extract for device performance, ground truth, or expert review. The device described, the HeRO Graft, is a vascular graft prosthesis, which is a physical implant used in hemodialysis patients.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study proving device meets acceptance criteria for an AI/ML powered device, as the provided text pertains to a traditional medical device.

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The HeRO® Graft is intended use in maintaining long term vascular access for chronic hemodialysis patients who have exhausted venous access sites suitable for fistulas or grafts.

The HeRO® Graft is indicated for end stage renal disease patients on hemodialysis who have exhausted all other access options. These catheter-dependent patients are readily identified using the KDOQI guidelines¹ as patients who:
• Have become catheter-dependent or who are approaching catheter dependency (i.e., have exhausted all other access options, such as arteriovenous fistulas and grafts).
• Are not candidates for upper extremity fistulas or grafts due to poor venous outflow as determined by a history of previous access failures or venography.
• Are failing fistulas or grafts due to poor venous outflow as determined by access failure or venography (e.g. fistula/graft salvage).
• Have poor remaining venous access sites for creation of a fistula or graft as determined by ultrasound or venography.
• Have a compromised central venous system or central venous stenosis (CVS) as determined by a history of previous access failures, symptomatic CVS (i.e., via arm, neck, or face swelling) or venography.
• Are receiving inadequate dialysis clearance (i.e., low Kt/V) via catheters. KDOQI guidelines recommend a minimum Kt/V of 1.4.

The HeRO Graft is a non-autogenous (i.e., synthetic) vascular graft prosthesis which provides arterial venous access with continuous outflow into the central venous system. The HeRO Graft is composed of the following components: (1) Venous Outflow Component (VOC), (2) Arterial Graft Component (AGC) or HeRO Adapter with Support Seal (used in conjunction with commercial vascular grafts), and (3) Accessory Component Kit (ACK). The VOC consists of a radiopaque silicone base tube, a nitinol braid (imparts kink and crush resistance), a distal radiopaque marker band, and an outer silicone elastomer encapsulation layer. During surgery, the VOC is cut to length for the patient anatomy and then advanced over the barbs of the AGC Connector or HeRO Adapter. The AGC is a conventional ePTFE vascular graft with a guideline and beading near the custom titanium alloy connector to provide kink resistance. As an alternative to the AGC, the titanium alloy HeRO Adapter with Support Seal allow the clinician to choose one of the commercially available 6mm ID vascular grafts qualified for use with the HeRO Graft. The ACK (a convenience kit) contains instruments that aid in the implantation of the HeRO Graft including, introducers, dilators, delivery stylet, hemostasis valve with stopcock, disposable clamp, and hemostasis plug. The HeRO Graft is a fully subcutaneous surgical implant single-use device provided sterile via ethylene oxide for long-term (>30 day) use.

This document describes the premarket notification (510(k)) for the Merit HeRO Graft, a vascular graft prosthesis. The provided text details the device description, indications for use, and a comparison to a predicate device, as well as a list of performance and design validation tests, and an animal study. However, it does not contain the specific acceptance criteria and detailed device performance results in a table format that would directly fulfill all aspects of your request. It rather lists the types of tests conducted and states that the device met the requirements.

Based on the provided text, I can infer and organize the available information to best answer your request, highlighting where direct numerical acceptance criteria or performance values are not explicitly stated in this FDA submission summary.

Here's a breakdown of the information that can be extracted and inferred, structured to align with your questions:

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

The document states that a "battery of tests was performed based upon the risk analysis and the requirements of the following internationally recognized standards and guidance documents pertaining to the device performance, as well as biocompatibility, sterilization, and labeling standards and guidance. Conformity to these standards demonstrates that the proposed HeRO Graft meets the acceptance criteria established by the standards as they apply to device safety and efficacy."

While specific numerical acceptance criteria and precise performance values are not given in a table, the document broadly describes the types of tests and the overall outcome.

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

• Animal Study Test Set Sample Size: 18 sheep.
• Data Provenance: The document does not specify the country of origin of the animal study data or if the performance/design validation tests were conducted externally. The animal study was generally described as "chronic study" with set time points (30-day, 90-day, 180-day), indicating a prospective setup for that specific component. The other performance and design validation tests are typical of pre-market, laboratory-based testing.

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

• The document describes a device (vascular graft), not an AI/diagnostic software. Therefore, the concept of "ground truth" established by human experts in the context of diagnostic interpretation (like radiologists) is not applicable here. The ground truth for device performance is established through physical and biological testing against established standards and controls (e.g., precise measurements, chemical analyses, histological assessments in the animal study).

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

• This concept applies to human interpretation of data, typically in diagnostic studies. As this is a medical device (vascular graft) and not a diagnostic AI, adjudication methods for expert interpretation are not relevant or described. Device performance testing relies on objective measurements and verified protocols.

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, an MRMC study was not done. This type of study is specific to evaluating the clinical performance of diagnostic AI systems in conjunction with human readers. The Merit HeRO Graft is a physical implantable device, not an AI software.

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

• This question is also not applicable. The device is a physical vascular graft, not an algorithm. Performance tests are inherently "standalone" in the sense that they evaluate the device's physical and biological properties.

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

• For Biocompatibility Testing: Ground truth is established by standardized laboratory assays and results against accepted biological safety limits (e.g., no cytotoxicity, no irritation, no genotoxicity).
• For Performance and Design Validation Testing: Ground truth is established by engineering specifications, physical measurements, and conformity to recognized international standards (e.g., ISO 7198, ASTM F756).
• For the Animal Study: Ground truth was established by direct observation, angiographic evaluation, and histopathologic evaluations (pathology) of the implanted grafts and non-target organs. Patency, stenosis, thrombogenicity, and cellular/tissue response were assessed and compared to control articles.

8. The sample size for the training set

• This question is for AI models. As this is a physical medical device, there is no "training set" in the AI sense. Device development involves design, prototyping, and testing, not machine learning model training.

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

• Not applicable, as there is no AI training set.

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HeRO is intended to acquire, store, and report on ECG data collected from infants. HeRO is intended to be used under the direct supervision of a licensed health care practitioner in a hospital neonatal or pediatric ICU environment.

HeRO is intended to be used for the variability in RR intervals (heart rate) and to report measurements of the variability of heart rate data (HRV). The HRV measurements reported by HeRO are specialized in nature, and intended to identify periods of transient decelerations and/or reduced baseline variability in the heart rate.

HeRO is intended to provide only specialized HRV measurements and is not intended to produce any interpretation of those measurements or any kind of diagnosis.

The specialized HRV measurements produced by HeRO have not been approved by the FDA for any specific clinical diagnosis.

HeRO acquires data from a user-supplied ECG monitor, and requires a user-supplied local area network.

HeRO Symphony, HeRO solo/duet, and HeRO ES are comprised of off-the-shelf Personal Computers (PC's) and special-purpose hardware capable of acquiring, storing, analyzing, and reporting ECG data from the cardiac monitoring real-time network. Data is acquired either on a special-purpose Data Acquisition Device (DAD) or via the physiological monitoring network. It is stored and analyzed on a HeRO Server or physiological monitor. Results of the analyses are reported on one or more Viewing Stations. The analysis algorithms identify Heart Rate Variability (HRV) patterns that reflect transient decelerations and/or reduced baseline variability.

Here's a breakdown of the acceptance criteria and supporting study details for the HeRO Symphony, HeRO solo/duet, and HeRO ES devices, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

The provided document does not explicitly list quantitative acceptance criteria for the HeRO Symphony, HeRO solo/duet, and HeRO ES devices. Instead, it asserts that the performance matches the product specifications and is "as safe, as effective, and perform as well as or better than HeRO 3.0" (the predicate device).

This implies that the acceptance criteria are implicitly tied to demonstrating equivalence to the predicate device, HeRO 3.0. The "performance matches product specifications" statement suggests internal verification, but the specifications themselves are not detailed in this document.

Table of Acceptance Criteria and Reported Device Performance (Inferred)

Study Information

The document describes non-clinical testing to support the substantial equivalence claim. It does not detail a separate clinical (human-subject) study specifically for HeRO Symphony, HeRO solo/duet, and HeRO ES to establish their individual performance against specific clinical acceptance criteria. Instead, it leverages the established performance and safety of its predicate device, HeRO 3.0.

Here's an analysis based on the provided text:

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

  • Test Set Size: Not explicitly stated for the current devices. The statement "The nonclinical testing... demonstrate the HeRO Symphony, HeRO solo/duet, and HeRO ES are as safe, as effective, and perform as well as or better than HeRO 3.0" suggests a comparative assessment, likely against HeRO 3.0's capabilities. There's no mention of a separate test set of patient data used to evaluate the new devices' performance independently.
  • Data Provenance: Not specified. Given the focus on non-clinical testing and equivalence to a predicate, it's likely this refers to testing of the software and hardware components rather than new patient data.

• 2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no described clinical test set for these specific devices that would require expert-established ground truth. The devices provide "specialized HRV measurements" and are explicitly stated not to produce interpretations or diagnoses.

• 3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no human-expert adjudicated test set is described for these specific devices.

• 4. 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. The document does not describe an MRMC study. HeRO devices are not explicitly marketed as AI-assisted diagnostic tools with human-in-the-loop improvement metrics. They provide physiological measurements (HRV) that are consumed by clinicians. The references listed pertain to studies on the general concept of heart rate characteristics monitoring in neonates (likely conducted with HeRO 3.0 or similar technology), not a comparative effectiveness study involving the new device iterations and human readers.

• 5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, implicitly. The device "acquires, store, analyze, and report on ECG data" and "report measurements of the variability of heart rate data (HRV)." It is explicitly stated: "HeRO is intended to provide only specialized HRV measurements, and is not intended to produce any interpretation of those measurements or any kind of diagnosis." This means its "standalone" performance is its ability to accurately measure and report these HRV metrics based on input ECG data. The non-clinical testing and statement that "performance matches the product specifications" covers this.

• 6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the new devices, the ground truth is likely defined implicitly by the performance of the predicate device (HeRO 3.0) and established engineering/physiological standards for ECG data acquisition and HRV calculation. For the underlying science of HRV monitoring (as referenced in the paper list), outcomes data (e.g., neonatal sepsis, neurodevelopmental outcome, necrotizing enterocolitis, mortality) were likely used in the original validation of the HeRO concept, but this applies to the predicate, not a new validation of these specific devices.

• 7. The sample size for the training set: Not applicable for these specific devices. Their software is stated to be the same as HeRO 3.0. Any "training" (in a machine learning sense, if applicable to the underlying algorithms – which are likely signal processing, not deep learning) would have been done for the HeRO 3.0 development.

• 8. How the ground truth for the training set was established: Not applicable for these specific devices, as the software is the same as the predicate. The underlying algorithms for HRV analysis are likely based on established physiological principles and signal processing techniques, not machine learning trained on annotated data in the typical sense.

In summary: The submission for HeRO Symphony, HeRO solo/duet, and HeRO ES relies heavily on demonstrating substantial equivalence to its predicate device, HeRO 3.0, and on compliance with non-clinical engineering standards (IEC 60601-1 and IEC 60601-1-2) and the manufacturer's own quality system (21 CFR 820). No new clinical studies with human subjects or expert adjudication for performance evaluation of these specific device iterations are described in this summary.

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The HeRO Graft is indicated for end stage renal disease patients on hemodialysis who have exhausted all other access options. These catheter-dependent patients are readily identified using the KDOQI guidelines[1] as patients who:

· Have become catheter-dependent or who are approaching catheter-dependency (i.e., have exhausted all other access options, such as arteriovenous fistulas and grafts).

• Are not candidates for upper extremity fistulas or grafts due to poor venous outflow as determined by a history of previous access failures or venography.

• Are failing fistulas or grafts due to poor venous outflow as determined by access failure or venography (e.g. fistula/graft salvage).

· Have poor remaining venous access sites for creation of a fistula or graft as determined by ultrasound or venography.

• Have a compromised central venous system or central venous stenosis (CVS) as determined by a history of previous access failures, symptomatic CVS (i.e., via arm, neck, or face swelling) or venography.

• Are receiving inadequate dialysis clearance (i.e., low Kt/V) via catheters. KDOQI guidelines recommend a minimum Kt/V of 1.4.[2]

The HeRO Graft is a non-autogenous (i.e., synthetic) vascular graft prosthesis which provides arterial venous access with continuous outflow into the central venous system. The HeRO Graft is composed of the following components: (1) Venous Outflow Component (VOC), (2) Arterial Graft Component (AGC) or HeRO Adapter with Support Seal (used in conjunction with commercial vascular grafts), and (3) Accessory Component Kit (ACK). The VOC consists of a radiopaque silicone base tube, a nitinol braid (imparts kink and crush resistance), a distal radiopaque marker band, and an outer silicone elastomer encapsulation layer. During surgery, the VOC is cut to length for the patient anatomy and then advanced over the barbs of the AGC Connector or HeRO Adapter. The AGC is a conventional ePTFE vascular graft attached to a custom titanium alloy connector. As an alternative to the AGC, the titanium alloy HeRO Adapter with Support Seal allow the clinician to choose one of the commercially available 6mm ID vascular grafts qualified for use with the HeRO Graft. The ACK (a convenience kit) contains instruments that aid in the implantation of the HeRO Graft including, introducers, dilators, delivery stylet, hemostasis valve with stopcock, vascular clamp and hemostasis plug.

The HeRO Graft is a fully subcutaneous surgical implant single-use

The provided text describes a 510(k) premarket notification for the Merit HeRO Graft, a vascular graft prosthesis. The document details the device's indications for use, comparison to a predicate device, and the performance data submitted to demonstrate substantial equivalence.

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

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

The document lists various performance tests and states that the device "met the acceptance criteria applicable to the safety and efficacy of the device" for these tests. However, it does not explicitly state the quantitative acceptance criteria for each test. Instead, it broadly indicates conformity to recognized standards and guidance documents.

Study that proves the device meets the acceptance criteria:

The study that proves the device meets the acceptance criteria is a series of performance tests conducted based on established FDA guidance documents and recognized performance standards. These standards include:

• FDA Guidance for Industry and FDA Staff: Guidance Document for Vascular Prostheses 510(k) Submissions, Nov 1, 2000
• FDA guidance document: Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process"
• FDA Guidance Document: Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment, Dec 11, 2014
• ISO 10555-1, Sterile, Single-Use Intravascular Catheters, Part 1: General Requirements
• ISO 7198, Cardiovascular implants and extracorporeal systems - Performance Vascular prostheses - Tubular vascular grafts and vascular Data patches.
• ISO 11135, Sterilization of health care products -Ethylene oxide - Requirements for the development, validation and routing control of a sterilization process for medical devices
• ISO 10993 series (Parts 1, 3, 4, 5, 6, 10, 11) for Biological Evaluation of Medical Devices
• ASTM F756, Standard Practice for Assessment of Hemolytic Properties of Materials
• ASTM F2052, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
• ASTM F2503 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
• ASTM F2119 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
• ASTM F2182 Standard Test Method for Measurement of Radio Frequency Induced Heating on or Near Passive Implants during Magnetic Resonance Imaging
• ASTM F2213 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
• United States Pharmacopeia, National Formulary 30, General Chapter <151>, Pyrogen Test.

The document states: "Conformity to these standards demonstrates that the proposed HeRO Graft meets the acceptance criteria established by the standards as they apply to device safety and efficacy."

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

The document lists "Performance Data" and "Biocompatibility testing" as being provided. These are laboratory/benchtop test results, not clinical study data with human patients. Therefore, the concepts of "sample size for the test set," "country of origin of the data," and "retrospective or prospective" are not applicable in the context of this 510(k) submission for mechanical/material and biocompatibility testing. The data provenance is from laboratory tests conducted by the manufacturer, Merit Medical Systems, Inc.

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 question is not applicable. The "ground truth" for these types of engineering and biocompatibility tests is based on the specifications defined by the recognized international and national standards (e.g., ISO, ASTM, USP) and FDA guidance documents. There is no mention of human experts establishing ground truth for these specific tests.

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

This question is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies for human reader interpretation of medical images or outcomes. This section of the document describes laboratory performance testing, not human reader studies.

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. The submission focuses on demonstrating substantial equivalence through non-clinical performance testing and biocompatibility. The device is a physical vascular graft, not an AI or imaging diagnostic tool that would involve human reader interpretation.

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

No, a standalone algorithm performance study was not done. The device is a physical vascular graft, not a software algorithm.

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

The "ground truth" for the performance tests and biocompatibility evaluation is derived from the quantitative specifications and methodologies outlined in the referenced national and international standards (ISO, ASTM) and FDA guidance documents. For instance, a tensile strength test would have a specified minimum allowed force, or a leakage test would have a maximum allowed leakage rate. Biocompatibility relies on adherence to the testing requirements and acceptable response limits defined in the ISO 10993 series.

8. The sample size for the training set

This question is not applicable. There is no mention of a "training set" as this is not an artificial intelligence or machine learning device. The 510(k) describes a physical medical device.

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

This question is not applicable, as there is no "training set."

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The Hero II Dental Implant System and the UI Dental Implant System are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The Hero II Dental Implant System and the UI Dental Implant System are for single and two stage surgical procedures. These systems are intended for delayed loading.

The Hero II Dental Implant System and the UI Dental Implant System are dental implant systems made of Titanium 6AL 4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. The systems are similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of these systems have been treated with R.B.M (Resorbable Blast Media) for fixtures and TiN coating for abutments.

The provided text describes a Special 510(k) submission (K130221) for the "Hero II Dental Implant System" and a renamed "UI Dental Implant System." This submission aims to add a new design fixture model and change a name, stating that the intended use and principal technology are unchanged from the unmodified device (K121047).

The document does not contain acceptance criteria or a study proving that the device meets those criteria, as typically understood for performance metrics like sensitivity, specificity, or reader agreement in AI/imaging devices. Instead, this 510(k) is a substantial equivalence determination based on comparison to a predicate device.

Here's an analysis based on the provided text, addressing the requested points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The document does not define specific performance acceptance criteria (e.g., accuracy, precision) for the dental implant system itself, nor does it report performance metrics against such criteria in the context of a clinical study or statistical analysis. The "performance" mentioned refers to the device's characteristics and materials.

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

Not applicable. No "test set" in the context of evaluating performance metrics (like for an AI or diagnostic device) is mentioned. The submission is based on non-clinical testing and comparison to a predicate device.

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

Not applicable. No "ground truth" establishment by experts for a test set is described.

4. Adjudication Method for the Test Set

Not applicable.

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

No. The document does not mention any MRMC study or any study comparing human readers with and without AI assistance. This device is a dental implant, not a diagnostic imaging device with an AI component in the described context.

6. Standalone (Algorithm Only) Performance Study

No. This is a physical medical device (dental implant), not an algorithm or AI system.

7. Type of Ground Truth Used

Not applicable. There is no mention of ground truth in the context of pathology, outcomes data, or expert consensus for assessing device performance. The "ground truth" in this submission relates to the device's physical and material characteristics being substantially equivalent to the predicate.

8. Sample Size for the Training Set

Not applicable. The device is a physical dental implant, not an AI model that requires a training set.

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

Not applicable.

Summary of Device Acceptance and Study (Based on the Provided Text):

The acceptance of the "Hero II Dental Implant System" and "UI Dental Implant System" in this 510(k) submission is based on demonstrating substantial equivalence to a previously cleared predicate device (K121047). The study that proves this is a comparison of the subject device's characteristics to those of the predicate device, supported by non-clinical testing.

Acceptance Criteria (Implicitly based on Substantial Equivalence):

• Intended Use: Must be the same as the predicate device.
• Technological Characteristics: Must be the same or similar to the predicate device, with any differences not raising new questions of safety or effectiveness.
• Material Composition: Must be the same as the predicate device (Titanium 6AL 4V ELI alloy).
• Performance Characteristics (Non-Clinical): Must meet the same non-clinical performance standards as the predicate device (e.g., cleanness after surface treatment, shelf-life, sterilization validation).

Study Proving Acceptance (Substantial Equivalence Determination):

• Purpose of Submission: To add a new design fixture model and change a name to an unmodified device cleared under K121047. The intended use and principal technology of the subject device are stated to be the same as the unmodified device.
• Device Description: The subject devices (Hero II and UI Dental Implant System) are dental implant systems made of Titanium 6AL 4V ELI alloy. Their surfaces are treated with R.B.M (Resorbable Blast Media) for fixtures and TiN coating for abutments. Size information for various diameters and lengths is provided.
• Indications for Use: The indications for use are identical to those of the predicate device, covering use in partially or fully edentulous mandibles and maxillae, supporting single or multiple-unit restorations, and intended for single and two-stage surgical procedures with delayed loading.
• Non-clinical testing:
  • Tests Conducted: Energy Disperse X-ray micro analyzer (EDX) and Scanning Electron Microscopy (SEM) Analysis to verify cleanness after surface treatment, shelf-life testing, and sterilization validation.
  • Rationale: These tests were conducted on the unmodified device (K121047) and reviewed in that previous 510(k) submission. The document states that "These characteristics have not been changed on the modified device; therefore it is substantially equivalent to the unmodified device in these regards."
• Basis for Substantial Equivalence:
  • Same intended use as predicate (K121047).
  • Same fundamental scientific technology: threaded, root form implants made of titanium.
  • Same internal hexagon abutment connection system with internal beveled interface.
  • Both are bone-level implants with similar body shape design (straight walled neck and tapered body design).
  • Difference: "minor thread design on the fixture." The submission implicitly argues this minor difference does not raise new questions of safety or effectiveness.
• Conclusion: The submission concludes that the subject devices are substantially equivalent to the predicate devices based on identical intended use, operating principle, basic design, and material.

In essence, the "study" is a technical and regulatory comparison against a predicate device, demonstrating that the new/modified dental implant systems do not introduce new safety or effectiveness concerns compared to already cleared devices.

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The HeRO Graft is intended for use in maintaining long-term vascular access for chronic hemodialysis patients who have exhausted peripheral venous access sites suitable for fistulas or grafts.

The HeRO® Graft is indicated for end stage renal disease patients on hemodialysis who have exhausted all other access options. These catheter-dependent patients are readily identified using the KDOQI guidelines as patients who:

• Have become catheter-dependent or who are approaching catheter-dependency (i.e., have exhausted all other access options, such as arteriovenous fistulas and grafts).
• Are not candidates for upper extremity fistulas or grafts due to poor venous outflow as determined by a history of previous access failures or venography.
• Are failing fistulas or grafts due to poor venous outflow as determined by access failure or venography (e.e. fistula/graft salvage).
• Have poor remaining venous access sites for creation of a fistula or graft as determined by ultrasound or venography.
• Have a compromised central venous system or central venous stenosis (CVS) as determined by a history of previous access failures, symptomatic CVS (i.e., via arm, neck, or face swelling) or venography.
• Are receiving inadequate dialysis clearance (i.e., low Kt/V) via catheters. KDOQI guidelines recommend a minimum Kt/V of 1.4.

The HeRO Graft is a non-autogenous (i.e., synthetic) vascular graft prosthesis composed of three components: Arterial Graft Component, Venous Outflow Component and Accessory Component Kit. The Venous Outflow Component is made of radiopaque silicone and contains reinforcing braided filaments that impart kink and crush resistance. During surgery, the Venous Outflow Component is sized to fit the patient by cutting it to the proper length and sliding it over the barbs of the connector on the Arterial Graft Component. The Arterial Graft Component is a conventional ePTFE hemodialysis graft that has been attached to a titanium connector. An alternate to the Arterial Graft Component is The Adapter which allows the physician to choose and connect a 6mm ID vascular graft from the list of qualified grafts. The Accessory Component Kit (a convenience kit) contains instruments that assist in the implantation of the HeRO Graft.

The provided text describes the HeRO® Graft, a vascular graft prosthesis, and its 510(k) clearance (K124039). The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (design verification testing). There is no information provided regarding a study conducted to prove the device meets specific acceptance criteria based on clinical outcomes or a comparison against a defined performance target. Instead, the submission states that "Additional clinical performance data was not required to support the modification of the device." and relies on "design verification testing" and comparison to a predicate device.

Therefore, many of the requested elements for a study proving acceptance criteria cannot be answered directly from the provided text.

Here's an analysis based on the available information:

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

The document provides a table of "Test Parameter" and "Results" which essentially act as acceptance criteria and their successful fulfillment.

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

The document refers to "design verification testing." However, it does not specify the sample sizes used for each of the non-clinical tests. For example, it says "None of the connections tested leaked," but not how many connections were tested. It also does not mention data provenance (country of origin) as these are non-clinical, in-vitro tests, nor does it specify if any clinical data was retrospective or prospective (as "additional clinical performance data was not required").

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)

For the "Human Factors/ Usability engineering" tests, it states "All doctors rated..." However, the number of doctors (experts) is not specified, nor are their specific qualifications (e.g., years of experience, specialty). For the other non-clinical tests, the "ground truth" would be established by engineering standards and measurements, not medical experts.

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

There is no mention of an adjudication method for any of the tests. For the human factors portion, it simply states "All doctors rated," implying either unanimous agreement or that individual ratings were sufficient without a formal adjudication process.

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

No MRMC comparative effectiveness study was done as this device is a vascular graft prosthesis, not an imaging AI diagnostic device. The application is for a physical medical device, not a software or AI-assisted diagnostic tool.

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

This question is not applicable as the device is a physical vascular graft, not an algorithm.

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

For the non-clinical performance data, the "ground truth" is based on engineering specifications, standardized test methods, and direct physical measurements of the device's components and connections. For the "Human Factors/Usability engineering" tests, the ground truth is based on subjective ratings by "doctors."

8. The sample size for the training set

This device is a physical product, not an algorithm that requires a training set. Therefore, this question is not applicable.

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

This question is not applicable as there is no training set for this type of device.

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The Hero I Dental Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The Hero I Dental Implant System is for single and two stage surgical procedures. The system is intended for delayed loading.

The Hero I Dental Implant System is made of Titanium 6AL 4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implant may be used to replace one or more missing teeth. The system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition an performance characteristics. The surface of the system has been treated with R.B.M (Resorbable Blast Media).

This submission (K121098) is for the Hero I Dental Implant System. It's a 510(k) summary, which means the manufacturer is asserting substantial equivalence to previously cleared devices, not necessarily demonstrating "meets acceptance criteria" through a comprehensive study with specific performance metrics.

The provided document does not contain information about:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test or training sets.
• Data provenance or ground truth establishment for a study related to acceptance criteria.
• Number of experts or their qualifications for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.

The document primarily focuses on establishing substantial equivalence based on similarities in intended use, technology, materials, and design to predicate devices. It states that "no new question of safety or effectiveness has been raised" when compared to the predicate devices.

Therefore, I cannot fulfill your request for this input, as the information required is not present in the provided text.

This 510(k) summary is analogous to an application stating "my new car is substantially equivalent to existing cars because it has four wheels, an engine, and seats, and therefore meets the same basic safety standards." It doesn't include details of crash test performance (acceptance criteria and reported performance) that would typically be found in a study demonstrating such.

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The Hero II Dental Implant System and the IS Dental Implant System are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The Hero II Dental Implant System and the IS Dental Implant System are for single and two stage surgical procedures. These systems are intended for delayed loading.

The Hero II Dental Implant system and the IS Dental Implant System are dental implant systems made of Titanium 6AL 4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. The systems are similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of these systems have been treated with R.B.M (Resorbable Blast Media).

The provided document does not contain acceptance criteria or study data for device performance in a clinical context.

Instead, this 510(k) summary focuses on demonstrating substantial equivalence of the Hero II Dental Implant System and the IS Dental Implant System to a predicate device (GS FIXTURE SYSTEM by OSSTEM IMPLANT CO., LTD (K072896)). Substantial equivalence is primarily proven through similarities in:

• Intended Use: Both the subject and predicate devices are dental implant systems used in the jaw for missing teeth, supporting various types of restorations, and for single or two-stage surgical procedures with delayed loading.
• Technological Characteristics: Both are threaded, root form implants made of titanium with RBM roughened surfaces and share the same internal hexagon abutment connection system. They are also bone-level implants with similar body shapes.
• Materials and Surface Treatment: Made of commercially pure titanium with RBM surface treatment.
• Sizes: Similar size ranges for fixtures and abutments.
• Sterilization Method: Gamma irradiation for fixtures.

Non-Clinical Testing:

The document mentions non-clinical testing performed to support safety and shelf life, which includes:

• Sterilization Validation: In accordance with ISO 11737-1 & ISO 11737-2 for gamma sterilization and ISO 17665-1 and ISO 17665-2 for steam sterilization.
• Shelf Life Validation: Three-year shelf life validated through accelerating testing.
• Chemical and SEM image analyses: To verify no residual after RBM treatment on the fixtures.

Therefore, I cannot provide the requested information in the table format or answer the questions related to clinical study design, sample sizes, ground truth establishment, or expert involvement, as these details are not present in the provided 510(k) summary. The 510(k) process for substantial equivalence typically relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often without requiring new clinical trials if sufficient evidence of technological similarity and non-clinical performance (like material properties, biomechanical characteristics, sterilization) exists.

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The HeRO® Graft is intended for use in maintaining long-term vascular access for chronic hemodialysis patients who have exhausted peripheral venous access sites suitable for fistulas or grafts.

The HeRO® Graft is indicated for end stage renal disease patients on hemodialysis who have exhausted all other access options. These catheter-dependent patients are readily identified using the KDOQI guidelines' as patients who:

• . Have become catheter-dependent or who are approaching catheter-dependency (i.e.. have exhausted all other access options, such as arteriovenous fistulas and grafts).
• Are not candidates for upper extremity fistulas or grafts due to poor venous outflow as . determined by a history of previous access failures or venography.
• Are failing fistulas or grafts due to poor venous outflow as determined by access failure . or venography (e.g. fistula/graft salvage).
• Have poor remaining venous access sites for creation of a fistula or graft as determined . by ultrasound or venography.
• Have a compromised central venous system or central venous stenosis (CVS) as . determined by history or previous access failures, symptomatic CVS (i.e., via arm, neck, or face swelling) or venography.
• . Are receiving inadequate dialysis clearance (i.e., low Kt/V) via catheters. KDOQI guidelines recommend a minimum Kt/V of 1.4.2

The HeRO Graft is a non-autogenous (i.e., synthetic) vascular graft prosthesis composed of three components: Arterial Graft Component, Venous Outflow Component and Accessory Component Kit. The Venous Outflow Component is made of radiopaque silicone and contains reinforcing braided filaments that impart kink and crush resistance. During surgery, the Venous Outflow Component is sized to fit the patient by cutting it to the proper length and sliding it over the barbs of the connector on the Arterial Graft Component. The Arterial Graft Component is a conventional ePTFE hemodialysis graft that has been attached to a titanium connector. The Accessory Component Kit (a convenience kit) contains instruments that assist in the implantation of the HeRO Graft.

This 510(k) premarket notification for the HeRO® Graft vascular prosthesis does not describe a study to establish acceptance criteria or demonstrate device performance against such criteria in the way a diagnostic AI/ML device submission would.

Instead, this submission is for a physical medical device (a vascular graft) and relies on demonstrating substantial equivalence to a previously cleared predicate device.

Therefore, many of the requested elements for a typical AI/ML device study's acceptance criteria and performance study are not applicable or cannot be extracted from this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not define specific quantitative "acceptance criteria" for performance metrics like sensitivity, specificity, accuracy, or a table of reported device performance against such criteria. For a physical device like a vascular graft, "performance" is typically assessed through aspects like graft patency, infection rates, blood flow, durability, and biocompatibility, often in clinical trials or through post-market surveillance. This 510(k) summary explicitly states:

• "No changes were made to the previously cleared packaging verification and sterilization validation. Additional clinical performance data was not required to support the modification of the device."

This indicates that the focus of this particular submission was on demonstrating that the modified device (HeRO® Graft) is as safe and effective as the predicate device (HeRO™ Vascular Access Device) without requiring new clinical performance studies for this specific clearance.

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

Not applicable. There is no "test set" in the context of an AI/ML diagnostic study described here. The submission is for a physical device.

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

Not applicable. There is no "test set" or "ground truth" establishment in the context of an AI/ML diagnostic study described here.

4. Adjudication method for the test set

Not applicable. No "test set" or adjudication method is described.

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

Not applicable. This is not an AI/ML diagnostic device, and no MRMC study is described. The device is a physical vascular graft.

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

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

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

Not applicable. There is no ground truth described in the context of AI/ML performance. For a physical device, "ground truth" would relate to the actual clinical outcomes in patients, which is not detailed as a new study in this 510(k). The submission relies on the established safety and effectiveness of the predicate device.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set mentioned.

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

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

Summary based on the document:

The core of this 510(k) submission is to demonstrate substantial equivalence of the HeRO® Graft to its predicate device (K071778, K091491, K120006).

• Acceptance Criteria for Substantial Equivalence: The primary "acceptance criteria" here relate to demonstrating that the modified device "raises no new questions of safety or effectiveness compared to the predicate device." This is achieved through:

  • Design Verification Testing: "Results of design verification testing demonstrate that the device system as modified is as safe as the predicate device."
  • Risk Assessment: "The risk assessment results... confirm that the HeRO Graft, as modified, raises no new questions of safety or effectiveness..."
  • Lack of Required New Clinical Data: "Additional clinical performance data was not required to support the modification of the device." This implies that existing data for the predicate and the "minor modification" were deemed sufficient to maintain equivalence in safety and effectiveness.

• "Study" Proving Acceptance: The "study" in this context is the design verification testing and risk assessment conducted by the manufacturer, which concluded that the changes (mainly branding and slight component-level modifications described in the Device Description) did not alter the fundamental safety or effectiveness profile of the device compared to the predicate. No new clinical trials or performance studies, as would be expected for a novel AI/ML device or a more significant device change, were conducted or required for this particular submission.

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