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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 CEDIATM Heroin Metabolite (6-AM) Assay is a homogeneous enzyme immunoassay for the in vitro qualitative and or semi-quantitative determination of the presence of heroin metabolite (6-AM) in human urine at a cut-off concentration of 10 ng/mL. The assay is intended to be used in laboratories and provides a rapid analytical screening procedure to detect 6-Acetylmorphine in human urine. The assay is designed for use with a number of clinical chemistry analyzers. This product is intended to be used by trained professionals only.

The semi-quantitative mode is for the purpose of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liquid Chromatography/tandem mass spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.

The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GC/MS) or Liquid chromatography with tandem mass spectrometry (LC-MS/MS) is the preferred confirmatory method.

Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used. For In Vitro Diagnostic Use Only.

CEDIA technology uses recombinant DNA technology to produce a unique homogeneous enzyme immunoassay system. The assay is based on the bacterial enzyme ßgalactosidase, which has been genetically engineered into two inactive fragments. These fragments spontaneously re-associate to form fully active enzymes that, in the assay format, cleave a substrate. This generates a color change that can be measured spectrophotometrically.

CEDIA™ Heroin Metabolite (6-AM) Assay is supplied as a two liquid and two lyophilized reagent kit homogeneous enzyme immunoassay. The assay uses an antibody that is specific for 6-Acetylmorphine and cross reacts with Heroin. The assay has minimal cross reactivity to structurally related and unrelated compounds. In the assay, analyte in the sample competes with analyte coniugated to one inactive fragment of B-galactosidase for antibody binding site. If analyte is present in the sample, it binds to antibody, leaving the inactive enzyme fragments free to form active enzyme. If analyte is not present in the sample, antibody binds to analyte conjuqated on the inactive fragment, inhibiting the reassociation of inactive ß- galactosidase fragments, and no active enzyme is formed. The amount of active enzyme formed and resultant absorbance change are directly proportional to the amount of drug present in the sample.

The provided FDA 510(k) summary for the Microgenics Corporation CEDIA™ Heroin Metabolite (6-AM) Assay (K231007) does not contain the detailed information necessary to fully address all aspects of your request. This document is a summary of the device's substantial equivalence to a predicate device, not a complete study report.

Specifically, the document does not contain details regarding the study design, sample sizes for test and training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance. The studies mentioned are focused on analytical performance characteristics (precision, spike recovery, dilution linearity, method comparison, specificity, stability) relevant to an in vitro diagnostic assay, rather than a typical AI/ML device assessment.

However, I can extract the available information regarding acceptance criteria and reported device performance:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size:
  • For Precision / Spike Recovery in Qualitative Mode: "All 20 replicates of spiked 7.5 ng/mL and 12.5 ng/mL samples" were used. This indicates 20 replicates for each of these two concentrations, plus presumably samples for the 10 ng/mL cutoff for comparison. The total number of individual samples is not explicitly stated beyond these replicates for specific concentrations.
  • For Method Comparison: No specific number for the test set is provided, only percentages of agreement.
  • For Specificity (Interference): "tested concentrations" are mentioned, but the number of samples is not provided.
  • For Reagent Stability: "one lot" for on-board, reconstituted, and open vial stability, and "three lots" for real-time stability.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The studies appear to be laboratory-based analytical performance studies. The "human urine" matrix is mentioned, indicating human samples were used.

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

This information is not provided in the document. For in vitro diagnostic devices like this assay, "ground truth" is typically established through a reference method (e.g., LC-MS/MS or GC/MS for drug levels) not by human experts interpreting images or other complex data.

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

This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation of medical images or other subjective data where consensus among experts is needed. For an immunoassay, the "ground truth" is determined by a quantitative chemical method, not by expert consensus.

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

This information is not applicable/not provided. An MRMC study is relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) interact with or are assisted by the AI. This device is an in vitro diagnostic immunoassay, not an AI imaging or diagnostic algorithm designed to assist human readers.

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

This information is not applicable/not provided in the context of AI algorithms. This device is an immunoassay, and its "standalone performance" is what is described in the precision, spike recovery, dilution linearity, and specificity sections. It's an automated chemical analysis, not an AI algorithm performing a task without human intervention in an AI/ML sense.

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

The document mentions that for confirmation, "A more specific alternative chemical method must be used...Gas chromatography/mass spectrometry (GC/MS) or Liquid chromatography with tandem mass spectrometry (LC-MS/MS) is the preferred confirmatory method." This indicates that confirmatory chemical analysis (LC-MS/MS or GC/MS) serves as the "ground truth" or reference method for determining the presence and concentration of 6-Acetylmorphine in urine samples.

8. The sample size for the training set

This information is not provided. The development of an immunoassay may involve optimization and calibration with a set of samples, but these are typically not referred to as a "training set" in the context of machine learning.

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

This information is not provided. Similar to point 8, the concept of a "training set" and its "ground truth" establishment as used in AI/ML is not directly applicable or documented for this type of in vitro diagnostic device in this summary. The development process would involve optimizing the assay's chemical components and reaction parameters using well-characterized samples.

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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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A Nitrile powder free exam glove is a disposable device, worn on the hand or finger to prevent contamination between examiner and patient or victim. This specialty glove has also been tested for use with the Opioid drugs Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid.

Intercept Free, Nitrile Two Toned White/Green, Textured Fingertips, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Examination Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)

This document describes the regulatory clearance of a medical device, specifically a type of examination glove, by the FDA. It does not contain information about an AI-powered diagnostic device or a study proving its performance against acceptance criteria in the context of AI/medical imaging, as is implied by the questions asking about MRMC studies, training/test sets, and expert consensus.

Therefore, I cannot provide the requested information based on the provided text. The document is a 510(k) clearance letter for a physical product (gloves) that has been tested for resistance to certain opioids, not an AI or algorithm-driven device.

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A Nitrile powder free exam glove is a disposable device, worn on the hand or finger to prevent contamination between examiner and patient or victim. This specialty glove has also been tested for use with the Opioid drugs Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid.

Get-A-Grip/Rescue-Grip, Nitrile Two Toned Black/Green, Diamond Grip Technology, Powder-Free. Non-sterile. Ambidextrous. Beaded Cuff. Medical Grade Exam Gloves. Tested for Use with the Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)

This document describes a 510(k) premarket notification for "Get-A-Grip/Rescue-Grip, Nitrile Two Toned Black/Green, Diamond Grip Technology, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves," which have been "Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)."

Here's an analysis of the acceptance criteria and study information provided:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for these gloves are defined by their resistance to permeation by specific opioid drugs. The performance is reported as the minimum breakthrough time.

• Heroin | (100mcg/2mL)
• (saturated solution) | >240 minutes | >240 minutes |
  | Fentanyl citrate (injectable)
• Heroin in Simulated Gastric
  Acid Mix | (100mcg/2mL)
  Saturated Solution into
  simulated Gastric Acid | >240 minutes | >240 minutes |

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state the specific sample size (e.g., number of gloves tested) or the provenance (country of origin, retrospective/prospective) of the data for these permeation tests. The information is presented as a summary of the test results rather than a detailed study protocol.

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

This information is not applicable to the type of device and study being described. The "ground truth" here is established by standardized chemical permeation testing, not by expert interpretation of medical images or clinical data.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where multiple human readers interpret data (e.g., medical images) and their disagreements need to be resolved. This is a material permeation test.

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

No, an MRMC comparative effectiveness study was not done. This type of study investigates the impact of AI assistance on human reader performance, which is not relevant for testing the chemical resistance of medical gloves.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

This concept is not directly applicable. The "device" in question is a physical glove, not an algorithm. The performance described is inherent to the material properties of the glove itself, measured through chemical testing, which is analogous to a "standalone" performance if we think of the glove's material as the "system" being evaluated. No human interpretation is involved in determining the breakthrough time.

7. The Type of Ground Truth Used

The ground truth used is standardized laboratory chemical permeation testing data. This involves precise measurements of the time it takes for specific concentrations of opioid substances to permeate the glove material under controlled conditions, as opposed to expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not applicable. These are medical exam gloves, not an AI or machine learning device requiring a training set.

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

This information is not applicable for the same reason as above; there is no training set for a physical exam glove. The performance criteria are based on established standards for chemical resistance in protective materials.

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The SIGNA Hero is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMI, spine, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body.

Depending on the region of interest being imaged, contrast agents may be used. The images produced by the SIGNA Hero reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician vield information that may assist in diagnosis.

SIGNA™ Hero is a whole body magnetic resonance scanner designed to support high resolution, high signal to-noise ratio, and short scan times. The systems use a combination of time-varying magnet fields (Gradients) and RF transmissions to obtain information regarding the density and position of elements exhibiting magnetic resonance. The system can image in the sagittal, coronal, axial, oblique, and oblique planes, using various pulse sequences, imaging techniques and reconstruction algorithms. The system features a 3.0T superconducting magnet with 70cm bore size. The system is designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).

The provided text describes information about the GE Healthcare SIGNA Hero MRI system (K213668). However, it does not contain details about specific acceptance criteria related to a specific diagnostic task (like detecting a particular disease), nor does it describe a study specifically designed to prove that the device meets such criteria for a diagnostic algorithm.

Instead, the document focuses on demonstrating substantial equivalence of the SIGNA Hero to its predicate device, the SIGNA Pioneer (K160621), as per FDA 510(k) premarket notification requirements.

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

The document does not provide a table of acceptance criteria for a specific diagnostic task or algorithm performance metrics (e.g., sensitivity, specificity, AUC). Instead, it states that the device was tested against safety and performance standards to demonstrate substantial equivalence to the predicate device.

Acceptance Criteria (General for MRI System Substantial Equivalence):

• Compliance with voluntary standards (ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-33, IEC 62304, ISO 10993-1, IEC 62464-1).
• Compliance with NEMA standards (MS 3, MS 4, MS 8, PS3 for DICOM).
• Successful biocompatibility track record (ISO 10993-1 testing and history of patient contacting materials).
• Acceptable diagnostic image performance comparable to the predicate device in accordance with FDA Guidance "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices."

Reported Device Performance:

• The SIGNA Hero and predicate device were subject to similar risk management testing.
• The SIGNA Hero complies with all listed standards.
• The SIGNA Hero has a successful biocompatibility track record.
• "The image quality of the SIGNA™ Hero is substantially equivalent to that of the predicate device."
• "The sample clinical images demonstrate acceptable diagnostic image performance of the SIGNA™ Hero..."
• The device performs as intended based on non-clinical tests.

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

The document mentions "sample clinical images" were included to demonstrate acceptable diagnostic image performance. However, it does not specify:

• The exact sample size of these clinical images.
• The provenance of the data (e.g., country of origin, retrospective or prospective).

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

The document states that images are "interpreted by a trained physician" but does not specify:

• The number of experts involved in reviewing the "sample clinical images."
• The specific qualifications of these experts (e.g., radiologists with certain years of experience).

4. Adjudication Method for the Test Set

The document does not mention any adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth or evaluating the clinical images.

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

No, the document explicitly states: "The subject of this premarket submission, the SIGNA™ Hero, did not require clinical studies to support substantial equivalence." Therefore, an MRMC study comparing human readers with and without AI assistance was not performed or detailed in this submission.

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

This submission is for an MRI scanner, not a specific diagnostic algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm isn't directly applicable in the context of this document. The performance evaluation focuses on the image quality and safety of the MR system itself.

7. The Type of Ground Truth Used

For the "sample clinical images," the ground truth implicitly refers to the interpretation by a trained physician regarding the diagnostic image performance. Beyond this, for the system's overall performance and safety, ground truth is established through compliance with established industry standards and recognized risk management practices.

8. The Sample Size for the Training Set

The document describes the submission of an MR scanner, not an AI/ML algorithm that requires a distinct training set. Hence, there is no mention of a training set sample size.

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

As there is no mention of an algorithm or training set, this information is not applicable.

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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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The CEDIA Heroin Metabolite (6-AM) Assay is a homogeneous enzyme immunoassay for the in vitro qualitative and/or semi-quantitative determination of the presence of heroin metabolite (6-AM) in human urine at a cut-off concentration of 10 ng/mL. The assay is intended to be used in laboratories and provides a rapid analytical screening procedure to detect 6-Acetylmorphine in human urine. The assay is designed for use with a number of clinical chemistry analyzers. This product is intended to be used by trained professionals only.

The semi-quantitative mode is for the purpose of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liquid Chromatography/tandem mass spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.

The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GC/MS) or Liquid chromatography with tandem mass spectrometry (LC-MS/MS) is the preferred confirmatory method.

Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used. For In Vitro Diagnostic Use Only

The assay consists of buffers (1 and 2) and lyophilized reagents (1a and 2a). The components include mouse monoclonal antibodies to 6-Acetylmorphine, recombinant microbial "enzyme donor" - 6-Acetylmorphine conjugate, "enzyme acceptor", chlorophenol red ß-Dgalactopyranoside, stabilizers and preservatives.

Here's a summary of the acceptance criteria and study details for the CEDIA Heroin Metabolite (6-AM) Assay, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

• 0 to 7.5 ng/mL (below cutoff): 80/0 (Negative/Positive) determinations.
• 10 ng/mL (at cutoff): 25/55 (Negative/Positive) determinations.
• 12.5 to 20 ng/mL (above cutoff): 0/80 (Negative/Positive) determinations.

Semi-Quantitative Mode:

• 0 to 7.5 ng/mL (below cutoff): 80/0 (Negative/Positive) determinations.
• 10 ng/mL (at cutoff): 46/34 (Negative/Positive) determinations.
• 12.5 to 20 ng/mL (above cutoff): 0/80 (Negative/Positive) determinations. |
  | Spike Recovery | Qualitative: No ± 2SD overlap between samples below, at, and above the cutoff. All replicates of spiked negative and positive controls should be accurately detected.
  Semi-quantitative: Spiked samples recover within 80-120% of nominal values. | Qualitative Mode: No ± 2SD overlap between 7.5 ng/mL, 10 ng/mL, and 12.5 ng/mL. All 20 replicates of 7.5 ng/mL were Negative, and all 20 replicates of 12.5 ng/mL were Positive, compared to 10 ng/mL.
  Semi-Quantitative Mode: Spiked samples recovered within 80-120% of nominal values (as seen in the Analytical Recovery table). |
  | Analytical Recovery and Dilution Linearity | Semi-quantitative mode: Demonstrates ability for sample dilution and QC across the assay range, with acceptable percent recovery. | Average Recovery (%) ranged from 97.3% to 115.6% for target concentrations from 0 to 20 ng/mL. Range of Recovery (%) was also provided. |
  | Method Comparison and Accuracy | High concordance (suggesting 100%) between the immunoassay and a confirmatory method (LC-MS/MS) for patient samples across various concentration ranges. | Qualitative & Semi-Quantitative Modes: Overall concordance between LC-MS/MS and CEDIA Heroin Metabolite (6-AM) Assay was 100% for the 103 samples tested. |
  | Specificity (Cross-reactivity with Metabolites) | 6-Acetylmorphine shows 100% cross-reactivity and heroin shows appropriate cross-reactivity (e.g., in this case, 8.3%). | 6-Acetylmorphine: 100% cross-reactivity at 10 ng/mL.
  Heroin: 8.3% cross-reactivity at 120 ng/mL. |
  | Specificity (Cross-reactivity with Structurally Related/Unrelated Compounds) | Structurally related or unrelated compounds should exhibit minimal cross-reactivity (e.g.,

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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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