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Bunkerhill MAC is a software device intended for use in detecting presence and estimating quantity of mitral annulus calcification for adult patients aged 40 years and above. The device automatically analyzes non-gated, non-contrast chest computed tomography (CT) images collected during clinical care and outputs the region of interest (intended for informational purposes only) and quantification of detected calcium.

The device-generated quantification can be viewed in the patient report at the discretion of the physician, and the physician also has the option of viewing the device-generated calcium region of interest in a diagnostic image viewer. The subject device output in no way replaces the original patient report or the original non-gated, non-contrast CT scan; both are still available to be viewed and used at the discretion of the physician.

The device is intended to provide information to the physician to provide assistance during review of the patient's case. Results of the subject device are not intended to be used on a stand-alone basis and are solely intended to aid and provide information to the physician. In all cases, further action taken on a patient should only come at the recommendation of the physician after further reviewing the patient's results.

Bunkerhill MAC is a software as a medical device (SaMD) product that interfaces with compatible and commercially available computed tomography (CT) systems. Bunkerhill MAC detects, localizes, and quantifies mitral annulus calcification in non-gated, non-contrast chest CT studies. The core features of the product are:

• Detection of mitral annulus calcification at an Agatston-equivalent score threshold of 0 AU.
• Quantification of the overall mitral annulus calcification burden in the form of an estimated Agatston Score up to 5000 Agatston-equivalent units
• Localization of estimated calcium burden in the form of circular region of interest applied to a copy of the original CT scan.

Here's a detailed breakdown of the acceptance criteria and the study proving the Bunkerhill MAC device meets them, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Test Set Sample Size: Not explicitly stated as a number of cases, but referred to as "the pivotal dataset."
   • Data Provenance: "curated from multiple sites across three geographical regions in the United States." (Retrospective study).

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

   • The document states "agreement of the device output compared to the established reference standard." It does not explicitly state the number of experts used or their qualifications for establishing this "established reference standard." It only refers to "clinical literature in high impact journals that investigate the inter-reader agreement of manual segmentation" as informing the acceptance criteria.

3. Adjudication method for the test set:

   • The document does not explicitly state an adjudication method (e.g., 2+1, 3+1) for establishing the ground truth of the test set. It refers to an "established reference standard."

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, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus human readers without AI assistance was not conducted or reported in this document. The study was a "stand-alone retrospective study for detection, localization and agreement of the device output compared to the established reference standard."

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

   • Yes, a standalone study was performed. The document explicitly states: "The Bunkerhill MAC performance was validated in a stand-alone retrospective study for detection, localization and agreement of the device output compared to the established reference standard."

6. The type of ground truth used:

   • The ground truth was an "established reference standard" which was used for comparison against the device's output. The document implies this reference standard is based on non-gated CT reference measurements and potentially "manual segmentation" informed by clinical literature. It does not explicitly state pathology confirmation or direct outcomes data as the primary ground truth.

7. The sample size for the training set:

   • The sample size for the training set is not provided in the document.

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

   • The document does not provide information on how the ground truth for the training set was established. It only refers to the performance validation on a "pivotal dataset" (test set).

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Bunkerhill ECG-EF is software intended to aid in screening for Left Ventricular Ejection Fraction (LVEF) less than or equal to 40% in adults at risk for, but not already diagnosed with low LVEF.

Bunkerhill ECG-EF is not intended to be a stand-alone diagnostic device for cardiac conditions, should not be used for monitoring of patients, and should not be used on ECGs with a paced rhythm. A positive result may suggest the need for further clinical evaluation in order to establish a diagnosis of Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%.

Additionally, if the patient is at high risk for the cardiac condition, a negative result should not rule out further non-invasive evaluation.

Bunkerhill ECG-EF is adjunctive and must be interpreted in conjunction with the clinician's judgment, the patient's medical history, symptoms, and additional diagnostic tests. For a final clinical diagnosis, further confirmatory testing, such as echocardiography, is required.

ECG-EF is a software-only medical device that employs deep learning algorithms to analyze 12-lead ECG data for the detection of low left ventricular ejection fraction (LVEF < 40%). The algorithm processes 10-second ECG waveform snippets, providing predictions to assist healthcare professionals in the early identification of patients at risk for heart failure.

ECG-EF algorithm receives digital 12-lead ECG data and processes it through its machine learning model. The output of the analysis is transmitted to integrated third-party software systems, such as Electronic Medical Records (EMR) or ECG Management Systems (EMS). The results are displayed by the third-party software on a device such as a smartphone, tablet, or PC.

ECG-EF algorithm produces a result indicating "Low EF Screen Positive - High probability of low ejection fraction based on the ECG", " Low EF Screen Negative - Low probability of low ejection fraction based on the ECG" or "Error – device input criteria not met " for cases that do not meet data input requirements. These results are not intended to be definitive diagnostic outputs but rather serve as adjunctive information to support clinical decision-making. A disclaimer accompanies the output, stating: "Not for diagnostic use. The results are not final and must be reviewed alongside clinical judgment and other diagnostic methods."

The Low Ejection Fraction AI-ECG Algorithm device is intended to address the unmet need for a point-of-care screen for LVEF less than or equal to 40% and is expected to be used by cardiologists, front-line clinicians at primary care, urgent care, and emergency care settings, where cardiac imaging may not be available or may be difficult or unreliable for clinicians to operate. Clinicians will use the Low Ejection Fraction AI-ECG Algorithm to aid in screening for LVEF less than or equal to 40% and making a decision for further cardiac evaluation.

Here's a breakdown of the acceptance criteria and the study details for the Bunkerhill ECG-EF device, based on the provided FDA 510(k) Clearance Letter:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: 15,994 patient records.
• Data Provenance:
  • Country of Origin: United States.
  • Source: Two health systems.
  • Type: Retrospective study.
  • Diversity: Representative of the U.S. population (65.5% White, 18.8% Hispanic, 5.7% American Indian or Alaska Native, 3.9% Asian, 3.0% Black/African American, 2.8% Other; 53% Male, 47% Female).
  • Geographical Distribution: Curated from 5 geographically distributed sites throughout the United States.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number of experts used or their specific qualifications for establishing the ground truth. It only mentions that the ground truth was established from echocardiograms.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the test set. The ground truth was derived directly from echocardiogram measurements.

5. MRMC Comparative Effectiveness Study

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size of human readers improving with AI vs. without AI assistance. The study focuses solely on the standalone performance of the AI algorithm.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone study evaluating the algorithm's performance without human-in-the-loop was conducted. The performance metrics (Sensitivity, Specificity, PPV, NPV) and the confusion matrix presented are for the algorithm's direct output.

7. Type of Ground Truth Used

The ground truth used was Transthoracic Echocardiogram (TTE) with disease, specifically using the Simpson's Biplane measurement method to determine Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%. The echocardiogram was taken less than 15 days apart from the ECG scan.

8. Sample Size for the Training Set

The document does not explicitly state the sample size used for the training set. It only mentions the retrospective study for validation involved 15,994 patient records.

9. How Ground Truth for the Training Set Was Established

The document states that the "Ground Truth for Model Training" was Transthoracic echocardiogram (TTE) with disease. It can be inferred that this same method (TTE, likely Simpson's Biplane) was used to establish ground truth for the training data, similar to the test set, but specific details on the process for the training set are not provided.

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Bunkerhill AAQ is a radiological image processing system software indicated for use in the analysis of CT exams with or without contrast, that include the L1 – L5 region of the abdominal aorta, in adults aged 22 and older.

The device is intended to assist appropriately trained medical specialists by providing the user with the maximum axial abdominal aortic diameter measurement of cases that include the abdominal aorta. Bunkerhill AAQ is indicated to evaluate normal and aneurysmal abdominal aortas and is not intended to evaluate post-operative aortas.

The Bunkerhill AAQ results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of cases. These measurements are unofficial, are not final, and are subject to change after review by a qualified interpreting physician. For final clinically approved measurements, please refer to the official radiology report. Clinicians are responsible for viewing full images per the standard of care.

Bunkerhill AAQ is a software-only medical device that employs deep learning algorithms to provide automatic maximal abdominal aortic diameter measurements from axial CT scans of the abdomen/pelvis, with or without IV contrast.

Bunkerhill AAQ receives DICOM instances and processes them chronologically by running the algorithm on relevant series to measure the maximum abdominal aortic diameter. Following the AI processing, the output of the algorithm analysis is transferred to standard radiology image review and reporting software.

Bunkerhill AAQ produces a preview image annotated with the maximum axial diameter measurement. The diameter marking is not intended to be a final output, but serves the purpose of visualization and measurement. The original, unmarked series remains available in the PACS as well.

The preview image presents an unofficial and not final measurement, and the user is instructed to review the full image and any other clinical information before making a clinical decision. The image includes a disclaimer: "Not for diagnostic use. The measurement is unofficial, not final, and must be reviewed by a qualified interpreting physician".

Here's a breakdown of the acceptance criteria and the study proving the device meets those criteria, based on the provided FDA 510(k) clearance letter for Bunkerhill Abdominal Aortic Quantification (AAQ):

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: 258 patients
• Data Provenance: Retrospective study. Data sourced from North Carolina, Alabama, the greater Washington D.C. area (all in the USA), and Sao Paulo, Brazil. This indicates a diverse geographical origin for the data.

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

• Number of Experts: 3
• Qualifications of Experts: U.S. Board Certified Radiologists. Specific experience level (e.g., 10 years) is not provided, but Board Certification implies a high level of expertise.

4. Adjudication Method for the Test Set

• The text states "a ground truth established by 3 U.S. Board Certified Radiologists." This implies a consensus-based approach among the three experts to establish the definitive ground truth reference. The specific adjudication method (e.g., majority vote, discussion to reach consensus) is not detailed, but the use of three experts suggests a robust process beyond a single reader.

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

• No, an MRMC comparative effectiveness study involving human readers with vs. without AI assistance was not reported. The study described is a standalone performance study of the algorithm against a defined ground truth.

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

• Yes, a standalone performance study was done. The text explicitly states, "The AAQ algorithm performance was validated in a stand-alone retrospective study for overall agreement of the device output compared to a ground truth established by 3 U.S. Board Certified Radiologists." The results (MAE, ΔICC, Bland-Altman limits) are all reflective of the algorithm's performance in isolation.

7. The Type of Ground Truth Used

• Expert Consensus. The ground truth was "established by 3 U.S. Board Certified Radiologists," indicating that their consensus measurements were considered the true values for comparison.

8. The Sample Size for the Training Set

• Not provided. The document only references the test set of 258 patients. Information regarding the training set size is not included in this excerpt.

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

• Not provided. Since the training set size itself is not mentioned, the method for establishing its ground truth is also absent from this document. It's common practice for similar methods (e.g., expert annotations) to be used for training data, but this specific excerpt doesn't confirm it.

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The Bunkerhill BMD Algorithm is a post-processing AI-powered software intended for adults 30 years and above to assess estimated DXA-measured average areal bone mineral density of spinal bones from existing CT scans and outputs a flag for low bone density below a pre-specified threshold. It is not intended to replace DXA or any other tests dedicated to BMD measurement.

Bunkerhill BMD is an opportunistic AI-powered tool that enables:(1) retrospective assessment of bone density from CT scans acquired for other purposes, (2) assessment of bone density in conjunction with another medically appropriate procedure involving CT scans, and (3) assessment of bone density without a phantom as an independent measurement procedure

The Bunkerhill BMD application is a software only medical device (SaMD) that includes deep- learning-based computer vision and post-processing algorithms that estimates the bone mineral density from previously obtained computed tomography (CT) images.

The results from Bunkerhill BMD are not intended to be used as the primary input for clinical decision making, but rather are intended to provide information that may assist the clinician to identify 'findings of interest' within existing imaging studies.

Here's a breakdown of the acceptance criteria and study details for the BunkerHill BMD device, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Device Performance Study for BunkerHill BMD

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for the Test Set

• Test Set Sample Size: 371 CT studies
• Data Provenance: The studies were collected from four (4) geographically diverse sites. The retrospective nature of the study is explicitly stated ("stand-alone retrospective study").

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number of experts used to establish the ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method (e.g., 2+1, 3+1, none) used for the test set.

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

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not reported in the provided text. The study described is a standalone performance evaluation of the algorithm.

6. Standalone Performance Study

Yes, a standalone (algorithm only without human-in-the-loop performance) study was done. The document states: "Bunkerhill BMD performance was validated in a stand-alone retrospective study for overall agreement of the device output compared to the established ground truth."

7. Type of Ground Truth Used

The type of ground truth used is implied to be based on DXA-measured average areal bone mineral density of spinal bones, as the device is intended to "assess estimated DXA-measured average areal bone mineral density." The text refers to "established ground truth" in relation to this assessment.

8. Sample Size for the Training Set

The document does not provide the sample size for the training set. It only describes the test set.

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

The document does not provide information on how the ground truth for the training set was established. It only refers to "established ground truth" for the test set evaluation.

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Bunkerhill AVC is a software device intended for use in detecting presence and estimating quantity of aortic valve calcification for adult patients aged 40 years and above. The device automatically analyzes non-gated, non-contrast chest computed tomography (CT) images collected during clinical care and outputs the region of interest (intended for informational purposes only) and quantification of detected calcium.

The output of the subject device is made available to the physician on-demand as part of his or her standard workflow. The device-generated quantification can be viewed in the patient report at the discretion of the physician, and the physician also has the option of viewing the device-generated calcium region of interest in a diagnostic image viewer. The subject device output in no way replaces the original patient report or the original non-gated, non-contrast CT scan; both are still available to be viewed and used at the discretion of the physician.

The device is intended to provide information to the physician to provide assistance during review of the patient's case. Results of the subject device are not intended to be used on a stand-alone basis and are solely intended to aid and provide information to the physician. In all cases, further action taken on a patient should only come at the recommendation of the physician after further reviewing the patient's results.

Bunkerhill AVC is a software as a medical device (SaMD) product that interfaces with compatible and commercially available computed tomography (CT) systems. Bunkerhill AVC detects, localizes, and quantifies aortic valve calcification in non-gated, non-contrast chest CT studies. The core features of the product are:

• Detection of aortic valve calcification at an Agatston-equivalent score threshold of 0 AU. •
• . Estimation of the overall aortic valve calcification burden in the form of an estimated Agatston-equivalent Score.
• Localization of estimated calcium burden in the form of AVC region of interest applied . to a copy of the original CT scan.

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

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

The provided text describes specific performance metrics that were evaluated, although it doesn't explicitly present a formal "acceptance criteria table" with target values. Instead, it describes how the device's observed performance met the acceptance criteria.

Notes on Acceptance Criteria: The document states that "The acceptance criteria were derived from the performance of the predicate device and clinical literature in high impact journals that inter-reader agreement of manual segmentation." This indicates a benchmark against established clinical practice and a comparable device.

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

• Sample Size for Test Set: Not explicitly stated as a numerical count of patients or cases. However, the data for the pivotal study was "curated from thirty-three (33) sites."
• Data Provenance:
  • Country of Origin: United States ("thirty-three (33) sites across three geographical regions in the United States").
  • Retrospective or Prospective: Retrospective ("standalone retrospective study").

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

The document does not provide information on the number or qualifications of experts used to establish the ground truth for the test set. It only mentions that the ground truth was "established."

4. Adjudication method for the test set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for the test set.

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

A multi-reader multi-case (MRMC) comparative effectiveness study assessing human reader improvement with AI assistance was not conducted or reported. The study described is a "standalone retrospective study for localization and agreement of the device output compared to the established ground truth." The device is intended as an "adjunctive information" tool, not a human-in-the-loop performance enhancer for diagnostic accuracy per se, but rather an aid for quantifying calcification.

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

Yes, a standalone study was done. The text explicitly states: "The Bunkerhill AVC performance was validated in a stand-alone retrospective study for localization and agreement of the device output compared to the established ground truth."

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

The type of ground truth used was "established ground truth." While this term is somewhat generic, given the context of Agatston-equivalent scores and "inter-reader agreement of manual segmentation" mentioned for acceptance criteria, it strongly implies ground truth established by expert (likely radiologist or cardiologist) review and manual measurement/segmentation. It is not stated to be pathology or outcomes data.

8. The sample size for the training set

The document does not provide the sample size for the training set. It only discusses the pivotal test set.

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

The document does not provide information on how the ground truth for the training set was established.

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Bunny Wax Personal Lubricant is a personal lubricant indicated for penile and/or vaginal application intended to lubricate and enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

Not Found

I am sorry, but the provided text is a letter from the FDA regarding the substantial equivalence determination for a medical device (Bunny Wax Personal Lubricant). It does not contain information about acceptance criteria, a specific study proving the device meets those criteria, or details regarding AI/ML algorithm performance.

Therefore, I cannot extract the requested information to fill in the table or answer the specific questions about a study and AI/ML performance. The document focuses on regulatory approval based on equivalence to predicate devices, not on performance metrics of an AI system.

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The Bunegin-Albin Air Aspiration Set is intended to aspirate venous air emboli.

The Bunegin-Albin Air Aspiration Set is comprised of an air aspiration catheter, wire guide, entry access needle, dilator, syringe, stopcock, and scalpel. The air aspiration catheter is manufactured from radiopaque extruded polyethylene tubing and is designed with a pre-molded winged fitting. The catheter is 5.8 French in size with an endhole diameter of 0.035 inches. The wire guide is manufactured from stainless steel coils, a safety wire, and a mandril wire. The access needle is manufactured from stainless steel. The dilator is manufactured from polyethylene and has a pre-molded proximal hub. The set also includes a 12 cc syringe, a low pressure three way stopcock, and a scalpel. The Bunegin-Albin Air Aspiration Set is sterilized by ethylene oxide and intended for one-time use.

This documentation outlines the acceptance criteria and the results of various studies conducted for the Bunegin-Albin Air Aspiration Set to demonstrate its performance and substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific numerical sample sizes for each physical and chemical test (e.g., Catheter Shaft Tensile, Wire Guide Corrosion). Instead, the document refers to compliance with international standards (e.g., BS EN ISO 10555-1, BS EN ISO 11070, ISO 594-2, BS EN 13868, USP 788) which would implicitly define sample sizes for such tests.

For the Animal Testing, a specific sample size is not stated, but the testing evaluated the "acute performance" in an animal model. The provenance would be experimental ("prospective" if considered in the context of device development) rather than clinical human data. The country of origin for the animal study is not specified in the provided text.

The data for all engineering performance and biocompatibility tests is based on prospective testing conducted specifically for this device submission to demonstrate compliance with standards and design input requirements. The country of origin of this testing data is not explicitly stated, but it is for a device manufactured by Cook Incorporated, presumably in the US or one of their international facilities.

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

For the engineering performance tests (tensile strength, kink resistance, leakage, etc.) and particulate testing, "ground truth" is established by adherence to quantitative specifications defined by international standards (e.g., ≥ 15 N, no air entry, no liquid leak, USP 788 thresholds). Therefore, these do not rely on human expert consensus in the same way clinical image interpretation might. The "experts" in this context would be the technicians and engineers performing and verifying the tests against the defined standards.

For Animal Testing, the grading of "adequate" or "good" for performance parameters and ability to remove air would imply evaluation by experts, likely veterinary surgeons or researchers with expertise in animal models and medical device performance. The number and specific qualifications of these experts are not provided.

For Biocompatibility testing, "ground truth" is established by the results of standardized tests per ISO 10993-1 and FDA guidance. Experts would be toxicologists and other scientific professionals interpreting these results, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

For the physical, chemical, and mechanical performance tests, the adjudication method is direct comparison of measured values against predefined numerical or qualitative acceptance criteria outlined in international standards. There is no mention of a human consensus or specific adjudication for these quantitative evaluations beyond meeting the standard.

For the Animal Testing, the "grading of 'adequate' or 'good'" suggests an assessment, but the specific adjudication method (e.g., single expert, 2+1 consensus) is not detailed.

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

No MRMC comparative effectiveness study was done. The device is a physical medical instrument (an air aspiration set), not an AI or imaging diagnostic device that would typically involve human readers interpreting cases.

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

Not applicable as this is a physical medical device. The "performance" studies are standalone in the sense that they evaluate the device's physical properties and functionality without human intervention being part of the device's performance mechanism, but rather as the operators and evaluators of the device.

7. Type of Ground Truth Used

The ground truth for the various tests is established through a combination of:

• International Standards and Specifications: For most physical, mechanical, and chemical tests (tensile strength, kink length, leakage, particulate counts, etc.), the ground truth is defined by the acceptance criteria set forth in specific ISO and BS EN standards (e.g., BS EN ISO 10555-1, BS EN ISO 11070, ISO 594-2, BS EN 13868, USP 788 thresholds).
• Empirical Observation/Expert Assessment: For animal testing, the ground truth is based on the observed "adequate" or "good" performance and the ability to remove air from target sites, likely evaluated by trained personnel.
• Biocompatibility Standards: For biocompatibility, the ground truth is compliance with the requirements of ISO 10993-1 and FDA guidance, demonstrated through specific laboratory test results.

8. Sample Size for the Training Set

Not applicable in the context of device performance testing for substantial equivalence. There is no mention of a "training set" as this device does not involve machine learning or AI algorithms requiring data for training. The studies described are for verification and validation of the manufactured product.

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

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

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LPV II Valves and Kits
The Standard-LPV II and Mini-LPV II Valves, utilized in the treatment of hydrocephalic patients in systems designed to shunt cerebrospinal fluid from the lateral ventricles of the brain into either the right atrium of the heart or the peritoneum. The Mini-LPV II Valve can be used in (but is not restricted to) situations where skin erosion may be a problem, as with older patients.

Novus Valves and Kits
The Novus and Novus Mini Valves, utilized in the treatment of hydrocephalic patients, are components in systems designed to shunt cerebrospinal fluid from the lateral ventricles of the right atrium of the heart or the peritoneum. The Novus Mini Valve can be used in (but is not restricted to) situations where skin erosion may be a problem, as with older patients. Valves with a Physiological Flow Device are intended to reduce the hazard of negative intraventricular pressure (with respect to atmospheric pressure) when the patient is sitting, standing or semi-recumbent.

Multi-Purpose Valve
The Multi-Purpose Valve, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles into either the right atrium of the heart or the perioneum. Valves with an Anti-Siphon Device are intended to reduce the hazard of negative intraventricular pressure when the patient is sitting, semi-recumbent or standing.

Mishler Dual Chamber Valve with Integral Connectors
The Mishler Dual Chamber Flushing Valve, Flat Bottom Design, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles into either the right atrium of the heart or the peritoneum. Valves with an Anti-Siphon Device are intended to reduce the hazard of negative intraventricular pressure when the patient is sitting, semi-recumbent or standing.

Pudenz Flushing Valve with Integral Connectors
The Pudenz Flushing Valve, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles of the brain into either the right atrium of the heart or the peritoneum. Valves with an Anti-Siphon Device are intended to reduce the intraventricular pressure when the patient is sitting, semi-recumbent or standing.

Ultra VS In-Line Valve System
The Ultra VS In-Line Valves, utilized in the treatment of hydrocephalic patients, are components in systems designed to shunt cerebrospinal fluid (CSF) from the lateral ventricles into either the peritoneal cavity or the right atrium of the heart. The in-line and burr-hole systems are designed to shunt cerebrospinal fluid from the lateral ventricles into the peritoneal cavity. A ventriculoperitoneal shunting system may be indicated to avoid the cardiovascular complications of an atrial shunt or for a hydrocephalic patient in whom an atrial shunt is contraindicated. The Small and Neonate Models can be used in (but are not restricted to) situations where skin erosion may be a problem, as with premature infants, pediatric patients and older patients.

Pudenz Cardiac and Infant Catheter
The Pudenz Cardiac Catheter, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles of the right atrium of the heart. The Infant Cardiac Catheter is utilized when the common facial and/or internal jugular veins are too small to accommodate the larger cardiac catheter.

Pudenz Ventricular Catheter
The Pudenz Ventricular Catheter, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles of the right atrium of the heart or the peritoneum.

Pudenz Peritoneal Catheter
The Pudenz Peritoneal Catheter, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventriculoperitoneum. A ventriculoperitoneal shunting system may be indicated to avoid the cardiovascular complications of an atrial shunt or for a hydrocephalic patient in whom an atrial shunt is contraindicated.

Peritoneal Reflux Control Catheter and Peritoneal Open-Ended Catheter With Slits
The Peritoneal Reflux Control Catheter and Peritoneal Open-Ended Catheter with Slits, utilized in the treatment of hydrocephalic patients, are components for systems designed to shunt cerebrospinal fluid from the lateral ventricles into the peritoneum. A ventriculoperitoneal shunting system may be indicated to avoid the cardiovascular complications of an atrial shunt or for a hydrocephalic patient in whom an atrial shunt is contraindicated.

Portnoy Ventricular Catheter
The Portnoy Ventricular Catheter, utilized in the treatments, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles into either the right atrium of the heart or the peritoneum.

Neuroview Endoscopic Ventricular Catheter
The Neuroview Ventricular Catheter, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles into either the right atrium of the heart or the peritoneum.

Integra CSF Reservoir with Integral Connectors
The Integra CSF Reservoir provides access to the lateral cerebral ventricles via hypodermic puncture for sampling and/or injection of fluids. It is useful in obtaining CSF samples for cytological and chemical studies, for monitoring ventricular fluid pressure and for ventricular drainage. The Convertible Integra CSF Reservoir may be utilized in hydrocephalic patients as a component in systems designed to shunt CSF from the lateral ventricles into either the right atrium of the heart or the peritoneum.

Essential Shunt Kit Burr Hole Design
The CSF Control Valve, utilized in the treatments, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles of the right atrium of the heart or the peritoneum.

Essential Shunt Kit Flat Bottom Design
The Essential Shunt Kit – Flat Bottom Design, utilized in the treatment of hydrocephalic patients, is designed to shunt cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum. The Essential Shunt Kit – Flat Bottom Design, can be used in (but is not restricted to) situations where skin erosion may be a problem, as with older patients.

Connectors for Neurosurgical Use
Integra connectors are utilized principally in the treatment of hydrocephalic patients, as components in systems designed to shunt cerebrospinal fluid from the lateral cerebral ventricles of the right atrium of the heart or the peritoneum.

On-Off Flushing Reservoirs
The On-Off Flushing Reservoir, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles into either the right atrium of the peritoneum. Reservoirs with an Anti-Siphon Device are intended to reduce the hazard of negative intraventricular pressure when the patient is sitting, semi-recumbent or standing.

Braden Flushing Reservoir
The Braden Flushing Reservoir, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles into either the right atrium of the heart or the peritoneum.

Foltz Flushing Reservoir
The Foltz Flushing Reservoir, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles into either the right atrium of the heart or the peritoneum.

Anti-Siphon Device
The Anti-Siphon Device, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles of the right atrium of the heart or the heart or the peritoneum. The device is designed to reduce the potential hazards of excessive lowering of intraventricular pressure (with respect to atmospheric pressure) when the patient is in a sitting, standing or erect position.

Integra Neurological Shunts and Accessories are used in the treatment of hydrocephalus. Hydrocephalus is commonly treated by creating a CSF flow pathway from a cerebral ventricle to the peritoneal spaces in the abdomen or to the right atrium of the heart. This is commonly referred to as "shunting". Integra markets a full line of products for CSF shunting procedures including catheters, valves, reservoir devices, connectors and accessories to aid in implantation.

A shunt system may comprise of a catheter, valve, reservoir and connectors, depending on clinician preference and use. In practice, a catheter is implanted into the space where CSF drainage is necessary (ventricles of the brain or lumbar subarachnoid space) and connected to a valve. The valve is used to control the CSF drainage rate. The other side of the valve is connected to a catheter which is placed to allow drainage to the desired site, typically the right atrium of the heart or the peritoneal cavity. As needed, a clinician may also incorporate a reservoir, for a closed ventricular access site, and/or additional connectors into the shunt system.

Catheters are silicone elastomer and some models are made from high durometer silicone elastomer. Valve mechanisms are categorized as diaphragm and miter. For diaphragm valves, the mechanism is an umbrella shaped component oriented at right angles to the flow path. Miter valves incorporates two silicone flaps in the shape of a duckbill. The flaps part in response to a pressure differential to allow flow. Some vales are available with low, medium or high closing pressure ranges and some contain an anti-siphon component. Reservoirs are available as standard or side-inlet or convertible and in various sizes; some have an on-off flushing feature. A variety of connectors, made of nylon or silicone elastomer material, are also available.

The provided text describes a 510(k) summary for Integra Neurological Shunts and Accessories. The summary focuses on establishing substantial equivalence to previously marketed devices, particularly regarding the addition of MRI safety information.

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

Focus of the Study: MRI Safety Information

The key aspect of the study described is the demonstration of MRI safety for the Integra Neurological Shunts and Accessories. The acceptance criteria and testing are designed to support an "MR Conditional" claim on the device labeling.

1. Table of Acceptance Criteria and Reported Device Performance

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

The text does not specify a numerical "sample size" in terms of number of individual devices tested. It refers to "the devices" or "all tested implants" for the RF Heating Test, implying that representative samples of the various Integra Neurological Shunts and Accessories products listed were tested. The data provenance is described as non-clinical testing performed by the applicant, Integra LifeSciences Corporation, in a laboratory setting to demonstrate MRI compatibility. There is no mention of country of origin of data or retrospective/prospective clinical data for these specific tests, as they are engineering/physical property tests.

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

This type of information is not applicable to the non-clinical engineering tests performed for MRI safety. Ground truth in this context is established by the physical laws and measurement protocols defined by the ASTM standards.

4. Adjudication Method for the Test Set

This is not applicable. The data from these tests are quantitative measurements against predefined criteria, not subjective assessments requiring adjudication.

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 is not applicable. The document describes non-clinical engineering tests related to MRI safety, not a clinical study involving human readers or AI.

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

This is not applicable. The device is a physical medical device (shunts and accessories), not an algorithm or AI software. Therefore, there is no "standalone algorithm" performance to report.

7. The Type of Ground Truth Used

The ground truth for these non-clinical tests is based on:

• ASTM Standard Operating Procedures and Definitions: For displacement force (ASTM F2052-06e1), torque (ASTM F2213-06), and RF heating (ASTM F2182-09). These standards define how the measurements are taken and what constitutes safe limits.
• Physical Properties: The inherent physical response of the device materials to magnetic fields and radiofrequency energy.

There is no "expert consensus," "pathology," or "outcomes data" used as ground truth for these MRI safety tests.

8. The Sample Size for the Training Set

This is not applicable. There is no training set mentioned or implied, as the described tests are non-clinical hardware evaluation, not a machine learning model development.

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

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

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The BUN Reagent is to be used for the quantitative determination of urea nitrogen in serum, plasma and urine on the Beckman SYNCHRON CX3® System to aid in the diagnosis of renal function and pre renal disease states, such as cardiac decompensation and others.

The Device is a reagent containing sufficient Urease, surfactants and other ingredients necessary for optimum system operation on the Beckman Synchron CX3® Analyzer.

Acceptance Criteria and Device Performance Study for GenChem, Inc. BUN Reagent

This document outlines the acceptance criteria and the results of a study demonstrating the performance of the GenChem, Inc. Electrode, Ion Specific, Urea Nitrogen (BUN) Reagent (K040973).

1. Table of Acceptance Criteria and Reported Device Performance

*ORDAC: Off-Range Dilution and Concentration

2. Sample Size and Data Provenance (Test Set)

• Precision/Reproducibility:

  • Sample Size: 60 replicates for each of 5 samples (3 serum, 2 urine) (N=60 for each sample type). Assayed twice per day in triplicate on 10 different days over a 30-day period.
  • Data Provenance: Not explicitly stated, but likely from laboratory controlled samples (control sera, diluted urine pools). This is typically a retrospective analysis of controlled lab materials.

• Linearity/Assay Reportable Range:

  • Sample Size: Analyzed 7 commercially available linearity standards ranging from 0 to 158 mg/dL in triplicate.
  • Data Provenance: Commercially available linearity standards, typically retrospective analysis in a controlled lab setting.

• Sensitivity:

  • Sample Size: 21 replicates of a diluted serum control.
  • Data Provenance: Diluted serum control, typically retrospective analysis in a controlled lab setting.

• Analytical Specificity:

  • Sample Size: Not explicitly stated as a numerical sample size but involved testing stock samples with varying concentrations of interferents (Hemoglobin, Bilirubin, Lipemia) against a base pool.
  • Data Provenance: Laboratory-prepared stock solutions and base pool, typically retrospective analysis in a controlled lab setting.

• Patient Comparison (Method Comparison):

  • Sample Size: 80 serum specimens, 80 plasma specimens, and 79 urine specimens.
  • Data Provenance: "Collected from adult patients." This indicates prospective or retrospective patient sample collection, but the context generally implies real patient samples that were de-identified and used for the study. The country of origin is not specified.

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

The studies described in the provided text are for an in vitro diagnostic reagent and system. For such devices, "ground truth" is typically established by comparative analysis with a well-characterized reference method or a legally marketed predicate device, rather than expert interpretation of images or clinical data.

• For Precision, Linearity, Sensitivity, and Analytical Specificity: Ground truth is established by the inherent properties of the reference materials used (e.g., certified control sera, linearity standards with known concentrations) or by accepted laboratory analytical methods. No external "experts" (like radiologists) are involved in establishing this type of ground truth.
• For Patient Comparison: The "ground truth" for the test set (GenChem BUN reagent) is the measurement obtained from the predicate device (Beckman BUN reagent for the CX3). The "experts" in this context would be the skilled laboratory technicians operating the instruments, but their role is to accurately perform the assays, not to interpret an uncertain "ground truth."

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are typically used in studies where subjective interpretation (e.g., imaging reads) is involved and discrepancies between readers need to be resolved. For an IVD reagent, data is quantitative and is compared statistically. Therefore, no adjudication method as typically understood in image-based studies was used. The comparison was a direct statistical correlation between the test device and the predicate device's quantitative results.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices that involve human interpretation of results (e.g., radiologists reading images and improved performance with AI assistance). The GenChem BUN Reagent is an automated in vitro diagnostic assay where the output is a quantitative value, not subject to human interpretation in the same way. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply here.

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

Yes, all performance studies described are essentially standalone performance studies for the reagent on the Beckman CX3® Synchron Analyzer. The analytical performance characteristics (Precision, Linearity, Sensitivity, Analytical Specificity, and Method Comparison) measure the reagent's performance as an "algorithm only" (in the sense of an automated test system yielding a quantitative result without direct human interpretation influencing the result itself). The human "in the loop" would be operating the instrument and performing quality control, but not providing an interpretation that the algorithm augments or replaces.

7. Type of Ground Truth Used

The primary ground truth used for the method comparison study (patient comparison) was the predicate device's measurement (Beckman BUN reagent for the CX3). For other performance characteristics like precision, linearity, and sensitivity, the ground truth was established by reference materials, certified standards, or accepted laboratory methods (e.g., known concentrations of linearity standards, the mean value for precision calculations). This is synonymous with a form of expert consensus if the reference methods are considered the established gold standard.

8. Sample Size for the Training Set

The provided documentation describes performance studies for regulatory submission (510(k)). These are analytical validation studies, not machine learning model development. Therefore, there is no explicit "training set" in the context of an AI/ML algorithm. The "training" in this context refers to the development and optimization of the reagent and its methods, which would typically be done by the manufacturer through various iterations using proprietary internal samples and methodologies, but these are not disclosed as a "training set" in a regulatory submission for an IVD reagent.

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

As there is no "training set" in the context of an AI/ML algorithm, this question is not applicable. The development of chemical reagents and analytical methods for IVD devices involves extensive R&D and optimization, where "ground truth" is established against known chemical properties, reference methods, and clinical needs during the development phase.

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Mission BUN Reagent is intended for in vitro diagnostic use for the quantitative determination of urea nitrogen in serum, plasma, and urine on Beckman Synchron CX & CX® Delta Analyzers. BUN measurements are useful in the diagnosis and treatment of certain renal and metabolic diseases.

Urea nitrogen concentration is determined by an enzymatic conductivity method employing a Beckman Conductivity Electrode. Electronic circuits determine the rate of increase in conductivity, which is directly proportional to the concentration of BUN in the sample. Mission uses a similar composition, description and packaging as that used by the OEM in its products.

Acceptance Criteria and Device Performance for Mission Diagnostic BUN Reagent

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a separate section. However, the performance characteristics (precision, method comparison, and recovery) are compared against a predicate device, implying that performance similar to or better than the predicate is considered acceptable.

2. Sample Size and Data Provenance:

• Precision:
  • Sample Size: For each of the 4 controls (2 serum, 2 urine), 'N' = 80 observations. This was obtained by running samples for 20 days, 2 runs per day, and 2 observations per run (20 * 2 * 2 = 80).
  • Data Provenance: Not explicitly stated, but based on the context of a new reagent being tested against a predicate, it is likely a prospective study conducted by Mission Diagnostics. No country of origin is specified.
• Method Comparison:
  • Serum: 'n' = 66 individual observations (derived from spiked/diluted samples run in triplicate).
  • Urine: 'n' = 40 individual observations (derived from spiked/diluted samples run in triplicate).
  • Data Provenance: Not explicitly stated, but likely prospective data collected by Mission Diagnostics. No country of origin is specified.
• Recovery to Expected Values:
  • Serum & Urine: Specific 'n' for individual recovery experiments not given, but refers to "Pooled Serum" and "Urine recovery samples" which were diluted and measured.
  • Data Provenance: Not explicitly stated, but likely prospective data collected by Mission Diagnostics.
• Functional Sensitivity:
  • Sample Size: For each dilution, 'N' = 20 (4 samples per run over 5 calibrated runs).
  • Data Provenance: Not explicitly stated, but likely prospective data collected by Mission Diagnostics.

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

Not applicable. This device is a diagnostic reagent for quantitative measurement of BUN, not an imaging or qualitative diagnostic device that requires expert interpretation for ground truth. The "ground truth" for the test set is established by the reference measurement from the predicate device and expected values from spiked/diluted samples.

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

Not applicable. No expert adjudication was involved as this is a quantitative chemical assay.

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

Not applicable. This is a chemical reagent, not an AI or imaging diagnostic device that relies on human readers.

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

This study directly reports the "standalone" performance of the Mission BUN Reagent as a chemical assay. The performance is assessed against a predicate device rather than an algorithm.

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

The ground truth for this study is based on:

• Reference measurements from the predicate device (Beckman BUN Reagent): Used for method comparison studies.
• Expected values from gravimetrically spiked or diluted samples: Used for recovery studies.

8. The sample size for the training set:

Not applicable. This is a chemical reagent, not an AI or machine learning model that requires a training set. The "training" for the device, if any, would be the calibration process of the Beckman Synchron CX & CX® Delta Systems according to manufacturer instructions.

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

Not applicable. See point 8.

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