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The BreathScan PRO is an in vitro medical device that quantitatively detects the presence of alcohol in the human breath. The system is used only as a screening device and is an indication of the presence of alcohol in the blood of the test subject.

The BreathScan PRO is quantitative screening test for alcohol in the human breath and provides a digital readout. The BreathScan PRO consists of a selfcontained electronic analyzer to quantitatively detect the presence of alcohol in the human breath. The detection level range is from 0.00% to 0.15%. Breath Alcohol concentrations higher than 0.15% will be displayed as BAC >0.15%. The electronic Analyzer is factory pre-calibrated and is ready to use when a Detector is fully inserted into the sample port. It is a re-usable device designed for use specifically with BreathScan®PRO detectors.

The detectors are disposable screening devices designed for one time use. The BreathScan®PRO Electronic Analyzer enables the user to read or interpret their BreathScan PRO Detectors charged by human breath. The system provides an indication of the possible presence of alcohol in the blood of the test subject.

The detectors contains chemicals that change color in the presence of alcohol vapors) utilizing the patented technology. The Detector consists of two parts. One part is a glass capsule containing light yellow crystals that change color when exposed to alcohol vapors. The other part is a plugged, plastic tube with an opening to blow into while running the test.

When the subject exhales into the tube, the fresh crystals interact with breath vapor and change color from yellow to blue green if alcohol is present. Note: The resulting color change is dependent upon the level of alcohol detected.

The blow bags are re-usable and serve as a method to assure that the subject has blown through the Detector with adequate air. With the BreathScan PRO. this is required (DOT/NHTSA compliance). ABI provides these in the starter kit and as an option for future orders.

Here's an analysis of the provided information regarding the BreathScan®PRO device, focusing on acceptance criteria and the supporting study:

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific quantitative acceptance criteria for parameters like accuracy, precision, or false positive/negative rates prior to presenting the study results. Instead, it implies a comparison to a predicate device (Breath Alcohol .02 Detection System K062971) and an evidentiary breath test (ALCO SENSOR IV).

However, the study results themselves can be interpreted as demonstrating the device's performance against an implicit standard set by the comparator device. The document also mentions meeting DOT/NHTSA guidelines as an acceptance benchmark.

Implicit Acceptance Criteria and Reported Device Performance:

Study that Proves the Device Meets the (Implicit) Acceptance Criteria:

The key study presented is a comparison of the BreathScan®PRO against the ALCO SENSOR IV, which is described as an "Evidentiary Breath Test" and a "DOT/NHTSA approved device."

The study is described as:

• Bench test and user testing data for safety and effectiveness.
• A comparison to the Evidentiary Breath Test (Alco-Sensor IV), the results of which are depicted in the scatter plot.
• User studies to assess user comprehension and proper usage, obtaining comparable results to a predicate device.

2. Sample Size and Data Provenance

• Test Set Sample Size: 62 total subjects were used for the comparison study with the Alco-Sensor IV.
• Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be prospective as it involves user testing and data collection for comparison.

3. Number of Experts and Qualifications for Ground Truth

• The document mentions comparison to the ALCO SENSOR IV, which is an "Evidentiary Breath Test" and a "DOT/NHTSA approved device." The results from this device are essentially considered the ground truth for the quantitative comparison.
• It also states that user studies obtained results "comparable to those provided by a predicate device administered by a trained technician." While not directly defining the ground truth for measurement, this implies the benchmark performance of the predicate device under expert operation.
• The number of "experts" (or trained technicians operating the Alco-Sensor IV) is not specified. Their specific qualifications (e.g., years of experience) are also not specified beyond "trained technician."

4. Adjudication Method

• The document does not describe an adjudication method (e.g., 2+1, 3+1) for establishing ground truth. The Alco-Sensor IV appears to be the single source of ground truth for BAC measurements.

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

• No, an MRMC comparative effectiveness study was not explicitly mentioned or performed in the provided text. The study focuses on comparing the device's readings to an evidentiary breath test and assessing user performance, not on how human readers' diagnostic accuracy improves with or without AI assistance. The BreathScan®PRO is a standalone device with a digital readout, not an AI-assisted diagnostic tool for human interpretation.

6. Standalone Performance Study

• Yes, a standalone performance study was done. The core "bench test" and "user testing data" with the comparison to the Alco-Sensor IV evaluates the algorithm's (device's) performance in generating the quantitative digital readout of BAC. The digital readout is inherently the algorithm's output.

7. Type of Ground Truth Used

• The primary ground truth used for quantitative comparison was the readout from a legally recognized evidentiary breath test device (ALCO SENSOR IV). This is a form of device-based ground truth using a gold-standard instrument.
• For the user studies, the ground truth was implied to be the results obtained by a trained technician operating a predicate device, which served as the benchmark for comparison of user-obtained results.

8. Sample Size for the Training Set

• The document does not specify the sample size for a training set. This is a device for detecting alcohol in breath, not typically an AI/ML model that undergoes a distinct training phase in the same way. The device is factory pre-calibrated.

9. How Ground Truth for the Training Set Was Established

• As a factory pre-calibrated device rather than a machine learning model, the concept of a "training set" and establishing ground truth for it in the typical AI context does not apply directly. The document states the electronic Analyzer is "factory pre-calibrated." The methods for this pre-calibration and the ground truth used during that calibration are not detailed in the provided text.

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The Breath Alcohol Z .02 Detection System and BreathScan® .02 Breath Alcohol Detection System are in vitro medical devices that qualitatively detect the presence of alcohol in the human breath. The test system detects equal to or greater than 0.02 percent breath alcohol. The system is used only as a screening device and is only an indication of the possible presence of alcohol in the blood of the test subject.

The Breath Alcohol 70 .02 Detection System and BreathScan® .02 Breath Alcohol Detection System are a visual qualitative test for alcohol in the human breath. The Breath Alcohol 20 .02 Detection System and BreathScan® .02 Breath Alcohol Detection System consist of a self-contained electronic analyzer to qualitatively detect the presence of alcohol in the human breath. It is a reusable device designed for use with a specific lot of Breath Alcohol Z . 02 or BreathScan® .02 Detectors. The detectors are disposable screening devices designed for one time use. The Breath Alcohol .02 and BreathScan .02 Electronic Analyzers enable the user to read or interpret their Breath Alcohol 70 .02 or BreathScan® .02 Detectors charged by human breath. The system provides an indication of the possible presence of alcohol in the blood of the test subject.

The detectors contains chemicals that change color in the presence of alcohol vapors) utilizing the patented technology (US Patent No. 4,740,475). The Detector consists of two parts. One part is a glass capsule containing light yellow crystals that change color when exposed to alcohol vapors. The other part is a plugged, plastic tube with an opening to blow into while running the test.

If alcohol is present. the crystals will change from yellow to light green/blue. How many crystals turn color will depend on the cut-off of the Detector and how much alcohol is in the breath.

The yellow crystals in the Detector are coated with potassium dichromate (K2Cr2O7) and sulfuric acid (H2SO4). The amount of these indicator chemicals is adjusted according to the selected cutoff of the Detector. A color change is produced when alcohol vapors are oxidized to acetic acid and the indicator chemicals change to chromium suffate [Cr2(SO4)3]. The majority of crystals change from yellow to light aqua (greenish-blue/bluish-green) when alcohol vapors are present at a level equal to or exceeding the cutoff of the Detector.

The blow bags are re-usable and serve as a method to assure that the subject has blown through the Detector with adequate air. With the Breath Alcohol . 02 Detection System, this is required (DOT/NHTSA compliance) and is listed as an option in the BreathScan® .02 Breath Alcohol Detection System.

The Breath Alcohol Z .02 and BreathScan® .02 Electronic Analyzers are selfcontained, sealed devices where the Breath Alcohol or BreathScan® Detector charged with human breath is inserted into the device to begin the reading process. The internal make-up of the Electronic Analyzer is the same for both models. The only difference is how the detector is positioned or inserted into the device. Using the Breath Alcohol .02 Detection System, the detector is inserted into a sample port; whereas using the BreathScan® .02 Breath Alcohol Detection System, the detector is placed in a nested holder.

The Electronic Analyzer automatically turns on and the lights will flash instantaneously, indicating the respective result. The device comes pre-calibrated to the user for the cut-off sensitivity of the Breath Alcohol 700.02 or BreathScan® .02 Detector lot being "read" in the analyzer. A negative result is indicated by a continuously flashing green LED and a positive result is indicated by a continuously flashing red LED.

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

Acceptance Criteria and Device Performance

The provided document describes the device's performance against two main types of criteria: comparison to an evidentiary breath test and compliance with DOT/NHTSA guidelines. The tables below summarize the device performance against the stated categories.

Detection System: Breath Alcohol 70 .02 Detection System and BreathScan® .02 Breath Alcohol Detection System

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size:
     • For the Breath Alcohol ® .02 Detection System: 22 + 3 + 8 + 11 = 44 cases
     • For the BreathScan® .02 Breath Alcohol Detection System: 22 + 3 + 8 + 11 = 44 cases
     • It appears to be the same set of 44 cases for both devices, as the performance numbers are identical in Table 1 and Table 2.
   • Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It describes "bench test and user testing data," which typically implies a prospective study conducted specifically for validation.

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

   • The ground truth was established by comparison to an "Evidentiary Breath Test (Alco-Sensor IV)," which is described as a "DOT/NHTSA approved device." This reference device acts as the "gold standard" or ground truth. The study does not mention human experts establishing ground truth for the alcohol levels themselves, but rather relies on the measurement from the Alco-Sensor IV.

3. Adjudication Method for the Test Set:

   • No adjudication method is mentioned in the context of resolving discrepancies between multiple readers or ground truth. The comparison is directly between the investigational device's reading and the "Evidentiary Breath Test" (Alco-Sensor IV) result.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This device is a standalone detection system, not an AI-assisted diagnostic tool for human interpretation.

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

   • Yes, the performance presented in Tables 1 and 2 appears to be a standalone (algorithm only) performance. The "Electronic Analyzer" automatically turns on and the lights flash indicating the result ("continuously flashing green LED" for negative, "continuously flashing red LED" for positive). There is no mention of human interpretation influencing the final reported result from the device itself for these comparison tests. User studies were performed to ensure proper device use, but the device's output is automatic.

6. Type of Ground Truth Used:

   • The ground truth used was comparison to a reference device, specifically the "Evidentiary Breath Test (Alco-Sensor IV)." The Alco-Sensor IV is considered a "DOT/NHTSA approved device," implying it is a validated and accepted method for determining breath alcohol concentration.

7. Sample Size for the Training Set:

   • The document does not provide information regarding a separate training set or its sample size. This type of device, based on a chemical reaction read by an electronic analyzer, typically undergoes calibration during manufacturing rather than machine learning training. The device "comes pre-calibrated... for the cut-off sensitivity."

8. How the Ground Truth for the Training Set Was Established:

   • As no training set is explicitly mentioned in the provided text for a machine learning context, the method for establishing its ground truth is not applicable or not provided. The device's calibration is mentioned, which would involve setting its sensitivity against known alcohol standards.

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The BreathScan® Alcohol Detector is an in vitro medical device to qualitatively detect the presence of alcohol in the human breath. It is a disposable screening device for one-time use. The detector is available at several detection cut-offs; 0.02, 0.04, 0.05, and 0.08 percent breath alcohol. The device is used only as a screening device and is only an indication of the possible presence of alcohol in the blood of the test subject. Correlation between breath alcohol_content and blood alcohol content depends on many variables. BreathScan is not intended to legally determine blood alcohol presence, level, or inference of intoxication.

The BreathScan® Alcohol Detector (Tester) is a visual qualitative test for alcohol in human breath. The Tester contains chemicals that change color in the presence of alcohol vapors) utilizing the patented technology (4,740,475). The Tester is made up of a 2-part glass vessel inside a plastic tube. One part contains light yellow crystals that change color when exposed to alcohol vapors. The other part is an opening to blow into while running the test. If alcohol is present, the crystals will change from yellow to light green/blue. How many crystals turn color will depend on the cut-off of the Tester and how much alcohol is in the breath. The yellow crystals in the Tester are coated with potassium dichromate (K)Cr30-) and sulfuric acid (H2SO4). The amount of these indicator chemicals is adjusted according to the selected cutoff of the Tester. A color change is produced when alcohol vapors are oxidized to acetic acid and the indicator chemicals change to chromium sulfate [Cr2(SO4)3]. The majority of crystals change from vellow to light aqua (greenish-bluish-green) when alcohol vapors are present at a level equal to or exceeding the cutoff of the Tester. The BreathScan® Tester is available in several cut-offs (.02%, .04%, .05%, and .08%). The cut-off is printed on the Tester label and is expressed as a specific percentage of breath alcohol.

Here's a breakdown of the acceptance criteria and the study information for the BreathScan® Alcohol Detector, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The provided text indicates that the BreathScan® Alcohol Detector was evaluated against the guidelines of the DOT/NHTSA Model Specifications for Alcohol Screening Devices. While specific numerical acceptance criteria from the DOT/NHTSA Model Specifications are not explicitly stated in the document, the device's performance is compared to a predicate device (ALCO SENSOR IV) and is assessed for user readability and usability.

Implicit Acceptance Criteria (derived from the text):

• Accuracy against a standard: Performance should be comparable to or meet the guidelines of validated evidentiary breath tests (like ALCO SENSOR IV) and DOT/NHTSA Model Specifications.
• User Usability: Users should be able to read and understand directions and properly use the device.
• Low False Positives: The device should have a low rate of false positive readings when no alcohol is present.

Here's a table summarizing the observed performance for the 0.04% BreathScan® Tester:

Additional Performance Metric:

• False Positives (without alcohol): 1 false positive reading out of 1200 readings (for the 0.04% tester) that did not contain alcohol. This indicates a very low rate of false positives when no alcohol is present.

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • For the comparison study with the Alco-Sensor IV: The numbers in Table 1 sum to 93 test cases (0+0+15+10+37+25+5+1 = 93) for the 0.04% tester's comparison to the predicate device.
  • For the false positive evaluation: 1200 readings of the 0.04% tester did not contain alcohol.
• Data Provenance: Not explicitly stated (e.g., country of origin). The data appears to be prospective as it involves "user studies" and "bench testing" performed to establish device performance.

3. Number of Experts and Qualifications (Ground Truth for Test Set)

• Number of Experts: Not specified.
• Qualifications of Experts: The ground truth comes from an "evidentiary breath test, the ALCO SENSOR IV manufactured by Intoximeters, Inc. which is a DOT/NHTSA approved device." It also mentions it was "administered by a trained technician." While not "experts" in the sense of medical specialists, the ground truth is established by a validated, approved device and trained personnel.

4. Adjudication Method for the Test Set

The adjudication method wasn't explicitly described in terms of "2+1" or "3+1." The comparison relies on a single predicate device (ALCO SENSOR IV) as the reference standard. The results from the BreathScan® are then compared directly to the categorization provided by the ALCO SENSOR IV.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or conducted as described (i.e., comparing human readers with and without AI assistance). The "user studies" mentioned focus on the user's ability to read directions and use the device, not on improving human reader performance with AI. The device itself is a standalone qualitative test.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance assessment was done. The BreathScan® Alcohol Detector is a standalone device that provides a qualitative visual result (color change) without human interpretation beyond observing the color. The "bench and user testing" results, particularly the comparison to the Alco-Sensor IV and the false positive rate evaluation, represent a standalone performance assessment of the device itself.

7. Type of Ground Truth Used (for Test Set)

The primary ground truth used for the test set was:

• Comparison to an Evidentiary Breath Test: The ALCO SENSOR IV, a DOT/NHTSA approved device, served as the reference standard for actual breath alcohol concentrations.
• Known Alcohol Content: For the false positive evaluation, the "1200 readings... that did not contain alcohol" indicates controlled samples with known negative alcohol content.

8. Sample Size for the Training Set

The document does not explicitly mention a separate "training set" or its sample size. This type of device (chemical reaction-based) typically does not involve machine learning or an explicit "training phase" in the way an AI algorithm would. Its development likely involved calibration and validation against known alcohol concentrations in a lab setting during its design and manufacturing, rather than a data-driven training set for an algorithm.

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

Since a "training set" for an AI algorithm is not applicable, the concept of establishing ground truth for it is also not applicable here. The device's calibration and performance were likely established through engineering and chemical validation against known concentrations of alcohol and performance testing against established standards (e.g., DOT/NHTSA).

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The Heparin/Platelet Factor 4 Antibody Serum Panel is an assayed control, intended for use as a serum QC control to monitor and evaluate precision and accuracy of the (qualitative) PIFA® Heparin/PF4 Antibody Assay. Included are both confirmed positive and negative control panel members.

The panel members enable the users to evaluate their PIFA® Heparin/PF4 Antibody Assay test systems and provide comprehensive data for comparative analysis.

The Heparin/Platelet Factor 4 Antibody Serum Panel is a well-qualified serum sample identified as a positive or negative sample against the PIFA® Heparin/Platelet Factor 4 Antibody Assay. The panels are assembled from its repository of frozen serum samples, with reactivity as determined by the (FDA cleared) GTT® PF4 ENHANCED® ELISA Assay test currently available within the United States. No preservatives are added. Samples are chosen to provide a broad range of reactivity and to include samples with low antibody levels and samples with high antibody levels. A "positive" identified serum panel has OD values greater than 0.400 as determined on the GTT® PF4 ENHANCED® ELISA Assay test.

Two types of kit configurations are available, specifically for use on the PIFA ® Heparin/Platelet Factor 4 Antibody Assay test systems: 2 Member QC Panel (1 positive and 1 negative sera) and Multi-Member Qualification Panel (either a 12-Member (10 positive and 2 negative sera) or 6-Member (5 positive and 1 negative sera)). All panel member vials each contain approximately 150 ul in total volume.

Here's an analysis of the acceptance criteria and study information provided for the Heparin/Platelet Factor 4 Antibody Serum Panel:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a numerical or target performance metric for the device itself. Instead, it describes the expected consistent performance of the control panel members when tested with the PIFA® Heparin/Platelet Factor 4 Rapid Assay and correlation with the GTT® PF4 ENHANCED® ELISA Assay. The performance is reported in terms of reproducibility and precision.

Here's a table summarizing the reported device performance in relation to what can be inferred as expected outcomes:

Note on "Acceptance Criteria": The document focuses more on demonstrating the consistency and stability of the control panels, rather than setting specific quantitative acceptance thresholds for accuracy or sensitivity/specificity of the control panels themselves. The "acceptance" is implied by the consistent and expected categorization (positive/negative) of the control samples.

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

• Reproducibility Study (Study #1):

  • Sample Size: 40 positive samples and 20 negative samples were tested repeatedly. (Total = 60 distinct samples, each tested in duplicate over 5 days through varying freeze-thaw cycles).
  • Data Provenance: Not explicitly stated, but the testing was performed "internally" and/or by an "independent laboratory." There is no mention of country of origin of the data. The study design ("repetition of the testing procedure utilizing the PIFA® Heparin/Platelet Factor 4 Rapid Assay in conjunction with the GTT® PF4 ENHANCED® ELISA Assay") suggests a controlled lab setting.
  • Retrospective/Prospective: Not explicitly stated, but the studies describe active testing being performed, suggesting a prospective design from the perspective of generating the performance data for the panels. The repository of frozen serum samples from which the panels are assembled would likely be existing (retrospective collection), but the testing itself is prospective.

• Precision Study (Study #2):

  • Sample Size: 30 positive samples and 20 negative samples were tested. (Total = 50 distinct samples, each tested in multiple formats.)
  • Data Provenance: Same as Reproducibility Study – "internally" and/or "independent laboratory", no country of origin, likely prospective testing on existing samples.

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

The ground truth for the test set (the characterization of the control samples as "positive" or "negative") was established using the FDA cleared GTT® PF4 ENHANCED® ELISA Assay.

• Number of Experts: Not applicable in the context of human experts.
• Qualifications of Experts: Not applicable. The ground truth relies on the performance of a previously cleared, predicate assay.
• The document states: "A 'positive' identified serum panel has OD values greater than 0.400 as determined on the GTT® PF4 ENHANCED® ELISA Assay test." This establishes the objective criterion for ground truth.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by an objective assay (GTT® PF4 ENHANCED® ELISA Assay) with a clear optical density (OD) cutoff, not through expert 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

Not applicable. This device is an assayed control panel, not an AI diagnostic device that assists human readers.

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

This is not an algorithm or AI device. It is a physical control panel. The performance described is the standalone performance of the control panel itself when used with the PIFA® Heparin/Platelet Factor 4 Rapid Assay, and its correlation with the predicate GTT® PF4 ENHANCED® ELISA Assay.

7. The Type of Ground Truth Used

The ground truth used for characterizing the control panel members (determining if they are "positive" or "negative") was based on the performance of a predicate, FDA-cleared laboratory assay (GTT® PF4 ENHANCED® ELISA Assay) with objective quantitative cutoff values (OD > 0.400 for positive).

8. The Sample Size for the Training Set

The concept of a "training set" is not directly applicable here in the machine learning sense. The panels are assembled from a repository of frozen serum samples, but the document does not specify the total size of this repository or how many samples were used for "training" in the sense of developing the panel characteristics. The samples chosen for the panels "provide a broad range of reactivity and to include samples with low antibody levels and samples with high antibody levels," implying selection criteria rather than an algorithmic training process.

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

Similarly to the test set, the characterization of the samples within the repository (and thus, for any "training" or selection process for the panels) would have been established by determining their reactivity using the GTT® PF4 ENHANCED® ELISA Assay. The document states that the reactivity was "as determined by the (FDA cleared) GTT® PF4 ENHANCED® ELISA Assay test."

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The InstaRead™ Lithium System is intended to measure lithium blood levels in whole blood (fingerstick or venous). Measurements of lithium are used to aid in the management of individuals taking lithium for the treatment of mental disturbances, such as manic-depressive illness (bipolar disorder).

Not Found

Here's the information about the acceptance criteria and the study for the InstaRead™ Lithium System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain specific acceptance criteria for performance metrics (like accuracy, precision, or comparison to a predicate device). It primarily focuses on the regulatory approval for marketing.

However, based on the context of a "Lithium test system," typical acceptance criteria would involve demonstrating equivalency to a legally marketed predicate device in terms of:

• Accuracy/Correlation: How well the device's measurements correlate with a reference method or predicate device.
• Precision/Reproducibility: The consistency of results when the same sample is tested multiple times.
• Linearity/Range: The ability of the device to accurately measure lithium across its claimed analytical range.

Since these specific criteria and their actual performance values are not detailed in the provided FDA letter, the table below reflects what would typically be expected in such a submission, but with "Not Specified" for the actual values. The document states a "substantial equivalence determination," implying these criteria were met.

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