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The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).

The Impact PEEK Union Nail System represents a cutting-edge fixation device crafted from advanced HA Enhanced PEEK. The system is versatile, offering a range of lengths and diameters to suit various clinical needs, and features a cannulated design for precise k-wire guidance. Additionally, it integrates tantalum pins to ensure optimal imaging visibility, enhancing surgical accuracy and outcomes.

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The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).

The Impact PEEK Union Nail System contains 3.0mm - 4.5mm diameter, 50mm long pins manufactured from HA Enhanced PEEK (ASTM F2026). The implants are designed with strategically placed ridges to improve initial stability and cannulated structure to simplify insertion over a k-wire. Additionally, it was designed to include tantalum pins to ensure optimal imaging visibility for device placement accuracy.

The provided document is a 510(k) clearance letter from the FDA for a medical device called the "Impact PEEK Union Nail System." This letter details the administrative aspects of the clearance, including the device name, manufacturer, regulatory classification, and the FDA's determination of substantial equivalence to predicate devices.

However, it does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria for software-based or AI/ML-driven medical devices.

The document specifically states:

• "No FDA performance standards have been established for the Impact PEEK Union Nail System."
• The non-clinical testing performed includes "Static and Dynamic Bending, Axial Pullout (ASTM F1264-16, ASTM F543-17)" and "Shear Testing (ASTM D2344)." These are mechanical and material property tests common for orthopedic implants, not studies designed to assess the performance of a software algorithm or AI model in an clinical setting.
• The "Equivalence to Predicate Devices" section emphasizes "similar design and similar dimensions," manufacturing material (HA Enhanced PEEK), "same intended use," and "similar technological characteristics," all referring to the physical implant rather than computational performance.

Therefore, I cannot extract the requested information from this document because it pertains to a physical orthopedic implant, not an AI/ML or software-driven medical device. The questions you've asked (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC studies, standalone algorithm performance) are highly relevant to the validation of AI/ML medical devices but are not applicable to the type of device described in this 510(k) clearance letter.

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ImPACT is intended for use as a computer-based neurocogntive test battery to aid in the assessment and management of concussion.

ImPACT is a neurocognitive test battery that provides healthcare professionals with objective measure of neurocognitive functioning as an assessment aid and in the management of concussion in individuals ages 12-80.

ImPACT® (Immediate Post-Concussion Assessment and Cognitive Testing) is a computer-based neurocognitive test battery that allows healthcare professionals to conduct a series of tests on individuals to gather data related to the neurocognitive functioning of the test subject. This test battery measures various aspects of neurocognitive functioning including reaction time, memory, attention, spatial processing speed, and records symptoms of a test subject. ImPACT Version 4 is similar to the paper-and-pencil neuropsychological tests that have long been used by psychologists to evaluate cognition, and memory related to a wide variety of disabilities.

The device is not intended to provide a direct diagnosis or a return-to-activity recommendation, it does not directly manage or provide any treatment recommendations, and any interpretation of the results should be made only by qualified healthcare professional. The neurocognitive assessment represents only one aspect of assisting healthcare professionals in evaluating and managing individuals with cognitive function impairment related to TBI (concussion).

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

Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to a predicate device (ImPACT Version 4, K202485) rather than explicitly listing quantitative acceptance criteria for each neurocognitive measure. However, the core of the performance demonstration rests on the establishment of a normative database for iPad use and test-retest reliability consistent with previous versions.

Implied Acceptance Criteria and Performance:

Detailed Study Information:

1. Sample Size and Data Provenance:

   • Test Set (Normative Data):
     • Sample Size: 1495 subjects.
     • Data Provenance: Prospectively collected from 4 different sites across the US in 2022 and 2023.
     • Type: Prospective.
   • Test Set (Test-retest Reliability):
     • Sample Size: 116 individuals, a subset of the normative sample.
     • Data Provenance: Prospectively collected from the same US sites as the normative data, in 2022 and 2023.
     • Type: Prospective.

2. Number of Experts and Qualifications for Ground Truth:

   • The document does not explicitly state the number or qualifications of experts used to establish a "ground truth" in the traditional sense of a diagnostic consensus.
   • For the normative and test-retest studies, the "ground truth" is primarily based on the self-reported health status of the participants (e.g., "not suffering from a concussion or being treated for a concussion in the past 6 months," "no known physical, neurological, behavioral or psychological impairment"). The inclusion criteria, which participants had to meet, effectively defined the "healthy" or "normal" population against which the device's performance is normed.
   • Clinical experts were part of the "cross-functional team" involved in "Walkthroughs and design reviews of mock-ups and prototypes" during software verification, but not explicitly for ground truth establishment for the clinical study data itself.

3. Adjudication Method for the Test Set:

   • The document does not describe an adjudication method for the clinical study data. The studies focused on collecting representative data from healthy individuals to establish norms and assess reliability, rather than evaluating the device's diagnostic accuracy against a separate, adjudicated clinical diagnosis.

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

   • No, an MRMC comparative effectiveness study was not performed. This device is a neurocognitive test battery, not an imaging AI diagnostic aid meant to be used by multiple readers on the same cases. The "human-in-the-loop" aspect is not about human readers interpreting AI output, but rather healthcare professionals using the device's objective measures to aid in assessment and management.

5. Standalone Performance:

   • The device ImPACT is a "computer-based neurocognitive test battery." The performance described (normative data collection, test-retest reliability) is inherently the "algorithm only" performance, where the "algorithm" refers to the test battery itself and its scoring methodology. The device provides "objective measure of neurocognitive functioning," which is its standalone output. The interpretation of these results is then done by a qualified healthcare professional.
   • So, yes, a standalone performance assessment was done in the form of normative data collection and test-retest reliability, demonstrating the device's intrinsic ability to measure cognitive function consistently in an uninjured population.

6. Type of Ground Truth Used:

   • The primary ground truth for the normative database was the self-reported clinical status and inclusion/exclusion criteria of the participants, aiming for a "healthy" or "uninjured" cognitive state. This serves as the reference for "normal" cognitive functioning.
   • For the test-retest reliability, the implicit ground truth is that the cognitive state of the healthy individuals should not have changed significantly between the two tests, allowing for an evaluation of the device's consistency.

7. Sample Size for the Training Set:

   • The document does not explicitly describe a separate "training set" for an AI or machine learning model in the context of this 510(k) submission.
   • The term "normative database" sometimes functions similarly to a reference or training set in that it establishes what "normal" looks like. In this case, the 1495 subjects for the normative database building represent the data used to define the expected range of performance.
   • The "training" of the neurocognitive test itself, being a standardized battery, is more akin to its initial development and validation stages prior to the specific modifications addressed in this 510(k). The current submission focuses on adapting an existing, validated test to a new platform (iPad) and updating its normative reference.

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

   • As mentioned above, if the normative database is considered the "training set" for defining normal performance, its "ground truth" was established by prospectively enrolling individuals who met strict inclusion criteria indicating they were healthy, English-speaking, not suffering from or recently treated for a concussion, and without other known neurological/physical impairments that would affect test performance. This was overseen by ethics boards and involved multiple US sites.

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This is a portable X-ray system with following limitations of use: The device may be used for handheld diagnostic imaging of body extremities. The device may be used for stand mounted diagnostic imaging of head, abdomen, or extremities. The device may be used for stand mounted imaging of the chest when used without a grid. - Not to be used on bariatric patients, unless imaging body extremities - Not for mammography use - This device is not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types.

This is a complete portable battery operated digital x-ray system with the indications for use stated above. It consists of the battery operator described in K182207 paired with the wireless battery operated digital x-ray acquisition components described in K191451. This is therefore a new combination of all previously cleared components. The digital x-ray receptor system uses a wireless panel and a Dell laptop computer fitted with a 300Mbps Mini Wireless N USB Adapter. The generator can be hand held (within the limitations of the indications), tripod mounted, or mobile stand mounted. Two models are proposed: IMPACT and X-RANGER. The two models differ in their targeted markets and in the type of computer supplied. The IMPACT uses a DELL PRECISION 3550 Laptop whereas the X-RANGER uses a DELL LATITUDE 7424 RUGGED LAPTOP. The IMPACT is aimed at the commercial market whereas the X-RANGER is aimed at the military market. The software is unmodified from that employed in our reference device (K191451) and it remains at a moderate level of concern. The image receptor (cleared under K191451) is wireless and measures 14x17 inches.

The provided text describes a 510(k) premarket notification for the MinXray IMPACT and X-Ranger portable X-ray systems, establishing substantial equivalence to a predicate device (TR90BH K182207) and referencing an imaging system (CMDR 2CW K191451).

However, the document does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria. Instead, it focuses on demonstrating substantial equivalence based on the device's intended use, technological characteristics, and compliance with various safety and performance standards for medical electrical equipment.

The relevant information regarding performance is limited to:

• Panel Performance: Panel MTF ~63% (@ 1lp/mm) and Panel DQE ~62% (@ 0lp/mm), which are properties of the digital image capture panel (from reference device K191451), not acceptance criteria for the overall X-ray system.
• Safety and Effectiveness: Stated that "The results of bench testing indicates that the new device is as safe and effective as the predicate device. Proper system operation is fully verified upon installation." This is a general statement, not a specific performance metric against acceptance criteria.

Therefore, many parts of your request for acceptance criteria and a study proving their fulfillment cannot be answered from the provided text.

Here's an attempt to answer the questions based on the available information, noting where data is missing:

1. Table of acceptance criteria and the reported device performance

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

• The document primarily describes non-clinical bench testing and compliance with standards. It does not refer to a test set in the context of image data for diagnostic performance evaluation.
• No information on data provenance (country of origin, retrospective/prospective) is provided, as no such image-based test set is detailed.

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

• Not applicable. No image-based test set with ground truth established by experts is mentioned. The software for image acquisition is described as "unmodified" and "remains at a moderate level of concern." "Overall operation" was verified by "reviewing test images," but the reviewers' qualifications are not stated.

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

• Not applicable. No image-based test set requiring an adjudication method is described.

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

• No MRMC or comparative effectiveness study involving human readers or AI assistance was performed or mentioned. The device is purely an X-ray system, not an AI-assisted diagnostic tool.

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

• Not applicable. This is an X-ray imaging device, not a standalone algorithm.

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

• Not applicable. No diagnostic ground truth was established as part of this submission, which focused on the safety and performance of the X-ray system itself.

8. The sample size for the training set

• Not applicable. No training set for an algorithm is mentioned as this is a hardware device submission.

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

• Not applicable.

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ImPACT is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion.

ImPACT is a neurocognitive test battery that provides healthcare professionals with objective measures of neurocognitive functioning as an assessment aid and in the management of concussion in individuals ages 12-80.

ImPACT® (Immediate Post-Concussion Assessment and Cognitive Testing) is a computer-based neurocognitive test battery that allows healthcare professionals to conduct a series of tests on individuals to gather data related to the neurocognitive functioning of the test subject. This test battery measures various aspects of neurocognitive functioning including reaction time, memory, attention, spatial processing speed, and records symptoms of a test subject. ImPACT Version 4 is similar to the paper-and-pencil neuropsychological tests that have long been used by psychologists to evaluate cognition, and memory related to a wide variety of disabilities.

The device is not intended to provide a direct diagnosis or a return-to-activity recommendation, it does not directly manage or provide any treatment recommendations, and any interpretation of the results should be made only by qualified healthcare professional. The neurocognitive assessment represents only one aspect of assisting healthcare professionals in evaluating and managing individuals with cognitive function impairment related to TBI (concussion).

Here's a breakdown of the acceptance criteria and the study information for the ImPACT Version 4 device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA submission primarily focuses on demonstrating substantial equivalence to a predicate device (ImPACT Version 3.3.0) rather than listing specific, quantitative acceptance criteria for each functional aspect. The document indicates that all software verification and validation tests met the required acceptance criteria, but these criteria are described generally rather than with specific metrics.

However, based on the summary of performance testing and clinical data, the implicit acceptance criteria relate to:

• Software Functionality: The software performs as intended, modifications did not affect existing functionality.
• Safety and Effectiveness: The device modifications do not raise new questions of safety and effectiveness.
• Test-Retest Reliability (for extended age range): Cognitive performance should remain stable over time.
• Construct Validity (for extended age range): ImPACT Version 4 scores should correlate with established neuropsychological tests.
• Normative Database Quality: The normative data should be accurately established for the specified age ranges, differentiating between input device types.

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

The document describes several "clinical studies" or investigations which serve as test sets for different aspects (normative data, reliability, validity).

• For the 12-59 age range (normative database update):
  • Sample Size: 71,815 subjects.
  • Data Provenance: Retrospective, de-identified data from the Company's test database of 766,093 subjects. Subjects were from the United States of America.
• For the 60-80 age range (normative database, test-retest reliability, construct validity):
  • Normative Sample Size: 554 subjects (174 males, 380 females).
  • Test-retest Reliability Sample Size: 93 individuals (a subset of the normative extension sample, 64.5% females, 35.5% males).
  • Construct Validity Sample Size: 71 individuals (ages 60-80, 63.4% females, 36.6% males).
  • Data Provenance: Prospective clinical investigation. Data collected from 8 different sites across the United States (universities, hospitals, clinics, private medical practices). Data collection began in 2017 and ended in 2020.

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

• The document does not explicitly state the number of experts used to establish a "ground truth" for the test set in the sense of adjudicating concussion status for individual subjects within the studies.
• For the construct validity study, the document states: "All measures were administered by Neuropsychologists trained in test administration as part of the study to collect data for normative dataset described above." These Neuropsychologists administered the comparative tests (HVLT, BVMT-R, SDMT) which served as the "ground truth" or reference standard for comparison, but they were not adjudicating the ImPACT scores or concussion status. They were experts in administering and interpreting the comparative neuropsychological tests.

4. Adjudication Method for the Test Set

• The document does not describe an "adjudication method" in the typical sense (e.g., 2+1 rater adjudication) for determining ground truth of concussion or for evaluating the ImPACT scores.
• Instead, the studies used established clinical methods:
  • For the normative database, subjects were selected based on self-reported criteria (no recent concussion, no neurological issues, no ADHD/LD diagnosis) and, for the 60-80 age range, MMSE scores (>24).
  • For construct validity, the reference standards were scores from other validated neuropsychological tests administered by trained neuropsychologists.

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, the document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study evaluating how human readers (healthcare professionals) improve with ImPACT Version 4 assistance versus without it.
• ImPACT is presented as an "aid" in assessment and management, providing objective measures, but the study design did not assess the human reader's diagnostic performance with and without the device.

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

• Yes, the performance testing described for ImPACT Version 4 is in a standalone capacity. The device itself (the neurocognitive test battery) collects and processes data, and its outputs (scores, validity indicators) are what were evaluated for reliability and validity against other tests or over time. The "performance" being assessed is that of the computerized test generating consistent and correlated results, not a human using the device to make a decision.

7. The Type of Ground Truth Used

• For the normative database: The "ground truth" for subject inclusion was based on self-reported health status (no recent concussion, no neurological issues, no ADHD/LD) and, for the older age group, a basic cognitive screen (MMSE score > 24). The purpose was to establish norms for a healthy population.
• For test-retest reliability: The "ground truth" was the expectation that cognitive performance in a stable individual should not significantly change over a short period.
• For construct validity: The "ground truth" was established by scores from other widely utilized and previously validated traditional neuropsychological tests (HVLT, BVMT-R, SDMT).

8. The Sample Size for the Training Set

• The document does not explicitly mention a "training set" in the context of machine learning model development. ImPACT is described as a "computer-based neurocognitive test battery" and its modifications primarily involve updating the normative database and output scores, not training a new predictive algorithm.
• The "normative database" could be considered analogous to a reference dataset that the device's scoring relies upon.
  • For ages 12-59: The normative database was constructed from 71,815 subjects.
  • For ages 60-80: The normative database was constructed from 554 subjects.

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

• As mentioned above, there isn't a "training set" for a machine learning model described.
• For the normative databases, which serve as the reference for interpreting individual test results, the "ground truth" for inclusion was:
  • For 12-59 age range: De-identified data selected from a large company database. Subjects had to meet criteria such as no concussion in the past 6 months, no other neurological issues, no ADHD/LD diagnosis. These were self-reported or existing medical history.
  • For 60-80 age range: Prospective data collection where subjects met strict inclusion criteria: ages 60-80, primary English speaking, not in a skilled nursing facility, not suffering from/being treated for a concussion, no known impairing physical/neurological/behavioral/psychological conditions, corrected hearing/vision within normal limits, and a Mini-Mental State Examination (MMSE) score of 24 or greater. This was established through screening and clinical assessment at 8 different sites.

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ImPACT is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion.

ImPACT is a neurocognitive test battery that provides healthcare professionals with objective measure of neurocognitive functioning as an assessment aid and in the management of concussion in individuals ages 12-59.

ImPACT® (Immediate Post-Concussion Assessment and Cognitive Testing) is a computer-based neurocognitive test battery.

lmPACT is a software-based tool that allows healthcare professionals to conduct a series of neurocognitive tests on individuals to gather basic data related to the neurocognitive functioning of the test subject. This computerized cognitive test battery evaluates and provides a healthcare professional with measures of various neurocognitive functions, including the reaction time, memory, attention, spatial processing speed and symptoms of an individual.

lmPACT provides healthcare professionals with a set of well-developed and researched neurocognitive tasks that have been medically accepted as state-of-the-art best practices and is intended to be used as part of a multidisciplinary approach to making return to activity decisions.

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

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it describes general claims of conformance and successful verification/validation. The core acceptance criterion for the device modification (allowing unsupervised baseline testing) appears to be that this change does not affect the safety or effectiveness of ImPACT for its intended use, particularly that the number of invalid self-administered tests are not different when compared to the supervised environment.

Study Details

This submission describes changes to an already cleared device, primarily regarding the use environment for baseline testing (allowing unsupervised baseline testing). Therefore, the "study" is focused on demonstrating that this modification does not negatively impact the device's performance or safety.

1. A table of acceptance criteria and the reported device performance: (See table above).

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

• Usability/Validity Study: 162 subjects.
  • Composition: 74 college students, 44 Middle and High School students, and 44 adults.
  • Provenance: Not explicitly stated, but implied to be from the US given the FDA submission. It's a prospective study conducted specifically for this device modification.
• Clinical Data (Test-Retest Reliability Study): 50 participants.
  • Provenance: Not explicitly stated, but implied to be from the US. This was a prospective 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 mention the use of experts to establish ground truth for this specific validation study related to the device modification.
• The clinical study focused on test-retest reliability within individuals performing the ImPACT test. The "truth" here is the individual's own performance consistency, not an external expert's diagnosis.
• The overall ImPACT device, as a "computerized cognitive assessment aid," is designed to provide "objective measures of neurocognitive functioning" that healthcare professionals interpret. The "ground truth" for concussion diagnosis itself relies on a multidisciplinary approach by healthcare professionals, which the device aids in, rather than determines independently.

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

• No adjudication method is described for the test sets. The studies are evaluating the device's output (invalidity rates, reliability scores) directly from participant interactions with the modified device.

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

• No MRMC comparative effectiveness study was done or described. This submission is for enabling unsupervised baseline testing, not for evaluating human reader performance with or without AI assistance. The device is the assessment aid for healthcare professionals.

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

• Yes, both "studies" implicitly evaluated the standalone performance of the ImPACT device in the context of the proposed unsupervised use environment.
  • The usability assessment determined the rate of invalid tests when self-administered.
  • The clinical data study evaluated the test-retest reliability of the ImPACT scores themselves, independent of human interpretation during the testing phase.
  • The device's output (scores, invalidity indicators) is generated by the algorithm, which is then provided to healthcare professionals.

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

• For the usability/validity study (unsupervised testing): The "ground truth" was internal to the ImPACT system – the device's own "Invalidity Indicator" function was used to determine if results were "invalid." This is based on pre-established criteria within the device, not external expert consensus for each individual test. The comparison was against reported invalidity rates in supervised environments from literature.
• For the test-retest reliability study: The "ground truth" was the consistency of an individual's performance on the test over time. This is assessed statistically using measures like Pearson correlations and Intraclass Correlation Coefficients (ICCs). There is no "ground truth diagnosis" being established here, but rather the reliability of the measurement.

8. The sample size for the training set:

• The document does not provide information on the training set or how the core ImPACT algorithm was initially developed/trained. This submission is for a device modification (change in use environment, minor UI adjustment) of an already cleared predicate device (K170209). The fundamental neurocognitive test battery design and algorithms are stated to be "identical to the original version."

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

• As mentioned above, this information is not provided in this 510(k) summary for the modified device. The document states that the neurocognitive tasks "have been medically accepted as state-of-the-art best practices," implying that the underlying methodology for generating the neurocognitive measures is well-established, but details on the initial training data and ground truth establishment for the original algorithm are absent.

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ImPACT Quick Test is intended for use as a computerized cognitive test aid in the assessment and management of concussion in individuals ages 12-70.

ImPACT Quick Test (ImPACT) QT is a brief computerized neurocognitive test designed to assist trained healthcare professionals in determining a patient's status after a suspected concussion. ImPACT QT provides basic data related to neurocognitive functioning, including working memory, processing speed, reaction time, and symptom recording.

ImPACT QT is designed to be a brief 5-7 minute iPad-based test to aid sideline personnel and first responders in determining if an athlete/individual is in need of further evaluation or is able to immediately return to activity. ImPACT QT is not a substitute for a full neuropsychological evaluation or a more comprehensive computerized neurocognitive test (such as ImPACT).

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

Acceptance Criteria and Device Performance

The document does not explicitly state a table of pre-defined acceptance criteria for the ImPACT Quick Test itself, in terms of specific performance thresholds (e.g., a minimum correlation coefficient). Instead, the studies aim to demonstrate construct validity, concurrent validity, and test-retest reliability as evidence of the device's performance, aiming to show substantial equivalence to the predicate device.

The reported device performance aligns with these goals:

Study Details

The provided document describes several studies to support the predicate device equivalence and performance of the ImPACT Quick Test.

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

   • Concurrent Validity Study: 92 subjects (41 males, 51 females; average age 36.5 years, range 12-76 years).
   • Construct Validity Study: 118 subjects (73 females, 45 males; average age 32.5 years, range 18-79 years).
   • Test-Retest Reliability Study: 76 individuals.
   • Normative Database Development: 772 subjects.
   • Data Provenance: All subjects were recruited from 11 sites across the United States. All subjects completed an IRB approved consent form and met eligibility criteria. The studies appear to be prospective in nature, collecting new data for these specific analyses.

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

   • The concept of "ground truth" for the test set in this context applies differently. For the concurrent and construct validity studies, the "ground truth" or reference standards were the predicate device (ImPACT) and established traditional neuropsychological tests (BVMT-R, CTT, SDMT). The performance of these reference tests themselves is considered the standard.
   • For the administration of the tests and data collection, the document states: "All testing was completed by professionals who were specifically trained to administer the test. These professionals consisted of neuropsychologists, physicians, psychology/psychology/psychology graduate students, certified athletic trainers and athletic training graduate students. All testing was completed in a supervised setting." While this describes the administrators, it doesn't specify how many "experts" established a singular ground truth for any given case, as the outputs are quantitative cognitive scores.

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

   • The document does not describe an adjudication method for the test set as would typically be seen in diagnostic studies where expert consensus determines a disease state. The outputs of the device and the comparison tests are quantitative scores, not subjective interpretations requiring adjudication.

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 focusing on human reader improvement with AI assistance was not done or reported in this document. The device is a "computerized cognitive assessment aid" providing quantitative scores, not an AI that directly assists human interpretation in the MRMC sense. It's an aid for trained healthcare professionals, but the study doesn't quantify their improvement with the aid versus without it.

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

   • Yes, the studies evaluating concurrent validity, construct validity, and test-retest reliability are essentially standalone performance evaluations. The ImPACT Quick Test (algorithm/device) generated cognitive scores which were then compared to other tests or re-administered. While trained professionals administered the test, their role was in test administration, not in altering the device's output or performing an "in-the-loop" interpretation that influenced the device's score generation. The "performance" being measured is the scores produced by the device itself.

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

   • The "ground truth" was established by comparison to established, validated neuropsychological tests and a predicate device (ImPACT).
     • For concurrent validity, the predicate device (ImPACT) was the reference standard.
     • For construct validity, traditional neuropsychological tests (Brief Visuospatial Motor Test (BVMT-R), Color Trails Test (CTT), Symbol Digit Modalities Test (SDMT)) served as the reference standards.
     • For test-retest reliability, the device's own repeated measurements served as the basis for evaluation, with consistency across measurements being the goal.

7. The sample size for the training set:

   • The normative database used to establish percentiles for the ImPACT Quick Test was developed using 772 subjects. This serves as a "training set" in the sense that it provides the reference data against which individual patient's scores are compared. It is not a software machine learning training set in the typical sense, but rather a reference population.
   • The document states that the new device "reports symptoms and displays test results in a form of composites score percentiles based on normative data" and that "The standardization sample was developed to be representative of the population of individuals ages 12-70 years".

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

   • For the normative database (which serves a similar function to a training set here), the "ground truth" was simply the measured performance of a large, representative sample of healthy individuals on the ImPACT Quick Test itself. These subjects were free from concussion within one year, neurological disorders, and psychoactive medication. Their scores define the "normal" range for different age, gender, and race stratifications, against which subsequent patient scores are compared. All subjects completed IRB approved consent and met eligibility criteria. Testing was completed by trained professionals in a supervised setting to ensure standardized administration.

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ImPACT is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion.

ImPACT is a neurocognitive test battery that provides healthcare professionals with objective measure of neurocognitive functioning as an assessment aid and in the management of concussion in individuals ages 12-59.

ImPACT® (Immediate Post-Concussion Assessment and Cognitive Testing) is a computer-based neurocognitive test battery.

ImPACT is a software-based tool that allows healthcare professionals to conduct a series of neurocognitive tests on individuals to gather basic data related to the neurocognitive functioning of the test subject. This computerized cognitive test battery evaluates and provides a healthcare professional with measures of various neurocognitive functions, including the reaction time, memory, attention, spatial processing speed and symptoms of an individual.

ImPACT provides healthcare professionals with a set of well-developed and researched neurocognitive tasks that have been medically accepted as state-of-the-art best practices and is intended to be used as part of a multidisciplinary approach to making return to activity decisions.

The ImPACT device is a computer-based neurocognitive test battery intended to aid in the assessment and management of concussion. The submission focuses on a device modification – a rewrite of the software from Adobe Flash to HTML5/CSS/JavaScript, while preserving all functions of the original version. The performance testing aims to demonstrate that this software change does not affect the device's functionality or performance.

Here's a breakdown of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a formal table of acceptance criteria with specific quantifiable metrics like sensitivity, specificity, or AUC, as might be seen for a diagnostic AI device. Instead, the acceptance criteria are implicitly tied to demonstrating non-inferiority or statistical and clinical insignificance of differences between the new HTML5 version and the predicate Flash version, specifically for reaction time. The primary performance metric assessed was "reaction time."

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

• Test Set Sample Size: "one in volunteers age 19-22". While a specific number is not provided, this indicates a human user study. The bench study would not involve a "sample size" in the same way, but rather controlled test conditions.
• Data Provenance: The document does not specify the country of origin of the data. It appears to be a prospective study conducted for the purpose of this submission, comparing the new and old software versions.

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

This information is not provided in the document. Given the nature of the device (a neurocognitive test battery for concussion assessment) and the type of performance testing described (comparison of reaction time between software versions), it's unlikely that external medical experts were used to establish "ground truth" in the typical sense (e.g., image annotation for disease presence). The "ground truth" here is the actual reaction time measurement as recorded by the device.

4. Adjudication Method for the Test Set

This information is not provided and is likely not applicable. Since the study is comparing measurements (reaction time) between two software versions rather than subjective interpretation of data, an adjudication method for reconciling expert opinions would generally not be needed.

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

A MRMC comparative effectiveness study was not done. The study described focused on direct comparison of output (reaction time) between two software versions rather than evaluating the impact of AI assistance on human readers' diagnostic performance. The device itself is an assessment aid, not an AI for image reading or interpretation that augments a human reader.

6. Standalone (Algorithm Only) Performance Study

The study described is essentially a standalone performance study in the context of the device modification. It evaluates the performance of the new HTML5 algorithm directly against the predicate Flash algorithm, without involving human interpretation or human-in-the-loop assistance in the performance assessment itself. The "volunteers" in the study are the subjects on whom the reaction time is measured by the device itself.

7. Type of Ground Truth Used

The "ground truth" for this performance study was the objective measurement of reaction time. The study aimed to show that the new software version produced reaction time measurements statistically and clinically equivalent to those from the predicate software version. This is not a ground truth derived from expert consensus, pathology, or outcomes data in the usual sense of a diagnostic device.

8. Sample Size for the Training Set

This information is not provided. As this submission relates to a software re-write of an existing device and not the development of a new AI/ML model from scratch, there might not be a separate "training set" in the conventional machine learning sense. If the underlying neurocognitive test battery involved trained algorithms, that training would have occurred for the original predicate device, and the re-write aimed to replicate its behavior.

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

This information is not provided. Similar to point 8, if there was initial algorithm training for the predicate device, the method for establishing its ground truth is not detailed in this document. Given it's a neurocognitive test battery, the initial "ground truth" would likely have been established through extensive psycho-metric validation, normative data collection, and clinical trials for the original ImPACT device to ensure its measurements accurately reflect neurocognitive function in the context of concussion.

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ImPACT is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion.

ImPACT is a neurocognitive test battery that provides healthcare professionals with objective measure of neurocognitive functioning as an assessment aid and in the management of concussion in individuals ages 12-59.

ImPACT Pediatric is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion.

ImPACT Pediatric is a neurocognitive test battery that provides healthcare professionals with objective measure of neurocognitive functioning as an assessment aid and in the management of concussion in individuals ages 5-11.

ImPACT® (Immediate Post-Concussion Assessment and Cognitive Testing) and ImPACT Pediatric are computer-based neurocognitive test batteries for use as an assessment aid in the management of concussion.

ImPACT and ImPACT Pediatric are software-based tools that allows healthcare professionals to conduct a series of neurocognitive tests that provide data related to the neurocognitive functioning of the test taker. This computerized neurocognitive test battery measures various aspects of neurocognitive functioning including reaction time, memory, attention, and spatial processing speed. It also records symptoms of concussion in the test taker.

ImPACT and ImPACT Pediatric provide healthcare professionals with a set of well-developed and researched neurocognitive tasks that have been medically accepted as state-of-the-art best practices. The devices are intended to be used as part of a multidisciplinary approach to concussion assessment and patient management.

This response summarizes the acceptance criteria and supporting studies for the ImPACT and ImPACT Pediatric devices, as detailed in the provided document.

Acceptance Criteria and Device Performance

The acceptance criteria for ImPACT and ImPACT Pediatric are primarily demonstrated through the establishment of their psychometric properties: construct validity, test-retest reliability, and the development of a robust normative database. The device performance is reported through the results of various peer-reviewed studies and clinical data supporting these properties.

Table 1: Acceptance Criteria and Reported Device Performance

Study Details Proving Device Meets Acceptance Criteria

The device relies on a collection of previously published peer-reviewed studies and additional clinical data submitted with the de novo request. The FDA's determination is based on the adequacy of this compiled evidence rather than a single, large prospective clinical trial specifically for this de novo submission.

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

• ImPACT:
  • Construct Validity Studies: Sample sizes for individual studies ranged from N=30 to N=100.
    • Iverson et al. (2005): N=72 athletes from PA high schools.
    • Maerlender et al. (2010): N=54 varsity athletes from Dartmouth College.
    • Schatz & Putz (2006): N=30 college students from St. Joseph's University, Philadelphia.
    • Allen & Gfeller (2011): N=100 psychology students from a private university (Midwestern).
  • Reliability Studies: Sample sizes for individual studies ranged from N=25 to N=369.
    • Schatz (2013): N=25
    • Cole (2013): N=44 (active duty military population)
    • Nakayama (2014): N=85
    • Elbin (2011): N=369 high school athletes
    • Schatz (2010): N=95
  • Normative Database: N=17,013 individuals. Data collected from high schools and colleges across the US, and adult athlete populations/coaches/administrators.
  • Data Provenance: Predominantly retrospective analysis of published literature and existing clinical data. Studies are from various locations within the United States (PA, Dartmouth, Philadelphia, Midwestern university) and some multinational data for normative database (South African sample mentioned for cross-cultural norming). The military population study (Cole, 2013) also indicates a specific cohort. Data is gathered from both concussed and concussion-free individuals for different study purposes (validity vs. norming).
• ImPACT Pediatric:
  • Normative Database: N=915 children. Data collected from clinical sites in Atlanta, GA; Annapolis, MD; Marquette, MI; Pittsburgh, PA; and Guelph, Ontario, Canada.
  • Reliability Study: N=100 children (ages 5-12 years) participating in youth soccer and hockey leagues. (Unpublished study reported).
  • Construct Validity Study: N=83 participants (ages 5-12 years).
  • Data Provenance: A mix of clinical sites across the US and Canada. Primarily retrospective analysis of previously collected data.

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

• The document does not specify a fixed number of experts for adjudicating individual cases within a test set, as this is not a diagnostic device relying on expert consensus on image interpretation.
• Instead, the "ground truth" for these performance studies is established by:
  • Clinical Standards: For construct validity, ImPACT was compared to traditional neuropsychological measures (e.g., Symbol Digit Modalities Test, WAIS-R, NFL Battery components). These traditional tests are themselves well-established and interpreted by qualified neuropsychologists or clinicians.
  • Normative Data Collection: "Professionals who were specifically trained to administer the tests," including "Neuropsychologists, Psychologists and Neuropsychology/Psychology graduate students, Certified Athletic Trainers and Athletic Training Graduate Students and Nurses." Their expertise ensures correct test administration and data collection for establishing norms.
  • Reference Standards: For the ImPACT construct validity studies, diagnoses of concussion were made using "then-applicable clinical standards including grading of concussion using AAN guidelines." For ImPACT Pediatric, construct validity was assessed against the "Wide Range Assessment of Memory and Learning-2 (WRAML-2)," a recognized neuropsychological battery.

3. Adjudication Method for the Test Set:

• Not applicable in the typical sense of a diagnostic medical device relying on image interpretation and expert consensus for ground truth. The "adjudication" is inherent in the established methodologies of traditional neuropsychological testing and statistical correlations.

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

• No MRMC study was performed in the traditional sense of comparing human readers with and without AI assistance for interpretation.
• This device is a Computerized Cognitive Assessment Aid, not an AI for image interpretation. Its function is to administer a neurocognitive test battery and provide objective measures. The "AI" component is more akin to sophisticated algorithms for scoring, norming, and identifying reliable change or invalid tests, rather than a system that assists human interpretation of complex medical imagery.
• The benefit is the "Ability to have access to a non-invasive cognitive assessment battery that can be used to compare pre-injury (baseline cognitive performance) to post-injury cognitive performance" and "Ability to compare cognitive test performance to a large normative database in the absence of baseline testing," replacing or augmenting less standardized manual methods.

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

• The device inherently operates as an "algorithm only" in generating scores and reports. However, it is explicitly not a standalone diagnostic device.
• The "performance" of the algorithm is demonstrated through its ability to accurately measure cognitive functions (construct validity), consistently produce results (reliability), and correctly apply the normative and change index calculations.
• The output (scores, RCIs, validity flags) is then interpreted by a healthcare professional. The device itself does not make a diagnosis. Therefore, its "standalone performance" is specifically in generating the objective data, which is then used by a human clinician as an aid.

6. Type of Ground Truth Used:

• Neuropsychological Test Scores: For construct validity, the device's scores were correlated with scores from established, traditional paper-and-pencil neuropsychological assessment batteries. These batteries serve as the "ground truth" for what cognitive functions are being measured.
• Clinical Standards/Diagnosis: For some ImPACT studies, comparison was made to individuals diagnosed with concussion based on "then-applicable clinical standards."
• Normative Data: The "normal" population for the normative database was established through "clinical work-up... including the establishment of inclusion and exclusion criteria" by trained professionals, ensuring subjects did not have medical conditions affecting test performance.

7. Sample Size for the Training Set:

• ImPACT: The standardization sample (normative database) served as the primary basis for the algorithm's "training" or establishment of "normal" values and internal psychometric properties. This sample consisted of 17,013 individuals.
• ImPACT Pediatric: The normative database for ImPACT Pediatric comprised 915 children.
• These are not "training sets" in the modern machine learning sense (where a model learns iteratively), but rather the large datasets used to establish the statistical properties and normative values from which the device's algorithms derive meaning (e.g., percentile rankings, Reliable Change Index).

8. How the Ground Truth for the Training Set (Normative Database) Was Established:

• ImPACT:
  • Data collected from high schools and colleges nationwide, ensuring representation of the intended use population.
  • Older adults included coaches, school administrators, nurses, and adult athletes.
  • Testing administered by specifically trained professionals: Neuropsychologists, Psychologists, Neuropsychology/Psychology graduate students, Certified Athletic Trainers, Athletic Training Graduate Students, and Nurses.
  • Tests completed in a supervised setting.
  • Data uploaded to a secure HIPAA-compliant server and de-identified.
  • Participants were English speakers, not reported to have underlying intellectual/developmental data, and not currently concussed or suffering from medical conditions that might affect performance.
• ImPACT Pediatric:
  • Large, age-stratified sample of children (5-12 years) from multiple clinical sites.
  • Tests administered by a researcher, clinician, or educational professional trained in the use of ImPACT Pediatric.
  • Tests taken on an iPad in a one-on-one basis (no group testing).
  • Children instructed to respond by touching the screen.
  • "Ground truth" for "normal" performance was derived from statistical analysis (means, standard deviations, t-tests for gender differences) of this large, carefully collected, and screened normative dataset. Factor analysis was conducted on a subset to derive relevant score clusters.

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The IMPACT Dx Factor V Leiden and Factor II Genotyping Test is a qualitative in vitro diagnostic device intended for use in the detection and genotyping of a single point mutation (G1691A, referred to as the Factor V Leiden mutation or FVL) of the Factor V gene, located on Chromosome 1q23, and a single point mutation (G20210A) of the prothrombin gene (referred to as Factor II or FII), located on Chromosome 11p11-q12, from genomic DNA isolated from EDTA anti- coagulated human whole blood samples. The test is to be performed on the IMPACT Dx System and is indicated for use as an aid in the diagnosis of patients with suspected thrombophilia.

The IMPACT Dx Factor V Leiden and Factor II Genotyping Test is a qualitative, multiplexed genetic testing device for parallel detection and genotyping of the point mutations G1691A of the Factor V gene and G20210A of the Factor II gene from genomic DNA isolated from EDTA anti- coagulated human whole blood samples. The test is to be performed on the IMPACT Dx System.

The IMPACT Dx Factor V Leiden and Factor II Genotyping Test is performed using the IMPACT Dx System, which includes the IMPACT Dx NANO and the IMPACT Dx MA, a matrix-assisted laser desorption / ionization time-of-flight (MALDI-TOF) mass spectrometer. The test involves Factor V and Factor II region-specific polymerase chain reaction (PCR) amplification of genomic DNA purified from human whole blood in a multiplexed reaction, followed by allele-specific single base primer extension reactions. The reaction products are desalted, dispensed onto a SpectroCHIP® Array using the IMPACT Dx NANO, and the genotyping products are resolved on the basis of mass using the IMPACT Dx MA.

The IMPACT Dx Factor V Leiden and Factor II Genotyping Test provides reagents for multiplex PCR, deoxynucleotide triphosphate dephosphorylation, and single base extension. The IMPACT Dx Factor V Leiden and Factor II Genotyping Test is comprised of the following components:

• IMPACT Dx Factor V Leiden and Factor II Primer Set
• IMPACT Dx PCR Reagent Set
• IMPACT Dx Extend Reagent Set

The IMPACT Dx Factor V Leiden and Factor II Genotyping Test utilizes a biochemistry process (Sequenom Biochemistry) that involves target-specific PCR amplification and single-base extension reactions with the subsequent analysis of the reaction products of the target nucleic acids by matrixassisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS),

The IMPACT Dx System (System) is a platform for highly accurate and sensitive genomic analysis and is designed for use with FDA cleared or approved assays citing its use. The IMPACT Dx System is comprised of the following instruments, software and consumables;

• IMPACT Dx NANO (NANO)
• IMPACT Dx MA (MA)
• TYPER Dx Software (TYPER Dx)
• System Consumables
• SpectroCHIP® Arrays (Chip)
• Clean Resin
• 3-Point Calibrant (Calibrant)

The System is intended to be used by trained operators in a professional laboratory to perform the following key tasks:

• De-salt (using Clean Resin) amplified nucleic acid samples, upon completion of polymerase chain reaction (PCR) and single-base extension reactions following the instructions provided in the Sequenom test-specific package insert;
• Transfer (using the IMPACT Dx NANO) de-salted nucleic acid samples from a microtiter plate onto a disposable 96-pad sample Chip;
• Obtain mass spectra (using the IMPACT Dx MA) from samples and 3-Point Calibrant on a Chip; and
• Analyze (using the TYPER Dx software) the mass spectra of the samples for genotyping results.

The IMPACT Dx System accomplishes genomic analysis and genotyping testing by coupling a biochemistry process (Sequenom biochemistry) that involves target-specific PCR amplification and single-base extension reactions with the subsequent analysis of the reaction products of the target nucleic acids by matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS). This biochemistry process is homogeneous and does not require purification of the PCR products or the extension products and thus is very amenable to high-throughput genotyping testing.

The IMPACT Dx NANO is a self-contained, enclosed instrument that uses computer-controlled robotics to transfer nanoliter volumes of analyte from a 96-well microtiter plate onto a Chip, which is subsequently processed by means of MALDI-TOF MS analysis on the IMPACT Dx MA. This instrument includes an integrated computer pre-loaded with the Nanodispenser software and provides a simple touch-screen interface for users.

The IMPACT Dx MA is a bench top mass spectrometer that processes analyte-loaded Chips by means of MALDI-TOF MS analysis. This instrument includes an integrated computer pre-loaded with the TYPER Dx software, a monitor, and a firewall for secure communication with the IMPACT Dx NANO. The main function of the IMPACT Dx MA is to acquire mass spectra from analytes that have been transferred onto a Chip, which has a chemical matrix on each pad. The mass spectra are captured and further analyzed by the TYPER Dx software.

The TYPER Dx software (TYPER Dx) manages the processing of Sequenom genotyping tests. It is deployed on the computer embedded within the IMPACT Dx MA.

The TYPER Dx software provides the following key functions:

• Allows users to create and manage panel runs;
• Monitors analyte transfer activities on the IMPACT Dx NANO;
• Controls user-initiated, automated mass spectrum acquisition runs on the IMPACT Dx MA;
• Analyzes the mass spectra acquired by the IMPACT Dx MA and makes genotype calls per a test-specific algorithm;
• Enables users to view and export results; and
• Allows an administrator to manage users to ensure secure access to the IMPACT Dx MA and panel run data.

Here's a summary of the acceptance criteria and study detailed in the provided document:

Acceptance Criteria and Device Performance

The IMPACT Dx Factor V Leiden and Factor II Genotyping Test aims for high agreement with a reference method for genotyping Factor II and Factor V genes.

Study Details

2. Sample Size and Data Provenance

• Test Set Sample Size:

  • Clinical Data (Method Comparison Study): 860 clinical samples
  • Analytical Specificity: 13 clinical genomic DNA from patient samples
  • Analytical Sensitivity: Not explicitly stated, but clinical genomic DNA from patient samples were used with a series dilution.
  • Carry-over Contamination: A panel of 3 clinical genomic DNA samples and a no template control sample.
  • Interferences: Leukocyte-depleted whole blood specimens spiked with cell lines.
  • Reproducibility: 12 human genomic DNA samples.

• Data Provenance: The document states "clinical genomic DNA obtained from patient samples" and "fresh EDTA anti-coagulated whole blood samples collected from normal human subjects." This implies the data is derived from human clinical samples, likely from retrospective collections for the method comparison and analytical studies, and potentially prospective collection for the fresh blood study. No specific country of origin is mentioned, but the submission is to the FDA (USA).

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

Relevant for the method comparison study:

• Number of Experts: Not explicitly stated as "experts." The ground truth was established by a bi-directional DNA sequencing reference method. While sequencing itself is a technical process, the interpretation of sequencing results could involve expert review. However, the document doesn't detail this.
• Qualifications of Experts: Not provided, as the ground truth relied on a reference method (bi-directional sequencing) rather than human expert consensus on image interpretation, for example.

4. Adjudication Method (Test Set)

Not applicable in the context of this document. The study compares the device's results directly against a bi-directional DNA sequencing reference method. Discrepancies would likely be investigated through re-testing or re-sequencing, as implied by the "Number of FII/FVL Calls After Repeat Testing" in the tables, but formal "adjudication" by multiple human readers is not described.

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

No, a MRMC comparative effectiveness study was not explicitly done or reported in this document. The study focuses on the analytical and clinical performance of the device itself, comparing it to a reference sequencing method, not on human reader performance with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone (algorithm only without human-in-the-loop performance) study was performed. The entire context of the "Non-clinical Bench Data" and "Clinical Data" sections describes the performance of the IMPACT Dx Factor V Leiden and Factor II Genotyping Test as a diagnostic device, which processes samples and generates genotype calls automatically or semi-automatically via the IMPACT Dx System's TYPER Dx software. The results (e.g., percent agreement with sequencing) reflect the algorithm's performance.

7. Type of Ground Truth Used

The ground truth used for the clinical data (method comparison study) was bi-directional DNA sequencing. This is considered a highly accurate and established reference method for genotyping.

8. Sample Size for the Training Set

The document does not explicitly mention a separate "training set" or its sample size. The reported studies primarily describe testing the device's performance (analytical and clinical validation) against known samples or a reference method. For in-vitro diagnostic devices, particularly those based on established molecular biology principles, the development might involve iterative testing and refinement, but a formal "training set" in the machine learning sense is not typically documented as a distinct phase with a specified sample size in regulatory submissions like this unless the device employs novel AI/ML components requiring such.

9. How Ground Truth for the Training Set Was Established

As a distinct "training set" is not explicitly mentioned, the method for establishing its ground truth is also not described. If development involved internal studies, it's highly probable that ground truth would have been established using methods similar to the validation, such as DNA sequencing or other orthogonal molecular techniques.

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