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I-Norm 100_18-45 is a quantitative tool for the comparison of patient measurements to a database of known normal subjects ages 18-45. I-Norm 100_18-45 presents data for interpretation by qualified medical personnel trained in vestibular, neurotologic, and neuro-ophtalmic diagnostic testing. I-Norm 100_18-45 is applicable to individuals only in the 18-45 age range.

The proposed intended use for I-Norm 100 18-45 is as following:

I-Norm 100 18-45 is designed to be used with the family of I-Portal® devices:

• I-Portal® Neuro Otologic Test Center (NOTC) (cleared by K083603, K143607)

• I-Portal® Video-Nystagmography System (VNG) SVNG-2 (cleared by K143607)

• I-Portal® Portable Assessment System™ Nystagmograph (I-PAS™) (cleared by K171884)

The I-Portal® devices with I-Norm 100_18-45 are nystagmograph devices intended for use in vestibular and neurotologic diagnostic testing. The addition of the I-Norm 100_18-45 does not change the intended use or the indication for use for these devices from their original clearances listed above.

I-Norm 100_18-45 is a software package that contains normative data for the segment of population ages 18 to 45, for oculomotor, vestibular, reaction time and cognitive (OVRT-C) tests delivered on the family of I-Portal® devices described below.

All I-Portal® devices function as nystagmographs, defined by 21 CFR 882.1460 as "devices used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball." Through their nystagmograph functionality, the I-Portal® devices are indicated for use as a measurement tool to assist trained physicians in their analysis of vestibular and neurotologic disorders, requiring a separation of central and peripheral nervous system deficits. The I-Portal® devices are used in an institutional environment on the order of a physician.

The I-Portal® NOTC features a rotational chair, optokinetic (OKN) optical stimulus, Pursuit Tracker (PT) laser target generator, I-Portal Video Oculography (VOG), I-Portal® and VEST™ software, and a test enclosure equipped with a communication system.

The I-Portal® VNG offers a subset of the NOTC tests and additional vestibular tests through a device with a smaller physical footprint. The VNG has many of the same elements used in the NOTC configuration: OKN optical stimulus, PT laser target generator, VOG, I-Portal and VEST™ software platforms.

The I-PAS™ is a portable, compact, 3D, head-mounted display system with integrated eye tracking that offers a set of tests equivalent to the VNG and additional vestibular and oculomotor tests, but with a smaller physical footprint. Stimuli are presented on a high-resolution digital screen (2560 x 1440 pixels) mounted in a virtual reality-like goggle system.

Software: All I-Portal® devices use VEST™ software to deliver a battery of oculomotor, vestibular, reaction time and cognitive (OVRT-C) tests and I-Portal® software to record eye movements and reaction time responses during these tests. The analysis of OVRT-C tests performed by VEST™ software provides the clinician with a number of physiological measurements to aid in the assessment of vestibular and neurotologic disorders. This application seeks to add I-Norm 100_18-45, a normative oculomotor, vestibular, reaction time and cognitive test database for ages 18-45 to the VEST™ software.

This document describes the I-Norm 100_18-45 software, a quantitative tool that compares patient measurements to a database of known normal subjects aged 18-45. It is designed to be used with Neuro Kinetics, Inc.'s I-Portal® devices (NOTC, VNG, I-PAS™).

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the I-Norm 100_18-45 software is the establishment and presentation of a normative oculomotor and vestibular database for ages 18-45 across various tests. The device performance is demonstrated by the calculation of 95% Reference Intervals (RI) with 90% Confidence Intervals (CI) for a wide range of variables across 16 different oculomotor, vestibular, reaction time, and cognitive (OVRT-C) tests.

The document does not explicitly state pre-defined "acceptance criteria" in a numerical target format (e.g., "accuracy > X%"). Instead, the performance is demonstrated by the successful collection, analysis, and presentation of these normative ranges. The implication is that the derived normative ranges themselves, with their associated confidence intervals, represent the "performance" for establishing what is considered "normal" for the target population.

Table 5-2 (pages 8-10 of the input) serves as the primary evidence of the reported device performance, providing the calculated normative ranges. A representative sample from Table 5-2 is shown below to illustrate the type of reported performance:

Representative Performance Data from Table 5-2 (I-Norm 100_18-45)

Note: "n/a" indicates a limit not of clinical interest for that specific variable (e.g., only an upper limit for latency, or only a lower limit for velocities/gains).

The "acceptance criteria" can be implicitly understood as the successful generation of these statistically robust normative ranges, allowing the device to perform its intended function of comparison. The software verification and validation testing mentioned under "Non-Clinical Performance Data" also implies acceptance criteria related to software functionality and display of norms.

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

• Sample Size for Test Set: The study collected data from a total of 466 subjects (males and females).
• Data Provenance:
  • Country of Origin: United States. Subjects were recruited at 3 different sites: the University of Miami, Naval Medical Center San Diego, and Madigan Army Medical Center.
  • Retrospective or Prospective: The data collection described appears to be prospective, as subjects were "recruited" and "tested" with a battery of tests.

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

This study is focused on establishing normative data for a specific age range, not on classifying or diagnosing specific conditions based on expert consensus. Therefore, the concept of "experts establishing ground truth" in the traditional sense (e.g., for disease diagnosis) isn't directly applicable here.

Instead, the "ground truth" for the normative data is derived from a carefully selected healthy population (ages 18-45) that met strict inclusion/exclusion criteria designed to ensure they were free from conditions that could impact oculomotor and vestibular tests. The establishment of this "healthy" ground truth was implicitly overseen by the Institutional Review Boards (IRBs) that approved the protocols and the researchers conducting the study, who are qualified in the field of vestibular, neurotologic, and neuro-ophthalmic diagnostic testing. The specific number and qualifications of these researchers/clinicians supervising data collection and subject selection are not detailed, but the general context implies medical and scientific expertise.

4. Adjudication Method for the Test Set

Since the study aims to establish normative ranges from healthy individuals rather than diagnose conditions requiring interpretation of ambiguous data, an explicit "adjudication method" for the test set (like 2+1 or 3+1 consensus) was not performed or needed. The raw data from the healthy subjects themselves, after passing the exclusion criteria, formed the basis for the normative ranges.

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

No MRMC comparative effectiveness study was mentioned or performed. This study's purpose was to establish normative data for the device, not to assess human reader improvement with AI assistance. The I-Norm 100_18-45 provides a quantitative comparison tool, but it does not act as an AI that assists in interpreting complex images or signals in a way that typically necessitates an MRMC study to show human performance improvement. It's a reference database rather than an assistive AI interpretation tool.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Performance

The device, I-Norm 100_18-45, is a software package that contains normative data. Its "performance" is its ability to accurately store and present these normative ranges and to allow comparison of patient data to these norms. It is not an algorithm that independently diagnoses or makes decisions, but rather a reference tool.

The "standalone performance" is demonstrated by the calculation of the 95% Reference Intervals (RI) and 90% Confidence Intervals (CI) presented in Table 5-2. These numerical values are a direct output of the algorithm's statistical analysis of the collected data, independent of human interpretation for their derivation. The software then displays these values and visually indicates if patient data fall within or outside these norms. The "Software Verification and Validation Testing" also confirms that the software correctly displays these norms as intended.

7. Type of Ground Truth Used

The ground truth used was normative data derived from a large cohort of healthy individuals (ages 18-45) who met specific inclusion/exclusion criteria. This is essentially "healthy population data" as a form of ground truth for establishing what constitutes "normal" ranges for the specific physiological measurements obtained by the I-Portal® devices. There was no "expert consensus" on individual cases of disease, pathology, or outcomes data used to establish this normative ground truth.

8. Sample Size for the Training Set

The document does not explicitly delineate a "training set" and a "test set" in the typical machine learning sense for an AI model that learns a function. Instead, the entire dataset of 466 subjects was used to establish the normative database. This database, once established, acts as the reference for future patient comparisons. In this context, the 466 subjects serve as the data from which the "normative model" (i.e., the reference intervals) was derived.

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

As noted above, there isn't a "training set" in the conventional AI sense. The ground truth for establishing the normative database (which acts as the reference for the device) was established as follows:

• Subject Selection: Healthy individuals aged 18-45 were recruited from the general population, including nonprofessional athletes, civilians, and military service members.
• Inclusion/Exclusion Criteria: Strict criteria approved by IRBs were used to select subjects. Exclusion criteria were focused on conditions/diseases that could impact oculomotor and vestibular tests (e.g., history of brain injury, severe neuropsychiatric disorders, neurodegenerative disorders of hearing and balance, cerebrovascular disorders, certain ear operations, systemic disorders like renal failure, cirrhosis, and pregnancy).
• Data Collection: Participants underwent a battery of oculomotor, vestibular, reaction time, and cognitive (OVRT-C) tests using I-Portal® NOTC or I-PAS™ devices.
• Statistical Analysis: The collected data from these rigorously selected healthy subjects were analyzed using a univariate general linear model to assess the effect of age, gender, and combined age x gender. Non-parametric methods were then used to calculate the 95% (2.5th and 97.5th) reference interval (RI) with 90% confidence interval (CI) for the lower and upper limits of each variable. This statistical derivation from a verified healthy population constitutes the "ground truth" for the normative data.

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I-Portal® Neuro Otologic Test Center (NOTC) is a rotary chair system used in vestibular and neuro-otologic diagnostic testing. The NOTC provides stimuli to a patient through motion profiles and/or visual cues, monitors the patient's response, and presents the data for interpretation by qualified medical personnel trained in vestibular diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.

l-Portal® Video-Nystagmography System (VNG) is used in vestibular and neuro otologic diagnostic testing. The VNG provides stimuli to a patient through visual cues, monitors the patient's response, and presents the data for interpretation by qualified medical personnel trained in vestibular diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.

I-Portal® Video Oculography (VOG) System is used to monitor and record eye movements from various stimuli used in vestibular diagnostic testing. The system measures and records horizontal, vertical, and torsional eve movements, as well as pupil area. It is used in conjunction with various stimuli (rotary chair, manual (done by clinician) positional maneuvers, caloric tests, external stimulus) to detect and record nystagmus and eye tracings for interpretation by qualified medical personnel trained in vestibular diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.

The I-Portal device functions as a nystagmograph, defined by 21 CFR 882.1460 as "a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball." Through its nystagmograph functionality, the device is indicated for use as a diagnostic tool to assist trained physicians in their analysis of vestibular disorders, which requires the separation of central and peripheral nervous system deficits. The I-Portal device is used in an institutional environment on the order of a clinician.

To achieve safe and effective clinical operation, the I-Portal devices use an extensive battery of tests within a family of products: the I-Portal NOTC, the VNG, and the VOG.

The I-Portal NOTC features a rotational chair, the optokinetics (OKN) optical stimulus, the Pursuit Tracker (PT) laser target generator, an I-Portal and VEST software, and a test enclosure equipped with a communication system. Through the use of these elements and the VEST™ analysis software, the physician is able to schedule a set of tests designed to help isolate, identify and understand oculomotor, neurologic and vestibular functions and related possible disorders.

The I-Portal VNG offers a subset of the NOTC tests and different vestibular tests through a device with a smaller physical footprint. The VNG has many of the same elements used in the NOTC configuration: OKN optical stimulus, PT laser target generator, VOG, I-Portal and VEST software platforms. However, unlike the NOTC. it does not have either the rotational chair or the enclosure & communication system, but the VNG can collect and analyze data from caloric and position tests. The VNG configuration is typically used in smaller clinics or conditions requiring a smaller sized device or some mobility.

The third NKI I-Portal configuration is a digital eve tracking system - the I-Portal VOG. The VOG is incorporated within the NOTC and VNG configurations; however, the VOG can be used as a stand-alone product with the VEST and I-Portal software, but offering a subset of the tests afforded by either the NOTC or VNG.

The provided text describes modifications to the I-Portal® Neuro Otologic Test Center (NOTC), I-Portal® Video Nystagmography System (VNG), and I-Portal® Video Oculography Eye Tracking System (VOG) and asserts their substantial equivalence to a previously cleared predicate device (K143607).

However, the document does not contain the detailed acceptance criteria for specific device performance metrics, nor does it present a study that quantifies the device's performance against such criteria. Instead, it focuses on software and hardware modifications and their verification.

Here's an analysis based on the information provided, highlighting what is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The document states, "The results of the testing met the acceptance criteria and did not identify any new unforeseen risks." However, it does not specify what those acceptance criteria were in terms of quantitative performance (e.g., accuracy, precision, sensitivity, specificity, resolution) for eye tracking, nystagmus detection, or other diagnostic capabilities. It refers to software verification and validation, implying that the acceptance criteria were related to the functionality and safety of the upgraded software and hardware components.

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

• Test Set Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

Explanation: The document refers to "Verification testing" and "System usability validation (with defined and documented Use Cases)" but does not provide details on the number of subjects, recordings, or cases used in these tests.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

Explanation: The document does not describe the specific ground truth establishment process for a test set, as it does not present a clinical performance study with a test set of patient data. The device is a "nystagmograph" that "presents the data for interpretation by qualified medical personnel trained in vestibular diagnostic testing" and "provides no diagnoses nor does it provide diagnostic recommendations." This implies human experts interpret the device output.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not specified.

Explanation: As no detailed clinical performance study with a test set and associated expert review is described, an adjudication method is not mentioned.

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

• MRMC Study: No, an MRMC comparative effectiveness study is not described. The document does not discuss human readers' improvement with or without AI assistance.

Explanation: This type of study would typically be conducted for diagnostic AI algorithms where human interpretation is assisted by the AI. This device is described as a data presentation tool for human interpretation, not an AI diagnostic assistant in the typical sense.

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

• Standalone Study: No, a standalone performance study is not explicitly described.

Explanation: The device is described as a tool that "presents the data for interpretation by qualified medical personnel." It's not an algorithm providing a diagnostic output independently. The performance data section focuses on "Software Verification and Validation Testing" and "Risk Analysis" to ensure the modified components function as intended and do not introduce new risks compared to the predicate device.

7. Type of Ground Truth Used:

• Type of Ground Truth: Not explicitly stated as a single type (e.g., pathology, expert consensus, outcomes data) for a clinical performance study.

Explanation: Given the nature of the device (a nystagmograph providing data for interpretation), the "ground truth" for its verification would likely involve engineering and functional validation against expected physical and optical performance, as well as software functionality tests, rather than a clinical ground truth established by pathology or expert consensus on patient diagnoses. The document mentions "System usability validation (with defined and documented Use Cases)."

8. Sample Size for the Training Set:

• Training Set Sample Size: Not applicable / Not specified.

Explanation: The document does not describe the development or training of an AI algorithm in the context of machine learning. The improvements mentioned ("Enhanced pupil detection using an auto threshold feature" and "improves video capture") sound more like traditional image processing and software engineering enhancements rather than a machine learning model requiring a training set.

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

• Ground Truth Establishment for Training Set: Not applicable / Not specified.

Explanation: As no machine learning training process is described, the establishment of ground truth for a training set is not pertinent to this submission.

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I-Portal® Portable Assessment System™ - Nystagmograph (I-PAS™) is used in vestibular and neuro otologic diagnostic testing. The I-PAS provides stimuli to a patient through visual cues, monitors the patient's response, and presents the data for interpretation by qualified medical personnel trained in vestibular diagnosic testing. This device does not provide diagnoses nor does it provide diagnostic recommendations.

The I-PAS is a head-mounted apparatus enclosing a digital display, infrared lights, dual mirrors, dual cameras, and optical focus knobs. It is attached to the head with straps. The head mounted goggle system displays independent stimuli separately to each eye on a small digital display while simultaneously recording motion from each eye independently with digital video cameras. The system also includes: a computer with Neuro Kinetics' I-Portal and VEST software packages: isolation transformer and connection cables; foot pedals and a hand-held control box with buttons that can be pressed to register motor responses. As with the I-Portal VNG, I-PAS includes the standard battery of VNG tests and can operate in conjunction with caloric test equipment.

The provided text describes the I-Portal® Portable Assessment System™ - Nystagmograph (I-PAS™), a medical device used for vestibular and neuro otologic diagnostic testing. The document is a 510(k) summary, which aims to demonstrate that the I-PAS is substantially equivalent to a legally marketed predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of acceptance criteria with specific performance metrics and corresponding reported device performance values. Instead, it describes general compliance and functional equivalence.

The key performance claims are related to:

• Functional Indistinguishability of Visual Cues: The visual cues provided by the I-PAS are functionally indistinguishable from those of the predicate device.
• Safety (No Dizziness): The I-PAS stimuli do not cause dizziness.
• Compliance with Standards: The device complies with ANSI-ASA S3.45-2009 and applicable IEC 60601 standards.
• Intended Performance: Verification and validation testing confirm that the I-PAS performs as intended.

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

The document does not specify the sample size for the clinical test set used to demonstrate functional equivalence or lack of dizziness, nor does it mention the data provenance (country of origin, retrospective/prospective). It only states that "Clinical studies were also run and confirmed..."

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth in any clinical testing. The device itself "presents the data for interpretation by qualified medical personnel trained in vestibular diagnostic testing," implying that human experts interpret the device's output, but this refers to its intended clinical use, not the validation study ground truth.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method (e.g., 2+1, 3+1) for the test set.

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

No MRMC comparative effectiveness study is mentioned. The study focuses on demonstrating the functional equivalence of the I-PAS to its predicate, not on the improvement of human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance:

The I-PAS is a nystagmograph that "monitors the patient's response, and presents the data for interpretation by qualified medical personnel." It explicitly states, "This device does not provide diagnoses nor does it provide diagnostic recommendations." Therefore, it is a data acquisition and presentation device, not an AI algorithm performing diagnostic interpretation. A standalone performance evaluation in the context of an "algorithm only" would not be applicable, as it requires human interpretation of its output.

7. Type of Ground Truth Used:

The type of "ground truth" for the clinical studies mentioned appears to be based on observations and comparisons related to the "functional indistinguishability" of visual cues and the absence of dizziness. This implies that the ground truth was likely established through direct comparison or expert assessment of the visual stimuli and patient comfort/symptoms, rather than comparison to a definitive diagnostic gold standard like pathology or long-term outcomes, as the device itself does not provide diagnoses.

8. Sample Size for the Training Set:

The device is not described as using machine learning or AI in a way that would involve a training set. It's a medical device for acquiring and presenting physiological data. Therefore, the concept of a "training set" is not applicable here.

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

Since there is no mention of a training set for a machine learning algorithm, this question is not applicable.

Summary of Provided Information Regarding Acceptance Criteria and Study:

The document provides a high-level overview of validation activities primarily focused on demonstrating the I-PAS's equivalence to its predicate device and adherence to relevant standards.

• Acceptance Criteria (Implied):
  • Functional indistinguishability of visual cues compared to predicate.
  • Absence of dizziness caused by I-PAS stimuli.
  • Compliance with ANSI-ASA S3.45-2009 and IEC 60601 standards.
  • Proper functioning of the device as intended.
• Reported Performance: "The clinical testing performed confirms that the visual cues are functionally indistinguishable from the predicate, and that I-PAS stimuli do not cause dizziness. Additionally, bench testing confirms that the I-PAS complies with ANSI-ASA S3.45-2009 and verification and validation testing demonstrate that users can safely and effectively use the I-PAS."
• Study Details:
  • Bench tests were performed for verification, validation, and standard compliance.
  • Clinical studies were run to confirm functional equivalence of visual cues and lack of dizziness.
  • No specific sample sizes, expert details, adjudication methods, MRMC studies, or AI training/ground truth information are provided in this summary. The device's function as a data acquisition and presentation tool means many of these AI-specific questions are not applicable.

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I-Portal® Neuro Otologic Test Center (NOTC) is a rotary chair system used in vestibular and neuro-otologic diagnostic testing. The NOTC provides stimuli to a patient through motion profiles and/or visual cues, monitors the patient's response, and presents the data for interpretation by qualified medical personnel trained in vestibular diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.

I-Portal® Video-Nystagmography System (VNG) is used in vestibular and neuro otologic diagnostic testing. The VNG provides stimuli to a patient through visual cues, monitors the patient's response, and presents the data for interpretation by qualified medical personnel trained in vestibular diagnostic testing. This device provides nor does it provide diagnostic recommendations.

I-Portal® Video Oculography (VOG) System is used to monitor and record eye movements from various stimuli used in vestibular diagnostic testing. The system measures and records horizontal, vertical, and torsional eve movements, as well as pupil area. It is used in conjunction with various stimuli (rotary chair, manual (done by clinician) positional maneuvers, caloric tests, external stimulus) to detect and record nystagmus and eye tracings for interpretation by qualified medical personnel trained in vestibular diagnostic testing. This device provides nor does it provide diagnostic recommendations.

The I-Portal device functions as a nystagmograph, defined by 21 CFR 882.1460 as "a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball." Through its nystagmograph functionality, the device is indicated for use as a diagnostic tool to assist trained physicians in their analysis of vestibular disorders, which requires the separation of central and peripheral nervous system deficits. The I-Portal is used in an institutional environment on the order of a physician.

To achieve safe and effective clinical operation, the I-Portal device uses a battery of tests within a family of products: the NOTC, the VNG, and the VOG.

The I-Portal NOTC features a rotational chair, the OKN optical stimulus, the PT laser target generator, the I-Portal VOG, and a test enclosure equipped with a communication system. Through the use of these elements and the VEST™ analysis software, the physician is able to schedule a set of tests isolating oculomotor and vestibular functions to help the physician understand possible vestibular disorders.

The I-Portal VNG offers a subset of the NOTC tests and different vestibular tests through a device with a smaller physical footprint. The VNG has many of the same elements used in the NOTC configuration: the OKN optical stimulus, the PT laser target generator, the VOG, and the VEST software platform. However, unlike the NOTC, it does not have the rotational chair, and does not utilize the enclosure / communication system, but the VNG can collect and analyze data from caloric and position tests. The VNG configuration is typically used in smaller clinics or conditions requiring device mobility.

The third configuration of the NKI I-Portal is a digital eye tracking system - the I-Portal VOG. The VOG is incorporated within the NOTC and VNG configurations; however, the VOG can be used as a stand-alone product with the VEST software, but offering a subset of the tests afforded by either the NOTC or VNG.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set (Clinical Testing for crHIT):
  • Sample Size: 22 control subjects and 20 subjects with complaints of dizziness (total 42 subjects).
  • Data Provenance: Not explicitly stated, but clinical testing implies prospective data collection for this specific study. No country of origin is mentioned.

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

• This document does not specify the number or qualifications of experts used to establish a "ground truth" for the clinical testing of crHIT. The comparison is made between the crHIT test and an existing "head thrust test" (a previously cleared predicate device's method), implying the "ground truth" for the clinical performance lies in the accepted interpretation of the outputs from these established tests by qualified medical personnel.

4. Adjudication Method for the Test Set

• The document does not describe an explicit adjudication method (like 2+1 or 3+1). The study focused on demonstrating the equivalence of test outputs between crHIT and the head thrust test.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not performed. The device is a diagnostic tool that presents data for interpretation by qualified medical personnel, not an AI-assisted diagnostic tool in the sense of directly impacting reader performance metrics.

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

• Yes, the performance data section mentions "Bench tests were executed to verify and validate the I-Portal." This includes verification of software and hardware requirements, and validation that the user interface was operating as intended. While not a pure "AI algorithm only" study in the modern sense (as the device is not solely an AI diagnostic), these bench tests represent standalone performance of the system's underlying functionalities before human interpretation. The device's function is to generate data; the interpretation is always done by a human.

7. The Type of Ground Truth Used

• For the clinical testing of the crHIT feature, the ground truth was based on the outputs of an established, previously cleared predicate device's test (the head thrust test), along with a classification of subjects as "control" or having "complaints of dizziness." The goal was to show equivalence of the new crHIT test outputs to those of the existing method.
• For other aspects (software, hardware, user interface), the ground truth was likely defined by pre-specified requirements and operational definitions verified through testing.

8. The Sample Size for the Training Set

• The document does not mention any "training set." This type of device (nystagmograph for vestibular diagnostic testing) processes real-time or recorded physiological data and presents it to a clinician for interpretation. It does not appear to be an AI/machine learning model that undergoes a training phase with labeled data in the way a typical AI diagnostic would.

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

• As no training set is mentioned or applicable in the context of this device's reported functionality, this question is not relevant.

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The i-port Advance™ injection port is indicated for patients who administer, or to whom is administered, multiple daily subcutaneous injections of physician prescribed medications, including insulin. The device may remain in place for up to 72 hours to accommodate multiple drug injections without the discomfort of additional needle sticks. The i-port Advance™ may be used on a wide range of patients, including adults and children. Model numbers for the device include 020110, 020210, 020102 and 020202.

The i-port Advance™ injection port was designed and developed through a technological collaboration between Unomedical A/S and Patton Medical Devices and modifies the Patton Medical Device i-port@ injection port (K052389) to include the automated insertion component ("Inserter") of the Unomedical Inset™ Infusion Sct (K032854).

The Injection Port component is a prescription only, sterile, single use, non-pyrogenic, external, disposable injection port with an indwelling catheter through which physician-prescribed medications can be injected subcutaneously from a standard syringe and needle, pen or alternative manual injection device. The indwelling catheter is installed using the integrated Inserter, a manually-operated springloaded catheter insertion tool that introduces the indwelling catheter into the subcutaneous tissue by automatically inserting the prefixed introducer needle to a predetermined depth below the skin surface.

Once applied, the insertion needle is removed, and only the soft cannula remains under the skin, acting as a gateway to the subcutaneous tissue. The user injects medicines directly through the resealable septum at the top of the device. The needle of the syringe or insulin pen remains above the surface of the skin, while the medication is delivered through the soft cannula and into the subcutaneous tissue. The device, which may be worn for up to 72 hours and receive up to 75 injections, is designed to reduce the hardships of multiple daily subcutaneous injections.

The Unomedical A/S i-port Advance™ injection port is indicated for patients requiring multiple daily subcutaneous injections of physician-prescribed medications, including insulin. The device can remain in place for up to 72 hours, accommodating multiple injections without additional needle sticks. This device is suitable for both adults and children.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative acceptance criteria with specific numerical thresholds for each test, but rather confirms that the device "meets all applicable design and performance requirements." The performance tests conducted are standard for this type of medical device and are designed to ensure safety and effectiveness.

2. Sample Size for the Test Set and Data Provenance

The document provided does not specify the sample sizes used for each performance test. The data provenance is "internal Unomedical protocols" and adherence to international standards (ISO, AAMI/ANSI). It is implied these are prospective tests conducted during the device development and validation phases, likely conducted in various Unomedical facilities. The country of origin of the data is implied to be relevant to Unomedical A/S (Denmark) and potentially Patton Medical Devices (USA), given the collaboration.

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

The provided text does not indicate the use of experts to establish ground truth for a test set. The studies conducted are performance and safety tests against engineering specifications and international standards, rather than clinical studies requiring expert interpretation of results (e.g., image analysis by radiologists). The "ground truth" for these engineering tests is derived directly from the test methodologies and metrics defined by the standards and internal protocols.

4. Adjudication Method for the Test Set

No adjudication method is mentioned as the tests are for device performance against predefined specifications, not for interpretation by multiple human readers.

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

No MRMC comparative effectiveness study was done or mentioned. This device is a physical medical device (an injection port), not an AI algorithm or diagnostic tool. Therefore, a study comparing human readers with and without AI assistance is not applicable.

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

No standalone algorithm study was done or mentioned. As stated, this is a physical medical device.

7. Type of Ground Truth Used

The "ground truth" for the performance tests conducted (Flow, Leak, Tension, Pull, Weld Strength, Disconnection Strength, Spring Loading Force, Insertion Depth, Biocompatibility, Sterility, Pyrogenicity, Packaging Integrity) is based on engineering specifications, international consensus standards (e.g., ISO, AAMI/ANSI), and internal Unomedical protocols. This means the device's performance was measured against established benchmarks for safety and functionality. For instance:

• Biocompatibility: Conformance to AAMI/ANSI/ISO 10993-1:2009.
• Sterility: Conformance to AAMI/ANSI/ISO 11135-1:2007 to a SAL of 10⁻⁶.
• Ethylene Oxide Residuals: Compliance with AAMI/ANSI/ISO 10993-7:2008.

8. Sample Size for the Training Set

No training set is mentioned or applicable as this is a physical medical device, not an AI/machine learning algorithm.

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

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

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I-Portal® 4D Video Oculography (VOG) System is used to monitor and record eye movements from various stimuli used in vestibular diagnostic testing. The system measures and records horizontal, vertical, and torsional eye movements, as well as pupil area. It is used in conjunction with various stimuli (rotary chair, manual (done by clinician) positional maneuvers, caloric tests, external stimulus) to detect and record nystagmus and eye tracings for interpretation by qualified medical personnel trained in vestibular diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.

Not Found

The provided document is limited to a "Substantial Equivalence Determination" from the FDA and does not contain the detailed study information required to answer your request. This type of FDA letter typically confirms that a device is substantially equivalent to a predicate device already on the market, meaning it has a similar intended use and technology, and any differences do not raise new questions of safety or effectiveness. It does not generally include a detailed description of the studies, acceptance criteria, or performance data that would be found in a 510(k) summary or full submission.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided document.
2. Sample size used for the test set and the data provenance: Not available.
3. Number of experts used to establish the ground truth for the test set and the qualifications: Not available.
4. Adjudication method: Not available.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned. The device is a "Video Oculography Eye Tracking System," which is a measurement device for eye movements, not typically an AI diagnostic algorithm that would be assessed with MRMC studies in the context of human reader improvement.
6. Standalone performance (algorithm only): Not mentioned, and likely not applicable for this type of device which seems to be a hardware/software system for capturing and presenting data.
7. Type of ground truth used: Not available.
8. Sample size for the training set: Not available.
9. How the ground truth for the training set was established: Not available.

The document focuses on the regulatory approval and outlines the device's intended use: "I-Portal® 4D Video Oculography (VOG) System is used to monitor and record eye movements from various stimuli used in vestibular diagnostic testing. The system measures and records horizontal, vertical, and torsional eye movements, as well as pupil area. It is used in conjunction with various stimuli (rotary chair, manual (done by clinician) positional maneuvers, caloric tests, external stimulus) to detect and record nystagmus and eye tracings for interpretation by qualified medical personnel trained in vestibular diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations."

To obtain the detailed study information, one would typically need to review the full 510(k) summary or the complete 510(k) submission, which is not provided in this excerpt.

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The I-PORT™, Injection Port is indicated for patients who administer, or to whom is administered, multiple daily subcutaneous injections of physician prescribed medications, including insulin. The I-PORT™, Injection Port may remain in place for up to 72 hours to accommodate multiple drug injections without the discomfort of additional needle sticks. This device may be used on a wide range of patients, including adults and children.

The 1-PORT™, Injection Port is a sterile, single use, low profile injection port through which physician prescribed medications can be injected subcutaneously from a standard syringe and needle, pen or alternative manual iniection device. The device is designed to reduce the hardships of multiple daily subcutaneous injections by allowing users to receive physician prescribed medication, including insulin, without repeated needle punctures of the skin. The I-PoRT™, Injection Port may remain in place for up to 72 hours to accommodate multiple drug injections without additional needle sticks.

The provided text describes the 510(k) summary for the I-PORT™ Injection Port, not a study evaluating its performance against acceptance criteria using AI or human readers. The document focuses on regulatory approval, establishing substantial equivalence to predicate devices, and demonstrating compliance with standards.

Therefore, many of the requested categories for summarizing a study with AI and expert review are not applicable to this document. I will fill in the relevant information that is present.

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

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the format you've requested for typical AI or diagnostic device studies. Instead, it states:

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

• Sample Size: Not specified. The document only mentions "Representative samples of the device" for bench testing.
• Data Provenance: Not specified. The testing described is laboratory/bench testing, not data collected from human subjects.

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

Not applicable. This is a medical device for drug administration, not an AI or diagnostic device with ground truth established by experts interpreting images or clinical data. The "ground truth" here is compliance with engineering and material specifications.

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

Not applicable. No expert adjudication method is described for this type of device testing.

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

Not applicable. This is not an AI-assisted diagnostic device; it is a physical medical device.

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

Not applicable. This is a physical medical device, not an algorithm. Bench testing evaluates the device's physical properties and functionality.

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

The "ground truth" in this context refers to engineering and material specifications, and compliance with recognized standards. For example:

• Internal specifications and user needs.
• Requirements of ANSI/AAMI/ISO 10993-1:2003 for biocompatibility.
• A Sterility Assurance Level (SAL) of 10-6.
• Pyrogen-free status as tested by LAL.
• Compliance with various ASTM and ISO standards for packaging, sterilization, and general requirements for intravascular catheters.

8. The sample size for the training set

Not applicable. No training set is relevant for this type of physical medical device and its associated testing.

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

Not applicable. No training set is relevant.

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