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The Madsen Zodiac (Type 1096) is an auditory impedance tester that is intended to change the air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear. This device is also used to measure the acoustic reflex threshold and decay testing as well as eustachian tube function testing for intact and perforated tympanic membranes. (Prescription Use).

The MADSEN Zodiac Type 1096 device is designed to measure and evaluate the acoustic impedance/admittance of the human ear by means of acoustic probe signals at different frequencies and with temporal characteristics. MADSEN Zodiac is a compact device for immittance testing. You can operate Zodiac as a stand-alone unit using the built-in keypad and display, or, if you are using the OTOsuite Immittance software module, you can operate Zodiac using the PC's keyboard and mouse with the OTOsuite Immittance module acting as the display. MADSEN Zodiac supports the following probes:

• The hand-held Quick Check probe
• The two diagnostic probe types, Classic and Comfort
• A contralateral insert phone or TDH-39.

Supported tests: Depending on the configuration, Zodiac supports the following tests and functionalities:

• Tympanometry
• Reflex Screening
• Reflex Threshold
• Reflex Decay
• ETF-I (Eustachian Tube Function - Intact)
• ETF-P (Eustachian Tube Function -Perforated)
• Admittance Recording (multiple uses, e.g. patulous Eustachian Tube evaluation, acoustic reflexes with external stimulus)
• Manual Tympanometry

This is a MODIFIED version of our previous model, the predicate device.

The document describes a 510(k) premarket notification for the "Madsen Zodiac Model 1096" auditory impedance tester. The acceptance criteria and supporting study information are derived from the comparison to the predicate device (OTOflex 100 Type 1012) and the non-clinical testing performed.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The acceptance criteria are generally established by meeting the technical specifications of the predicate device and adhering to recognized standards. The "Reported Device Performance" column reflects the specifications of the Madsen Zodiac 1096.

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The ICS Impulse System Model 1085 is used in the assessment of the vestibular-ocular reflex (VOR) and nystagmus by measuring, recording, displaying, and analyzing eye and head movements.

The device is a combination of hardware and software. The patient wears a pair of lightweight, tightly-fitting goggles on which is mounted a very small, very light, very fast, USB video camera and a half silvered mirror. This transparent mirror reflects the image of the patient's eye into the camera. The eye is illuminated by a low-level infra-red light emitting diode which is not visible to the patients. A small sensor on the goggles measures the head movement. The whole goggle system is lightweight but it must be secured tightly to the head to minimize goggle slippage. The software records and displays the information obtained during what is known as a "head impulse test". The basic head impulse test starts with the tester standing behind the patient who is wearing the goggles. While the patient is asked to stare at the fixation dot placed on a projection surface in front of them, the tester rotates the patient's head horizontally through a small angle (about 10-20 degrees) in a brief, abrupt and unpredictable manner, varying the direction and the velocity. The goggles collect both head and eye data. The gyroscope measures the velocity of the head movement (the stimulus). The high-speed camera captures the image of the eye. The OTOsuite Vestibular software processes the head velocity data and velocity data for eye movement (the response). Simultaneous displays of the data for head movement and for eye movement allow the clinician to determine if the response is within normal limits or not. The software also records and displays the information obtained during Positional and Oculomotor tests. A Positional test is performed by moving that patient from one position to another position. In the example of Dix-Hallpike, the patient is sitting and the patient's head is turned 45 degrees to one side and then the patient is moved from the sitting position to the supine position. An Oculomotor test is performed by having the patient stare in various directions or under various environments. In the example of Gaze, the patient is sitting and the patient is asked to stare left, right, up, down or center. The Gaze test can be performed with vision or with vision denied. For both Positional and Oculomotor the goggles collect head and eye data. The accelerometer in the small sensor measures where the head is in space. That information is taken and the patient's head position or any movement during testing is displayed in the software. The high speed camera captures the image of the eye. The OTOsuite Vestibular software processes the eye velocity data (the response). The eye movement is analyzed to determine the slow phase velocities (SPV). The head data is only used during collection to display if the patient's head is moving and to guide the tester to position the patient's head appropriately for the test. This is what we refer to as "Head Position Feedback". Tests where slow phase velocity is measured display the eve position trace and slow phase velocity beats in a graph. In Oculomotor there are 2 tests VOR and Skew Deviation that are not SPV tests. VOR (vestibular ocular reflex) which allows for both visual VOR (VVOR) and VOR suppression (VORS). This test is very similar to the head impulse test but the head movement is slow (0.5 Hz) and small (10 degrees). In VVOR the patient is sitting and the examiner moves the head from side to side (like a sinusoid) while the patient stares at a fixed target. In VORS the patient is sitting and the examiner moves the head from side to side (like a sinusoid) while the patient stares at a moving dot projected from the goggle using one of the lasers. The analysis is similar to head impulse, simultaneous displays of the data for head movement and for eye movement allow the clinician to determine if the response is within normal limits or not. In Skew Deviation (also known as cover test or alternate cover test) the patient is sitting and the tester covers and uncovers. The OTOsuite Vestibular software measures the eye position trace during the cover and uncover environments and displays an average eye position shift.

The provided text describes a 510(k) premarket notification for the ICS Impulse System Model 1085, which is a nystagmograph used to assess vestibular-ocular reflex (VOR) and nystagmus by measuring, recording, displaying, and analyzing eye and head movements.

However, the document is a Summary of Substantial Equivalence, not a full study report of the device's performance against specific acceptance criteria. It primarily focuses on comparing the new device (ICS Impulse Model 1085) to previously cleared predicate devices (K061791 ICS Chartr 200 VNG and K122550 ICS Impulse Type 1085) to demonstrate substantial equivalence, rather than providing detailed performance metrics from a specific study against pre-defined acceptance criteria.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and specific performance metrics are not available in the provided text.

Here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document declares that "The ICS Impulse adequately meets the design requirements and acceptance criteria" but does not provide a specific table of acceptance criteria with corresponding performance results. The "Description of Testing" section mentions:

• UL Electrical Safety testing (passed)
• EMC testing (passed)
• Software validation (performed)
• Risk analysis (performed)
• Biocompatibility testing (successfully performed)
• Clinical analysis based on published literature (performed)

These are general types of testing, but no quantitative acceptance criteria or performance metrics are detailed.

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

• Not explicitly stated for a performance test set. The document mentions "A clinical analysis based on published literature." This suggests that the clinical validation was not based on a new, direct clinical study with a specific test set but rather a review of existing literature, likely supporting the underlying principles of the device's measurements (VOR, nystagmus). Therefore, there is no specific "test set" with a defined sample size or provenance in the context of a prospective study of the device itself.

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

• Not applicable based on the provided text. Since a direct clinical performance study with a defined test set and ground truth established by experts is not described, this information is not available. The "clinical analysis based on published literature" does not involve fresh ground truth establishment for a specific device test set.

4. Adjudication Method for the Test Set:

• Not applicable based on the provided text. No adjudication method is described as there is no specific test set undergoing human expert review for performance evaluation.

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

• No indication of an MRMC study. The document focuses on demonstrating substantial equivalence to predicate devices, not on showing how much human readers improve with AI vs. without AI assistance. This suggests that no MRMC study was performed or reported in this 510(k) summary. The device, a nystagmograph, primarily measures and displays physiological data; it's not described as an AI-powered diagnostic aid that assists human readers in interpreting images or data.

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

• The document implies that the device "measures, records, displaying, and analyzing eye and head movements." The software processes data: "The OTOsuite Vestibular software processes the head velocity data and velocity data for eye movement (the response)." and "The OTOsuite Vestibular software processes the eye velocity data (the response)." This indicates the algorithm performs analysis alone to generate data. However, specific performance metrics of this standalone algorithmic analysis (e.g., sensitivity, specificity, accuracy against a true measurement) are not reported in this 510(k) summary document. It states the system allows the clinician to "determine if the response is within normal limits or not," implying human interpretation of the algorithm's output.

7. The Type of Ground Truth Used:

• Not explicitly detailed for device performance evaluation. Given that the clinical analysis was based on published literature, the "ground truth" would refer to the accepted understanding and measurement of VOR and nystagmus as established in the scientific and medical community. There's no mention of a specific, newly established ground truth (e.g., pathology, outcomes data) for validating the device's measurements in a direct study.

8. The Sample Size for the Training Set:

• Not applicable/Not provided. The document describes software validation and risk analysis, but it does not mention a "training set" in the context of a machine learning or AI algorithm that would require one. The device measures physical parameters, and its "analysis" seems to be based on known physiological principles rather than statistical learning from a large dataset.

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

• Not applicable/Not provided. As there's no mention of a training set, this information is not relevant to the provided text.

In summary, the provided document is a 510(k) summary focused on demonstrating substantial equivalence, not a detailed report of a clinical performance study with specific acceptance criteria and results. Therefore, most of the detailed information requested regarding study design, sample sizes, ground truth, and expert involvement is not present.

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The ICS Chartr EP 200 with VEMP is indicated for auditory evoked potential testing as an aid in assessing hearing loss and lesions in the auditory pathway. The Vestibular Evoked Myogenic Potential is indicated for vestibular evoked potential testing as an aid in assessing vestibular function in adult patients. The device is to be used only by qualified medical personnel with prior knowledge of the medical and scientific facts underlying the procedure.

"Vestibular Evoked Myogenic Potentials (VEMPs) are short latency electromyograms (EMGs) evoked by high level acoustic stimuli recorded from surface electrodes over the tonically contracted sternocleidomastoid (SCM) muscle." Akin FW & Murnane OD (2001).
The ICS Chartr EP 200 with VEMP is used to test the auditory and vestibular functions of children and adults in a hospital, in an Ear, Nose and Throat Clinic or in an Audiology office. The ICS Chartr EP 200 system measures evoked potentials from the patient using repeated auditory stimuli and averaging EEG or EMG activity in order to abstract the response from the noise resulting in an analysis of the auditory/vestibular system functions.

The ICS Chartr EP 200 is a PC-based system, which consists of software modules for installation on a PC, an isolation transformer, a hardware platform, pre-amp, a mains adapter, stimulation devices and recording devices. The stimulation and recording devices are connected to the preamp, which is connected to the hardware platform, which is connected to the PC via a USB cable - no hardware installation inside the PC is required. The PC and hardware platform are powered from the isolation transformer which is powered from the mains.

One added item as compared to the standard EP200 is the VEMP monitor. The Chartr EP (USB) VEMP monitor assesses the level of tonic EMG and displays if the level is adequate or inadequate. The monitor light will display the following based on the EMG level: Low (blue) -EMG level is below the Min value- Good (green) - EMG level is between Min value and the Max value - High (amber) - EMG level is above the Max value

Summary: VEMP is an evoked potential (EP) just like ABR obtained using any commercially available EP system. The unique feature with the ICS Chartr EP 200 is the ability to perform EMG monitoring during VEMP data collection.

The VEMP function of the EP 200 does not make a diagnosis. The diagnosis is made by a medical professional.

The provided text describes a 510(k) premarket notification for the ICS Chartr EP 200 with VEMP, an auditory and vestibular evoked potential testing device. It does not contain information about an AI/ML medical device. Therefore, a comprehensive answer to the user's request for acceptance criteria and study proving an AI/ML device meets them cannot be wholly extracted from the given text.

However, I can extract the information relevant to the device's validation and substantial equivalence, and then address the remaining points by stating the information is not present in the provided document.

Here's an attempt to answer the user's request based only on the provided text, highlighting what is available and what is not:

Based on the provided FDA 510(k) summary for the ICS Chartr EP 200 with VEMP:

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

The document does not explicitly define "acceptance criteria" in a quantitative table format for performance metrics relevant to an AI/ML device (e.g., sensitivity, specificity, AUC). Instead, it focuses on demonstrating the reproducibility of VEMP waveforms and comparing the new device's features and safety/effectiveness to a predicate device.

The closest equivalent to "reported device performance" in the context of this device is the correlation values for VEMP waveform reproducibility.

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

• Test Set Sample Size:
  • 60 normal cVEMP subjects
  • 58 pathologic cVEMP subjects
  • 20 normal oVEMP subjects
• Data Provenance: Studies were collected at two different facilities, one in the USA and one in Canada. The document states these were "clinical studies," implying they were prospective, but does not explicitly state "retrospective" or "prospective."

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

This information is not present in the provided text. The device assesses auditory and vestibular function, and the "ground truth" seems to be the VEMP waveform itself and its reproducibility, rather than a clinical diagnosis established by experts. The diagnosis is stated to be made by a medical professional.

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

This information is not present in the provided text. The study focuses on correlation and reproducibility of waveforms, not on classification or diagnostic accuracy adjudicated by multiple readers.

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

• MRMC Study: No, an MRMC study was not done. This device is an evoked potential testing system, not an AI-powered diagnostic algorithm assisting human readers.
• Effect Size of AI assistance: Not applicable, as this is not an AI/ML device.

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

• Standalone Performance: Not applicable in the context of AI/ML. The device's "performance" is its ability to reliably acquire and display VEMP waveforms. The clinical conclusion and diagnosis are explicitly stated to be made by a medical professional. "The VEMP function of the EP 200 does not make a diagnosis. The diagnosis is made by a medical professional."

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

The "ground truth" implicitly used for the reproducibility study is the VEMP waveform itself and its consistency across repeated measurements. The study aimed to demonstrate that the device could reliably produce these waveforms. For patients with disorders, the "pathologic" status serves as a descriptor for that cohort, with results indicating lower correlation due to the nature of their conditions (absent or abnormal VEMPs).

8. The sample size for the training set

This information is not present in the provided text. This is not an AI/ML device that requires a "training set" in the machine learning sense. Clinical studies presented were to confirm reproducibility, not to train an algorithm.

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

This information is not present in the provided text, as it is not an AI/ML device with a training set and corresponding ground truth.

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The Type 1077 device is indicated for use in the recording and automated analysis of human physiological data (screening auditory brainstem responses and/or otoacoustic emissions) necessary for the diagnosis of auditory and hearing-related disorders.

Distortion Product Otoacoustic Emissions and Transient Evoked Otoacoustic Emissions: The Type 1077 DPOAE module and TEOAE module can be used for patients of all ages, from children to adults, including infants and geriatric patients. It is especially indicated for use in testing individuals for whom behavioral audiometric results are deemed unreliable, such as infants, young children, and cognitively impaired adults.

Auditory Brainstem Response: The Type 1077 ABR module is especially intended for infants from 34 weeks (gestational age) up to 6 months of age.

When the device is used to screen infants. they should be asleep or in a quiet state at the time of screening. The device is intended for use by audiologists. ENT's and other healthcare professionals.

The device is identical to our own device described in K122067. Only the indications for use has changed. The age range has been expanded. Different models of the device are capable of the following list of tests: AccuScreen TE (TEOAE), AccuScreen DP (DPOAE), AccuScreen TE/DP (TEOAE and DPOAE), AccuScreen ABR (ABR), AccuScreen ABR/TE (ABR and TEOAE), AccuScreen ABR/DP (ABR and DPOAE), AccuScreen ABR/TE/DP (ABR, TEOAE and DPOAE). The measurement application is controlled from a self-contained firmware (software) module installed in the handheld device. The firmware module can be configured to allow different OAE measurement types (DPOAE and/or TEOAE) by a license key stored in the device. For automated OAE measurements, the handheld device uses an OAE probe, designed and manufactured by PATH Medical GmbH. The OAE probe is fitted with an ear-tip (constructed of biocompatible material) and inserted in the ear canal of the patient. The AccuScreen device plays stimulus sounds in the ear canal via small speakers in the OAE probe. The AccuScreen device measures the patient's response to the stimulus sounds via a microphone in the probe. The measured response is processed by the AccuScreen device using statistics to help deter or not a hearing loss may be present. When the OAE measurement is a DPOAE measurement, the stimulus signal is composed of two pure tone signals, each presented by a speaker in the OAE measurement is a TEOAE measurement, the stimulus signal is a series of broadband clicks presented by one speaker in the OAE probe.

Here's an analysis of the acceptance criteria and the study details for the MADSEN AccuScreen Type 1077, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The clinical study's primary objective was to demonstrate comparable performance to the predicate device (Echo-Screen T, TA, TD, TDA, TC, K013977) across an expanded age range for OAE measurements. The acceptance criteria essentially translate to reaching a high percentage agreement with the predicate device.

2. Sample Size and Data Provenance for Test Set

• Sample Size for Test Set: 130 ears were tested. (This implicitly refers to 65 individuals if testing both ears.)
• Data Provenance: Not explicitly stated, but the study was conducted to compare against a predicate device, which implies a prospective data collection for the comparison. The country of origin is not mentioned.

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

• The ground truth for the primary comparison was the predicate device's result.
• In cases of discrepancy between the device under review (Type 1077) and the predicate, a "diagnostic OAE device" was used to re-test the subjects. The summary does not specify the number or qualifications of experts involved in operating this diagnostic device or interpreting its results to resolve discrepancies.

4. Adjudication Method for the Test Set

• The primary method was a direct comparison between the Type 1077 and the predicate device.
• For discrepant results (where Type 1077 and the predicate did not agree), a "diagnostic OAE device" was used for re-testing. This acts as an adjudication method, essentially using a third, presumably more accurate or established, method to determine the "correct" result in ambiguous cases. The document does not specify if expert consensus was involved in interpreting the diagnostic OAE device results.

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

• No, an MRMC comparative effectiveness study was not done. This study focuses on device performance comparison rather than human reader improvement with or without AI assistance. The device is an automated screening tool, not an AI-assisted diagnostic aid for human readers.

6. Standalone Performance Study

• Yes, a standalone performance was done in the sense that the device's output (Pass/Refer for DPOAE and TEOAE) was directly compared to the predicate device's output. The goal was to establish that the Type 1077 provides results comparable to a legally marketed equivalent device without human intervention in the interpretation of the screening result.

7. Type of Ground Truth Used

• The primary "ground truth" for the comparison was the result from the predicate device (Echo-Screen).
• For discrepant cases, the ground truth was derived from re-testing using a "diagnostic OAE device." This implies a more definitive diagnostic result was used to resolve discrepancies between the two screening devices.

8. Sample Size for the Training Set

• The document does not provide information about a training set. This is a medical device clearance for an auditory stimulator and analysis system, not a machine learning algorithm that typically requires a distinct training set. The device likely relies on established signal processing and statistical methods for OAE analysis, which were developed and validated during its initial design (pre-K122067 and K122067).

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

• Not applicable, as no training set is mentioned in the provided documentation.

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The ICS Impulse System is used in the assessment of the vestibular-ocular reflex (VOR) by measuring, recording, displaying, and analyzing eye and head movements. (Prescription use).

The device is a combination of hardware and software. The patient wears a pair of lightweight, tightly-fitting goggles on which is mounted a very small, very light, very fast, fire-wire video camera and a half silvered mirror. This transparent mirror reflects the image of the patient's eye into the camera. The eye is illuminated by a low-level infra-red light emitting diode which is not visible to the patients. A small sensor on the goggles measures the head movement. The whole goggle system is lightweight but it must be secured tightly to the head to minimize goggle slippage. The software records and displays the information obtained during what is known as a "head impulse test" The basic head impulse test starts with the tester standing behind the patient who is wearing the goggles. While the patient is asked to stare at the fixation dot placed on a projection surface in front of them, the tester rotates the patient's head horizontally through a small angle (about 10-20 degrees) in a brief, abrupt and unpredictable manner, varying the direction and the velocity. The goggles collect both head and eye data. The gyroscope measures the velocity of the head movement (the stimulus). The high-speed camera captures the image of the eve. The OTOsuite Vestibular software processes the head velocity data and velocity data for eye movement (the response). Simultaneous displays of the data for head movement and for eye movement allow the clinician to determine if the response is within normal limits or not.

The provided text describes the ICS Impulse device, its intended use, and a comparison to predicate devices, but it does not include detailed information regarding specific acceptance criteria for performance, nor does it present the results of a study designed to explicitly "prove the device meets the acceptance criteria" in a quantitative manner as typically expected for medical device approvals of this nature (e.g., sensitivity, specificity, accuracy against a gold standard in a clinical trial).

The document states that "Clinical testing compared test results to Scleral Search Coils test results. ICS Impulse adequately meets the design requirements and acceptance criteria." However, it does not elaborate on what these "design requirements and acceptance criteria" were in terms of specific performance metrics or thresholds, nor does it provide the detailed results of this clinical testing.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

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

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country, retrospective/prospective).
  The text only says "Clinical testing compared test results to Scleral Search Coils test results."

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)

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
  The "Scleral Search Coils" are referred to as the reference standard, which is an objective measurement technique rather than an expert interpretation. If expert interpretation was involved in the "Scleral Search Coils test results," it's not detailed.

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

• Not specified.

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 specified. The document does not describe the device as an "AI" or "CAD" system in the context of human reader improvement. It's a measurement and display device.

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

• The device performs measurements and displays data for a clinician to interpret. The "clinical testing" implicitly refers to the device's measurements being compared to a reference standard, which is a form of standalone performance evaluation of the measurement capability, even if the final interpretation is by a human. However, explicit "standalone" performance metrics (e.g., sensitivity, specificity, accuracy) are not provided.

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

• The ground truth (reference standard) used for the clinical testing was "Scleral Search Coils test results." Scleral Search Coils are considered a gold standard for precise eye movement measurement.

8. The sample size for the training set

• Not specified. The document does not explicitly mention a "training set" in the context of machine learning. The clinical testing described seems to be a validation/comparison study.

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

• Not applicable/Not specified, as a training set is not explicitly mentioned.

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The Aurical HIT Type 1082 is intended to be used by audiologists, technicians, and other professionals who perform hearing instrument testing. Used in conjunction with the OTOSuite software, the Type 1082 permits presentation of acoustic sounds and magnetic field stimuli in order to assess the audio processing and telecoil functionality of the hearing instrument.

AURICAL HIT is designed for Hearing Instrument Testing and Coupler-Based Fitting. AURICAL HIT connects via USB to a computer running the OTOsuite software. With the OTOsuite HIT Module one can perform traditional hearing instrument testing according to either the ANSI or IEC test protocols, and obtain a consistent picture of every hearing instrument, regardless of manufacturer or type. With the OTOsuite PMM Module one can perform Probe Microphone Measurements in a coupler for pre-programming and pre-fitting hearing instruments without the client being present. It is easy to position hearing instruments on snap-on couplers inside the AURICAL HIT test chamber and it is easy to access the hearing instruments in the test chamber during test without disturbing the test setup. The battery pill types are recognized automatically, and the reference microphone ensures reliable positioning in the test chamber.

The document provided describes the Aurical HIT Type 1082, a hearing aid calibrator. The evaluation involved non-clinical performance testing against established standards, rather than studies involving human participants or complex AI algorithms. Therefore, many of the requested categories are not applicable.

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes "non-clinical performance testing of the device against the applicable parameters specified in the following standards: ANSI S3.22: 2003, and IEC 60118-7:2005." This indicates bench testing of the device's physical and functional characteristics.

• Test set sample size: Not applicable in the context of human data. The "sample" here refers to the device itself and its components undergoing tests according to industry standards.
• Data provenance: Not applicable. The data is generated from performance testing of the manufactured device in a controlled lab environment according to specified international standards. It is not from a clinical population or geographical region.

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

Not applicable. The "ground truth" for this device is defined by the objective performance parameters outlined in the referenced ANSI and IEC standards for hearing aid calibrators. There is no mention of expert consensus being used to establish these fundamental technical standards.

4. Adjudication Method for the Test Set:

Not applicable. As the testing involves objective measurement against established technical standards, adjudication by experts is not described or required.

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. The device is a hearing aid calibrator, a piece of diagnostic equipment, not an AI system designed to assist human "readers" (e.g., radiologists, pathologists). Therefore, MRMC studies are not relevant.

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

Not applicable. This is a hardware device with accompanying software for instrument control and data acquisition, not a standalone algorithm or AI. The performance tested is the device's ability to precisely measure and present acoustic/magnetic stimuli as per the established technical standards.

7. The Type of Ground Truth Used:

The ground truth used is based on technical specifications and performance requirements defined by international standards:

• ANSI S3.22: 2003 (American National Standard for Hearing Aid Characteristics)
• IEC 60118-7: 2005 (International Electrotechnical Commission standard for Hearing Aids - Part 7: Measurement of the performance characteristics of hearing aids for quality inspection purposes)
• IEC 61010-1 (Safety requirements for electrical equipment for measurement, control, and laboratory use)
• IEC 61326-1 (Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements)

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/machine learning system that requires a training set.

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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AccuScreen is a portable instrument used to screen infants for hearing loss. The instrument uses the Distortion Product Otoacoustic Emissions (DPOAE), Transient Evoked Otoacoustic Emissions (TEOAE) and Auditory Brainstem Response (ABR) technologies. The instrument is intended for screening infants from 34 weeks (gestational age) up to 6 months of age that are well enough to be ready for discharge from the hospital. Infants should be asleep or in a quiet state at the time of screening. AccuScreen is intended for use by audiologists, ENTs and other health care professionals.

GN Otometrics Type 1077 AccuScreen is a handheld examination system based on Otoacoustic Emissions (OAE) and/or Auditory Brainstem Response (ABR). The Type 1077 AccuScreen is designed to be easy to use, and employs automated OAE and/or ABR tests. The measurement flow is menu-guided and evaluation is based upon signal statistics. The Type 1077 AccuScreen is designed for trained personnel in a medical or home environment to examine hearing in infants from 34 weeks (gestational age) up to 6 months of age that are well enough to be ready for discharge from the hospital.

The Type 1077 AccuScreen OAE system consists of the AccuScreen handheld device, a Docking Station with mains adapter, OAE probe with disposable probe- and ear-tips, and AccuLink software for installation on a PC. When ABR is included an optional ear coupler cable and disposable ear couplers can be included in the system, as well.

The AccuScreen handheld device comes in two hardware versions; one for OAE screening only and one for both OAE and ABR screening. Both versions are based on a common hardware platform (printed circuit board), but with different configurations.

The measurement application is controlled from a self-contained firmware (software) module installed in the handheld device. The firmware module can be configured to allow different OAE measurement types (DPOAE and/or TEOAE) by a license key stored in the device.

For automated OAE measurements, the handheld device uses an OAE probe, designed and manufactured by PATH Medical GmbH. The OAE probe is fitted with an ear-tip (constructed of biocompatible material) and inserted in the ear canal of the patient. The AccuScreen device plays stimulus sounds in the ear canal via small speakers in the OAE probe. The AccuScreen device measures the patient's response to the stimulus sounds via a microphone in the probe. The measured response is processed by the AccuScreen device using statistics to help determine whether or not a hearing loss may be present.

When the OAE measurement is a DPOAE measurement, the stimulus signal is while and of two pure tone signals, each presented by a speaker in the OAE probe. When the OAE measurement is a TEOAE measurement, the stimulus signal is a series of broadband clicks presented by one speaker in the OAE probe.

For automated ABR measurements, the device uses the OAE probe, or an ABR ear coupler cable for providing the acoustical stimulus for the patient. When the ABR ear coupler cable is used, its speakers are inserted in the ABR Ear Couplers, which are then placed over the patient's ear with a biocompatible adhesive gel on the ear coupler rim. The stimulus signal is a series of broadband clicks and the AccuScreen device measures the patient's response as an electrical signal from three electrodes placed on the head of the patient. The measured response is processed by the AccuScreen device using statistics to help determine whether or not a hearing loss may be present.

The 1077 Docking Station serves as a means of providing power to charge the rechargeable battery in the AccuScreen handheld device. The Docking Station also provides an interface to an optional label printer or to a PC. The label printer is used for printing test results from the AccuScreen handheld device. The PC is used for transferring patient demographical data to the AccuScreen handheld device and for collecting measurement results from the AccuScreen handheld device by using the AccuLink PC software.

The provided text is a 510(k) summary for the GN Otometrics Type 1077 AccuScreen device. It primarily focuses on demonstrating substantial equivalence to a predicate device (Echo-Screen) by comparing design, functionality, and compliance with various medical device standards. Crucially, this document does not contain details about specific acceptance criteria or a dedicated study proving the device meets performance claims through clinical evaluation.

The “performance data” mentioned refers to compliance with safety, EMC, software lifecycle, usability, and biocompatibility standards, rather than clinical performance metrics like sensitivity or specificity for hearing loss detection against a ground truth.

Therefore, many of the requested sections cannot be answered from the provided document.

Here's what can be extracted and what cannot:

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

Based on the provided document, there are no specific performance-based acceptance criteria (e.g., sensitivity, specificity, accuracy) or reported clinical performance metrics for the device to screen for hearing loss. The document focuses on demonstrating substantial equivalence through:

• Design and principal similarity to the predicate device (Echo-Screen).
• Compliance with recognized electrical, software, and biocompatibility standards.

The "performance data" section in the document refers to compliance with standards, not clinical performance metrics.

The following information cannot be determined from the provided text:

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

• The document does not describe a clinical performance study with a test set. It relies on demonstrating substantial equivalence to a predicate device and compliance with standards.

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, as no clinical performance study with a test set and ground truth establishment is described.

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

• Not applicable, as no clinical performance study with a test set 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

• This device is an automated screening tool, not an AI assistance tool for human readers. No MRMC study is mentioned.

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

• The document implies standalone performance comparison to the predicate, as both are automated screening devices ("both devices give a Pass/Refer result as an automated screening result"). However, specific performance metrics (sensitivity, specificity) of this standalone operation are not provided beyond the claim of being "very similar" to the predicate. No dedicated standalone validation study with concrete performance data is detailed.

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

• Not applicable, as no clinical performance study with a ground truth is described.

8. The sample size for the training set

• This document describes a device whose "measurement application is controlled from a self-contained firmware (software) module." There is no mention of a machine learning or AI model that would require a "training set" in the conventional sense. The device's "statistics" for determining hearing loss are likely based on pre-programmed algorithms and thresholds, not a learned model from a large training dataset.

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

• Not applicable, as no training set for a machine learning model is mentioned.

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Type 1053 FreeFit is intended for audiologists, hearing instrument dispensers, ENTs, speech therapists and other health care professionals. The intended use is that the user is able to visualize the amplified signal recorded in the ear(s) of persons with a hearing loss together with reference information such as target curves in order for the user to have an objective basis for adjusting the Hearing Instrument settings.

The GN Otometrics Type 1053 FreeFit is a PC-based system that contains hardware and software for one or more applications. The applications are controlled from selfcontained software modules installed on a common software platform. The following applications are available: Real ear measurement system (i.e., audio fitting system) and Simulator system.

As a real ear measurement system, the Type 1053 FreeFit plays calibrated sound files and measures the sound pressure level in the ear canal. The difference between the measured sound level outside the ear and in the ear canal gives the gain from the hearing aid. This allows for adjusting hearing aids and demonstrating hearing aid features like noise suppression. The Type 1053 FreeFit system also shows target curves that the hearing aid dispenser can use as guidelines for adjusting the hearing aid.

The real ear measurement system consists of a neckset, a charger unit with mains adapter, two probes connected to the neckset, software for installation on a PC (i.e., OTOsuite Probe Microphone Measurements (PMM)) and hardware for connection to a PC. The neckset is connected to the PC via a Bluetooth radio link (i.e. no physical connection to the PC).

The FreeFit Neckset is the actual measuring device. It contains 2 probes (one for each ear) each with 2 microphones used for measuring the sound level outside and inside the ear. Digital signal processing in form of Fast Fourier Transformations takes place inside the device and the obtained frequency spectra are transmitted to the OTOsuite via Bluetooth. The microphones measuring outside the ear are used for calibrating the sound level. Measurements inside the ear canal (near the eardrum) are conducted with a biocompatible silicone tube guiding the sound waves to the microphone. And the probes contain an o-ring also in biocompatible material for fastening at the ear (pinna).

The FreeFit Charger is used to charge the FreeFit neckset via an inductive coil system. The charger includes a power adaptor connected to mains and providing DC input to the charger stand.

OTOsuite PMM is a software platform required for measuring with the Type 1053 FreeFit, displaying the results and controlling the played sound files and levels. OTOsuite runs on most windows based PCs.

The Type 1053 FreeFit also has the capability to act as a hearing loss simulator and a hearing instrument simulator. These applications are commonly used to demonstrate the level of hearing loss suffered by a patient and the degree to which that loss can be overcome by use of a hearing instrument.

The simulator consists of software for installation on a PC (i.e., OTOsuite Counseling and Simulation (C&S)) and hardware for connection to a PC (i.e., headphones).

OTOsuite C&S is a software application that is required for simulating hearing loss and hearing instruments as part of the counseling process.

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly define specific numerical acceptance criteria for the Type 1053 FreeFit device in terms of performance metrics like accuracy, sensitivity, or specificity. Instead, the acceptance criteria are implicitly tied to demonstrating substantial equivalence to a predicate device (SpeechLink 100 Type 1053) and compliance with various established international and national standards.

Therefore, the table will reflect the general nature of the "acceptance" as described in the document, which primarily focuses on demonstrating equivalence and compliance rather than specific performance thresholds.

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

The document does not specify a sample size for any "test set" in the context of patient data or clinical trials. The testing described is primarily non-clinical, involving comparisons against a predicate device and compliance with technical standards.

• Sample Size for Test Set: Not applicable / Not specified for patient or clinical data. The "test set" here refers to the device itself being tested in a laboratory setting for compliance with standards.
• Data Provenance: Not applicable for patient or clinical data. The data provenance relates to engineering and testing against technical standards.

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

This information is not applicable as the document describes non-clinical performance data and compliance with technical standards for a sound measurement system, not a diagnostic or AI-driven system that would require expert-established ground truth from patient data.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable for the reasons stated above. There's no mention of human adjudication in the context of device performance testing against technical standards.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done, and therefore, there is no information on the effect size of human readers improving with or without AI assistance. The device described is a Real Ear Measurement System, which is a tool for audiologists to measure sound pressure levels, not an AI diagnostic or interpretive tool for "readers" to analyze cases.

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

The document describes the device as a "PC-based system that contains hardware and software." The "FreeFit Neckset is the actual measuring device," and "Digital signal processing... takes place inside the device." The "OTOsuite PMM is a software platform required for measuring... displaying the results and controlling the played sound files and levels."

This strongly suggests a standalone performance assessment was indeed central to verifying compliance with standards. The device's ability to accurately measure sound pressure levels and perform signal processing (Fast Fourier Transformations) and calculate gain curves without human intervention in the measurement process itself is the core of its function. The "improved calibration scheme" leading to "significantly greater measurement accuracy" is a direct measure of its standalone performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance testing is defined by established technical standards and methods for acoustical measurement. Specifically:

• ANSI S3.46-1997: "Methods of Measurement of Real-Ear Performance Characteristics of Hearing Aids." This standard dictates how real-ear measurements should be performed and what constitutes accurate measurement.
• EN/IEC 61669: "Electroacoustics - Equipment for the measurement of real-ear acoustical characteristics of hearing aids." Similar to ANSI S3.46, this standard provides a framework for accurate acoustical measurements.

The device's performance is gauged against the requirements and specifications outlined in these standards, which serve as the "ground truth" for its functional accuracy.

8. The Sample Size for the Training Set

Not Applicable. The Type 1053 FreeFit is a measurement device that performs digital signal processing based on established acoustical principles. It is not an AI/ML device that requires a "training set" in the conventional sense to learn patterns or make predictions. Its "learning" is based on its engineering design and adherence to scientific principles.

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

Not Applicable. As established in point 8, there is no training set in the context of AI/ML. The "ground truth" for the device's design and operation is rooted in the principles of electroacoustics and signal processing, validated by compliance with relevant international and national standards.

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The ICS Chartr EP 200 is indicated for auditory evoked potential testing as an aid in detecting hearing loss and lesions in the auditory pathway.

The ICS CHARTR EP 200 is a PC-based svstem, which consists of software modules for installation on a PC, an isolation transformer, a hardware platform, pre-amp, a mains adapter, stimulation devices and recording devices. The stimulation and recording devices are connected to the pre-amp, which is connected to the hardware platform, which is connected to the PC via USB cable - no hardware installation inside the PC is required. This submission is for a modification to K083399. The same hardware is used but the software has the additional ASSR (Auditory Steady State Response) feature as implemented on the system described in K031986.

The provided document K092373 describes a software modification to an existing medical device, the ICS CHARTR EP 200, which is an Auditory Evoked Potential System. This submission focuses on adding the Auditory Steady State Response (ASSR) feature and minor software and user interface enhancements to an already cleared hardware platform. As such, the acceptance criteria and supporting study are primarily focused on demonstrating the equivalence of the modified device to a predicate device, rather than proving novel performance metrics in a clinical study.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a modification to an existing device, the "acceptance criteria" are primarily established through substantial equivalence claims to predicate devices rather than novel performance benchmarks. The performance is assessed by comparing the new device's features and safety/effectiveness to those of the predicate devices.

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

The document does not describe a specific clinical "test set" with a sample size of patient data. This submission is a 510(k) for a device modification, focusing on documenting substantial equivalence through technical specifications, safety standard compliance, and a logical comparison to predicate devices, rather than a clinical performance study with patient data.

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

Not applicable. As noted above, there is no clinical "test set" and thus no ground truth established by experts.

4. Adjudication method for the test set

Not applicable. No test set requiring expert adjudication 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

Not applicable. This device is not an AI-assisted diagnostic tool where human reader performance would be evaluated with and without AI. It is an auditory evoked potential system.

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

This refers to the performance of the Auditory Evoked Potential (AEP) system itself in generating and processing auditory evoked potentials, particularly the new ASSR feature. The document implies that the ASSR algorithm's performance is accepted based on its implementation from the cleared predicate device K031986. The submission states: "The same hardware is used but the software has the additional ASSR (Auditory Steady State Response) feature as implemented on the system described in K031986." This suggests either:
* The original K031986 submission had data supporting the ASSR algorithm's standalone performance.
* The ASSR algorithm is a well-established and accepted method in the scientific community, and thus, its re-implementation in a new software simply needs to demonstrate correct functionality, not re-prove its fundamental performance characteristics.

The document does not explicitly describe a new standalone performance study for the modified device, relying instead on the established performance of the predicate device's ASSR feature and the device's compliance with electrical safety and EMC standards.

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

For an Auditory Evoked Potential system, the "ground truth" for its diagnostic performance would typically be established through comparison to:

• Clinical diagnosis: Established by an audiologist or medical doctor based on multiple tests and patient history.
• Behavioral audiometry: Pure tone audiometry, speech audiometry, which define the patient's hearing thresholds.
• Pathology/imaging: In cases of lesions in the auditory pathway, this could serve as anatomical ground truth.

However, the provided 510(k) summary does not detail any new clinical studies or the type of ground truth used for such studies for THIS submission. The statement "The ICS CHARTR EP 200 is an Auditory Evoked Response device for replacement of an existing product of a technology type that is available and accepted in the market" implies that the underlying technology's ability to detect hearing loss and lesions has been previously validated and accepted.

8. The sample size for the training set

Not applicable. This device is not described as using machine learning or AI that would require a "training set" of data in the typical sense. It is a signal processing and measurement device.

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

Not applicable, as there is no training set for a machine learning model.

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The ICS Chartr EP 200 is indicated for auditory evoked potential testing as an aid in detecting hearing loss and lesions in the auditory pathway.

The ICS CHARTR EP 200 is a PC-based system, which consists of software modules for installation on a PC, an isolation transformer, a hardware platform, pre-amp , a mains adapter, stimulation devices and recording devices, The stimulation and recording devices are connected to the pre-amp, which is connected to the hardware platform, which is connected to the PC via USB cable - no hardware installation inside the PC is required.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ICS CHARTR EP 200 device:

The provided text is a 510(k) summary for the ICS CHARTR EP 200, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a novel clinical study. As such, many of the requested data points for a traditional clinical study are not present in this document.

The "Effectiveness" section explicitly states: "The ICS CHARTR EP 200 is an Auditory Evoked Response device for replacement of an existing product of a technology type that is available and accepted in the market." This indicates that the regulatory pathway is based on similarity to already approved devices, not on proving new performance metrics.

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

Based on the 510(k) summary, formal "acceptance criteria" in the sense of specific performance targets (e.g., sensitivity, specificity, accuracy for a diagnostic device) and corresponding "reported device performance" from a dedicated study are not explicitly stated or provided.

Instead, acceptance is demonstrated by showing substantial equivalence to predicate devices. The "performance" is implicitly deemed acceptable because the device's technical characteristics and intended use are similar to those of devices already on the market.

The closest we get to "acceptance criteria" are the compliance with recognized electrical safety and EMI/EMC standards, and the statement of "Indication for use EP."

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

Not applicable/Not provided. This document does not describe a clinical study with a "test set" sample size or data provenance in the way one would for a new diagnostic or prognostic device's performance evaluation. The device type (auditory evoked potential system) is well-established, and the focus is on demonstrating safety and efficacy through equivalence to existing technology, rather than a de novo clinical trial.

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

Not applicable/Not provided. Since there's no clinical study described with a "test set" and corresponding "ground truth" to be established by experts for performance evaluation, this information is not present.

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

Not applicable/Not provided. As there is no clinical study described that involved expert adjudication of a test set, this information is not available.

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/Not provided. An MRMC study is relevant for evaluating the impact of an AI algorithm on human reader performance, particularly in image interpretation. The ICS CHARTR EP 200 is an auditory evoked potential system, not an AI-assisted diagnostic imaging device, and the submission is a 510(k) for substantial equivalence, not a new technology requiring such a study.

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

Not applicable/Not provided. The device is an Auditory Evoked Potential System, which is inherently a human-in-the-loop diagnostic tool, used by clinicians to perform tests and interpret results. It is not an "algorithm only" device in the context of standalone performance evaluation like an AI diagnostic tool.

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

Not applicable/Not provided. As no dedicated performance study is described, no specific "ground truth" for evaluating the device's diagnostic accuracy is mentioned in the document.

8. The sample size for the training set

Not applicable/Not provided. The device is not an AI/machine learning product that requires a "training set" in the conventional sense. Its development is based on established principles of auditory evoked potential measurement and engineering standards.

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

Not applicable/Not provided. As there is no "training set" for an AI algorithm described, the method for establishing its ground truth is not relevant or mentioned.

Summary of the Study and Device Performance as Presented in the 510(k):

The provided document, a 510(k) summary, demonstrates the device's substantial equivalence to legally marketed predicate devices primarily through comparison of:

• Intended Use: Identical to predicates for auditory evoked potential testing.
• Technological Characteristics: Similar to predicates, with minor differences (e.g., external hardware, USB connection, lack of OAE/ASSR features present in some, but not all, predicates).
• Safety Standards: Compliance with recognized international and national electrical safety and EMI/EMC standards (EN 60601 series, UL, CAN/CSA).
• Quality Management Systems: Compliance with ISO 9001 and ISO 13485.

The submission relies on the established safety and effectiveness of the predicate devices in the market, rather than a new clinical study to establish performance against novel acceptance criteria. The "study" here is essentially the detailed comparison showing that the new device's features, intended use, and adherence to safety standards are sufficiently similar to approved devices.

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