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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.

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 explicitly states: "Testing consisted of mainly non-clinical performance testing of the device against the applicable parameters specified in the following standards." This indicates that testing was primarily bench testing against technical specifications and standards, rather than a clinical study with a "test set" of patient data. Therefore, details regarding sample size, country of origin, or retrospective/prospective nature of a clinical test set are not applicable/provided.

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)

Given that the testing was non-clinical performance testing against standards and product specifications, there was no requirement for human experts to establish "ground truth" in the clinical sense for a test set. The ground truth was the established parameters within the cited industry standards (e.g., IEC 60601-1, EN 60645-5, ANSI S3.39) and the internal product specifications.

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

Not applicable, as there was no clinical test set requiring adjudication.

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

Not applicable. This device is an auditory impedance tester, which measures physical parameters of the ear. It does not involve AI for interpretation or human "readers" in the context of image analysis or similar tasks where MRMC studies are typically employed.

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

This refers to the performance of the device itself (algorithm only) without human intervention in operating the device or interpreting its direct output that is not supported by the device itself using its internal software. The submitted "non-clinical performance testing of the device against the applicable parameters specified in the following standards" (Section 7 and the comparison table) serves as this standalone performance evaluation. The device generates measurements and displays them, and its accuracy in doing so was assessed.

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

The ground truth for the non-clinical performance testing was based on:

• Established industry standards: such as IEC 60601-1, IEC 60601-1-2, EN/IEC 60645-5, and ANSI S3.39. These standards define the acceptable performance limits and measurement methodologies for auditory impedance testers.
• Manufacturer's own product specifications: The device was tested to assure compliance with the internal product specifications, which are detailed in the comparative table in Section 5.

8. The sample size for the training set

Not applicable. This device is a measurement instrument, not an AI/machine learning system that requires a "training set" in the conventional sense. Its functionality is based on established physical principles and calibrated measurements, not learned patterns from data.

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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