(87 days)
The Interacoustics MT10 Handheld Impedance Audiometer is an easy to use handheld diagnostic middle ear analyzer that is well suited for providing quick and reliable results in both diagnostic and screening settings. The tympanometry test features a user selectable extended pressure range that is capable of -600daPa. Four ipsilateral reflexes at different frequencies may be tested at each ear. Reflex testing operates either at a user defined fixed level or uses an automatic intensity search function. It assists in the diagnosis of now sible otologic disorders.
Our device, the Model MT10 Handheld Impedance Audiometer is an easy to use handheld diagnostic middle ear analyzer that is well suited for providing quick and reliable results in both diagnostic and screening settings. The tympanometry test features a user selectable extended pressure range that is capable of -600daPa. Four ipsilateral reflexes at different frequencies may be tested at each ear. Reflex testing operates either at a user defined fixed level or uses an automatic intensity search function. It assists in the diagnosis of possible otologic disorders.
The provided text describes the Interacoustics Model MT10 Handheld Impedance Audiometer and its similarity to a predicate device, the Grason Stadler GSI-37 Auto Tymp, for the purpose of 510(k) clearance.
However, the document does not contain information about specific "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for the device, nor does it detail a study that proves the device meets such criteria. Instead, the submission focuses on demonstrating substantial equivalence to a legally marketed predicate device based on technical specifications and adherence to relevant standards.
Therefore, many of the requested sections about acceptance criteria, device performance, and details of a performance study cannot be filled from the provided text.
Here's an attempt to answer the questions based on the available information:
Acceptance Criteria and Device Performance
The submission does not specify quantitative acceptance criteria in terms of clinical performance metrics, nor does it present detailed study results in that format. The "acceptance criteria" in this context appear to be compliance with established performance and safety standards, and demonstrating substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance (vs. Predicate/Standards) |
|---|---|
| (Functional/Technical Specifications - Implicit criteria are that the device performs comparably to or better than the predicate, and meets relevant standards) | |
| Display Type | Digital (Equivalent to Predicate) |
| Form Factor | Lightweight, handheld (Equivalent to Predicate) |
| Hardcopy Printout | Provides objective documentation of otitis media and other middle ear disorders (Equivalent to Predicate) |
| Intensity Range | 10dBHL to 50dBHL (Predicate: Not applicable) |
| Pressure Range | +300 -600 daPa/sec. (Predicate: +200 -400 daPa/sec.) - Range is broader than predicate. |
| Compliance Range | .0 to 2.5 cc displayed; .0 to 5.0 cc numeric (Predicate: .0 to 1.5 cm³ displayed) - Range is broader than predicate. |
| Tests Performed | Tympanometry, acoustic reflex and screening audiometry (Predicate: Tympanometry) - More tests than predicate. |
| Software Compatibility | Compatible Windows Software: laBase 95 database program; Printview for on-line PC monitoring and printing; NOAH hearing aid fitting software (Predicate: None) - Additional functionality. |
| Applicable Standards | Meets or exceeds IEC 1027-1995, ANSI 3.60 -1989, ANSI 3.60-1985, Safety IEC 601-1-1988. Approved for Medical CE-marking by Danish Notified Body D.G.M. Identification No. 0543, Quality System Certificate DGM 016 (CE 0543) (Predicate: Meets ANSI S3.39 - 1987 for Type 4 Instrument and IEC 601-1-1988) - Meets specified performance and safety standards. |
| Available Frequencies | .5kHz, 1kHz, 2kHz, 3kHz & 4kHz (Predicate: Not applicable) |
| Probe Tone Frequency | 226 Hz, +/-3% (Equivalent to Predicate) |
| Probe Tone Amplitude | 85dB SPL +/-3dB (Predicate: 85.5 dB SPL, +/-2.0 dB) - Comparable. |
| Power Source | NiMH batteries or Standard AA NiCa batteries (Predicate: NiCad batteries) - Similar. |
| Direction of Pressure Sweep | Positive to negative (Equivalent to Predicate) |
| Size and Weight (Probe) | 4" x 10" x 5"; 1 lb. (Predicate: 2.4" x 8.3" x 4.3"; 10.5 oz) - Differences in physical dimensions. |
| External Power Supply | (optional) 1.8 lbs (recharger power supply EPS11 power transformer-11 volts) (Predicate: (optional) 1.5 lbs. (recharger power supply -9 volts)) - Similar. |
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 or performance study with a test set of data or human subjects. The submission relies on technical comparisons and adherence to standards rather than clinical data for demonstrating substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set requiring ground truth established by experts is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring 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 an impedance audiometer, providing objective measurements, not an AI-assisted diagnostic tool that would involve human readers interpreting results in conjunction with AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is an impedance audiometer providing objective measurements. The concept of "standalone algorithm performance" as typically applied to AI/imaging diagnostics does not directly apply here. The device itself performs the measurements. Its "standalone" performance is dictated by its technical specifications and adherence to standards, which are detailed in the comparison table.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical performance study with defined ground truth is described. The "ground truth" for this type of device's regulatory submission is its capability to meet technical specifications and established standards, and its equivalence to a predicate device in performing its intended function.
8. The sample size for the training set
Not applicable, as this device would not typically involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable, for the same reasons as above.
Summary of Device Approval Approach:
The provided 510(k) summary indicates that the Interacoustics Model MT10 Handheld Impedance Audiometer received clearance based on:
- Substantial Equivalence: Demonstrating that it is as safe and effective as a legally marketed predicate device (Grason Stadler GSI-37 Auto Tymp) through a comparison of technical specifications and indications for use.
- Compliance with Standards: Meeting recognized national and international performance and safety standards (IEC 1027-1995, ANSI 3.60 -1989, ANSI 3.60-1985, Safety IEC 601-1-1988).
- CE Mark Approval: The device was also approved for Medical CE-marking, indicating compliance with European safety and performance requirements.
The document does not detail any clinical performance studies that might involve patient data, expert interpretations, or statistical measurements of accuracy, sensitivity, or specificity.
§ 874.1090 Auditory impedance tester.
(a)
Identification. An auditory impedance tester is a device 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. The device is used to determine abnormalities in the mobility of the tympanic membrane due to stiffness, flaccidity, or the presence of fluid in the middle ear cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor followup treatment for inflammation of the middle ear.(b)
Classification. Class II (special controls). The device, when it is a tympanometer or auditory impedance tester that complies with FDA-recognized consensus standard ANSI S3.39, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.