(156 days)
AIO HD otoscope is used to provide images of the ear canal and tympanic membrane. The AIO HD otoscope can be used to allow a physician a clear and focused view of the ear canal or tympanic membrane on a computer or monitor screen.
AIO camera system consists of the camera hand probe, main storage unit and otoscope tip. The camera hand probe dimensions are 45 mm (w) x 60 mm (l) x 151 mm (h). The main unit dimensions are 235 mm (w) x 225 mm (l) x 58 mm (h). The otoscope tip is carefully inserted into the external ear to view the ear canal and ear drum.
The provided document is a 510(k) summary for the 'AIO HD Otoscope'. This document focuses on demonstrating substantial equivalence to predicate devices, primarily through comparison of technological characteristics and safety features, rather than presenting a performance study with acceptance criteria in the typical sense of a clinical or analytical performance study required for higher-risk devices or novel technologies.
Here's a breakdown based on the information provided, and where information is not provided due to the nature of this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The 510(k) summary for this Class I device primarily compares characteristics to a predicate, rather than setting and meeting formal clinical acceptance criteria with statistical measures. The 'acceptance' here is demonstrated by showing the AIO HD Otoscope's characteristics are comparable to the predicate device, the Dr.Camscope.
| Characteristic Measured | Acceptance Criteria (Predicate Device: Dr.Camscope) | Reported Device Performance (AIO HD Otoscope) |
|---|---|---|
| Luminance measurements and light intensity | Minimum illumination 2 lux | 10 cm: 316.2 lux |
| 15 cm: 160.2 lux | ||
| 20 cm: 103.1 lux | ||
| Electrical specifications (operating voltage) | 12V | 12V |
| Temperature of device | 49.9 C | 27.6 C |
| Physical characteristics | 2mm lamp (implies form factor) | Camera: 45(w)x60(l)x151(h)mm |
| Main unit: 235(w)x225(l)x58(h)mm (These are the dimensions of the new device, not directly comparable to "2mm lamp" beyond showing physical form.) |
Explanation of "Acceptance": For a Class I device seeking 510(k) clearance, "acceptance criteria" often revolve around demonstrating that the new device does not raise new questions of safety and effectiveness compared to a predicate device. In this case, the AIO HD Otoscope is "accepted" if its performance characteristics (like light intensity, temperature, electrical specs) are shown to be equivalent or superior to the predicate, and it functions as intended without introducing new risks. The reported performance shows the AIO HD Otoscope provides significantly higher illumination and operates at a lower temperature than the predicate device, which would be considered favorable for safety and effectiveness.
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not describe a formal "test set" in the context of a performance study involving patient data or clinical outcomes. This submission focuses on engineering and basic performance specifications (light intensity, temperature, electrical, physical dimensions). Therefore, there is:
- No reported sample size for a test set.
- No data provenance (e.g., country of origin, retrospective/prospective) because this type of data is not applicable to the technical specification comparison presented.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since there was no "test set" involving clinical data or human diagnoses, there were:
- No experts used to establish ground truth.
- No qualifications for such experts provided or needed for this type of submission.
4. Adjudication Method for the Test Set
As there was no clinical "test set" requiring human interpretation or diagnosis, there was no adjudication method described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This is a technical specification comparison, not a clinical effectiveness study. The device is an otoscope which provides images for human interpretation, and this 510(k) does not address AI assistance or changes in human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
A standalone algorithm performance study was not done. The AIO HD Otoscope is a device for capturing images, not an AI algorithm for interpreting them.
7. The Type of Ground Truth Used
The "ground truth" in this context is the measured technical specifications of the device itself (e.g., light intensity in lux, temperature in Celsius, voltage, physical dimensions). It is based on engineering measurements, not clinical outcomes, pathology, or expert consensus on clinical data.
8. The Sample Size for the Training Set
The concept of a "training set" is relevant for AI/ML algorithms. This device is a medical imaging device (otoscope), not an AI/ML product. Therefore, there is no training set in the AI/ML sense. The "training" for this device would be its design and manufacturing processes.
9. How the Ground Truth for the Training Set Was Established
As there is no AI/ML training set, this question is not applicable. The 'ground truth' for the device's design and manufacturing is based on established engineering principles, regulatory standards for medical devices, and performance benchmarks set by predicate devices.
§ 874.4770 Otoscope.
(a)
Identification. An otoscope is a device intended to allow inspection of the external ear canal and tympanic membrane under magnification. The device provides illumination of the ear canal for observation by using an AC- or battery-powered light source and an optical magnifying system.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9 only when used in the external ear canal.