(121 days)
The OtoSet - Ear Cleaning System (OtoSet) is indicated to remove earwax from the external ear canal with irrigation and suction in adults.
The OtoSet – Ear Cleaning System (OtoSet) is an automated ear irrigation device used to remove earwax, or cerumen, from the external ear canal of adults. The OtoSet consists of an adjustable head strap, two ear units, two single-patient-use disposable ear tips, and two singlepatient-use disposable waste containers.
In addition to the disposable ear tips and waste containers, each ear unit houses a solution container, liquid pump, vacuum pump, printed circuit board electronics, rechargeable batteries, and electrical and plumbing elements to connect these items together. The device can be used to clean the left, right, or both external ear canals at the same time.
The OtoSet includes components that come in contact with the patient during use. The singlepatient-use disposable ear tips, ear pads and head strap pad (all made of silicone rubber) are surface contacting components having limited contact duration (
The provided text describes the submission of the SafKan OtoSet Ear Cleaning System for 510(k) clearance. The focus of the clinical testing was to demonstrate the effectiveness of earwax removal and equivalence to a predicate device, rather than strictly defining acceptance criteria with specific thresholds for performance metrics.
However, based on the information provided, we can infer some "acceptance criteria" through the objective of the clinical studies and the results presented.
Here's an attempt to structure the information based on your request, acknowledging that explicit numerical acceptance criteria are not detailed in this FDA document for this Class I device.
Implied Acceptance Criteria and Reported Device Performance for the OtoSet Ear Cleaning System
1. Table of Acceptance Criteria (Implied) and Reported Device Performance
| Performance Metric | Implied Acceptance Criteria (Objective) | Reported Device Performance |
|---|---|---|
| Effectiveness of Earwax Removal (Occlusion Scale) | To demonstrate effective earwax removal using a 0-3 Degree of Occlusion Scale. | The second study (n=23 subjects, 31 ears) "evaluated the subject device's ability to effectively remove earwax (also using a 0-3 Degree of Occlusion Scale)." The results "support the proposed intended use of the OtoSet." (Exact effectiveness percentage or change in occlusion score not provided). |
| Equivalence to Predicate Device | To demonstrate equivalence in earwax removal effectiveness compared to the primary predicate, the Welch Allyn Ear Wash System. | The first study (n=31 subjects, 62 ears) "evaluated the OtoSet against the device's primary predicate, the Class I Welch Allyn Ear Wash System." "The data in these studies show that the OtoSet is equivalent to the predicate device in terms of removing earwax from the external ear canal." |
| Safety | To ensure the device does not raise new issues of safety compared to the predicate device. | Non-clinical testing (biocompatibility, software validation, electromagnetic compatibility and electrical safety, and usability testing) and clinical testing were performed. "It can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate device." |
| Usability | Intended users can successfully perform simulated scenarios and sub-tasks and provide feedback. | Usability testing was assessed by 15 individuals representative of the intended user population. "All participants successfully performed simulated scenarios and sub-tasks, and provided feedback on the use of the subject device." |
2. Sample Sizes and Data Provenance for the Test Set
- Study 1 (Equivalence):
- Sample Size: 31 subjects, 62 ears.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Given that it's clinical testing for a 510(k) submission, it's highly likely to be prospective data collected specifically for this purpose.
- Study 2 (Effectiveness):
- Sample Size: 23 subjects, 31 ears.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Likely prospective.
3. Number of Experts and Qualifications for Ground Truth
- The document does not specify the number of experts used to establish ground truth or their qualifications.
- The studies used a "0-3 Degree of Occlusion Scale" to assess earwax removal. This scale likely involves a clinical assessment by a trained medical professional (e.g., an ENT specialist, nurse, or physician) examining the ear canal, but the specific individuals establishing this "ground truth" for the study are not detailed.
4. Adjudication Method for the Test Set
- The document does not specify an adjudication method (e.g., 2+1, 3+1) for the ground truth assessment in the clinical studies. Since the "ground truth" here is a clinical assessment of earwax obstruction rather than, for example, image interpretation, a multi-reader adjudication method might not have been applicable in the traditional sense. It's more likely a single trained clinician made the assessment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not explicitly done. The clinical studies focused on comparing the device's performance to a predicate device and evaluating its standalone effectiveness in earwax removal. This is a Class I device, and the type of comparative effectiveness study typically seen with AI algorithms reading medical images (i.e., human readers with/without AI assistance) is not relevant here.
6. Standalone (Algorithm Only) Performance
- This concept is not applicable here. The OtoSet is a physical medical device, not an AI algorithm. Its "standalone performance" refers to its direct application in earwax removal by a user (clinical staff or patient, depending on prescription status). The clinical studies evaluated the performance of the device itself (though operated by a user), not an algorithm's performance independent of human interaction.
7. Type of Ground Truth Used
- The ground truth used was based on a "0-3 Degree of Occlusion Scale" which represents a clinical assessment of earwax removal. This is a form of clinical assessment/outcome data related to the device's intended use.
8. Sample Size for the Training Set
- Not applicable / Not disclosed. This device is a physical medical device. It does not use machine learning algorithms that require "training sets" in the conventional sense. The "training" for this device would refer to its design and engineering iterations, followed by verification and validation testing (non-clinical and clinical), but not a data-driven "training set" for an algorithm.
9. How Ground Truth for the Training Set Was Established
- Not applicable. As stated above, there is no "training set" in the context of machine learning for this device.
§ 880.6960 Irrigating syringe.
(a)
Identification. An irrigating syringe is a device intended for medical purposes that consists of a bulb or a piston syringe with an integral or a detachable tube. The device is used to irrigate, withdraw fluid from, or instill fluid into, a body cavity or wound.(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 § 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.