(206 days)
The TrueTear Intranasal Tear Neurostimulator provides a temporary increase in tear production during neurostimulation to improve dry eye symptoms in adult patients with severe dry eye symptoms.
The TrueTear Intranasal Tear Neurostimulator is a non-surgical, non-implantable device intended for the application of low level electrical stimulation to sensory neurons of the nasal cavities to increase tear production to improve dry eye symptoms in adult patients with severe dry eye symptoms. The device consists of four distinct non-sterile subassemblies: Disposable Tips, a reusable Base Unit, a reusable Charging Station, and a reusable Cover. The device design has not been significantly modified from the device granted under DEN160030, with technical changes including enabling Bluetooth functionality for one-way wireless communication, removal of material used in the disposable tip, disabling of the tip detection feature in the Base Unit, and addition of an optional mobile application (TrueTear App) for reading and summarizing device usage data.
Here's a breakdown of the acceptance criteria and the study details for the TrueTear Intranasal Tear Neurostimulator, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly defined as pass/fail thresholds in the provided text for overall device performance regarding dry eye symptom improvement. Instead, the FDA's decision to grant De Novo classification is based on a benefit-risk determination and the device's ability to demonstrate "meaningful improvement in symptoms." The reported device performance is presented as the proportion of subjects achieving a clinically important change (MCID) in their OSDI score.
| Acceptance Criteria (Inferred from Benefit-Risk Conclusion & Special Controls) | Reported Device Performance (Severe Dry Eye Subgroup) |
|---|---|
| Clinical performance testing must evaluate improvement of dry eye symptoms under anticipated conditions of use. (Special Control 1) | OSDI Change from Baseline (Severe Dry Eye Subgroup): |
- At Day 7 (MCID 7.3): 42.86% (33/77) improved, 12.99% (10/77) worsened
- At Day 30 (MCID 7.3): 38.67% (29/75) improved, 12.00% (9/75) worsened
- At Day 7 (MCID 13.4): 23.38% (18/77) improved, 5.19% (4/77) worsened
- At Day 30 (MCID 13.4): 25.33% (19/75) improved, 6.67% (5/75) worsened
Conclusion: "There were more participants with severe dry eve symptoms that had a meaningful improvement in symptoms as measured with the Ocular Surface Disease Index (OSDI) than the number with clinically significant worsening of symptoms at day 7 and at day 30." |
| Probable benefits outweigh probable risks. | Based on the above OSDI results, and a low incidence of self-limited, non-serious adverse events, the FDA concluded: "The probable benefits outweigh the probable risks for the TrueTear Intranasal Tear Neurostimulator." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Overall enrolled participants: 97
- Participants with severe dry eye symptoms at screening (used for primary analysis): 77
- Participants with severe dry eye symptoms seen at Day 30: 75
- The moderate dry eye group's sample size was "too small to make meaningful inferences."
- Data Provenance: The study was a prospective clinical trial (OCUN-010) conducted by the applicant (Allergan). The document does not specify the country of origin of the data, but Allergan is based in Irvine, California.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The ground truth for device effectiveness was established using patient-reported outcomes via the Ocular Surface Disease Index (OSDI). Therefore, traditional "experts" like radiologists establishing a ground truth in image analysis are not applicable here. The "ground truth" for severity categories was based on OSDI scores (Severe dry eye: OSDI total score of 33 or more).
4. Adjudication Method for the Test Set
Not applicable. The study relied on a patient-reported outcome measure (OSDI) rather than expert adjudication of clinical findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not conducted. This device is not an AI diagnostic tool that assists human readers in interpreting cases. It's a medical device for direct patient treatment. The study design focused on the patient's self-reported improvement in symptoms.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the effectiveness study (OCUN-010) evaluated the device's performance standalone, meaning its direct effect on patients (human-with-device) without a human interpreter in the loop. The device itself is the "standalone" treatment. The study assessed the device's ability to improve dry eye symptoms through neurostimulation. While patient training was involved, the performance being measured was that of the device and the patient's physiological response, not an AI algorithm's diagnostic accuracy.
7. The Type of Ground Truth Used
The primary ground truth used was patient-reported outcomes data, specifically the Ocular Surface Disease Index (OSDI). Clinically meaningful change was defined using published Minimal Clinically Important Difference (MCID) thresholds from Miller et al. (Arch Ophthalmol. 2010;128(1):94-101).
8. The Sample Size for the Training Set
No separate "training set" is mentioned in the context of clinical efficacy for this device. The clinical trials (OCUN-009 and OCUN-010) are described as pivotal studies for effectiveness and safety. For software development and validation, specific training set information is not provided, but it states "The submission contained all the elements of software documentation corresponding to the "Moderate" level of concern, as outlined in the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
9. How the Ground Truth for the Training Set Was Established
As there's no explicitly defined "training set" for clinical efficacy in the provided text, this question is not directly applicable. For software ground truth, internal specifications and hazard analyses would have guided the verification and validation (V&V) testing.
§ 886.5310 Intranasal electrostimulation device for dry eye symptoms.
(a)
Identification. An intranasal electrostimulation device for dry eye symptoms is a prescription non-implantable, electrostimulation device intended to increase tear production for improvement in dry eye symptoms.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing must evaluate improvement of dry eye symptoms under anticipated conditions of use.
(2) Non-clinical performance testing must assess the following electrical output specifications: waveforms, output modes, maximum output voltage, maximum output current, pulse duration, frequency, net charge per pulse, maximum phase charge at 500 ohms, maximum current density, maximum average current, and maximum average power density.
(3) Patient-contacting components of the device must be demonstrated to be biocompatible.
(4) Performance testing must demonstrate the electrical, thermal, and mechanical safety along with electromagnetic compatibility (EMC) of the device in the intended use environment.
(5) Software verification, validation, and hazard analysis must be performed.
(6) Training for the proper use of the device must be provided.
(7) Physician and patient labeling must include:
(i) Summaries of electrical stimulation parameters;
(ii) Instructions on how to correctly use and maintain the device;
(iii) Instructions and explanations of all user-interface components;
(iv) Information related to electromagnetic compatibility classification;
(v) Instructions on how to clean the device; and
(vi) Summaries of clinical performance testing demonstrating safety and effectiveness.