(252 days)
The TrueTear Intranasal Tear Neurostimulator provides a tear production during neurostimulation to improve dry eye symptoms in adult patients with severe dry eye symptoms.
The TrueTear device is a prescription only, non-implantable, electrostimulation device intended to increase tear production for improvement in dry eye symptoms. The device's technological principle is the application of low-level electrical stimulation to sensory neurons located in the nose to acutely increase tear production and improve dry eye symptoms. The device consists of three distinct non-sterile subassemblies - a base unit which controls and produces electrical stimulation waveform and enables the patient to control the neurostimulation, a disposable tip that is inserted into the nose and provides the contact surface for the stimulation to the target tissue located in the nose, and a charger case that protects the device and replenishes the sealed battery inside the base unit between uses.
The provided text describes a 510(k) summary for the TrueTear Intranasal Tear Neurostimulator, which is a medical device and not an AI/ML algorithm. Therefore, many of the requested categories in the prompt, such as data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set information (which are relevant to AI/ML studies), are not applicable to this device submission.
The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data, primarily related to electrical output specifications, biocompatibility, electrical safety, software validation, wireless communications, and mechanical durability. The document states that no animal or clinical studies were required due to the nature of the modifications and the equivalence to the predicate device whose clinical safety and effectiveness were previously established.
Here's an attempt to answer the prompt given the available information, noting the inapplicability of AI/ML specific criteria:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Electrical Output | Performance results met the intended electrical output design specifications (unchanged from predicate device), including waveform, modes, max voltage, max current, pulse duration, frequency, net charge per pulse, max phase charge at 500 ohms, max current density, max average current, and max average power density. |
| Biocompatibility | Met requirements of ISO 10993-1:2018, ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-10:2010, and ISO 10993-18:2005 for a surface device with long-term mucosal membrane contact. Stainless steel 316 electrode conforms to ASTM MIM-316L. |
| Electrical Safety / EMC | Complies with IEC 60601-1-2 (Edition 4.0):2014, IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012, IEC 60601-1-11:2015, and IEC 60601-2-10:2012 for home use. |
| Software | Verification and validation testing performed. Complies with IEC 62304:2006 + A1:2015 (2015-06). Software assigned a "moderate" level of concern (unchanged from predicate). |
| Wireless Communications | Cybersecurity and coexistence evaluations performed. Appropriate mitigations for cybersecurity in place. Coexistence testing confirmed essential performance unaffected by near-range devices and data transmission in presence of active RF energy sources. |
| Other Performance Data | Electrical and mechanical bench testing for the disposable tip over 28-day intended use duration met specified design criteria. Worst-case conditions for electrical stimulation durability and insertion/cleaning durability demonstrated tips maintained electrical and mechanical integrity throughout maximum usage period, meeting design specifications. |
| Clinical Studies | Not required; modifications did not raise different questions of safety and effectiveness, relying on the predicate device's established clinical safety and effectiveness. |
| Animal Studies | Not required; design modifications did not require animal studies to demonstrate substantial equivalence. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the submission primarily relies on bench testing and comparisons to a predicate device, rather than a "test set" in the context of an AI/ML algorithm or a clinical trial with human subjects for novel device performance. The performance data listed (electrical output, biocompatibility, safety, software, wireless, mechanical)是由实验室测试得出的。
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)
Not applicable. The device performance is assessed against engineering and regulatory standards (e.g., ISO, IEC) through bench testing, not expert-adjudicated ground truth as would be relevant for an AI/ML diagnostic device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is relevant to expert review processes for AI/ML ground truth, not device performance testing against engineering standards.
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 is not an AI/ML device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical neurostimulation device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is compliance with established engineering and safety standards (e.g., electrical output parameters, biocompatibility standards, EMC standards, software validation standards) and mechanical design specifications, demonstrated through verified bench testing and documented in the 510(k) submission.
8. The sample size for the training set
Not applicable. There is no AI/ML algorithm or "training set" for this device.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML algorithm or "training set" for this device.
§ 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.