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The iTEAR100 Neurostimulator is an electromechanical nerve stimulator device, indicated for temporary use (up to 30 days) to increase acute tear production during vibratory stimulation of the external nasal nerve in adults, under prescription of an eye care provider.

iTEAR100 Neurostimulator is a hand-held, portable electromechanical actuator intended to acutely increase tear production through vibratory stimulation of the external nasal nerve in patients. The device is battery-operated with a single vibratory tip. As the effective tip is pushed against the tissue, the beam deflects inward until it is deflected fully into the device. The device is comprised of a direct current vibration motor, vibrating beam(cantilever), a control circuit with micro SD card, tactile switch.

The motor is attached to a cantilever beam made from acrylonitrile butadiene styrene (ABS), a control circuit to charge the battery and deliver power to the motor, and a housing also made from ABS. The motor and cantilever beam move together to produce a linear vibration at the tip of the cantilever (oscillating tip). A lithium-ion rechargeable battery is supplied inside the device, and is not removable or replaceable. A micro USB port on the device allows for charging. The device is locked by firmware from use after a predetermined number of stimulation days has been triggered.

This document describes the iTEAR100 Neurostimulator, an electromechanical tear stimulator. While the document contains details on clinical studies and safety, it does not provide acceptance criteria in the typical format of a medical device performance study, nor does it present device performance against specific, pre-defined quantitative acceptance criteria like those often seen for AI/ML devices or diagnostic tools.

Instead, the document focuses on demonstrating the device's effectiveness (increase in tear production) and safety through two clinical studies. The "acceptance criteria" for this device appear to be primarily qualitative and related to its intended use and safety profile rather than specific performance metrics (e.g., sensitivity, specificity, or accuracy for a diagnostic device).

Therefore, I will interpret "acceptance criteria" based on the established "Special Controls" and the "Benefit-Risk Conclusion" outlined in the document, as these represent what the FDA has deemed necessary for market clearance. The "reported device performance" will be derived from the clinical study results.

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Acceptance Criteria and Device Performance for iTEAR100 Neurostimulator

1. Table of Acceptance Criteria and Reported Device Performance

As this device is an electromechanical stimulator and not a diagnostic or AI/ML-driven device with traditional performance metrics, the acceptance criteria are interpreted from the "Special Controls" and "Benefit-Risk Determination" sections of the De Novo request. The reported device performance is drawn directly from the clinical study summaries.

1. Evaluate tear production under anticipated conditions of use.
2. Evaluate all adverse events (including tissue damage, pain, headache, discomfort).
3. Demonstrate probable benefits outweigh probable risks. | 1. Tear Production (CLP-007 Study - Sham-Controlled):

• Statistically significant increase in Schirmer's test scores in the active group (mean within-subject change pre- to post-stimulation = 21.7mm) compared to sham (mean within-subject change pre- to post-stimulation = -0.5mm).
• Between-group difference of 22.2mm (SD 2.61) favoring the active device.
  Tear Production (CLP-002 Study - Longitudinal):
• Stimulated Schirmer's test score was greater than unstimulated at each visit during 30-day follow-up.
• Trend of decreased effectiveness (tear production) over time was observed but mechanism not identified.

2. Adverse Events (Safety):

• CLP-002 (180-day follow-up):
  • 2 events definitely related (headache, sneezing, ticking sensation; intermittent nose soreness).
  • 7 events possibly related (Table 5).
  • Most common related events: headache and dizziness.
  • 7/9 related AEs were mild, 1 moderate, 1 severe.
  • One serious unanticipated AE (continuous nausea, dizziness, lightheaded, headache for 30 days) possibly related, led to subject discontinuation.
  • 4 subjects experienced VA loss (attributed to disease fluctuations/lack of correction/dry eye, resolved).
• CLP-007 (Single visit, sham-controlled):
  • No device-related adverse events or serious adverse events reported.
  • One unrelated near-syncopal episode.
  • No significant changes in visual acuity, corneal edema, facial neurological exams, or hemodynamic parameters.

3. Benefit-Risk Conclusion:

• Probable benefits (statistically significant acute tear production increase) outweigh probable risks (few, mostly self-limited non-serious AEs; one serious AE resolved without treatment) through clinical data. |
  | Non-Clinical Performance:

1. Demonstrate device performs as intended.
2. Assess mechanical output specifications (vibration amplitude/frequency, pressure/force, acoustic levels).
3. Validate mechanical safety safeguards.
4. Conduct use life testing. | 1-4. Bench Testing & Biocompatibility (refer to "SUMMARY OF NONCLINICAL/BENCH STUDIES"):

• Acoustic Levels: Passed (criteria (b)(4)).
• Safeguards related to pressure/force: Passed.
• Vibrational amplitude/frequency: Passed (criteria (b)(4)).
• Thermal performance: Passed.
• Use Life: Passed ("no change in mechanical parameters or physical characteristics" after X hours simulating (b)(4) bilateral treatments).
• Biocompatibility: Acceptable performance for cytotoxicity, skin irritation, skin sensitization per ISO 10993-5 and ISO 10993-10.
• EMC/Electrical Safety: Passed conforming to ES 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62133. |
  | Software Performance:

1. Software verification, validation, and hazard analysis.
2. Address potential hazards with satisfactory results.
3. "Moderate" level of concern addressed. | Software Documentation & Testing:

• Submission contained all elements per "Moderate" level of concern FDA guidance.
• Adequate documentation (specifications, architecture, development environment, traceability, revision history, unresolved anomalies, cybersecurity).
• Hazard analysis performed to characterize software risks (malfunction, measurement errors, cybersecurity).
• V&V testing performed with satisfactory results. |
  | Biocompatibility:

1. All patient-contacting components demonstrated to be biocompatible. | Biocompatibility Evaluation:

• Tested per ISO 10993-5:2009 (MEM elution cytotoxicity) and ISO 10993-10:2010 (intracutaneous skin irritation, guinea pig maximization skin sensitization).
• Results demonstrated acceptable performance. |
  | Electrical Safety, Thermal Safety, EMC:

1. Performance data demonstrating compliance. | Electrical, Thermal, EMC Testing:

• Conformed to ES 60601-1:2005/(R)2012, IEC 60601-1-2 Edition 4.0 2014-02, IEC 60601-1-6 Edition 3.1 2013-10, IEC 62133:2012. |
  | Labeling:

1. Physician and patient labeling includes specified information. | Labeling Adequacy:

• Labeling is adequate and meets 21 CFR 801.109 requirements.
• Summarizes clinical trial results, probable benefit, identified risks, prescription-only use, patient training, etc. |

(Note: Criteria with "(b)(4)" indicate redacted information in the original document, likely specific numerical thresholds that were proprietary.)

2. Sample Sizes Used for the Test Set and Data Provenance

The primary "test sets" for effectiveness and safety were the cohorts in the two clinical studies:

• CLP-002 Study:
  • Sample Size: 108 subjects enrolled. 101 subjects completed 30 days of follow-up. 80 subjects agreed to continue, 58 reached the 180-day endpoint.
  • Data Provenance: Multi-center (8 US sites). Prospective, open-label, single-arm study.
• CLP-007 Study:
  • Sample Size: 60 subjects enrolled (28 in Active group, 32 in Sham group). Subject accountability was 100% for assessments.
  • Data Provenance: Multi-center (sites not specified, but context implies US). Prospective, double-masked, randomized, sham-controlled, single-visit clinical trial.

There is no mention of specific "test sets" in the context of an algorithm's performance on a separate dataset, as this is not an AI/ML device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This device is not a diagnostic tool where "ground truth" is established by expert interpretation of images or other data. The ground truth for effectiveness is objective physiological measurement (Schirmer's test score, a direct measure of tear production). Safety data (adverse events) were reported by subjects and assessed by investigators at the study sites.

Therefore, the concept of "experts establishing ground truth for a test set" with qualifications like "radiologist with 10 years of experience" does not directly apply here. The expertise lies in the clinical investigators (eye care providers) performing and interpreting the Schirmer's test and monitoring for adverse events.

4. Adjudication Method for the Test Set

Given the nature of the device and the objective measurement of tear production via the Schirmer's test, a formal "adjudication method" like "2+1" or "3+1" (common in image interpretation studies) is not described or implied.

• Quantitative Endpoint (Schirmer's): The Schirmer's test is a standardized measurement.
• Adverse Events: Adverse events were reported and assessed by the study investigators. There's no mention of an independent, blinded adjudication committee for adverse events, which is sometimes done in larger trials but not explicitly stated here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

An MRMC study was not applicable as the iTEAR100 Neurostimulator is a therapeutic device, not an AI/ML diagnostic or assistive tool for human readers. The clinical studies focused on the direct physiological effect of the device (tear production) and its safety, not on improving human interpretive performance.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-loop Performance) was Done

This is not applicable. The iTEAR100 Neurostimulator is a human-operated electromechanical device. Its performance is inherently "standalone" in the sense that it directly causes tear production. There is no underlying algorithm performing a diagnostic task that could be evaluated without human interaction.

7. The Type of Ground Truth Used

The "ground truth" for the primary effectiveness endpoint (tear production) was obtained through direct physiological measurement using the Schirmer's test. This test objectively quantifies tear volume (length of wetting on a filter paper strip).

For safety, the "ground truth" for adverse events involved patient self-reporting, clinical observation by investigators, and medical assessment.

8. The Sample Size for the Training Set

This concept is not applicable to the iTEAR100 Neurostimulator. This is a medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The device's design and mechanical parameters are established through engineering and bench testing, not through data training. The clinical studies are for validation of safety and effectiveness in humans, not for "training."

9. How the Ground Truth for the Training Set was Established

As mentioned in point 8, the concept of a "training set" for this device does not apply.

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