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Nasolacrimal Compression Device (NCD) is indicated to temporarily occlude the nasolacrimal ducts in adult patients to reduce outflow through the nasolacrimal ducts.

The Nasolacrimal Compression Device is a modified spectacle frame made of polyvinyl chloride (PVC) coated soft carbon steel wire covered with silicone rubber where the device contacts the nose bridge. The fastening bands are made from flame-retardant nylon hook and loop fabric. The frame width, nose bridge width, and nose pad shape of the subject device may be adjusted. The nose pad is contoured such that it lies over the nasal aspect of the orbital rims where the nasolacrimal systems are underneath. There are fastening bands attached to each temple that allow the user to adjust pressure applied to the nasolacrimal system.

The provided text does not describe acceptance criteria for a study demonstrating device performance. Instead, it outlines bench testing and limited clinical observations to support the classification of a Nasolacrimal Compression Device as Class I (exempt from premarket notification).

The document is primarily a regulatory submission (DE NOVO CLASSIFICATION REQUEST), not a detailed study report with formal acceptance criteria and a comprehensive study to prove those criteria were met.

However, based on the information provided, I can extract the closest equivalents to acceptance criteria and performance as presented in the document:

Acceptance Criteria and Reported Device Performance (Bench Testing & Limited Clinical Observations)

Study Details Based on Provided Information:

The provided text describes several non-clinical/bench studies and limited clinical information/observations, rather than a single, comprehensive "study proving the device meets acceptance criteria."

1. Sample size used for the test set and the data provenance:

• Bench Testing:

  • No specific sample size (N) for devices tested is stated for the Spring, Pressure, Metal Fatigue, or Hook and Loop Bands tests, other than "None of the tested devices broke" for Metal Fatigue.
  • Data Provenance: Implied to be prospective controlled testing performed by the applicant (Innovatex, Inc.) in a lab setting. Country of origin not specified, but the applicant is based in Weston, MA, USA.

• Clinical Information/Observations:

  • Dye Disappearance Test: One subject.
  • Fitness Adjustment Validation: Seven subjects. The trial group consisted of 2 Asian females, 2 white females, and one white male (total 5 specific individuals mentioned, implying the remaining 2 are not detailed or were part of a different subgroup).
  • Data Provenance: Prospective clinical observations/validation. Country of origin not specified, but assumed to be local to the testing facility or applicant.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Bench Testing: For the Pressure Test, the definition of "skin tolerable pressure" (6 psi) was established from "literature articles provided by the applicant." No specific expert count or qualifications mentioned for these literature articles. The analysis itself was performed by the applicant.
• Clinical Information/Observations:
  • Dye Disappearance Test & Clinical Study: "a board-certified ophthalmologist" performed the test and verified occlusion. This implies at least one expert (the ophthalmologist). Qualifications: Board-certified ophthalmologist.
  • Fitness Adjustment Validation: "patients could fit the device to their face following instructions as would be provided by a clinician." This suggests a clinician was involved in assessing the fit, but their specific number or qualifications are not explicitly stated, other than for the Dye Disappearance Test within this validation, which was noted to be performed by "a simplified dye disappearance... performed on one subject to demonstrate that nasolacrimal drainage was obstructed." It is reasonable to infer the board-certified ophthalmologist also performed this.

3. Adjudication method for the test set:

• Bench Testing: Not applicable. These were direct physical measurements and analytical assessments.
• Clinical Information/Observations: Not applicable. Given the very small sample sizes (1 and 7 subjects) and the nature of the observations (dye persistence, ability to fit), formal adjudication methods like 2+1 or 3+1 (common in image-based diagnostic studies) were not described or likely employed. The ophthalmologist's assessment served as the primary clinical judgment.

4. 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:

• No MRMC comparative effectiveness study was done. This device is a mechanical compression device, not an AI-powered diagnostic or assistive tool. The concept of "human readers improve with AI" is not relevant to this device or its evaluation as described.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a physical medical device, not an algorithm.

6. The type of ground truth used:

• Bench Testing: Engineering measurements and calculations (e.g., force, pressure, cycles to failure). Some criteria were derived from "literature articles."
• Clinical Information/Observations:
  • Dye Disappearance Test: Direct observation of fluorescein dye persistence in the eye by a board-certified ophthalmologist. This is a clinical observation/assessment recognized as a standard method for assessing nasolacrimal drainage.
  • Fitness Adjustment Validation: Direct observation of subjects' ability to follow instructions and achieve proper fit, confirmed by a simplified dye disappearance test on one subject.

7. The sample size for the training set:

• Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set" in the computational sense. The device's design was based on engineering principles and existing medical understanding.

8. How the ground truth for the training set was established:

• Not applicable. As above, there is no training set. The "ground truth" for the device's design and operation principles would be established through ophthalmological and anatomical knowledge, and general engineering practices.

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