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OcuCool is a cooling anesthesia device intended for topical application to the conjunctiva and sclera. OcuCool is intended for the temporary reduction of pain associated with intravitreal injections.

OcuCool is indicated for patients who are allergic to deep penetrating pharmaceutical based anesthetics used for temporarily reducing pain during and following intravitreal injections.

The OcuCool is a hand-held, cooling anesthesia device that provides rapid and controlled cooling to the conjunctiva and sclera. It is intended to provide an anesthetic effect via a controlled cooling treatment. The main device performs controlled thermoelectric cooling of a single-use sterile OcuCool Tip. The hand-held device has a rechargeable battery, an LCD display screen to show device status, and two LED indicators to show cooling status and battery charging status. Other features of the hand-held device include the Priming Button, which activates the cooling process in preparation for device use and the Cooling Trigger, which activates the cooling anesthesia process. The device has a built-in 30 second timer and alarm to indicate the effective duration of the anesthetic effect after device use.

Here's a breakdown of the acceptance criteria and the study that proves the OcuCool device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

2. Validation of all safety features to prevent use outside the intended temperature range and intended treatment duration. | 1. "Device functionality for producing the required temperature profile was confirmed via validation testing in 'Test Mode'."
3. "Safety features for cooling deactivation when the temperature is exceeded and for time error code for prolonged use were validated with bench testing." |
   | Animal Performance | Evaluate the safety profile of the device over the intended cooling temperature and treatment duration, including a detailed evaluation of all ocular adverse events. | "A total of 16 eyes of New Zealand white rabbits were treated at -5° and -20°C with the cooling anesthesia device once a week for 10 or 24 weeks showed no signs of hemorrhage, inflammation, or necrosis." (Note: The device delivers -15°C to the conjunctiva, so the -5°C and -20°C tested in animals encompass this target.) |
   | Software | 1. Verification, validation, and hazard analysis.
4. Description of cooling temperature, contact verification, and contact timing alerts to limit excessive cooling.
5. Description of all timing alerts for safe detachment and appropriate anesthetic effect duration. | Software developed/tested per FDA guidance. FDA reviewed and found acceptable.
   Software controls implement timing for:

• Tip reaching -13°C, contact within 20s, pressure verification.
• Cooling trigger within 5s, 10s cooling duration.
• Tip warming to -3°C for safe detachment.
• 30s countdown for IVT administration. |
  | Biocompatibility | Device patient-contacting components must be demonstrated to be biocompatible. | Biocompatibility assessment performed in accordance with ISO 10993-1, -5, -10. All tests in GLP. Found acceptable. |
  | Shelf Life/Sterility | Performance data must support shelf life by demonstrating continued sterility, package integrity, and device functionality. Performance testing must demonstrate sterility of patient-contacting components. | OcuCool Tips sterile with SAL of 1 x 10^-6. Gamma irradiation validated per ANSI/AAMI/ISO 11137. Packaging validated for 3-year shelf-life per ASTM F88/F88M and F1929. Testing demonstrates consistent device performance following conditioning and aging. Found acceptable. |
  | Electrical Safety/EMC | Performance testing must demonstrate electrical safety and electromagnetic compatibility (EMC) in the intended use environment. | Testing per IEC 60601-1, -1-6, -1-2. Found acceptable. Battery certified to IEC 62133. |
  | Human Factors | Human factors validation testing must demonstrate that intended users can correctly use the device, based solely on the instructions for use. | Study in simulated-use format. Participants observed, difficulties/errors documented and analyzed. Concluded device is safe and effective for intended users, uses, and environments. |
  | Labeling | Must include:

1. Summaries of treatment parameters.
2. Summary of clinical performance testing, including patient population.
3. Detailed summary of postmarket surveillance data (for updated labeling). | Labeling found sufficient, satisfying 21 CFR 801.109. Describes device use, treatment procedure, user interface. Includes intended patient population and summary of clinical study (including demographics/racial distribution). Includes contraindications, warnings, precautions. (Note: Item 3 on postmarket data is for future updates based on a required postmarket study). |

Study Details (Clinical Performance - "COOL-3" Study)

1. Sample Size Used for the Test Set and Data Provenance:

   • Enrollment: 90 participants enrolled. 44 to OcuCool group, 46 to control group.
   • Per-Protocol (PP) Cohort: 39 participants in OcuCool group, 41 in control group.
   • Provenance: Prospective, multi-center, randomized, controlled, double-masked trial conducted across eight sites in the United States.

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

   • The "ground truth" for the primary effectiveness endpoint was patient-reported pain scores using a numeric rating scale (NRS). This is a subjective patient outcome, not an expert-determined ground truth in the traditional sense of diagnostic accuracy studies.
   • For safety outcomes, healthcare providers (implied to be trained for intravitreal injections, likely ophthalmologists or retina specialists) would have performed examinations (slit-lamp, indirect ophthalmoscopy, IOP assessment). Their qualifications are not explicitly stated, but they are referred to as "healthcare provider trained and qualified to diagnose and treat ophthalmic disease and perform intravitreal injections."

3. Adjudication Method for the Test Set:

   • Not applicable as the primary outcome was patient-reported pain scores (NRS) and direct clinical measurements of adverse events. These are typically recorded directly by the treating or observing clinician and do not involve an "adjudication" of expert opinions on a specific case.

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:

   • Not applicable. This study is a comparative effectiveness study of two anesthesia methods (OcuCool vs. Lidocaine gel) on patient-reported pain and safety. It does not involve human readers interpreting images, nor does it involve AI assistance in that context.

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

   • Not applicable. OcuCool is a physical medical device, not an algorithm, and it requires a human operator for its use.

6. The type of ground truth used:

   • Patient-reported outcome (PRO): Mean pain score as measured by a numeric rating scale (NRS) 5 minutes after IVT.
   • Clinical observation/measurement: Adverse event reporting, visual acuity, slit-lamp biomicroscopy, indirect ophthalmoscopy, changes in intraocular pressure (IOP), fluorescein staining, and SPEED questionnaire results.

7. The sample size for the training set:

   • Not applicable. This study pertains to the clinical evaluation of a medical device, not an AI/ML model that requires a training set. The "COOL-3" study is a pivotal clinical study to evaluate the device's performance directly.

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

   • Not applicable, as there is no training set mentioned or implied for this device's evaluation.

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