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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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TargetCool™ (Cooling mode / Boosting mode) is indicated for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures, minor sprains or other minor sports injuries, and as an adjunct to rehabilitative treatment (e.g., intermittent cold with stretch).

TargetCool™ (Freezing mode) is indicated for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures

• Molluscum Contagiosum
• Skin Tags
• Actinic Keratosis
• Lentigo
• Verruca Plana
• Verruca Vulgaris
• Verruca Lesions
• Genital Lesions
• Seborrheic Keratosis

TargetCool™ is a handheld device that can deliver rapid, precise, and controlled cooling to the skin tissue. The TargetCool™ device consists of a main device, nozzle, a guard, a filter, and a cartridge.

The main device produces controlled cooling based on thermoelectric cooling, which controls the temperature of the targeted area. TargetCool™ displays the skin temperature measured in real time, the set cooling temperature and the device status through the LCD display. Also, if the measured temperature is below -1 ℃ and lasts for more than 1 second, the status light blinks in blue with a beep sound.

The principle of pain relief through skin cooling is as the skin cools by spraying the cryogen onto the skin, the nerve conduction velocity (NCV) of the skin decreases, increasing the pain threshold (PTH) and pain tolerance (PT). Through this mechanism, pain in the skin is relieved. The advances represented by TargetCool™ lie in the fact that the device executes this process in a precise, controlled, and rapid way.

The provided text describes the 510(k) premarket notification for the TargetCool™ device. However, it does not include detailed acceptance criteria or a specific study proving the device meets those criteria with performance metrics, sample sizes, or ground truth establishment relevant to AI/ML device evaluations.

The document focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and safety. The performance data section refers to bench testing (compliance with standards, biocompatibility, hazard analysis) and mentions "Clinical publications and clinical data demonstrated the safety and effectiveness of the TargetCoolTM for treatment of pediatric patient," but it does not provide specifics about these clinical studies in the context of acceptance criteria.

Therefore, many of the requested details cannot be extracted from the provided text.

Here's what can be inferred and what is missing:

1. A table of acceptance criteria and the reported device performance:

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TargetCool™ is indicated for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures, minor sprains or other minor sports injuries, and as an adjunct to rehabilitative treatment (e.g., intermittent cold with stretch).

TargetCool™ is a handheld device that can deliver rapid, precise, and controlled cooling to the skin tissue. The TargetCool™ device consists of a main device Cooling-Nozzle, a guard, a filter, and a cartridge. In Cooling mode, the main device produces controlled cooling based on thermoelectric cooling, which controls the temperature (2-4°C) of the targeted area. TargetCool™ displays the skin temperature measured in real time, the set cooling temperature and time, and the device status through the LCD display. Also, if the measured temperature is below -1 ℃ and lasts for more than 1 second, the status light blinks in blue with a beep sound.

The provided document is a 510(k) Summary for the medical device TargetCool™ (K221234). It compares this device to a predicate device, also named TargetCool (K220674).

Here's an analysis of the acceptance criteria and the study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents a comparison between the subject device (TargetCool™ K221234) and its predicate (TargetCool K220674) to establish substantial equivalence. While explicit acceptance criteria are not tabulated with numerical performance, the comparison acts as a de facto set of criteria since the subject device is stated to be "Same" as the predicate for all listed characteristics.

Study Proving Device Meets Acceptance Criteria:

The document states: "TargetCool™ is the same as the device cleared in K220674. No changes have been made to the device to change the contraindication. TargetCool™, the subject device, is equivalent to the predicate device."
This indicates that the "study" proving the device meets the acceptance criteria is primarily a direct comparison and declaration of sameness to a previously cleared device (K220674), rather than new, independent performance testing for the subject device against the listed criteria.

2. Sample size used for the test set and the data provenance

The document does not describe a separate "test set" in the context of a clinical study for the K221234 device. Instead, it relies on the predicate device's clearance. It mentions "Clinical publications and clinical data demonstrated the safety and effectiveness of the TargetCoolTM for treatment of pediatric patient" but does not provide details on the sample size or provenance of this data. Given the context of establishing substantial equivalence to an identical device, new clinical testing specific to K221234 for comparing against acceptance criteria is not detailed.

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

Not applicable. No new test set for the K221234 device is described, as the substantial equivalence is based on the device being functionally identical to the predicate (K220674). The ground truth for the safety and effectiveness of the predicate device (and thus implicitly the subject device) would have been established during its regulatory review, likely based on scientific principles of cryotherapy and any historical clinical data available for similar devices, but this document does not provide details about that.

4. Adjudication method for the test set

Not applicable. There is no new "test set" with expert adjudication described for K221234 in this document.

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 device is a cryosurgical unit, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI assistance are not relevant.

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

Not applicable. This device is a physical medical device, not an algorithm, so standalone algorithm performance testing is not relevant.

7. The type of ground truth used

The ground truth for the functionality and safety of the subject device (K221234) is established by its direct equivalence to the predicate device (K220674), which itself would have been cleared based on a combination of bench testing, adherence to standards (electrical safety, EMC, biocompatibility), and existing clinical literature/data for cryotherapy devices. The statement "Clinical publications and clinical data demonstrated the safety and effectiveness of the TargetCoolTM" refers to the scientific basis for the predicate device's (and thus the subject device's) application.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that would require a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/machine learning device.

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TargetCool™ is indicated for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures, minor sprains or other minor sports injuries, and as an adjunct to rehabilitative treatment (e.g., intermittent cold with stretch).

TargetCool™ is a handheld device that can deliver rapid, precise, and controlled cooling to the skin tissue. The TargetCool™ device consists of a main device Cooling-Nozzle, a guard, a filter, and a cartridge,

In Cooling mode, the main device produces controlled cooling based on thermoelectric cooling. which controls the temperature (2-4℃) of the targeted area. TargetCool™ displays the skin temperature measured in real time, the set cooling temperature and time, and the device status through the LCD display. Also, if the measured temperature is below -19C and lasts for more than 1 second, the status light blinks in blue with a beep sound.

The principle of pain relief through skin cooling is as follows: As the skin cools by spraying the cryogen onto the skin, the nerve conduction velocity (NCV) of the skin decreases, increasing the pain threshold (PTH) and pain tolerance (PT). Through this mechanism, pain in the skin is relieved. The advances represented by TargetCool™ lie in the fact that the device executes this process in a precise, controlled, and rapid way.

Here's a breakdown of the acceptance criteria and the study information for the TargetCool™ device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The text states, "TargetCool Temperature accuracy tests were conducted targeting three different treas (wrist, arm, back of neck) by three physicians at three different temperature settings (-10, -5, 5 degree C)." This implies the "test set" for temperature accuracy involved 3 anatomical areas and 3 temperature settings. The number of individual measurements or subjects is not explicitly stated beyond these categories.
• Data Provenance: Not explicitly stated (e.g., country of origin). The study seems to be a prospective bench test/performance test conducted by the company to confirm device specifications rather than a clinical trial with patient data.

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

• Number of Experts: Three physicians were involved in conducting the temperature accuracy tests.
• Qualifications of Experts: The specific qualifications (e.g., years of experience, specialty) of these three physicians are not specified in the provided text.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not mentioned. The study described is a performance test, not one that requires adjudication of expert interpretations. The physicians conducted the tests and observed the device's output.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. The document describes bench testing and a comparison to a predicate device based on technical specifications and indications for use, not a study evaluating human readers' improvement with or without AI.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, a standalone performance test was done. The "Performance Data" section details bench testing where the device's temperature accuracy and compliance with various standards were evaluated directly. This is a standalone performance assessment of the device's physical function.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the temperature accuracy tests, the ground truth was based on the measured skin surface temperature using presumably calibrated instruments in a controlled testing environment, compared against the device's set temperature. For the other performance criteria (electrical safety, EMC, etc.), the ground truth was adherence to established international standards (e.g., ISO, IEC).

8. The Sample Size for the Training Set

• Not applicable/not mentioned. The TargetCool™ device is a cryosurgical unit, a physical medical device that applies cold therapy. It is not an AI/ML algorithm that requires a training set in the conventional sense. The "training" or development of the device would involve engineering design and iterative testing, not data-driven machine learning.

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

• Not applicable/not mentioned. As explained in point 8, this is not an AI/ML device requiring a training set with established ground truth from data.

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