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 time, and the device status through the LCD display. Also, if the measured temperature is below -1°C and lasts for more than 1 second, the status light blinks in blue with a beep sound.

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The CryoFreeze Wart and Skin Tag Remover is intended for the over-the-counter treatment of common warts and plantar warts in individuals ages 4 years and older and the over-the-counter treatment of skin tags in individuals ages 22 and older.

The CryoFreeze Wart and Skin Tag Remover is an over-the-counter (OTC) cryotherapy device designed for the treatment of common warts, plantar warts, and skin tags. The device includes:

• A pressurized aerosol canister filled with a liquid mixture of compressed gases
• Applicator swabs
• Detailed instructions, including illustrated descriptions

To use the device, the user must insert an applicator swab into the actuator, saturate the swab with cryogen, and apply the foam tip of the swab directly onto the lesion, holding it in place for 40 seconds. After removal, the frozen tissue will appear white and begin to thaw, typically taking 20-40 seconds. The device is non-sterile and intended for home use by laypersons. No special training or sterilization is required for operation.

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

The main device produces controlled cooling based on thermoelectric cooling, which controls the temperature of the targeted area. TargetCool-e 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°C and lasts for more than 1 second, the status light blinks in blue with a beep sound.

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The Verruca-Freeze H Plus cryosurgical system is intended for use by trained medical professionals to treat the following benign skin lesions:

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

The main component of the Verruca-Freeze® H Plus cryosurgical system is the pressurized aerosol canister containing cryogen spray. The canister is used with foam swabs, which are non-sterile, single-use applicators that are disposed of after each use. The foam swabs allow the cryogen to be localized to a target lesion.

The procedure begins by saturating a foam swab with cryogen and then placing it directly onto the lesion for 15–40 seconds. Upon removal of the swab from the skin, the frozen tissue appears white and begins thawing. The typical thaw time is 20–40 seconds. This treatment methodology is simple and has been an accepted practice used by physicians for decades. It utilizes a cryogen formulation to freeze lesions and destroy the underlying tissue through evaporative cooling. On the cellular level, both extracellular and intracellular ice formation occur. This submission includes a modification to the cryogen formulation. No other changes were made to the device design, intended use, or operating principle.

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The Skin Clinic Freeze Point product is intended for the treatment of common warts, plantar warts, and skin tags by OTC consumers. Treat skin tags in adults age 22 years or older

Not Found

This 510(k) clearance letter details the clearance of a medical device, "Skin Clinic Freeze Point for Warts and Skin Tags," which is a cryosurgical unit. However, the provided document does not contain any information about the acceptance criteria or the study that proves the device meets the acceptance criteria.

The 510(k) process is primarily focused on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive clinical trials to prove efficacy and safety in the same way a PMA (Premarket Approval) application would. While a 510(k) submission does include performance data, this particular clearance letter only states that the device is substantially equivalent and provides regulatory information, such as:

• Device Name: Skin Clinic Freeze Point for Warts and Skin Tags
• Regulation Number: 21 CFR 878.4350
• Regulation Name: Cryosurgical Unit And Accessories
• Regulatory Class: Class II
• Product Code: GEH
• Indications for Use: Treatment of common warts, plantar warts, and skin tags by OTC consumers; treat skin tags in adults age 22 years or older.
• Type of Use: Over-The-Counter Use

Therefore, I cannot provide the requested information regarding acceptance criteria and study details based solely on this document.

To answer your prompt, I would need a different type of document, such as a summary of safety and effectiveness data (SSED) or a detailed study report that would typically be part of a 510(k) submission but is not included in the clearance letter itself.

Without that information, I cannot fill in the table or address the points about sample size, expert ground truth, adjudication, MRMC studies, standalone performance, training set details, or ground truth establishment.

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The Skin Clinic Nitro Clear Wart Remover is intended for the OTC treatment of common warts and plantar warts in adults and children 4 years of age and older.

The Skin Clinic Nitro Clear Wart Remover device utilizes extreme cold to facilitate the removal of common and plantar warts by freezing. Each device contains a container of cryogen gas in a plastic holder along with instructions for use. The Skin Clinic Nitro Clear Wart Remover device is for OTC use and utilizes Nitrous Oxide cryogen delivered from the cartridge into a tip which acts as a reservoir for the cryogen gas. The applicator tip is cooled to as low as -89°C. Depending on the location and size, the applicator is placed against the common wart or plantar wart between 10-40 seconds which freezes the targeted area. The frozen wart falls away over time and new epidermis grows in its place. One to four treatments with intervals of two weeks may be required.

Acceptance Criteria and Study Details for Skin Clinic NitroClear

Based on the provided FDA 510(k) clearance letter for the Skin Clinic NitroClear Wart Remover, here's a breakdown of the acceptance criteria and the studies conducted:

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative "acceptance criteria" for the device's performance in terms of efficacy (e.g., a specific percentage of wart clearance). Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices. This equivalence is established by:

• Comparable technological characteristics: The subject device operates on the same principle (cryotherapy to destroy tissue with extreme cold) and has similar design and safety features to its predicates.
• Achieving equivalent or lower temperatures: Through bench testing, the device demonstrated its ability to reach temperatures comparable to or lower than the predicate devices. This implies it can achieve the intended cryotherapeutic effect.
• Demonstrated cell killing efficacy (in vitro): The in vitro test showed that the device is capable of effectively destroying cells, aligning with its mechanism of action for wart removal.
• Human factors usability: The device's usability was deemed acceptable for over-the-counter use by consumers based on a dedicated study.

2. Sample Size for Test Set and Data Provenance

The document does not specify a quantitative "test set sample size" for a clinical efficacy study. The performance data primarily relies on:

• Bench Testing: This would involve laboratory setups to measure temperature, not human subjects.
• In vitro Test: This was conducted on cells in an agar matrix, not human subjects.
• Human Factors Usability Study: While not explicitly stated, this study would involve human participants to assess usability. The document does not provide the sample size, country of origin, or whether it was retrospective or prospective.

Given the nature of the clearance (510(k) for substantial equivalence), a large-scale clinical efficacy trial with a dedicated test set of patients for wart clearance is usually not required if the technology is deemed sufficiently similar to a predicate.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth for a clinical test set from a diagnostic or efficacy perspective. The testing described (bench, in vitro, usability) does not typically involve expert consensus for ground truth on patient outcomes.

• For Biocompatibility: Experts in biocompatibility testing (toxicologists, material scientists) would have been involved in the evaluation against ISO 10993 standards.
• For Human Factors: Experts in human factors engineering would have designed and evaluated the usability study.

No specific number or qualifications are provided in the document.

4. Adjudication Method for the Test Set

Since there is no mention of a clinical test set with patient outcomes requiring adjudication (e.g., for diagnostic accuracy of an AI or efficacy of treatment), there is no adjudication method described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This type of study is typically performed for diagnostic imaging devices involving multiple readers interpreting cases, often with and without AI assistance, to measure changes in diagnostic performance. The Skin Clinic NitroClear is a cryosurgical treatment device, not a diagnostic imaging AI.

6. Standalone Algorithm Performance Study

No standalone (algorithm only without human-in-the-loop) performance study was done. The device is a physical cryosurgical unit, not a software algorithm that operates independently. Its performance is inherent in its physical function and interaction with a user.

7. Type of Ground Truth Used

• For Biocompatibility: The ground truth would be established by the requirements of the ISO 10993 standard.
• For Temperature Attainment: The ground truth would be objective temperature measurements using calibrated equipment.
• For Cell Killing (in vitro): The ground truth would be the observed viability of cells in the agar matrix after treatment, typically assessed through laboratory methods.
• For Human Factors Usability: The ground truth would be observations of user interaction and performance against predefined usability objectives or tasks.

There is no mention of pathology, expert consensus on images, or long-term outcomes data as "ground truth" in the context of this 510(k) submission, as it focuses on substantial equivalence for a physical treatment device rather than a diagnostic or AI-driven system.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable here as the Skin Clinic NitroClear is a physical device, not an AI or machine learning model that requires training data.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a machine learning model.

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The CryoFreeze Wart and Skin Tag Remover is intended for use in the over-the-counter treatment of common warts and plantar warts in adults and children age 4 years or older and over-the-counter treatment of skin tags in adults age 22 years or older.

The CryoFreeze Wart and Skin Taq Remover is an over-the-counter (OTC) cryotherapy device designed for the treatment of common, plantar warts, and skin tags. The device includes:

• A pressurized aerosol canister filled with a liquid mixture of the compressed gases dimethyl ether, propane, and isobutane
• Applicator swabs
• Detailed instructions, including illustrated descriptions

To use the device, the user must insert an applicator swab into the actuator, saturate the swab with cryogen, and apply the foam tip of the swab directly onto the lesion, holding it in place for 40 seconds. After removal, the frozen tissue will appear white and begin to thaw, typically taking 20-40 seconds.

The device is non-sterile and intended for home use by laypersons. No special training or sterilization is required for operation.

The provided document is a 510(k) summary for the CryoFreeze Wart and Skin Tag Remover, which is a cryosurgical unit. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results with acceptance criteria in the same way a PMA (Pre-Market Approval) or de novo submission might.

Therefore, the document does not contain the detailed information required to fully answer all aspects of your request, specifically regarding clinical studies, sample sizes, expert qualifications, or ground truth establishment relevant to AI/algorithm performance. The device described is a physical medical device, not an AI/software as a medical device (SaMD).

Here's an analysis based on the available information:

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

The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical trial for performance outcomes (e.g., cure rates, recurrence). Instead, substantial equivalence is demonstrated through technological comparison and non-clinical performance testing against a reference device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size for Test Set: Not applicable in the context of this 510(k) for a physical cryosurgical device. The document mentions "comparative performance testing against the reference device," but it does not specify sample sizes for these non-clinical tests (e.g., how many times temperature was measured, or how many freeze cycles were observed).
• Data Provenance: Not specified, but generally, non-clinical tests for 510(k) devices are conducted by the manufacturer or a contract research organization.

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):

• This information is not provided because the device is a physical cryosurgical unit, and the testing described is non-clinical performance testing rather than clinical evaluation against an expert-determined ground truth for diagnostic accuracy, for example.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable/Not provided as the testing described is non-clinical performance testing, not a clinical trial requiring adjudication of patient outcomes or diagnostic readings by experts.

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:

• No MRMC study was done. This device is a direct-to-consumer physical cryosurgical tool, not an AI or imaging device that would involve human readers or AI assistance.

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

• No standalone algorithm performance study was done. This device does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the non-clinical performance tests, the "ground truth" would be the measured physical properties (e.g., temperature) as determined by calibrated instruments, and visual observations (e.g., ice ball formation). This is not a "ground truth" in the clinical or diagnostic sense.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML product and does not have a "training set."

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

• Not applicable. This device is not an AI/ML product and does not have a "training set."

In summary, the provided 510(k) letter and summary establish substantial equivalence for the CryoFreeze Wart and Skin Tag Remover based on its technological characteristics and non-clinical performance being comparable to previously cleared predicate and reference devices. It does not involve AI or clinical studies with expert-adjudicated ground truth as would be relevant for software/AI-based medical devices.

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The Co-Ablation System with Sterile Co-Ablation Probe is designed to destroy solid tumors, intended for use in open. minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, neurology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The system is designed to Co-Ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts.

In addition, the system is also intended for use in the following indications:

General Surgery

• · Destruction of warts or lesions.
• · Palliation of tumors of the oral cavity, rectum, and skin.
• · Ablation of breast fibroadenomas.
• Ablation of leukoplakia of mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemangiomas, recurrent cancerous lesions.

Urology
· Ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia.

Gynecology

• · Ablation of malignant neoplasia or benign dysplasia of the female genitalia.
  Oncology
• · Ablation of cancerous or malignant tissue.
• · Ablation of benign tumors.
• · Palliative intervention.
• Neurology
• · Freezing of nerve tissue in pain management/cryoanalgesia.

Dermatology
· Ablation or freezing of skin cancers and other cutaneous disorders.

Proctology

• · Ablation of benign or malignant growths of the anus and rectum.
• · Ablation of hemorrhoids.

Thoracic Surgery

• · Ablation of cancerous lesions.

The Co-Ablation System with Sterile Co-Ablation Probe is a device designed to freeze/ablate tissue. It utilizes phase change effect to generate extremely low temperature and high temperature to destroy lesion tissues with a combined working mode, to achieve better clinical efficacy, safety and efficiency.

Main components: Co-Ablation System, Sterile Co-Ablation Probe. Accessory: Sterile Temperature Probe.

The Co-Ablation System is a mobile medical equipment. The Co-Ablation System consists a host of Co-Ablation System including liquid nitrogen storage tank (referred to as cryotank), cryo-valve, warm working medium storage tank (referred to as warmtank), warm-valve, waste bottle,insulated pipe and control/display system, etc. The Co-Ablation System has model number with AI Epic S40U and AI Epic S20U.

The Sterile Co-Ablation Probe is a single-use sterile product, consisting of a handle, quick release connector, probe tip and probe shaft. It must be used in conjunction with the Co-Ablation System. During treatment, the Sterile Co-Ablation Probe is inserted into the lesion to be ablated. The freezing channel is opened, and the freeze working medium (liquid nitrogen) rapidly flows to the probe and evaporates to absorb heat, rapidly freezing and destroying tissue near the probe tip. When the system is switched from the freeze mode to warm mode, high temperature steam passes to the tip of the Sterile Co-Ablation Probe, rapidly heating the tip portion of the Sterile Co-Ablation Probe so that the frozen tissue around the Sterile Co-Ablation Probe is quickly melted, and the Sterile Co-Ablation Probe is easily pulled out. The Sterile Co-Ablation Probe consists of right-angle and straight configurations with model number Elite, and comprises 20 specifications as listed below:

The Sterile Temperature Probe is designed for use with the Co-Ablation System to monitor temperatures in the surrounding tissue. The Sterile Temperature Probe with model number Ease, and comprises 4 specifications: TSS08, TSL08, TMS15 and TML15.

The provided text is a 510(k) Summary for the Hygea Medical Technology Co., Ltd.'s Co-Ablation System with Sterile Co-Ablation Probe. It details comparisons to predicate devices and lists non-clinical performance data.

However, there is no information presented regarding acceptance criteria, reported device performance against those criteria, or a specific study proving the device meets those criteria in the context of an AI/algorithm's diagnostic performance. The document focuses on the substantial equivalence of the cryoablation system as a medical device based on its design, function, and non-clinical safety/effectiveness tests (electrical safety, EMC, usability, software, sterilization, biocompatibility, shelf life, ex-vivo, and animal testing).

Specifically, the document states:

• "No clinical data was necessary to determine the substantial equivalence of this device." This directly indicates that no clinical study, which would typically contain acceptance criteria and performance metrics for a diagnostic device, was conducted or submitted for this 510(k) clearance.
• The "Software Testing" section mentions "the software verification/validation met the acceptance criteria," but these acceptance criteria are related to general software development standards (IEC 62304, FDA guidance for software and cybersecurity) and not to the diagnostic performance of an AI/algorithm.

Therefore, I cannot provide the requested table and information because the provided text does not contain data related to:

1. A table of acceptance criteria and reported device performance for an AI/algorithm's diagnostic capability.
2. Sample size and data provenance for a test set for AI/algorithm performance.
3. Number and qualifications of experts for ground truth establishment for AI/algorithm performance.
4. Adjudication method for an AI/algorithm test set.
5. MRMC comparative effectiveness study results for AI assistance.
6. Standalone performance of an AI algorithm.
7. Type of ground truth used for AI/algorithm performance.
8. Sample size for the training set of an AI algorithm.
9. How the ground truth for an AI training set was established.

This 510(k) summary is for a cryoablation system, which is a therapeutic device, not an AI-powered diagnostic device. The performance data presented refers to the physical and software functionalities of the system in performing cryoablation, not to the diagnostic accuracy of an AI.

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The Advanced Cryo Wart Remover is designed as an over-the-counter (OTC) self-care device indicated for adults and children from the age of four years and older for the treatment of common and plantar warts.

The Advanced Cryo Wart Remover is an over-the-counter (OTC) cryotherapy device designed for the treatment of common and plantar warts. The device includes:

• A 15 mL / 0.51 oz pressurized aerosol canister containing a freezing agent (1,1-Difluoroethane, Propane, and Isopentane).
• A metal tip that applies the cryogen directly to the wart
• Detailed instructions, including illustrated descriptions.
  To activate the product, the lay user must, while holding the device facing downward, press the side buttons firmly five times in a row. Apply the cold metal tip for 20 seconds on warts located on the hands, tops of feet, and toes. Apply for 40 seconds on plantar warts in areas with thicker or calloused skin.
  The device is non-sterile, reusable, and intended for home use by laypersons. No special training or sterilization is required for operation.

The provided text is a 510(k) premarket notification for the "Advanced Cryo Wart Remover." It describes the device, its intended use, and the non-clinical performance data used to demonstrate substantial equivalence to predicate devices. However, this document does not contain information about a study that establishes acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) or the results of such a study.

The document details:

• Non-clinical Performance Data (Section 9):
  • Biocompatibility Testing (ISO 10993 series)
  • Shelf Life Testing (ASTM D3090-72)
  • Transportation Testing (ASTM D4169)
  • Bench Testing (comparative thermal performance, freeze temperature extremes, plateau, and duration)
  • Label and IFU Comprehension Study (Flesch test)
  • Human Factors Study (usability study compliant with EN ISO 8317:2004, secondary usability study on timing, self-assessment study on wart identification)

These studies are primarily focused on safety, usability, and the physical characteristics of the device (such as its ability to freeze at certain temperatures or its shelf life). They do not involve a clinical study with a test set, ground truth experts, or metrics like sensitivity/specificity for wart removal effectiveness. The "self assessment study" mentioned under Human Factors is related to label comprehension, not the device's efficacy.

Therefore, I cannot provide the requested table or answer the questions related to clinical performance, as the provided text does not contain that information. The 510(k) pathway for this device relied on demonstrating substantial equivalence primarily through non-clinical performance data and comparison to legally marketed predicate devices, rather than a new clinical efficacy study with performance acceptance criteria like those often seen for AI/ML-driven devices.

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The Verruca-Freeze® H cryosurgical system is indicated for use in the treatment of the following skin lesions:

• · Actinic Keratosis
• · Genital Warts
• · Lentigo
• · Molluscum Contagiosum
• · Seborrheic Keratosis
• · Skin Tags
• · Verruca Plantaris
• · Verruca Vulgaris
• · Verruca Plana

The Verruca-Freeze® H cryosurgical system is used for treatment of benign skin lesions. The device consists of:
• Canister filled with a liquid mixture of the compressed gases dimethyl ether, propane, and isobutane
• Polyurethane foam swabs
• Detailed instructions including illustrated descriptions

The main component of the device is the pressurized aerosol canister containing cryogen spray. The canister is used with foam swabs, which are non-sterile, single-use applicators that are disposed after each use. The foam swabs allow the cryogen to be localized to a target lesion.

The one- to two-minute procedure begins by spraying cryogen onto a foam swab, which is then placed directly onto held for 15-40 seconds. Upon removal of the swab from the skin, the frozen tissue appears white and begins thaw time is 20-40 seconds.

This treatment methodology is simple and has been an accepted by physicians for decades. It utilizes a standard cryogen composition profile to freeze lesions and destroy the underlying tissue through evaporative cooling. On the cellular level, both extracellular and intracellular ice formation are occurring.

The provided document is a 510(k) premarket notification letter and summary for a medical device called "Verruca-Freeze H," a cryosurgical unit. It establishes substantial equivalence to a predicate device. However, the document does not contain any information about acceptance criteria, device performance metrics (such as sensitivity, specificity, or accuracy), or details of a study that proves the device meets specific performance criteria beyond stability testing for the product's shelf life.

The 510(k) process for this device, a cryosurgical unit, primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device through technological characteristics, materials, and intended use. It is not an AI/ML medical device submission, which typically requires rigorous performance studies to demonstrate the algorithm's effectiveness in diagnosis or treatment.

Therefore, I cannot fulfill your request for information on acceptance criteria and study details related to AI/ML device performance from the provided text. The document explicitly states:

• "The subject device has the same technological characteristics as the same design, energy source, materials, and other features." (Page 5)
• "A stability protocol was developed to ensure that the product is maintained throughout its labeled dating period. Testing conducted under controlled conditions at room temperature and under accelerated conditions." (Page 5)

These statements indicate that the "study" conducted was related to stability and comparison to a predicate device, not an evaluation of an AI algorithm's diagnostic or therapeutic performance using patient data, ground truth, and expert adjudications.

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