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Celsi Warmer is intended for use in hospitals under a clinician's supervision or at their direction to assist nurses in continuous temperature monitoring and thermal treatment of neonates.

a. Maintain pre-set body temperature as determined by the physician.
b. Celsi Warmer is appropriate for neonates greater than 28 weeks gestational age who weigh between 1-4 kg.
c. Monitoring and controlling patient temperature.

The Celsi Warmer is a portable, non-invasive thermal regulating system, indicated for continuous temperature monitoring and thermal treatment of neonates that require extra warmth to maintain normal body temperature. It uses a non-invasive thermometer (using direct mode) that measures the temperature of an infant's skin via a temperature probe placed on their abdomen to provide input into a physiological control loop that controls the mattress temperature. The Celsi Warmer is intended for use in hospitals under a clinician's supervision and is appropriate for neonates greater than 28 weeks gestational age who weigh between 1-4 kg. The Celsi Warmer is comprised of the following components:

• Warming Mattress
• Controller Tower
• Celsi Temperature Probe and Celsi Belt
• Power Supply and Cables

I apologize, but the provided text from the FDA 510(k) Clearance Letter for the Celsi Warmer does not contain the detailed information necessary to answer your specific questions regarding acceptance criteria and the study that proves the device meets those criteria.

The document focuses on:

• Formal FDA clearance: Confirmation of the 510(k) submission, product classification, and general regulatory requirements.
• Device description and indications for use: What the Celsi Warmer is and what it's intended for.
• Comparison to a predicate device: Highlighting similarities in intent, technology, and use environment.
• Summary of non-clinical testing: A list of standards and types of testing performed (Biocompatibility, Software V&V, EMC/Electrical Safety, Usability).

However, it does not include:

1. A table of specific acceptance criteria and reported device performance: While it mentions testing, it doesn't provide the quantifiable metrics or the results of those tests.
2. Sample sizes for a test set, data provenance, ground truth establishment, or expert details for performance studies.
3. Details about MRMC comparative effectiveness studies or standalone algorithm performance.
4. Information on training set sample sizes or ground truth for training data.

The 510(k) summary typically provides a high-level overview. Detailed performance data, acceptance criteria, and study methodologies (like those involving expert human readers or specific statistical analyses) are usually found in the full 510(k) submission document, which is not publicly available in this format from the clearance letter.

Therefore, I cannot populate the table or provide answers to the specific questions based solely on the provided text.

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Celsi Monitor is intended for use in hospitals under a clinician's supervision or at their direction to assist nurses in continuous temperature monitoring of neonates. The device abdominal skin temperature through direct contact.

Celsi Monitor is a non-invasive continuous temperature monitor. Celsi Monitor achieves its intended purpose by measuring temperature at the surface of a neonate's abdomen by sensing changes in electrical resistance of a thermistor that is in thermal contact with the skin at the measured point. Celsi Monitor is provided with the Celsi Belt. The Celsi Monitor is powered by two rechargeable lithium-ion batteries. Both the Celsi Belt and Celsi Probe are reusable. The device displays measured patient body temperature for up to 12 hours and alarms when the temperature falls outside normothermic levels (37.5 °C). The device is a skin contacting surface device with duration of contact

This document is a 510(k) Premarket Notification from the FDA for the "Celsi Monitor" device. It outlines the device's characteristics, intended use, and a comparison to a predicate device, along with summaries of testing performed.

Acceptance Criteria and Device Performance:

The document doesn't explicitly list "acceptance criteria" in a table form with specific performance thresholds for the Celsi Monitor. Instead, it describes general compliance with standards and comparable performance to a predicate device. Its primary acceptance criterion for the 510(k) clearance is demonstrating substantial equivalence to an existing legally marketed device (the predicate device). This substantial equivalence is shown through similar intended uses, technological characteristics, and a demonstration that any differences do not raise new questions of safety or effectiveness.

The "study that proves the device meets the acceptance criteria" refers to the non-clinical and clinical testing performed to support the claim of substantial equivalence.

Here's an attempt to structure the information based on the prompt's request for acceptance criteria and device performance, drawing from the provided text:

Table of Performance and (Implied) Acceptance Criteria:

Detailed Study Information:

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

   • Test Set Sample Size: Not explicitly stated in terms of number of neonates or temperature readings. The document mentions "A short duration (3 hour) and long duration (12 hour) clinical evaluation was performed".
   • Data Provenance: Not explicitly stated (e.g., country of origin). The studies were "clinical evaluations" and thus would be prospective in nature, designed to test the device's performance directly on subjects.

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

   • Not applicable in the context of this device. This is a temperature monitor; ground truth is established by a reference thermometer (Philips Intellivue MP30) or direct physical measurements, not by expert interpretation.

3. Adjudication Method for the Test Set:

   • Not applicable as the ground truth is objective temperature measurement rather than subjective interpretation requiring adjudication.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No, a MRMC study was not described. This type of study is typically for evaluating diagnostic imaging AI where human readers interpret cases. The Celsi Monitor is a measurement device.

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

   • Yes, the clinical evaluation directly assessed the device's (Celsi Monitor's) temperature measurement performance. While used by nurses, the core "performance" being evaluated (temperature accuracy) is a standalone function of the device itself.

6. The Type of Ground Truth Used:

   • Reference device measurement: The "subject device was compared to the reference device, the Philips Intellivue MP30 (K061610)." The Philips Intellivue MP30 serves as the ground truth for temperature measurements.

7. The Sample Size for the Training Set:

   • Not applicable. This document describes the clearance of a medical device (a thermometer), not an AI/ML algorithm that requires a "training set" in the conventional sense for machine learning. The device's performance is based on its physical design and calibration, not learned from data.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable, as there is no "training set" for this type of device.

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The Pocket Colposcope is a digital video colposcope intended for gynecological examination. It provides a portable means of magnified visualization of the tissues of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and selecting areas for biopsy. The image system is intended to provide documentation of the image in the field of view of the colposcope. The Pocket Colposcope System is intended to be inserted into the vagina via a speculum by trained medical personnel in hospitals, clinics, and private offices, and is not intended for home use.

The Pocket Colposcope is a reusable, high-definition video colposcope intended to be used in a hospital / clinical environment for examination of the tissues of the vagina, cervix and external female genitalia in order to aid in diagnosing abnormalities and selecting areas for biopsy. The Pocket Colposcope can be used outside of the body to capture images of the vagina and external genitalia or can be inserted through a vaginal speculum to capture images of the cervix and surrounding tissue. The Pocket Colposcope it is not intended to come into direct contact with the body.

The Pocket Colposcope utilizes a ring or single loop of LED lights to illuminate the target tissue. The digital color image generated by the Pocket Colposcope is intended to be used to aid in diagnosing abnormalities and selecting areas for biopsy. Users can switch between the white and green light illumination and zoom in or out to capture images at different working distances.

The Pocket Colposcope has a 5 MP CMOS camera with a 0° angled lens. The Pocket Colposcope uses a computer-based software program to display the camera output on a computer screen and to capture images. Together, the Pocket Colposcope and the software comprise the Pocket Colposcope System.

The provided text does not contain detailed acceptance criteria or a study directly comparing the device's performance against specific clinical efficacy metrics. Instead, it focuses on demonstrating safety, essential performance, and technological equivalence to a predicate device.

However, based on the Summary of Performance Testing section, we can infer some general "acceptance criteria" through the standards the device was tested against and the statement "All test results met pre-determined acceptance criteria."

Here's an attempt to answer your request based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Since specific numerical acceptance criteria (e.g., minimum sensitivity/specificity for a diagnostic claim) are not provided, the table below reflects what can be inferred from the regulatory submission document. The "Reported Device Performance" here refers to the outcome of the testing mentioned, which is that the device complied or met the standards.

2. Sample Size for Test Set and Data Provenance

The document does not specify a "test set" in terms of cases (e.g., patient images for diagnostic performance). The performance testing described is primarily engineering and usability-focused.

• Sample Size for Test Set: Not applicable in the context of clinical diagnostic performance. For the "Design Validation" where medical professionals evaluated the device, the sample size is referred to as "several trained medical professionals," which is not a specific number.
• Data Provenance: Not applicable for engineering and usability testing as described. If "Design Validation" involved patient interaction, the provenance is not specified.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: "several trained medical professionals"
• Qualifications of Experts: "trained medical professionals (intended users)" - no specific experience level (e.g., "10 years of experience") or specialization (e.g., "radiologist") is given. They are described as "intended users."

4. Adjudication Method for Test Set

Not applicable. The performance testing described does not involve a multi-reader, multi-case adjudication process for establishing ground truth for diagnostic accuracy, as it's not a diagnostic AI device requiring such. The "Design Validation" focused on user satisfaction and device function, not diagnostic accuracy.

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

• Was an MRMC study done? No, the document does not mention an MRMC comparative effectiveness study where human readers improve with AI vs. without AI assistance. The Pocket Colposcope System is a physical imaging device, not an AI diagnostic aid for human readers in the described context.
• Effect size of improvement: Not applicable.

6. Standalone (Algorithm Only) Performance

• Was a standalone performance study done? No. The device itself is an imaging tool. The "Software Verification and Validation Testing" focused on the software within the device meeting regulatory requirements, not on a standalone diagnostic algorithm's performance on a dataset.

7. Type of Ground Truth Used

• For the engineering and usability tests, the "ground truth" was compliance with established industry standards (e.g., IEC, ISO, ANSI/NEMA, CISPR) and, for design validation, user feedback on device function and meeting needs.
• The document does not describe a ground truth derived from expert consensus, pathology, or outcomes data in the context of clinical diagnostic accuracy testing for the device.

8. Sample Size for Training Set

Not applicable. This device is an imaging system, not a machine learning algorithm that requires a training set for diagnostic classification.

9. How Ground Truth for Training Set was Established

Not applicable, as there is no mention of a training set or machine learning components that would require such ground truth.

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