Search Results
Found 5 results
510(k) Data Aggregation
(405 days)
TECNIMED S.R.L.
VisioFocus SMART and VisioFocus Mini are infrared thermometers intermittent measurement of human body temperature in people of all ages. This thermometer is for a measurement site of forehead.
Not Found
This document is a 510(k) premarket notification from the FDA for a clinical electronic thermometer (VisioFocus SMART and VisioFocus Mini). It primarily focuses on the device's substantial equivalence to a predicate device and its indications for use.
Therefore, this document does not contain the information requested regarding the acceptance criteria and the study that proves the device meets those criteria. Specifically, it lacks:
- A table of acceptance criteria and reported device performance.
- Details on sample sizes and data provenance for test sets.
- Information on ground truth establishment, including the number and qualifications of experts and the adjudication method.
- Any mention of Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance studies.
- Information about the training set's size or ground truth establishment.
The document is a regulatory approval letter, not a scientific study report.
Ask a specific question about this device
(617 days)
TECNIMED S.R.L.
Zanza-Click (or Disc-o-Click, or Mini-Click) is indicated for temporarily reducing the swelling and itching caused by mosquito bites.
The Zanza-Click (or Disc-o-Click, or Mini-Click) is a hand held device, consisting primarily of housing, a push button (which the user depresses to excite the piezoelectric crystal by means of a spring), a "Piezo unit" (containing piezoelectric crystal) and electrical output terminals (placed flush to the user's skin) intended to deliver electrical current to the skin.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: | |
| No cutaneous burns from appropriate use. (Mitigated by: Characterization of Electrical Output, Labeling) | The device output was characterized and determined to be 2.24 kV and up to 222.83mA, with a duration of 30 microseconds. Labeling includes instructions to limit activation (max 10 clicks for adults, 5 for children) and warnings about repeated excessive use on the same site to avoid burns. |
| Biocompatible patient-contacting materials to prevent adverse skin reactions. (Mitigated by: Biocompatibility Assessment) | Patient-contacting materials (acrylonitrile butadiene styrene (ABS), styrene butadiene copolymer (SBC), and polypropylene) have provided justification supporting biocompatibility for external, single-user contact. |
| No damage to sensitive tissue (eyes, lips, mouth, open wounds). (Mitigated by: Labeling) | Labeling includes warnings against use in or around sensitive areas (mouth, tongue, eyes, ear canal, etc.), over open wounds or rashes, infected areas, or if sensitive to electric stimulus. Also advises caution on areas lacking normal sensation. |
| No infection from appropriate use. (Mitigated by: Labeling) | Labeling states the device cannot be sterilized, is for single patient use, and if accidental contact with open wounds/blood occurs, it should be disposed of after disinfection. |
| No burns/injuries from ignition of flammable substances. (Mitigated by: Labeling) | Labeling warns against use with insect repellent and/or flammable substances containing alcohol, and advises waiting until such substances have thoroughly dried. |
| No interference with implanted devices or other patient care devices. (Mitigated by: Labeling) | Labeling includes warnings against use if the user has a cardiac pacemaker, implanted defibrillator, or other implanted electronic device, and against use in the presence of electronic monitoring equipment. Electromagnetic Compatibility testing was performed per IEC 60601-1-2:2007. |
| Accurate targeting of the correct patient population and condition (temporary reduction of itching and swelling from mosquito bites). (Mitigated by: Labeling) | The Indications for Use specify the device is for "temporarily reducing the swelling and itching caused by mosquito bites." Labeling includes warnings that the device was only found to temporarily remove itching and swelling, and advises seeking medical attention for infected bites, and not to use it to remove toxins or infection. A labeling comprehension study indicated users understood cautionary language and instructions. |
| Effectiveness: | |
| Device must deliver at least 20,000 charges. (Mitigated by: Non-clinical (Bench) Testing, Labeling) | Mechanical degradation testing showed the device delivered at least 25,000 charges before failure. The labeling states, "Works for up to 20,000 clicks!" |
| Temporary reduction of itching and swelling caused by mosquito bites. (Mitigated by: Human Performance Testing) | At 1 hour (after first application): |
| 10% Swelling Reduction: Active Group: 86% (43 of 50) vs. Control (Sham) Group: 48% (24 of 50), with a Fisher's exact p-value |
Ask a specific question about this device
(217 days)
TECNIMED S.R.L.
VisioFocus 06400, 06450, 06480 and 06490 series are infrared thermometers intended for intermittent measurement of human body temperature in people of all ages.
Not Found
This document is a 510(k) clearance letter for a medical device, the VisioFocus infrared thermometer. It primarily focuses on regulatory approval rather than providing detailed study results that would typically include comprehensive acceptance criteria and performance data.
Therefore, the requested information, particularly detailed acceptance criteria and a study proving the device meets them with specific metrics (like sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC effectiveness), is not present in the provided text.
The document states that the FDA reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This equivalence is based on the provided indications for use and other unspecified information in the 510(k) submission.
Without the actual 510(k) submission document, which would contain the detailed performance testing, it's impossible to completely fill out the requested table and answer all questions definitively.
Here's what can be inferred or stated based on the provided text, and what is missing:
The core information requested for a detailed study report is absent. The document is an FDA clearance letter, which confirms regulatory approval based on submitted data, but does not detail that data.
Ask a specific question about this device
(30 days)
TECNIMED S.R.L.
Thermofocus 0800, 0900, 01500, 0700 Series are infrared thermometers intended for the intermittent measurement of human body temperature in people of all ages.
Thermofocus devices belonging to the 0800, 0900, 01500, 0700 series are hand-held and battery-operated thermometers. They take skin temperature mainly in the middle of the forehead, on the navel, neck or under the armpit. The Thermofocus devices use the principle of surveying the natural emission of infrared thermal radiation from all objects, including the human body. Thermofocus thermometers take temperature at distance, without any contact with the patient.
The provided text describes a 510(k) submission for new models of the Thermofocus infrared thermometer, which are updates to previously cleared devices. It states that "Performance tests were not required as the modified devices are essentially equivalent to previously cleared predicate devices." However, it does mention that "Certain performance tests were conducted as part of the risk analysis and demonstrated acceptable results for devices safety and effectiveness." It also indicates that "Both devices meet the ASTM E1965-98 Standard for Infrared Thermometer for Intermittent Determination of Patient Temperature, as far as this standard applies to them."
Based on the provided information, a full study (as commonly understood for AI/ML devices) demonstrating device performance against specific acceptance criteria is not detailed because the submission focuses on equivalence to a predicate device and adherence to a recognized standard.
Here's an attempt to fill in the requested information based on the provided text, with explicit notes about what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a specific table of acceptance criteria with corresponding performance metrics from a dedicated study. Instead, it relies on conformance to the ASTM standard and equivalence to predicate devices.
| Acceptance Criteria (Inferred from ASTM E1965-98) | Reported Device Performance |
|---|---|
| Conformance to ASTM E1965-98 Standard | Meets ASTM E1965-98 Standard (as far as applicable) |
| Device Safety and Effectiveness | Acceptable results from performance tests conducted as part of risk analysis |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: Not specified. The document states that "Performance tests were not required as the modified devices are essentially equivalent to previously cleared predicate devices." "Certain performance tests were conducted as part of the risk analysis," but the sample size for these tests is not mentioned.
- Data Provenance: Not specified. The manufacturer is Tecnimed srl, Italy, which could imply European testing standards, but details are absent.
- Retrospective/Prospective: Not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable/not specified. The device is a thermometer, and "ground truth" for temperature measurement typically refers to calibrated reference thermometers, not expert human assessment in the way it's used for diagnostic imaging.
- Qualifications of Experts: Not applicable/not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not specified. This concept is typically relevant for studies involving human interpretation or subjective assessments, which is not the primary focus for a thermometer's performance evaluation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. This type of study assesses how AI impacts human reader performance, which is not relevant for a standalone temperature measurement device.
- Effect Size: Not applicable.
6. Standalone (Algorithm only without Human-in-the-loop performance) Study
- Standalone Study Done: Yes, in principle. A thermometer's performance is inherently standalone. The document states, "Certain performance tests were conducted as part of the risk analysis and demonstrated acceptable results for devices safety and effectiveness." and "Both devices meet the ASTM E1965-98 Standard for Infrared Thermometer for Intermittent Determination of Patient Temperature, as far as this standard applies to them." These statements imply standalone performance evaluations against established standards.
7. Type of Ground Truth Used
- Type of Ground Truth: For a thermometer, the "ground truth" would be established by a highly accurate and calibrated reference thermometer. The document implies adherence to the ASTM E1965-98 standard, which would define the methods and reference standards for temperature measurement accuracy. Specific details of the reference thermometer used are not provided in this excerpt.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is an infrared thermometer, not an AI/ML device that requires a "training set" in the computational sense. Its function is based on physical principles of infrared radiation, calibrated during manufacturing, rather than learned from a dataset.
9. How Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no "training set" in the AI/ML context for this device. The device is calibrated during manufacturing against physical standards to ensure accurate temperature readings, which is a different process than establishing ground truth for machine learning.
Ask a specific question about this device
(182 days)
TECNIMED S.R.L.
The Thermotocus series 0800, 01500 and 0700 are infrared thermometers intended for the intermittent measurement of human body temperature of people of all ages
Thermofocus devices belonging to the 0800, 0900, 01500, 0700 series are hand-held and battery-operated, taking skin temperature mainly in the middle of the forehead. In case of difficult to take the temperature on this area it is also possible to take the temperature on the navel or under the armpit. The Thermofocus devices use the principle of surveying the natural emission of infrared thermal radiation from all objects, including the human body. Thanks to an exclusive optic aiming system, the peculiarity of Thermofocus thermometers is to take the temperature at distance, without any contact with the patient.
The provided document is a 510(k) summary for the Tecnimed Thermofocus series of infrared thermometers. It describes the device, its intended use, and provides a summary of performance testing.
Here's an analysis of the acceptance criteria and study information contained within:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Accuracy tests | Pass | Pass |
| Repetability tests | Pass | Pass |
| °F vs °C tests | Pass | Pass |
| Error messages tests | Pass | Pass |
| Display limits tests | Pass | Pass |
| DFU evaluation | Pass | Pass |
| Current leakage tests | Pass | Pass |
| Variable voltage tests | Pass | Pass |
| EMC tests | Pass | Pass |
| Clinical Performance | Substantial equivalence to predicate (Sensortouch) | Substantial equivalence demonstrated |
Note: The document states "Both devices meet the ASTM E1965-98 Standard for Infrared Thermometer for Intermittent Determination of Patient Temperature, as far as this standard applies to them." This ASTM standard would contain specific quantitative acceptance criteria for parameters like accuracy and repeatability, but these specific values are not explicitly detailed in this 510(k) summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states that "The numerous tests conducted in our laboratories and also in hospital and clinics, on several subjects..." but does not specify the exact sample size for subjects or cases used in the clinical performance testing.
- Data Provenance: The tests were conducted in "our laboratories" and "hospital and clinics." This indicates prospective data collection through internal testing and clinical sites. The country of origin for Tecnimed srl is Italy.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The clinical performance testing focused on demonstrating "substantial equivalence between Thermofocus and the predicate Sensortouch," implying a comparison to the predicate device's readings rather than a separate expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This section is not applicable. The device is an infrared thermometer, not an AI-powered diagnostic tool requiring human reader interpretation or improvement.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The device is a standalone thermometer (algorithm-only in its functional sense, as it autonomously measures and displays temperature). The document implicitly describes standalone performance testing as part of the "Summary of non-clinical Performance Testing" (e.g., accuracy, repeatability) and the comparative clinical testing against the predicate.
7. The Type of Ground Truth Used
For the clinical performance testing, the ground truth was based on comparison to a legally marketed predicate device (TemporalScanner thermometer, formerly known as SensorTouch). The study aimed to demonstrate "substantial equivalence" to this predicate. For the non-clinical performance tests (accuracy, repeatability, etc.), the ground truth would typically be established against calibrated reference standards or methods as defined by the ASTM E1965-98 standard, though not explicitly stated here.
8. The Sample Size for the Training Set
This information is not applicable/not provided. The Thermofocus is a physical electronic device that measures infrared radiation; it does not explicitly use a "training set" in the machine learning sense to develop an algorithm. Its "algorithm" is likely embedded mathematical adjustments based on physics and sensor readings, not learned from a dataset.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the reasons stated above (no training set in the machine learning context).
Ask a specific question about this device
Page 1 of 1