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By using oscillometric method, the device measure automatically human's Systolic, Diastolic, mean blood pressure, and heart rate. This device is intended for use on adults for age 18 and above. The cuff size is fit for arm circumference of 22-32 cm. The device has the irregular heartbeat indicator feature. The color bar gives a warning signal with readings. The BPU321 can be compatible with the device of Bluetooth Smart-enabled. All values will be read out in LCD panel.

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The provided text is a 510(k) premarket notification letter from the FDA regarding the Oregon Scientific BLE Upper Arm Blood Pressure Monitor (BPU 321). It confirms substantial equivalence to a legally marketed predicate device. While it mentions the device measures blood pressure and heart rate using an oscillometric method and is intended for adults aged 18 and above, it does not contain the detailed study information or acceptance criteria for device performance.

Therefore, I cannot provide the requested table or comprehensive study details. The letter primarily focuses on regulatory approval based on demonstrating substantial equivalence, not on presenting performance study results.

To fulfill the request, information such as the clinical study protocol, results, and statistical analysis would be required, which are typically found in the full 510(k) submission not included in this document.

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By using oscillometric method, measures automatically human's Systolic, Diastolic, mean blood pressure, and heart rate. All values will be read out in LCD panel.

Blood-pressure meter, Model BPW120

The provided document is a 510(k) premarket notification approval letter for a blood pressure meter. It does not contain information about acceptance criteria, study details, or ground truth for an AI/ML device. Therefore, I cannot extract the requested information from this document.

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The device measures body weight, and impedance using Bioelectrical Impedance The uevice measures body worgin, and cally fat percentage, BMI, with results displayed in LCD panel.

The intended use of this device is for 7 to 99 years old normal subjects and not for I he intended use of ans econmended personal with implanted internal device like pacemaker or pregnant women to use this device.

The device measures body weight, and impedance using Bioelectrical Impedance The uevice measures body worgin, and cally fat percentage, BMI, with results displayed in LCD panel.

This document is a 510(k) premarket notification approval letter for the Oregon Scientific High Precision Body Weight Monitor with Body Fat Index, Model GA101, and an "Indications for Use" statement.

The provided text does not contain the acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested. This is a regulatory approval document and not a scientific study report.

Specifically, the document states:

• "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
• The "Indications for Use" are: "The device measures body weight, and impedance using Bioelectrical Impedance Technology (BIA) and calculates body fat percentage, BMI, with results displayed in LCD panel. The intended use of this device is for 7 to 99 years old normal subjects and not for recommended personal with implanted internal device like pacemaker or pregnant women to use this device."

To answer the detailed questions about acceptance criteria and study design, a different kind of document (e.g., a clinical study report, a validation report submitted as part of the 510(k) application, or the 510(k) summary itself)containing performance data would be needed.

Therefore, many of the requested fields cannot be populated from the provided text.

Here's how to address the request based on the lack of specific information in the provided document:

Acceptance Criteria and Device Performance Study (Not Available in Provided Text)

The provided document is an FDA 510(k) clearance letter, which confirms substantial equivalence to a predicate device, rather than providing detailed performance data or acceptance criteria from a specific study. Therefore, most of the requested information cannot be extracted directly from this document.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified in this document.
• Data Provenance: Not specified in this document. Often, data for 510(k) clearance might come from internal company testing, or if clinical data was used, its origin (e.g., country) would be in a study report. The document itself is from the USA FDA.
• Retrospective or Prospective: Not specified in this document.

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

• Not applicable/Not specified in this document. Ground truth for body composition measurements would typically be established using reference methods (e.g., DEXA for body fat), not expert consensus in this context.

4. Adjudication method for the test set:

• Not applicable/Not specified in this 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:

• Not applicable/Not specified in this document. This device is a standalone body weight and body fat monitor, not an AI-assisted diagnostic tool involving human readers.

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

• The "Indications for Use" describes the device's function: "The device measures body weight, and impedance using Bioelectrical Impedance Technology (BIA) and calculates body fat percentage, BMI, with results displayed in LCD panel." This implies standalone algorithmic performance for calculating body fat and BMI from impedance measurements. However, no specific performance metrics like accuracy or precision are provided in this document.

7. The type of ground truth used:

• Not specified in this document. For body composition devices, ground truth for body fat percentage would typically be established using a gold standard method such as Dual-energy X-ray Absorptiometry (DEXA), underwater weighing, or MRI.

8. The sample size for the training set:

• Not specified in this document. (If algorithms are involved, training sets would be used, but this document does not contain details about model development).

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

• Not specified in this document.

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The FT101 Forehead Thermometer is an over-the-counter, non-sterile, reusable, infrared clinical electronic thermometer intended for the intermittent measurement and assessment of the skin forehead temperature of humans of all age ranges. The measured temperature correlates to axillary temperature.

The FT101 Forehead Thermometer is an over-the-counter, non-sterile, reusable, nonpredictive clinical electronic thermometer designed to measure and assess the temperature of humans of all age ranges using an infrared detector to detect heat emission from the forehead. The measured temperature correlates to axillary temperature, and is displayed on a built-in LCD display. Calendar/clock functions are provided, and a memory function stores up to 10 temperature readings. The temperature reading range is 34 °C – 42.2 °C (92.3 F to 108.0 F), and the time of measurement is approximately 2 seconds, with a recommended cycle time of at least 30 seconds between readings. The unit operates in an ambient temperature range of 16 C – 35 C (61 F to 95 F). The FT101 Forehead Thermometer is entirely self-contained within one housing, and is battery-powered. The device is compact in size and weight, easy to use, portable and may be used in a variety of home or clinical settings.

The provided documentation is a 510(k) summary for the FT101 Forehead Thermometer, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for novel efficacy claims. As such, information regarding comprehensive clinical trials with specific acceptance criteria, sample sizes for training/test sets, expert qualifications, and detailed statistical analysis often found in studies for new drugs or high-risk devices is generally not included in this format.

Based on the provided text, here's what can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria or a detailed breakdown of reported device performance as one might expect from a formal efficacy study. However, it states compliance with voluntary standards, which implicitly define performance criteria.

• Implied Acceptance Criteria (from standard compliance):

  • Accuracy: Conformance with ASTM E1965-98 (Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature). This standard likely specifies accuracy limits (e.g., maximum permissible error at certain temperature ranges).
  • Safety: Conformance with EN 60601-1/A13 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) and EN 60601-1-2 (Electromagnetic compatibility - Requirements and tests).
  • Specific Temperature Range: The device claims a reading range of 34 °C – 42.2 °C (92.3 F to 108.0 F).
  • Measurement Time: Approximately 2 seconds, with a recommended cycle time of at least 30 seconds between readings.
  • Ambient Temperature Range: Operates in 16 C – 35 C (61 F to 95 F).

• Reported Device Performance: The document only generally states that "safety and efficacy performance of the device has been established clinically and non-clinically through comparative testing to market-cleared devices in accordance with ASTM E1965-98 and prEN 12470-5 voluntary standards, and without raising new safety or effectiveness issues." No specific accuracy figures (e.g., mean difference, standard deviation of error) or sensitivity/specificity values are provided.

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

The document does not explicitly state the sample size used for clinical testing or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "comparative testing to market-cleared devices." For a 510(k), often the clinical data requirement is less stringent than for a PMA, sometimes relying on equivalence to a predicate device's performance rather than large-scale de novo efficacy trials.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not provided in the document. Given that the device measures a physical parameter (temperature), the "ground truth" would likely be established by a reference thermometer standard (e.g., a calibrated contact thermometer) rather than expert consensus on interpretation.

4. Adjudication Method

The document does not mention any adjudication method, which is typically relevant for studies involving subjective interpretation (e.g., reading medical images) rather than objective measurements.

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

No MRMC study is mentioned. This type of study is usually conducted for diagnostic imaging devices where human readers interpret outputs, often with AI assistance. The FT101 is a direct measurement device, not an interpretation aid.

6. Standalone Performance Study (Algorithm Only)

The FT101 is a standalone device in the sense that it performs the temperature measurement directly without human interpretation of an algorithm's output. The performance data refers to the device's ability to measure temperature, not an algorithm's ability to process data, so this question isn't directly applicable in the typical sense of AI/algorithm performance. Its "standalone performance" is implicitly covered by the "safety and efficacy performance" mentioned as being established through testing against standards.

7. Type of Ground Truth Used

The ground truth for temperature measurement would be established by:

• Calibrated reference thermometers: This is the most common method for validating the accuracy of clinical thermometers, where the device's reading is compared against a highly accurate and calibrated reference.
• Axillary temperature: The indication states the output "correlates to axillary temperature," suggesting that axillary temperature taken with a validated method was likely used as a comparative ground truth in some part of the "clinical" testing.

8. Sample Size for the Training Set

The concept of a "training set" is usually applicable to machine learning algorithms. While the FT101 uses an infrared detector, it's not described as an AI-driven device requiring a training set in the typical sense. Therefore, no training set sample size is mentioned.

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

As there's no mention of a training set or an AI algorithm, this information is not applicable and not provided.

In summary: The provided 510(k) summary states that the FT101 Forehead Thermometer meets performance criteria by conforming to voluntary standards (EN 60601-1/A13, EN 60601-1-2, ASTM E1965-98, prEN 12470-5) through "comparative testing to market-cleared devices clinically and non-clinically." However, it does not provide detailed quantitative results, sample sizes for testing, or information about how ground truth was specifically quantified beyond compliance with these broad standards. This is typical for a 510(k) where the focus is on demonstrating substantial equivalence to a predicate device rather than novel efficacy studies.

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By using oscillometric method, measures automatically human's Systolic, Diastolic, mean blood pressure, and heart rate. All values will be read out in LCD panel.

Blood-pressure meter, Model BPW128

This document is a 510(k) clearance letter from the FDA for a blood pressure monitor (Model BPW128) and largely focuses on regulatory approval rather than a detailed study report with acceptance criteria. As such, most of the requested information cannot be extracted from the provided text.

Here is what can be determined from the document:

• Device: Blood-pressure Meter, Model BPW128
• Intended Use: "By using oscillometric method, measures automatically human's Systolic, Diastolic, mean blood pressure, and heart rate. All values will be read out in LCD panel. The intended for use of this device is for age 15 and above."

The document does not contain the following information:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size.
• Whether a standalone performance study was done.
• The type of ground truth used.
• Sample size for the training set.
• How the ground truth for the training set was established.

In summary, this document is an FDA clearance letter confirming substantial equivalence to a predicate device, which implies the device meets certain safety and effectiveness standards, but it does not provide the specific details of performance data and study methodologies that would typically be included in a technical report or scientific publication.

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