Search Results

To measure the human body temperature in regular mode orally, rectally or underarm. The devices are reusable for clinical or home use on people of all ages.

The GF-MT501 and GF-MT502 digital thermometer comprise of a thermistor for measuring sensor, a reference resistor for comparison of the temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermistor contacts. The thermometers use a DC 1.5V battery for operation of complete system whenever the battery is low, the ASIC circuit will detect the low battery condition automatically, and displays ' in LCD display.

Here's an analysis of the provided information regarding the GF-MT501 and GF-MT502 digital thermometers:

1. Table of Acceptance Criteria and Reported Device Performance:

Note on "Complied with requirements": The provided text states the devices "complied with the requirements" of the listed standards and that bench testing "confirmed" various performance aspects. However, it does not provide specific numerical values for accuracy, temperature range, resolution, or repeatability from these tests. These specific performance metrics are typically defined within the cited standards.

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

• Sample size: Not explicitly stated. The document refers to "bench testing" but does not specify the number of units tested or the number of measurements taken.
• Data provenance: Not explicitly stated. However, since the manufacturer is Hangzhou Universal Electronic Co., Ltd. located in China, it is reasonable to infer the testing was likely conducted in China. The study appears to be prospective bench testing as it was performed to demonstrate compliance for the 510(k) submission.

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

• Not applicable. This study involves bench testing of a medical device (digital thermometer) against technical standards. It does not involve human expert interpretation of data or images to establish a "ground truth" in the way a diagnostic AI study would. The ground truth for temperature measurement would be established by calibrated reference thermometers in a controlled laboratory environment.

4. Adjudication method for the test set:

• Not applicable. As this is bench testing of a physical device against technical standards, there is no need for expert adjudication. The compliance is determined by measurements against specified thresholds and methodologies outlined in the standards (e.g., ASTM E1112).

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. This is a regulatory submission for a simple digital thermometer, not an AI-powered diagnostic device, so an MRMC study is not relevant or included.

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

• Yes, in essence. The testing described is standalone performance testing of the digital thermometer itself. The device's measurement capabilities (accuracy, resolution, etc.) were assessed independently against established standards and reference measurements, without human interaction influencing the measurement process (beyond operating the device in a standard way). However, it's not "algorithm only" in the context of AI, but rather the device's inherent design and functionality.

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

• The ground truth for the bench testing would be calibrated reference measurements from highly accurate and traceable temperature sensors/probes in a controlled laboratory environment, as specified by the testing standards (e.g., ASTM E1112).

8. The sample size for the training set:

• Not applicable. This device is a digital thermometer, not an AI/machine learning model, so there is no concept of a "training set" in the context of the provided documentation.

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

• Not applicable. As there is no training set for an AI model, this question does not apply.

Ask a specific question about this device

Both the VORTEK and BIOSOFT versions of the ureteral double loop stent are intended for the exact same use as the current silicone ureteral double loop stent. The ureteral double loop stent are intended for drainage of the upper urinary tract where indicated such as in the case of ureteral obstruction, fistula, calculus debris/fragmentation, tumor, etc. The "flush" ureteric configuration with certain models (reference numbers) is intended to flush the lithiasis to the kidney before ESWL.

VORTEK® and BIOSOFT® Ureteral Double Loop Stents

This document is a 510(k) premarket notification decision letter from the FDA regarding VORTEK and BIOSOFT Ureteral Double Loop Stents. It confirms substantial equivalence to a predicate device but does not contain information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with specific acceptance criteria, sample sizes, ground truth establishment, or expert involvement.

Ask a specific question about this device

MediSurf is intended to facilitate access to clinical images and information in distributed locations. Along with image processing capabilities, MediSurf can be used by radiologists for on-call teleradiology over "intranets", Internet, direct or dial-up lines, and for providing second opinion services. It can also be used by physicians for enhanced interpretation of cases through the inclusion of images in imaging related reports and in patient records in general. Similarly it can be used by healthcare organization staff for facilitated access to clinical images throughout the healthcare organization.

The MediSurf server is an access engine to healthcare information. MediSurf provides its end-users with easy access to DICOM devices and networks for the retrieval of images in full diagnostic quality using adaptive progressive compression for efficient transfer over different communication links. The server also provides the user with the software applets needed to display, process, store, and send the retrieved clinical data.

The MediSurf server is based on off-the-shelf UNIX based computer that complies with the accepted international standards for computer systems. The system also comprises software developed and validated by Algotec Systems Ltd..

The provided text is a 510(k) summary for the MediSurf device, which is a teleradiology system. It explicitly states that the device is substantially equivalent to a predicate device (ProVision Diagnostic Workstation) and does not introduce new features affecting safety or effectiveness. As such, the document does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way a medical AI/CADe device would.

The submission focuses on the substantial equivalence argument based on the device's technological characteristics and intended use being similar to the predicate device. It highlights that the core functionalities (image viewing, processing, archiving, communication) are largely shared, with the primary difference being the user interface (web browser vs. dedicated workstation interface).

Therefore, I cannot populate the requested table and answer the specific questions about performance studies, sample sizes, expert ground truth, adjudication, or MRMC studies, as this information is not present in the provided 510(k) summary. These types of studies and details are typically required for different classes of medical devices or for AI/CADe devices demonstrating clinical performance, which MediSurf, as described here, is not.

Ask a specific question about this device

Shifa Syringes are intended for injection of

Shifa Syringes are sterile disposable medical piston syringes consisting of barrel with luer-lock or slip-lock nozzle, gasket, and a needle. They are sold with or without needles. The barrel, and plunger are polypropylene, the gasket is natural rubber, and the needle is stainless steel.

This document describes a medical device, a sterile disposable syringe, and its testing for substantial equivalence to predicate devices. It is not a study proving the device meets acceptance criteria in the context of AI/ML performance. Therefore, I cannot extract the information required by your prompts, as they are specific to AI/ML studies.

Here's a breakdown of why and what information is present:

Context: The provided text is a "Summary of Safety and Effectiveness" for the SHIFA SYRINGES-STERILE DISPOSABLE, under a K962614 submission (likely a 510(k) premarket notification to the FDA). This document demonstrates the equivalence of a new medical device to existing predicate devices, primarily through physical characteristics, material composition, intended use, and a battery of standard safety and performance tests for syringes.

Why your specific questions cannot be answered: Your questions (#1-9) are designed to elicit information about the performance evaluation of an Artificial Intelligence (AI) or Machine Learning (ML) enabled medical device. This document describes a traditional medical device (a syringe) and its compliance with established standards, not an AI/ML algorithm.

Information I can provide based on the text (reformatting some of your questions to fit the content):

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

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: Not specified. This type of regulatory submission typically tests a representative sample of units (e.g., a batch) to demonstrate compliance, but specific numbers are not usually detailed in the public summary.
• Data provenance: The manufacturer is Alshifa Medical Supplies Industry, Dubai, United Arab Emirates. The tests would have been conducted by or for this manufacturer. The nature of these tests (e.g., chemical analysis, physical properties) means they are generally performed prospectively on manufactured units.

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)

• N/A. This is a physical device; "ground truth" in the AI/ML sense (e.g., an expert label on an image) is not applicable. The "truth" is determined by established scientific and engineering measurement methods (e.g., chemical assays, physical property tests).

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

• N/A. This is not an AI/ML study involving human interpretation.

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

• N/A. This is not an AI/ML study.

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

• N/A. This is not an AI/ML study.

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

• Scientific and Engineering Standards: The "ground truth" for the tests performed (e.g., sterility, heavy metals, pH, physical dimensions) is implicitly derived from established scientific and engineering principles, analytical chemistry techniques, and recognized pharmacopeial standards (like USP XXII).

8. The sample size for the training set

• N/A. There is no AI/ML algorithm requiring a training set.

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

• N/A. There is no AI/ML algorithm requiring a training set.

Ask a specific question about this device