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The Softrans® Temp UPC & System may be used during the intrapartum period to monitor intrauterine pressure, to monitor intrauterine temperature, to amnioinfuse or to perform amniotic fluid sampling.

An intrauterine catheter with a pressure transducer at the tip, a thermistor located near the tip, a port for amnioinfusion and amniotic fluid sampling, signal wires, and an introducer which is removed after placement. System includes a reusable cable that contains a rezero mechanism, cable check and temperature display unit. An attachment strap is provided.

This 510(k) summary describes a medical device, the Softrans® Plus Intrauterine Pressure Catheter System (IUP 5000 Softrans® Plus IUPC), which is intended to monitor intrauterine pressure and temperature during labor, and to facilitate amnioinfusion or amniotic fluid sampling.

Here's an analysis of the provided information, structured according to your request:

Acceptance Criteria and Reported Device Performance

The provided document states: "FDA has not established special controls or performance standards for this device. Graphic Controls has established its own specifications and the product meets or exceeds those specifications."

This indicates that external, regulatory acceptance criteria were not predefined by the FDA for this specific device at the time of submission. Instead, the manufacturer, Graphic Controls, developed its own internal specifications. The document does not explicitly list these internal specifications. Therefore, a table of acceptance criteria and reported performance cannot be fully constructed from the provided text.

However, based on the description of the device's functionality and the comparison to predicate devices, the implied performance criteria would be:

Study Details

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed de novo clinical study with specific acceptance criteria and detailed performance statistics.

Here's how the other requested study information applies:

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

   • The 510(k) summary does not mention any specific clinical study sample sizes or patient data related to the performance of the device's pressure or temperature measurement functions. The primary "test set" for this submission appears to be comparisons of the device's design, technology, and functionality to predicate devices and established standards, rather than direct patient outcome data from a large cohort.
   • For biocompatibility, it states: "Biocompatibility This device was subjected to biocompatibility testing and the data was submitted with the predicate device notification." This implies a previous study with the predicate, but details are not provided here.

2. 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):

   • Not applicable in the context of this 510(k) summary, as it does not describe a clinical study requiring expert ground truth establishment for a test set. Substantial equivalence relies on comparing the new device's technical characteristics and intended use to a predicate.

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

   • Not applicable as no clinical study with expert adjudication is described in the provided document.

4. 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:

   • Not applicable. This device is a medical monitoring instrument (catheter system), not an AI-assisted diagnostic tool involving human readers/interpreters.

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

   • Not applicable. This is a physical medical device, not an algorithm. Its performance is inherent in its measurement capabilities, which would be validated through engineering tests and comparison to predicate devices, not algorithm-only performance.

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

   • For the biocompatibility aspect, the ground truth was derived from specific biocompatibility tests (e.g., irritation, cytotoxicity, sensitization) following established standards.
   • For the functional performance of pressure and temperature measurement, the ground truth would typically be established by calibrated reference instruments or established measurement standards, against which the device's readings are compared. The document implies these internal tests were conducted as it states "the product meets or exceeds those specifications," but it doesn't detail them.
   • For substantial equivalence, the "ground truth" is the performance and safety profile of the legally marketed predicate device (Softrans® IUPC System and Welch Allyn (DIATEK) SureTemp Thermometer).

7. The sample size for the training set:

   • Not applicable within this 510(k) summary, as it describes a hardware medical device and not a machine learning model that would require a training set.

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

   • Not applicable, as there is no training set mentioned or implied for this device's submission.

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