Search Results

The Softrans Temp™ IUPC System may be used during the interpartum 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.

Catheters are packaged within a PETG tray with a heat sealed tyvek lid. Unit of sale is a case of 10 IUPC's.

Cables are packaged in protective wrap and corrugated shippers.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Softrans Temp™ Intrauterine Pressure Catheter System:

It's important to note right away that the provided 510(k) summary (K991235) is for a predicate device where the main change is the addition of a specific claim in labeling: "intrauterine temperature measured by the device is clinically equivalent to oral temperature and that intrauterine temperature can be used in place of oral temperature measurements in laboring patients."

The document heavily relies on the substantial equivalence to a previously marketed predicate device also named Softrans Temp™ Intrauterine Pressure Catheter System. This means that many of the original performance studies and acceptance criteria from the initial approval of the predicate device are not explicitly detailed in this specific 510(k) summary. The current submission is primarily about demonstrating that the new device (with the added temperature claim) is still substantially equivalent to the existing predicate.

Therefore, some of the requested information (like specific sample sizes, expert qualifications for the original device tests, etc.) is not present in this document because it defaults to the established equivalence of the predicate. The focus here is on the new claim about temperature equivalence.

Acceptance Criteria and Device Performance for K991235

The acceptance criteria for K991235 primarily revolve around the substantial equivalence to the predicate device and the validation of the new labeling claim regarding intrauterine temperature equivalence to oral temperature.

Study Details (based on available information):

Due to the nature of this 510(k) being a claim of substantial equivalence to a predicate device, the detailed study information for many aspects is not provided, as it would have been part of the original predicate device submission. The primary new aspect is the temperature equivalence claim.

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

   • Not specified in this document. For the new temperature equivalence claim, a clinical study would have been required to compare intrauterine temperature readings to oral temperature readings. The number of patients, their demographics, country of origin, and whether it was retrospective or prospective data are not mentioned.

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

   • Not specified. For the temperature equivalence claim, the "ground truth" would likely be established through standard clinical thermometry (e.g., oral temperature taken with a validated thermometer) and, potentially, expert clinical assessment of patient condition. The number and qualifications of clinicians involved in such a study are not provided.

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

   • Not applicable/Not specified. For a temperature measurement equivalence study, adjudication methods like those used for image interpretation (2+1, etc.) are generally not relevant. The comparison would be between numerical measurements.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No. An MRMC study is typically for evaluating diagnostic imaging devices where human readers interpret cases with and without AI assistance. This device is a direct physiological measurement device, not an imaging interpretation tool.

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

   • Yes, implicitly. The device itself is standalone in terms of generating the pressure and temperature measurements. The "performance" in this context is the accuracy and equivalence of these measurements. For the temperature claim, the device's measured intrauterine temperature would have been compared directly to an established reference (e.g., oral temperature). The document states the device provides "continuous monitoring and display" of temperature, implying autonomous measurement.

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

   • For the temperature equivalence claim, the most likely ground truth would be clinical measurements from a recognized standard of care (e.g., oral temperature using a calibrated thermometer), and/or potentially comparison to core body temperature (though oral is specified in their claim).
   • For the pressure monitoring capabilities, the ground truth would be based on direct physiological measurement principles and validation against established pressure measurement standards.

7. The sample size for the training set:

   • Not applicable/Not specified. This device is hardware-based (catheter with transducers) and likely uses direct physical principles for measurement, rather than a machine learning algorithm that requires a "training set" in the conventional sense. If there were any internal calibrations or algorithms for temperature conversion, those details are not provided.

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

   • Not applicable/Not specified. As above, a training set is not typically associated with this type of device. The ground truth for functional performance (pressure, temperature accuracy) would be established through engineering validation and, for the clinical equivalence claim, through direct comparative clinical studies against established methods.

Summary of Limitations in Information:

This 510(k) summary is very high-level regarding performance data, as is common for submissions based on substantial equivalence. It confirms that internal specifications are met and biocompatibility was previously established for the predicate. However, it does not provide detailed clinical study data (e.g., sample size, methodology, results) to support the specific new claim that "intrauterine temperature measurements correspond to oral temperature measurements and can be used in place of oral temperature measurements in laboring patients." This information would have been part of supporting documentation provided to the FDA but is not included in the public summary.

Ask a specific question about this device

The ProCam Medical Pediatric Dispersive Electrode is indicated for use in monopolar electrosurgical applications as a non-sterile, disposable device, for single patient use, only. It is intended to disperse the current as it is removed from the patient during the electrosurgical process. By connecting to the electrosurgical generator, via the pre-attached cable or re-useable cable, the circuit is completed causing successful cutting or coagulation in the patient. This electrode is intended for use in electrosurgery on pediatric patients weighing 25 lbs. or less and with the generator power settings less than 150 watts. The Pediatric Dispersive Electrode is not indicated for use for high-powered procedures such as transurethral resection (TUR). The device will work with any standard generator.

The function of the Ludlow Technical Products pediatric ESD electrodes is to complete the electrosurgical circuit between the patient, the active electrode, and the generator. The products are the same in their construction using conductive adhesive hydrogel along with a foil/polyester conductor plate and a foam insulation backing.

This document is a 510(k) premarket notification for a medical device submitted to the FDA, not a study report for an AI/ML device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, sample sizes, ground truth establishment, or human-in-the-loop studies for an AI/ML device.

This submission is for an Electrosurgical Dispersive Electrode, a physical medical device. The "acceptance criteria" and "device performance" in this context refer to engineering and safety standards for this hardware, not algorithmic performance.

Here's what can be extracted from the document based on the device type:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance: Not applicable. This is for a physical device, not an AI/ML model. Testing involved compliance with engineering standards on a physical product.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML model doesn't apply here. Compliance was assessed against established engineering and safety standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is not a diagnostic or prognostic AI/ML device requiring human adjudication of results. Compliance was determined by meeting predefined technical specifications in standards.

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: Not applicable. This is a physical electrosurgical dispersive electrode, not an AI/ML diagnostic or assistive device for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This section pertains to AI/ML algorithm performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for an AI/ML model. For this device, the "ground truth" or standard for safety and effectiveness was adherence to published industry standards such as ANSI/AAMI HF 18-1993 and ISO 10993.

8. The sample size for the training set: Not applicable. This section pertains to AI/ML models.

9. How the ground truth for the training set was established: Not applicable. This section pertains to AI/ML models.

Ask a specific question about this device

This hydrogel dressing is a sterile wound dressing for the management of partial thickness wounds, first and second degree burns, donor sites and superficial injuries. Ad-Heal™ Bydrogel Dressing is indicated for: First and Second Degree Burns Partial Thickness Wounds Donor Sites Pressure Ulcers Abrasions Note: Ad-Healm is not indicated for full thickness or infected wounds or for third degree burns. This is a disposable, short term (less than 72 hours between changes) device for single patient use

This hydrogel dressing is a sterile wound dressing for the management of partial thickness wounds, first and second degree burns, donor sites and superficial injuries. This is a disposable, short term (less than 72 hours between changes) device for single patient use

This is a medical device approval letter from the FDA for the Ad-Heal™ Hydrogel Dressing. The letter states that the device is substantially equivalent to legally marketed predicate devices. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter primarily focuses on regulatory approval, labeling limitations, and general controls provisions of the Federal Food, Drug, and Cosmetic Act.

Therefore, I cannot provide the requested information based on the provided text. The document does not contain details regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for a test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Ask a specific question about this device

Ask a specific question about this device