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The rotatable connector is intended for use as part of a temporary cardiac pacing system. It connects a cardiovascular stimulating instrument to a cardiac pacing lead. It is intended for use by trained clinicians in a clinical environment.

The Model 5944RL rotatable connector is a pair of single use, disposable surgical cables with two adaptors. The cables are designed to connect a cardiovascular stimulating instrument to a cardiac pacing lead system.

The provided document is a 510(k) Premarket Notification Submission for a medical device called "Rotatable Connector (5944RL)". This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results to prove meeting specific acceptance criteria in the way a diagnostic AI/ML device would.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets them in the context of an AI/ML or diagnostic device.

Specifically, the document states:

• "The subject of this premarket submission did not require clinical studies to support substantial equivalence." This means no clinical trials were performed to establish the device's performance against specific clinical acceptance criteria.
• The comparison is primarily focused on technical characteristics, intended use, and safety standards against a predicate device.

Given this, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: No such clinical performance metrics or acceptance criteria are listed.
2. Sample sizes used for the test set and the data provenance: No test set or data provenance from a clinical study are mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there's no clinical test set for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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, as this is a physical medical device (a connector), not an AI/ML diagnostic.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document primarily focuses on non-clinical tests (e.g., biocompatibility, sterilization, electrical safety) to demonstrate substantial equivalence to a previously cleared predicate device.

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The Disposable Temperature Probe (body surface type) is to be used with a compatible medical monitor that has temperature measurement function to continuously measure the patient's skin temperature.

The Disposable Temperature Probe (celomic type) is to be used with a compatible medical monitor that has temperature measurement function to continuously measure the patient's oral, rectal, nasopharyngeal cavity temperature.

The Disposable Temperature Probe is a noninvasive, quick-acting, safe and secure way for continuous temperature monitoring. It provides an effective way for doctors to obtain patient's temperature. The Disposable Temperature Probe obtains temperature information through the influence degree that the thermal balance has on the resistance value of thermistor sensor after it has contacted human body. The Disposable Temperature Probe is intended to be connected to a compatible medical monitor which is Model C30 (Manufacturer: COMEN) to continuously measure the patient's temperature, which can only be used by professionals for single use. It has two types which are body surface type (model: TAS03-15. TAS03-16. TAS03-17) and celomic type (model: TAE03-09S, TAE03-10S, TAE03-12S, TAE03-13S, TAE03-13S, TAE03-14S, TAE03-15S, TAE03-16S). The body surface type is mainly pasted under the axilla while the celomic type is inserted into the oral, rectal or nasopharyngeal cavity. The temperature probes should not be used for more than 24 hours. The Disposable Temperature Probe is composed of plug, cable and temperature sensing probe. For patient-contacting components, their materials have all been tested and evaluated for biocompatibility.

The provided text describes the acceptance criteria and the study that demonstrates the performance of the Disposable Temperature Probe.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size used for any test sets (e.g., for accuracy, biocompatibility, electrical safety, or EMC). It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective). It generally states that "Non-clinical testings have been conducted" and refers to compliance with international standards.

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

This information is not provided in the document. The document refers to compliance with international standards for performance and safety tests, which typically involve laboratory testing rather than expert-established ground truth for a clinical dataset.

4. Adjudication method for the test set

This information is not provided in the document. As mentioned above, the tests described are primarily engineering and laboratory-based, not clinical studies requiring adjudications.

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

An MRMC comparative effectiveness study was not conducted. This device is a disposable temperature probe, which is a physical measurement device, not an AI-assisted diagnostic tool for which an MRMC study would be relevant.

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

This concept is not applicable to this device. The Disposable Temperature Probe is a sensor; it does not contain an algorithm in the sense of AI or image analysis. Its performance is evaluated through direct physical measurements against established standards.

7. The type of ground truth used

For accuracy, the ground truth would be precise temperature measurements from calibrated reference instruments or environments during laboratory testing. For biocompatibility, the ground truth is established by the accepted biological responses to materials as defined by ISO 10993 standards. For electrical safety and EMC, the ground truth is compliance with the limits and conditions specified in the respective IEC standards.

8. The sample size for the training set

This device does not involve a "training set" in the context of machine learning or AI. Therefore, this information is not applicable.

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

As there is no training set for this device, this information is not applicable.

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