(363 days)
Esophageal / Rectal temperature probe (4009-ER and 40012-ER):
The Starboard Medical Esophageal / Rectal temperature probe is indicated for continuous patient temperature monitoring, when these placement sites are clinically recommended. The probe is designed for insertion into the esophagus, nasopharynx, or rectum.
Esophageal Stethoscope with temperature sensor (4009-ES, 40012-ES, 40018-ES, and 40024-ES):
The Starboard Medical Esophageal Stethoscope with temperature sensor is indicated for continuous monitoring of patient temperature along with auscultation of the heart and lung sounds. The probe is designed for insertion into the esophagus.
The Starboard Medical temperature probes are intended for use in clinical situations where continuous monitoring of patient's body temperatures is required. The probes are compatible with all monitoring instrumentation designed to accept YSI 400 series temperature probes or equivalent.
This 510(k) includes the following probes:
4009-ER (Esophageal / Rectal temperature probe - 9FR) 40012-ER (Esophageal / Rectal temperature probe - 12FR) 4009-ES (Esophageal Stethoscope with temperature sensor - 9FR) 40012-ES (Esophageal Stethoscope with temperature sensor - 12FR) 40018-ES (Esophageal Stethoscope with temperature sensor - 18FR) 40024-ES (Esophageal Stethoscope with temperature sensor - 24FR)
The probes are single use, and they are sterile.
This is a 510(k) summary for a set of disposable temperature probes/sensors, not an AI device. Therefore, the typical acceptance criteria and study mechanisms for AI-driven devices (like those involving test sets, training sets, ground truth establishment, expert adjudication, or MRMC studies) are not applicable here.
The provided text describes a medical device clearance process for temperature probes, which relies on demonstrating substantial equivalence to predicate devices rather than proving performance against specific AI-related metrics.
Here's a breakdown of the relevant information provided:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in the way an AI device would have accuracy or F1 scores. Instead, the "acceptance criteria" are based on the device's characteristics being "substantially equivalent" to predicate devices.
| Acceptance Criteria (General) | Reported Device Performance (General) |
|---|---|
| Substantial Equivalence to Predicate Devices | The devices are considered "as safe and effective as the predicate devices" based on material, technology, manufacturing processes, and performance. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable. The device is a physical temperature probe, not a software algorithm that processes dataset inputs. Performance was assessed through engineering tests, not a clinical trial with a "test set" in the AI sense.
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)
This is not applicable. Ground truth, in the context of AI, refers to annotated data. For a temperature probe, performance is verified through metrological accuracy testing, not expert consensus on interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. There was no "test set" in the AI sense that required adjudication.
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
This is not applicable. An MRMC study is relevant for AI assistance to human readers, which is not the nature of this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a standalone physical medical device (temperature probe), not a standalone AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable in the AI sense. The performance of the temperature probes would be validated against calibrated temperature standards, which serves as the "ground truth" for temperature measurement accuracy.
8. The sample size for the training set
This is not applicable. There is no AI training set for this device.
9. How the ground truth for the training set was established
This is not applicable. There is no AI training set for this device.
Summary of Device Performance Testing from the Document:
The document mentions that the devices underwent:
- Raw materials bio-compatibility testing: To ensure the materials are safe for patient contact.
- Accuracy testing: To verify that the temperature measurements are accurate. This would involve comparing the probe's readings against a known, accurate temperature source (the "ground truth" for a physical sensor).
- Electrical testing and comparison: To ensure electrical safety and performance, often compared against established standards or predicate devices.
The conclusion is that these tests support the claim that the differences between the new devices and the predicate devices are minor, establishing substantial equivalence.
§ 868.1920 Esophageal stethoscope with electrical conductors.
(a)
Identification. An esophageal stethoscope with electrical conductors is a device that is inserted into the esophagus to listen to a patient's heart and breath sounds and to monitor electrophysiological signals. The device may also incorporate a thermistor for temperature measurement.(b)
Classification. Class II (performance standards).