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Found 3 results
510(k) Data Aggregation
(29 days)
Patients at Risk for DVT:
These include:
a. Major orthopedic procedures e.g. knee surgery
Major abdominal thoracic surgery including urogenital surgery
Neurosurgery, subarachnoid hemorrhage and stroke
Bedridden Medical patients
b. Patients with chronic venous insufficiency
Not Found
The provided document is a 510(k) premarket notification letter for a device called "Pulstar Logix Pump." It primarily focuses on the FDA's decision regarding substantial equivalence to a predicate device and administrative information. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC).
Therefore, I cannot fulfill your request for the specific details outlined concerning acceptance criteria and study findings. The document confirms the device's classification and regulatory path but does not delve into the technical performance studies that meet specific acceptance criteria.
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(107 days)
Patients at risk for DVT. These include a. Major orthopedic procedures, e.g. knee surgery Major abdominal, thoracic surgery including urogenital surgery Neurosurgery, subarachnoid hemorrhage and stroke Bedridden Medical patients b. Patients with chronic venous insufficiency
Pulstar Logix Intermittent Pneumatic Compression System
This document is an FDA 510(k) clearance letter for the Pulstar Logix Intermittent Pneumatic Compression System. It does not contain information about a study proving the device meets acceptance criteria, an AI/ML component, or detailed performance data. Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance for a study.
- Types of ground truth or training set details.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices..." This indicates the clearance is based on substantial equivalence to existing devices, not on a new study demonstrating specific performance metrics against pre-defined acceptance criteria for an AI/ML algorithm.
The "Indications for Use Statement" only lists the medical conditions for which the device is intended. It does not provide any performance data or study results.
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(42 days)
Light source for the purpose of curing light activated dental composites and activating dental bleaching agents.
Not Found
The provided text is an FDA 510(k) clearance letter for a device named PULSTAR™. This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
The letter is a regulatory document confirming that the device is substantially equivalent to legally marketed predicate devices and can proceed to market. It does not include the technical details of the device's validation or verification.
Therefore, I cannot provide the requested information based on the input text.
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