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Found 5 results
510(k) Data Aggregation
(73 days)
FIBRA SONICS, INC.
The Fibra Sonics LithoSonic Model LS-2000 Ultrasonic Lithotripsy System is intended to fragment urinary calculi in the kidney, ureter, and bladder.
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This document is a letter from the FDA regarding a 510(k) premarket notification for a medical device. It does not contain information about acceptance criteria, device performance, study details (sample size, provenance, expert qualifications, adjudication), MRMC studies, standalone performance, or training set details. It is a regulatory approval document, not a study report.
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(85 days)
FIBRA SONICS, INC.
The Fibra Sonics Exonix Ultrasound device is used to produce therapeutic deep heat for the following conditions:
- Temporary relief of pain
- Muscle Spasms
- Joint contractures
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I am sorry, but to provide an answer to this prompt, I would need additional information regarding the performance data of the Exonix device. The provided text is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to a predicate device and can be marketed. However, it does not contain the specific acceptance criteria, reported device performance, details of the study that proves the device meets the acceptance criteria, or any of the other requested information (e.g., sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details).
To answer your request, I would need access to the actual 510(k) summary or the underlying study report submitted to the FDA for the Exonix device.
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(90 days)
FIBRA SONICS, INC.
Vitreoretinal Procedures (Ultrasonic emulsification and removal of cataracts)
Fibra-Sonics Phaco III and IIIP Fragmentation System
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a device called "FIBRA-SONICS PHACO III or IIIP Fragmentation Systems". It states that the device is "substantially equivalent" to predicate devices, but it does not include details on specific acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert qualifications.
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(91 days)
FIBRA SONICS, INC.
The Fibra Sonics Ultrasonic Surgical Aspirator System has been designed or use in the The Flora Somes Offication and aspiration of soft tissues as used in the following surgical areas:
NEUROSURGERY
For the ablation and aspiration of various intracranial and spinal cord soft tissue tumors, which may include but are not necessarily limited to the following:
Astrocytoma Pituitary adeonoma Acoustic neuroma Meningioma Glioma Brain stem tumors Spinal cord tumors.
GASTROENTEROLOGY
Various Gastroenterological and General surgery procedures along the GI tract , which may include, but are not necessarily limited to the following:
Hepatic resection Liver trauma Hepatic cysts Colon cancer Rectal Tumor Bowel tumor Retropertioneal turnor
ORTHOPEDICS
Various orthopedic procedures which may include, but are not necessarily limited to the following:
Discectomy
Fibra Sonics Ultrasonic Surgical Aspirator Model 1000
I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to Fibra-Sonics, Incorporated regarding their Ultrasonic Surgical Aspirator System Model 1000. It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the general regulatory requirements.
This document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any details typically found in a study report proving a device meets acceptance criteria.
Therefore, I cannot extract the requested information as it is not present in the provided text.
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(194 days)
FIBRA SONICS, INC.
The Fibra Sonics Ultrasonic Surgical Aspirator System has been designed for use in the fragmentation, emulsification and aspiration of soft tissues as used in the following surgical areas:
- (a) Neurosurgery
- (b) Gastrointestinal and affiliated organ surgery
- (c) Urological surgery
- (d) Plastic and reconstructive surgery
- (e) Gynecological procedures
- (f) Orthopedic Surgery
These indicated uses are equivalent to the predicate device. Appropriate warnings and cautions are indicated in the Operator's Manual.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device called "Fibra Sonics Ultrasonic Surgical Aspirator System Model 2100 USSTA." This letter is a regulatory document and does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.
Therefore, I cannot provide the requested information from the given input. The letter primarily states that the device has been reviewed and determined to be substantially equivalent to a legally marketed predicate device, allowing it to be marketed.
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