(154 days)
The Ultracut 2000 and CUSA are both ultrasonic surgical instruments intended for use to cut or fragment tissue, bone, or organs in orthopedic surgery.
The Ultralase Ultracut 2000 is equivalent to the predicate device Cavitron Corporation's Cavitron Ultrasonic Surgical Aspirator (CUSA). The Ultracut 2000 has the same general intended use, similar principles of operation, and similar technological characteristics as The Ultracut 2000 and CUSA are both ultrasonic surgical the predicate device. instruments intended for use to cut or fragment tissue, bone, or organs in orthopedic surgery.
This document is a 510(k) premarket notification for a medical device submitted to the FDA in 1996. It solely focuses on demonstrating substantial equivalence to a predicate device, not on clinical performance studies or establishing acceptance criteria for a new device's performance.
Therefore, most of the requested information regarding acceptance criteria and performance studies (items 1 through 9) cannot be extracted or inferred from this document.
The document explicitly states: "The Ultralase Ultracut 2000 is equivalent to the predicate device Cavitron Corporation's Cavitron Ultrasonic Surgical Aspirator (CUSA)." The entire submission is built around a comparison chart to demonstrate this equivalence based on general intended use, similar principles of operation, and similar technological characteristics.
Here's a breakdown of why the requested information isn't available and what can be said about the document's content:
-
A table of acceptance criteria and the reported device performance:
- Not applicable. This document is not presenting performance data against acceptance criteria. It's comparing technical specifications to a predicate device.
-
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. There is no "test set" in the context of a clinical performance study. The comparison is based on the specifications of the two devices.
-
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):
- Not applicable. No expert ground truth establishment for a test set is mentioned or relevant to this type of submission.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No adjudication method for a test set is mentioned.
-
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 device is an ultrasonic surgical aspirator, not an AI-assisted diagnostic tool. No MRMC study is mentioned.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a surgical device, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No ground truth in the context of clinical validation is discussed. The "truth" being established here is the technical and functional similarity to the predicate device.
-
The sample size for the training set:
- Not applicable. There is no "training set" for a machine learning model; this is a physical medical device.
-
How the ground truth for the training set was established:
- Not applicable. See point 8.
In summary: This document serves as a "Summary of Safety and Effectiveness" for a 510(k) submission, aiming to demonstrate substantial equivalence to an already legally marketed device. It does not contain information about clinical performance studies, acceptance criteria, or ground truth establishment for the device's efficacy or diagnostic accuracy.
N/A