(131 days)
TarqoBeam is an aiming device intended to be used to verify and control correct angulation of interventional -----devices such as needles used in CT- or MRI-quided punctures, biopsies, and related procedures.
The TargoBeam is an aiming device which utilizes lasers to precisely place the correct angulation and position on interventional device such as a biopsy an needle.
Here's an analysis of the provided text regarding the TargoBeam device's acceptance criteria and study information.
It's important to note that the provided documents are a 510(k) summary and an FDA clearance letter from 1997. These documents are primarily focused on demonstrating substantial equivalence to pre-existing devices, rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics in the way modern device submissions often do.
Based on the provided text, the specific details regarding acceptance criteria and a structured study proving device performance are not explicitly available in the format requested. The documents emphasize substantial equivalence to predicate devices rather than meeting a pre-defined performance threshold through a dedicated study.
However, I can extract the available information and highlight what is missing based on your request.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance (Explicitly Stated in Document) |
|---|---|
| Substantial Equivalence to Predicate Devices | The TargoBeam is "similar to predicate devices, and existent methodologies in its intended use." (Implied performance is similar to predicates, but no specific metrics are given.) |
| Intended Use: "verify and control correct angulation of interventional devices such as needles used in CT- or MRI-guided punctures, biopsies, and related procedures." | The device is an "aiming device which utilizes lasers to precisely place the correct angulation and position on interventional device such as a biopsy an needle." (This is a description of its capability, not a measured performance against specific criteria). |
| Non-invasive | "The TargoBeam is entirely noninvasive" |
| Suitable for use under MRI | "suitable for use under MRI." |
Missing Information: There are no quantitative acceptance criteria (e.g., accuracy +/- X degrees, success rate > Y%) or quantified performance metrics (e.g., "The device achieved an average angular deviation of 0.5 degrees, meeting the acceptance criterion of
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.