(63 days)
This table is intended for use in a diagnostic x-ray system to support patients during general purpose radiological procedures in the horizontal, vertical and trendelenburg positions.
The Legacy/Legacy-D table is a patient support providing angulation to +/- 90 degrees and tabletop motion in the longitudinal and lateral directions. It includes an integrated table bucky and a spot film/fluoroscopic tower. The new bucky has the same function as the older version.
This submission, K973039, describes the GE Legacy/Legacy-D Radiologic Table. This is a device for patient support during diagnostic x-ray procedures and as such, does not require a study with acceptance criteria.
Here's a breakdown based on the provided documents:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: Device is as safe as other diagnostic x-ray tables of similar design. | "The design of the Legacy/Legacy-D raises no new questions of safety or effectiveness." |
| Effectiveness/Performance: Device performs as well as other diagnostic x-ray tables of similar design. | "In the opinion of GE Medical Systems the Legacy/Legacy-D is as safe, and performs as well as other diagnostic x-ray tables of similar design having the same intended uses." |
| Intended Uses: Supports patients during general purpose radiological procedures in horizontal, vertical, and trendelenburg positions. | "This table is intended for use in a diagnostic x-ray system to support patients during general purpose radiological procedures in the horizontal, vertical and trendelenburg positions." |
| Substantial Equivalence: Substantially equivalent to currently marketed radiologic tables that comply with the same or equivalent standards. | "Legacy/Legacy-D Radiologic Table is substantially equivalent to currently marketed radiologic tables that comply with the same or equivalent standards and have the same intended uses." |
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. This is a 510(k) submission for a non-AI/diagnostic device, and no specific test set or clinical study data is presented to prove performance based on a sample size. The equivalence is asserted based on design and intended use compared to predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. No ground truth was established for a test set in the context of a performance study for this device.
4. Adjudication Method for the Test Set:
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. This is not an AI-powered diagnostic device, and therefore, no MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device does not involve an algorithm or AI.
7. The Type of Ground Truth Used:
Not applicable. Performance for this device is based on its mechanical and functional specifications, compared to predicate devices, not on diagnostic accuracy against a ground truth.
8. The Sample Size for the Training Set:
Not applicable. This device does not involve machine learning or a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable.
Summary of the Study (or basis for clearance):
The GE Legacy/Legacy-D Radiologic Table obtained 510(k) clearance by demonstrating substantial equivalence to existing, legally marketed diagnostic x-ray tables. The "study" in this context is the comparison of the new device's design, materials, and intended use against predicate devices. The manufacturer's conclusion is that the device "is as safe, and performs as well as other diagnostic x-ray tables of similar design having the same intended uses" and that its design "raises no new questions of safety or effectiveness." The FDA's review agreed with this assessment, confirming substantial equivalence and allowing the device to proceed to market. There was no clinical trial or performance study with acceptance criteria in the traditional sense for this type of medical device clearance.
§ 892.1980 Radiologic table.
(a)
Identification. A radiologic table is a device intended for medical purposes to support a patient during radiologic procedures. The table may be fixed or tilting and may be electrically powered.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.