(34 days)
The Practix Convenio is a mains independent motor driven mobile x-ray system, to x-ray body parts of patients to create images for medical diagnostic purposes. The Practix Convenio is intended to x-ray in rooms for medical use.
The Practix Convenio is a motor driven battery supplied mobile x-ray unit to be operated indoors only. The system contains: Battery cluster including battery charger, two passive and two motor driven wheels, 20 kHz converter x-ray generator excluding the high voltage unit, 360° turn able column and a telescope arm to carry x-ray unit, x-ray tank (x-ray tube housing assembly and high voltage unit), collimator (beam limiting device) and a drawer to carry x-ray film cassettes and an anti scatter grid. The following components are optional: Removable pre filter, dose area product measurement, automatic exposure control and an infrared remote control.
This document is a 510(k) summary for the Practix Convenio, a mobile x-ray system. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it provide details on device performance metrics, sample sizes, expert involvement, or ground truth establishment.
The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical performance studies with detailed acceptance criteria in the same way a PMA (Pre-Market Approval) submission would.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study to prove they are met based only on the provided text.
Here's why and what kind of information is missing:
Information NOT available in the provided text:
- A table of acceptance criteria and the reported device performance: The document only describes the device and its intended use, not specific performance metrics or acceptance thresholds.
- Sample size used for the test set and the data provenance: There is no mention of a specific test set or clinical study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As no test set is described, neither are experts or ground truth establishment.
- Adjudication method for the test set: No test set is described.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: No such study is mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This device is a hardware system, not an AI algorithm, so this concept doesn't directly apply.
- The type of ground truth used: No ground truth is discussed.
- The sample size for the training set: No training set is discussed or implied.
- How the ground truth for the training set was established: No training set is discussed.
Summary of what the document does provide:
- Device Name: Practix Convenio
- Intended Use: "The Practix Convenio is a mains independent motor driven mobile x-ray system, to x-ray body parts of patients to create images for medical diagnostic purposes. The Practix Convenio is intended to x-ray in rooms for medical use."
- Predicate Device: RT-125 ROUGH TERRAIN MOBILE X-RAY UNIT (also known as PMX 2000) by Lorad (K894643)
- Claim of Equivalence: "The Practix Convenio does not introduce any new indications for use, nor does the use of the device result in any new potential hazard. Philips Medical Systems considers the Practix Convenio to be substantially equivalent with the predicate device."
- Regulatory Decision: The FDA determined the device is substantially equivalent, allowing it to be marketed.
To answer your full request, you would need different documentation, such as a more detailed technical report, design verification and validation reports, or clinical study protocols and results, which are not part of this 510(k) summary.
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.