(57 days)
The SPECTRA-LOR, Loss of Resistance Syringe is intended for use, in conjunction with an epidural needle, to verify the needle tip placement is in the epidural space by use of the Loss of Resistance Technique as detailed in medical textbooks and medical journal articles. The LOR Syringe is not intended for injection or aspiration.
The construction of the SPECTRA-LOR, Loss of Resistance Syringe is similar to that of a standard piston syringe; it has a barrel, a plunger and a bung. The barrel has graduations which correspond to a capacity of 10 ml and is available in a Luer Lock or Luer Slip tip.
The provided text is a 510(k) summary for the SPECTRA-LOR, Loss of Resistance Syringe. It describes the device, its intended use, and its equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance metrics, or any studies conducted to prove the device meets specific acceptance criteria.
The document explicitly states: "The SPECTRA-LOR, Loss of Resistance Syringe is equivalent to the predicate device, AVID-NIT Loss of Resistance Syringe in materials of construction, intended use, capacity and bench testing." This indicates that the regulatory clearance was based on substantial equivalence to a predicate device, rather than new studies proving pre-defined acceptance criteria for the SPECTRA-LOR syringe's performance.
Therefore, I cannot provide the requested information from the text.
If this were a typical AI device submission, the response would look like this (but based on the actual information provided, such details are absent):
1. Table of Acceptance Criteria and Reported Device Performance
(No specific acceptance criteria or performance metrics were provided in the document for the SPECTRA-LOR syringe. Its approval is based on substantial equivalence to a predicate device.)
2. Sample Size Used for the Test Set and Data Provenance
(Not applicable, as no dedicated study with a test set was described to prove specific performance metrics for the SPECTRA-LOR syringe.)
3. Number of Experts Used to Establish Ground Truth and Qualifications
(Not applicable, as no specific study involving expert-established ground truth was described.)
4. Adjudication Method for the Test Set
(Not applicable.)
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
(Not applicable. This device is a physical syringe, not an AI-assisted diagnostic tool.)
6. Standalone (Algorithm Only) Performance Study
(Not applicable. This device is a physical syringe, not an algorithm.)
7. Type of Ground Truth Used
(Not applicable, as no ground truth was established for performance metrics in a study for this device.)
8. Sample Size for the Training Set
(Not applicable. This device is a physical syringe, not a machine learning model requiring a training set.)
9. How the Ground Truth for the Training Set Was Established
(Not applicable.)
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).