(90 days)
The RI. MOS. Cervical and Intracervical Anaesthesia Needles are used to apply cervical and intracervical anesthesia block.
The RI. MOS. s.r.l. cervical and intracervical needles operate with standard medical syringes are are sterile, single-use, disposable devices.
The provided text is a 510(k) summary for a medical device: "RI. MOS. s.r.l. cervical anesthesia needle and intracervical anesthesia needle." This document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study that establishes performance against specific acceptance criteria.
Therefore, most of the requested information regarding acceptance criteria and performance studies is not available in the provided text. The 510(k) process for devices like needles primarily relies on showing that the new device has the same intended use, technological characteristics, and performance as an existing, legally marketed device.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Not Available. The document does not define specific acceptance criteria (e.g., in terms of mechanical strength, sterility, or anesthesia efficacy) nor does it report the device's performance against such criteria. The submission is a claim of substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Available. No test study or data provenance is mentioned.
3. 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 Available. There is no mention of a test set, experts, or ground truth establishment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Available. No adjudication method is mentioned as there is no test set or study.
5. 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 is a medical needle, not an AI-assisted diagnostic device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a medical needle, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Available. No ground truth is established or mentioned in the context of a performance study. For a 510(k) submission of this type, the "ground truth" for regulatory review is the substantial equivalence to a predicate device based on its intended use and technological characteristics.
8. The sample size for the training set
- Not Applicable. This is not a machine learning or AI device that would require a training set.
9. How the ground truth for the training set was established
- Not Applicable. As above, no training set or associated ground truth establishment.
Summary of available information from the document:
- Device Name: RI. MOS. s.r.l. cervical anesthesia needle and intracervical anesthesia needle.
- Intended Use: Applying cervical and intracervical anesthesia block.
- Predicate Device: Potocky Needle® marketed by CooperSurgical.
- Basis for Acceptance: Substantial equivalence to the predicate device, meaning the new device has "the same or similar technological characteristics" and intended use as the predicate. The FDA's letter (FEB 1 1999) explicitly states that the device is "substantially equivalent" for the stated indications for use.
- Device Characteristics: Sterile, single-use, disposable devices that operate with standard medical syringes.
§ 884.5100 Obstetric anesthesia set.
(a)
Identification. An obstetric anesthesia set is an assembly of antiseptic solution, needles, needle guides, syringes, and other accessories, intended for use with an anesthetic drug. This device is used to administer regional blocks (e.g., paracervical, uterosacral, and pudendal) that may be used during labor, delivery, or both.(b)
Classification. Class II (performance standards).