(27 days)
The ON-Q Introducers are intended for the percutaneous introduction and placement of catheters into or around surgical wound sites and/or close proximity to nerves. Introducers with a luer hub may be used to aspirate or inject a bolus of fluid or medication prior to placing the catheters.
The ON-Q Introducers consist of the following two components: The first component is a stainless steel shaft (trocar) with a handle or luer hub. The trocar diameter ranges from 11 to 17 GA and the length ranges from 3.25 to 12 inches. The trocar may have a sharp, beveled tip or a blunt, rounded tip. The second component is a peelable (split T-Handle) plastic sheath that is designed to fit over the trocar. The model configurations are designated as follows: Models with a blunt tip are called ON-Q Tunnelers. The sheaths may be sold separately and are single use only. Some versions of the ON-Q Tunnelers may be reusable. Models with a sharp tip are called ON-Q Introducers Needles which are single use only. The ON-Q Introducers are intended for the percutaneous introduction and placement of catheters into or around surgical wound sites and/or close proximity to nerves. Introducers with a luer hub may be used to aspirate or inject a bolus of fluid or medication prior to placing the catheters.
The provided document (K063234) is a 510(k) summary for the ON-Q Introducers, a medical device. It does not contain information about studies conducted to meet specific acceptance criteria through performance metrics like sensitivity, specificity, or AUC, as would be common for diagnostic AI/ML devices.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices by meeting recognized consensus standards for device design and performance requirements. The concept of "acceptance criteria" here refers to compliance with these established standards and the safety and effectiveness profile similar to already marketed devices.
Therefore, for this particular device (ON-Q Introducers), the request for details on acceptance criteria and a study proving the device meets them needs to be interpreted within the context of a 510(k) submission for a non-AI/ML device.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Compliance with Standards) | Reported Device Performance (Claim of Substantial Equivalence) |
|---|---|
| ISO 10555-5:1996: Sterile, Single-Use Intravascular Catheters - Over Needle Peripheral Catheters | Device meets the requirements of this standard. |
| ISO 10555-1:1995: Sterile, Single-Use Intravascular Catheters - General Requirements | Device meets the requirements of this standard. |
| ISO 594-1:1986: Conical Fittings with 6% (Luer) Taper - Part 1 | Device meets the requirements of this standard. |
| ISO 594-2:1998: Conical Fittings with 6% (Luer) Taper - Part 2 | Device meets the requirements of this standard. |
| ISO 9626:1991: Stainless Steel Needle Tubing | Device meets the requirements of this standard. |
| Overall Safety and Effectiveness: Device is safe and effective for its intended use. | The ON-Q Introducers are substantially equivalent to existing introducers that are currently marketed. |
| Intended Use: Percutaneous introduction and placement of catheters into or around surgical wound sites and/or close proximity to nerves. Introducers with a luer hub may be used to aspirate or inject a bolus of fluid or medication prior to placing the catheters. | Device performs as intended and is equivalent to predicate devices for these indications. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document primarily focuses on compliance with international standards and comparison to predicate devices, rather than a clinical study with a "test set" in the context of diagnostic performance.
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)
This information is not provided and is not applicable to this type of device submission. Ground truth, in the sense of expert consensus for diagnostic interpretation, is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not applicable to this type of device submission.
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
There is no indication of an MRMC study being performed. This is not an AI/ML device, and the submission is not focused on improving human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not an AI/ML device, so a standalone algorithm performance study is not applicable and not mentioned.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For this type of device, ground truth relates to the physical and functional properties of the device meeting established engineering standards (e.g., sterility, material properties, luer taper dimensions, needle tubing specifications). This is assessed through laboratory testing and manufacturing controls, rather than diagnostic "ground truth." The document does not detail specific testing protocols or results in full.
8. The sample size for the training set
This information is not provided and is not applicable. The device is not an AI/ML product that would require a "training set."
9. How the ground truth for the training set was established
This information is not provided and is not applicable, as there is no "training set" for this device.
§ 868.5120 Anesthesia conduction catheter.
(a)
Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.(b)
Classification. Class II (performance standards).