(238 days)
Certa Catheter™ continuous peripheral nerve block catheter set is indicated for delivery of medication for regional anesthesia and pain management in lower extremity blocks. It may be used by a qualified healthcare professional in a perioperative monitored care setting.
Certa Catheter™ is intended for use in adult patients only. It should always be inserted and placed under ultrasound guidance by a healthcare professional.
The Certa Catheter has not been evaluated for use in upper extremity blocks.
Certa Catheter™ is a single patient use, disposable device which is the combination of a needle and catheter, intended for delivery of local anesthetic for continuous peripheral nerve blocks.
Certa Catheter™ is intended to be placed with the use of ultrasound guidance. The procedure is performed using aseptic technique.
Certa Catheter™ consists of a curved needle to which the catheter is attached. The curved needle is available in several radius and lengths. To assist with the control of the needle during insertion, there is a Hub which allows the user to rotate the needle during the insertion and placement along or above the target nerve. The Hub is removed and then the user is able to grab the needle tip and pull the cather through the entry and exit locations. The needle is then cut from the catheter and the user is able to pull the catheter back and forth to locate the eyelets in the proper location along or above the target nerve. The catheter is then fixed on one side to secure its location. The system consists of: Curved needle; Hub – a handle that helps during insertion and is removed afterwards; which has a Luer port; Catheter with single or multiple orifices; and echogenic markings for ultrasound detection.
The provided document is a 510(k) premarket notification for a medical device called the "Certa Catheter Continuous Peripheral Nerve Block Catheter Set" (K171193). This document is primarily focused on demonstrating substantial equivalence to a predicate device (Halyard ON-Q QuikBloc Over-the-Needle Catheter set K143164) rather than presenting a detailed clinical study for a novel AI/software medical device.
Therefore, the information required to address your specific questions about acceptance criteria, test set sample size, expert ground truth establishment, MRMC studies, standalone performance, training set details, and adjudication methods for an AI/software medical device is largely not present in this document.
However, I can extract information related to the device's non-clinical performance testing and the clinical studies mentioned, although they are not structured as an AI algorithm performance study.
Here's an attempt to answer your questions based on the available information, noting where details are not provided in the document:
Device Name: Certa Catheter™ Continuous Peripheral Nerve Block Catheter Set (K171193)
Device Type: Anesthesia Conduction Catheter (hardware medical device, not an AI/software medical device)
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner for the non-clinical performance tests, but it presents comparative performance data against a predicate device. The implicit acceptance criterion is "substantially equivalent" or "within specifications of the predicate and reference devices."
Non-Clinical Performance Testing Comparison:
| Feature | Acceptance Criteria (Predicate/Reference Performance, or Implied) | Reported Device Performance (Certa Catheter™) |
|---|---|---|
| Strength of bond | Predicate: Average bond strength between catheter and its luer is $34.64N +/- 2.34N$ | Average bond strength between catheter and its luer is $34.91N +/- 4.09N$ (Deemed substantially equivalent) |
| Tensile strength | Predicate: Average tensile strength of catheter (at its weakest point) is $30.28N +/- 1.66N$. Implied: Comparable to predicate or legally marketed reference device specifications that have been found safe and effective. | 1 hole model: Average tensile strength of catheter (at its weakest point) is $20.12N +/- 0.75N$. |
| 3 holes model: Average tensile strength of catheter (at its weakest point) is $18.43N +/- 0.33N$. | ||
| Discussion: Lower than predicate but higher than a legally marketed reference device with similar indications for use. Deemed not to raise different safety/effectiveness concerns. | ||
| Leakage | Tested to EN 1618:1997 Annex B (Implied compliance) | Tested to EN 1618:1997 Annex B (Implied compliance) |
| Luer fitting | Compliant with ISO 594-2 (Implied compliance) | Tested and compliant with ISO 594-2 (Implied compliance) |
| Sharpness | Predicate: Average penetration force is $3.7N +/- 0.31N$ | Average penetration force is $2.93N +/- 0.33N$ (Deemed substantially equivalent) |
| Flow rate | Predicate: Average flow rate is $83.91ml/min +/- 2.73ml/min$. Implied: Sufficient for regional anesthesia and pain management. | 1 hole model: Average flow rate $5.24ml/min +/- 0.08ml/min$. |
| 3 holes model: Average flow rate $5.2ml/min +/- 0.1ml/min$. | ||
| Discussion: Lower than predicate but clinician determines effectiveness; allows for slower assessment. Deemed not to alter risk profile. | ||
| Catheter Kinking | Predicate: kink resistant up to 0.25" (6.35mm) | Kink resistant up to at least 1.11mm catheter (Deemed substantially equivalent, potentially implying a different resistance metric or superior performance if 1.11mm refers to diameter) |
| Biocompatibility | All applicable components meet ISO 10993-1 requirements for external communicating, tissue/bone, limited/prolonged duration; surface contact, intact/breached skin, limited/prolonged duration. | All applicable components meet ISO 10993-1 requirements. Results supported materials meet biocompatibility. |
| Sterility | Validation of EO and ECH residuals per ISO 10093-7 and LAL endotoxins. | Sterilization validated. |
| Effects of Aging | No adverse effect on device performance post-aging. | Results supported aging does not have an effect on the performance. |
| Clinical Performance (Safety) | No adverse events in studies regarding insertion technique, catheter fixation, or infection at puncture sites. Safe and effective with proper placement. | No adverse events recorded on study days in the two healthy volunteer studies. Safety and risk profiles deemed substantially equivalent to predicate based on MAUDE database and literature review. Supports safety and substantial equivalence with recommended placement. |
Note: The document is a 510(k) submission, not a scientific publication for an AI algorithm. The "acceptance criteria" are implied by demonstrating substantial equivalence to a predicate device through comparative bench testing and clinical use (not a comparative clinical trial).
2. Sample sizes used for the test set and the data provenance
- Test Set Sample Size:
- Non-clinical (Bench) Tests: The document details performance metrics (mean and standard deviation), implying samples were used for these tests (e.g., for tensile strength, flow rate, sharpness). However, the specific number of samples used for each bench test (e.g., N=10, N=20) is not reported.
- Clinical Studies: The document mentions "several clinical trials related to the insertion technique of the Certa Catheter™," including "healthy volunteers." It states "two studies." The exact number of healthy volunteers in these studies is not specified.
- Data Provenance:
- Non-clinical (Bench) Tests: Not specified, but generally conducted by the manufacturer or a contract testing lab.
- Clinical Studies: "One of the studies performed on healthy individuals with a high level of mobility showed an increased incidence of transient neurologic deficits when the catheter was placed below the nerve [CONTINUOUS ADDUCTOR CANAL BLOCK WITH A SUTURE-METHOD CATHETER - PRIMARY PLACEMENT AND SECONDARY REPOSITIONING; ESRA Academy. Lyngeraa T. Sep 8, 2016; 138581]". This suggests at least one study was prospective, potentially conducted in Europe (ESRA Academy). The other mentioned clinical studies' provenance is not detailed beyond being "several clinical trials." It states "No adverse events were recorded on study days in the two studies."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a hardware device submission, not an AI/software device requiring subjective expert labeling for ground truth. The "ground truth" for the clinical evaluation was observed events (e.g., adverse events, transient neurological deficits) in healthy volunteers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a hardware device submission, not an AI/software device requiring subjective expert labeling for ground truth.
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 hardware device submission. No MRMC study involving AI assistance was performed or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware device submission. There is no AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the human clinical studies mentioned, the "ground truth" was observational clinical outcomes, specifically:
- Occurrence of adverse events.
- Incidence of transient neurologic deficits (linked to catheter placement location relative to the nerve).
- Catheter fixation method outcomes.
- Infection at puncture sites.
For the bench testing, the "ground truth" or reference was the measured performance of the predicate device and established engineering standards (e.g., ISO 594-2, EN 1618:1997, ISO 10993-1).
8. The sample size for the training set
Not applicable. This is a hardware device submission. There is no AI algorithm or training set.
9. How the ground truth for the training set was established
Not applicable. This is a hardware device submission. There is no AI algorithm or training set.
§ 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).