(225 days)
The Stimuplex® Onvision® system is intended for clinically trained physicians to perform regional anesthesia and pain therapy to target peripheral nerves by tracking the B.Braun Stimuplex® Onvision® needle tip position by overlaying a circle at the given location using the Philips Xperius® Ultrasound and Onvision® System. The B.Braun Stimuplex® Onvision® needle is used to inject local anesthesia or analgesic to the targeted nerve bundle to induce regional anesthesia for surgical procedures. The Stimuplex® HNS 12 can also be used for nerve stimulation when connected to the system cable.
The proposed Stimuplex® Onvision® system is an add-on device to the Philips Xperius ultrasound system (K182529) that is intended to be used during peripheral nerve block (PNB) procedures. The proposed Stimuplex® Onvision® system consists of:
- a sterile, dedicated single-use Stimuplex® Onvision® needle (manufactured by B. Braun)
- Onvision system (manufactured by Philips) which contains:
- a non-sterile reusable hardware with battery,
- needle tip tracking software
- and a system cable.
The Stimuplex Onvision system is also compatible with the Stimuplex HNS 12 nerve stimulator( K070134).
The following information is extracted from the provided text regarding the acceptance criteria and the study proving the device meets these criteria for the Stimuplex Onvision system.
1. A table of acceptance criteria and the reported device performance:
The document states that "Results of the functional and performance testing conducted on the proposed device demonstrate that the Stimuplex® Onvision® system complies with user need requirements as well as the requirements specified in the international and FDA-recognized consensus standards, and meets the acceptance criteria and is adequate for its intended use." However, it does not provide a quantitative table of specific acceptance criteria values and the measured performance of the device against those values. Instead, it lists the types of nonclinical and validation testing performed and states that they were "successfully completed" or "passed."
Based on the information provided, the acceptance criteria are generalized as meeting specifications and user needs. The reported performance is that the device "performs as intended," "verifies the requirements," and "all tests were passed."
Here's a table based on the types of tests and their stated outcomes, as quantitative data for acceptance criteria and performance data points are not explicitly provided in the furnished text.
| Acceptance Criteria Category (Implied) | Stated Device Performance |
|---|---|
| Material Biocompatibility | Passed (ISO 10993-1) |
| Cvtoxicity | Passed |
| Sensitization | Passed |
| Irritation/Intracutaneous reactivity | Passed |
| Material mediated Pyrogenicity | Passed |
| Acute Systemic Toxicity | Passed |
| Hemocompatibility | Passed |
| Sterilization Efficacy | Passed |
| Sterilization Residual testing | Passed (ISO 10993-7) |
| Sterilization Validation | Passed (ISO 11135) |
| Cannula Mechanical Properties | Passed |
| Cannula stiffness | Passed (ISO 9626, ISO 7864) |
| Tensile load | Passed (ISO 9626, ISO 7864) |
| Resistance to breakage | Passed (ISO 9626, ISO 7864) |
| Needle Performance & Function | Passed |
| Flowrate | Passed |
| Liquid Tightness | Passed |
| Compatibility with Philips Xperius System | Passed |
| Shelf Life Testing | Passed (2 years) |
| Electrical Safety | Passed (ANSI AAMI ES 60601-1) |
| EMC Safety | Passed (IEC 60601-1-2) |
| Software Life Cycle Processes | Passed (IEC 62304) |
| Non-clinical Performance (System) | Passed |
| Functional requirements | Passed |
| Performance requirements | Passed |
| Service requirements | Passed |
| Physical requirements | Passed |
| Interface requirements | Passed |
| Bench-top System Validation | Passed |
| Needle tip position | Passed |
| Connectivity | Passed |
| Power indicator | Passed |
| Battery | Passed |
| Boot-up time | Passed |
| System cable clip | Passed |
| Operational | Passed |
| Self-test | Passed |
| Needle tip not shown | Passed |
| Preclinical Cadaver Testing (Workflow) | Passed |
| Intended use validation | Passed |
| User needs validation | Passed |
| Safety related measure effectiveness | Passed |
| Usability Evaluation | Passed (IEC 62366-1) |
| Safety for intended use/users/env. | Passed |
| Effectiveness for intended use/users/env. | Passed |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
-
Test Set Sample Size: The document does not specify exact "sample sizes" in terms of number of patients or images for a dedicated test set in the way a clinical trial would. The testing described is primarily non-clinical, including bench-top testing, and a preclinical cadaver study.
- For bench-top testing, "an artificial media" was used. The number of tests/runs is not specified.
- For preclinical testing, "human cadaver" was used. The number of cadavers or distinct use cases is not specified.
- Usability evaluation was performed with "anesthesiologist(s)" in a simulated environment; the number of participants is not specified.
-
Data Provenance: The document does not explicitly state the country of origin for the non-clinical and preclinical testing data. Philips Medical Systems Nederland B.V. (The Netherlands) is the submitter. The studies are described as "nonclinical testing" and "preclinical testing," suggesting they are newly generated specifically for this submission (prospective in that sense, rather than retrospective analysis of existing data).
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)
- Number of Experts: For the preclinical cadaver study and usability evaluation, "physician (anesthesiologist)" or "anesthesiologist" were involved. The exact number of individuals is not specified.
- Qualifications of Experts: The experts were identified as "clinically trained physicians" or specifically "anesthesiologist(s)." No further details about their experience level (e.g., years of experience) are provided. Their role appears to be as users and evaluators of the device's performance in a simulated/cadaver environment, rather than establishing numerical "ground truth" data points for an algorithm in an image dataset.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any specific adjudication method (like 2+1 or 3+1) for establishing ground truth, as the testing performed is not a multi-reader imaging study. The "ground truth" for the non-clinical tests would be defined by the pre-specified technical requirements and measurements, and for the cadaver study and usability, the observed operational success and safety aspects assessed by the participating anesthesiologist(s).
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
No MRMC comparative effectiveness study was conducted or described in the provided text. The device is a "needle tip tracking system" used during regional anesthesia, not an AI-assisted diagnostic imaging device requiring human reader improvement comparison. The FDA states, "No clinical testing was required as substantial equivalence was demonstrated by the attributes of intended use, technological characteristics, and non-clinical testing."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document implies standalone performance testing of the system's components and the integrated system during bench-top testing. For example, "Needle tip position" verification in artificial media would be an assessment of the algorithm's performance. However, the exact "standalone" performance metrics (e.g., accuracy of needle tip tracking in mm) are not quantified in the text. The closest is the statement that "functional and performance testing to internal specifications" was conducted and "Non-clinical validation testing has been performed to validate that the proposed Stimuplex® Onvision® system conforms its intended use and user needs."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance evaluation can be inferred from the types of testing:
- Bench-top testing: The ground truth would be defined by engineering specifications and physical measurements (e.g., for flowrate, liquid tightness, accuracy of simulated needle tip position).
- Preclinical Cadaver Testing: The ground truth for this validation would be the successful execution of the specified workflow, the system functioning as intended, and the evaluation of safety measures within the simulated clinical environment, assessed by the anesthesiologist.
- Usability Evaluation: The ground truth would be based on the qualitative and quantitative observations of user interaction, identification of usability issues, and the overall assessment by the anesthesiologists that the system is safe and effective for its intended use and environment.
No pathological or outcomes data-based ground truth is discussed, as this is a device for real-time guidance during a procedure, not a diagnostic device.
8. The sample size for the training set
The document does not mention any "training set." This type of device (needle tip tracking system) is not typically developed using machine learning models that require a separate, large training set of data in the way AI/ML algorithms for image analysis are. The "training" in this context refers to the development and refinement of the tracking algorithm based on engineering principles and iterative testing, not statistical model training.
9. How the ground truth for the training set was established
As no training set (in the AI/ML sense) is described, the concept of establishing ground truth for it is not applicable here. The device's functionality is based on its physical design and real-time sensor processing, not a trained AI model.
§ 868.5150 Anesthesia conduction needle.
(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).