(117 days)
The Patient Return Electrode is indicated for use only with Target Therapeutics GDC System as the patient return electrode.
Target Therapeutics' Patient Return Electrode (PRE) is a single use, disposable, non-sterile electrode. The PRE is intended to be used as an alternative patient return electrode for Target Therapeutics GDC system (K951256 & K960705). A hypodermic needle is currently used as the patient return electrode. The PRE is applied to the skin on the patient's upper arm (deltoid). The PRE is being made available for patient comfort and has no effect on the safety or efficacy of the GDC system as functional testing indicates.
A small Prep pad is included with the PRE to exfoliate the skin prior to applying the PRE.
This is a 510(k) premarket notification for a medical device (Patient Return Electrode). This type of submission generally does not contain detailed studies with acceptance criteria, sample sizes, expert ground truth, or MRMC studies as would be expected for AI/ML device evaluations. The focus of a 510(k) is to demonstrate substantial equivalence to a predicate device.
Therefore, many of the requested fields cannot be directly answered from the provided text. I will extract the information that is available and note when information is not present.
Here's a breakdown based on your request:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, specific quantitative acceptance criteria and their corresponding reported device performance values (like sensitivity, specificity, AUC) are not explicitly stated as they would be for an AI/ML device. The document mentions "functional testing" and "bench testing" but does not provide specific metrics or thresholds.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Efficacy (no adverse effect on GDC system) | "has no effect on the safety or efficacy of the GDC system as functional testing indicates." |
| Substantial Equivalence to predicate devices | "supports the substantial equivalence claims of the PRE for its intended use." |
| Performance in bench testing (Tensile Test, Impedance Test) | "Results of the bench testing...effectively demonstrate the PRE is substantially equivalent to the predicate devices." |
| Performance in animal studies | "Results of the...animal studies...effectively demonstrate the PRE is substantially equivalent to the predicate devices." |
| Biocompatibility | "Results of the...biocompatibility testing...effectively demonstrate the PRE is substantially equivalent to the predicate devices." |
2. Sample size used for the test set and the data provenance
- Sample size for the test set: Not specified. The document mentions "bench testing," "animal studies," and "biocompatibility testing" but does not give sample sizes for these tests.
- Data provenance: Not specified. (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not applicable/Not specified. For this type of device (Patient Return Electrode), ground truth is established through physical/electrical measurements and biological responses, not expert interpretation of data.
- Qualifications of experts: Not applicable/Not specified.
4. Adjudication method for the test set
- Adjudication method: Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are typically used when human interpretation of data (e.g., medical images) is involved in establishing ground truth. This is not pertinent to the evaluation of a Patient Return Electrode.
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
- MRMC study: No. An MRMC study is relevant for AI/ML diagnostic devices where human readers interpret medical images or data. This is not applicable to a Patient Return Electrode.
- Effect size of human reader improvement: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: Not applicable in the context of AI/ML algorithms. The device itself (Patient Return Electrode) is a standalone component; its performance is evaluated in direct physical/electrical tests and biological studies, not as an algorithm.
7. The type of ground truth used
For this device, the "ground truth" would be established by:
- Physical/Electrical measurements: For the Tensile Test and Impedance Test, ground truth is based on engineering specifications and physics.
- Biological responses: For animal studies and biocompatibility testing, ground truth is based on observed physiological reactions and histological analyses against established safety standards.
8. The sample size for the training set
- Sample size for the training set: Not applicable. This document does not describe the development or evaluation of an AI/ML algorithm, so there is no concept of a "training set" in the sense of machine learning.
9. How the ground truth for the training set was established
- How ground truth was established for the training set: Not applicable (as there is no training set for an AI/ML algorithm).
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).