(16 days)
Inspirstar Glove Electrode is intended to for use with legally marketed electrostimulation devices such as TENS to deliver stimulation current for pain relief.
Inspirstar Glove Electrode is cutaneous electrode to be used with legally marketed TENS stimulating device. The glove electrodes will deliver the stimulation signals generated by the stimulator to the skin with which they are contact.
Inspirstar Glove Electrode is the conductive glove knitted from a continuous silver coated nylon yarn into the form of the glove. The conductivity is derived from the silver material of nylon yarn. Nylon yarn provides elasticity which can ensure skin contact. Inspirstar Glove Electrode has the same conductivity for dry or wet usage. The entire glove electrode is conductive having the resistance of less than 7 ohms per inch consistently.
The provided document is a 510(k) summary for the Inspirstar Glove Electrode, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria. Therefore, much of the requested information regarding detailed study design, sample sizes, expert involvement, and ground truth establishment is not present in this filing.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The filing does not explicitly define "acceptance criteria" in a quantitative, measurable sense for the glove electrode's performance as a medical device. Instead, it focuses on demonstrating technological characteristics similar to a predicate device. The primary performance characteristic mentioned is conductivity.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conductivity (resistance per inch) | Less than 7 ohms per inch consistently (for the entire glove) |
| Ability to deliver stimulation current | Functions as a conductive electrode for TENS devices |
| Substantial equivalence to predicate device | Deemed substantially equivalent in indications for use, technological characteristics, conductivity performance, connector interface, and use/care characteristics. |
2. Sample Size Used for the Test Set and Data Provenance
The document states "Inspirstar Glove Electrode is tested to verify the device meets the design requirement. Predicate devices are also tested to support substantial equivalence." However, it does not specify the sample size of glove electrodes that were tested, nor does it detail the specific tests conducted beyond mentioning resistance measurement.
- Sample Size (Test Set): Not specified.
- Data Provenance: The document does not provide details on the specific data provenance (e.g., country of origin, prospective or retrospective) for the testing. It's implied the testing was conducted by or for Inspirstar Inc. for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable/not provided in this type of 510(k) submission for a device like a glove electrode. Establishing "ground truth" with human experts is typically relevant for diagnostic devices that interpret complex data (e.g., medical images, physiological signals), where clinical consensus or pathology reports serve as the gold standard. For a conductive glove, the "ground truth" is based on physical property measurements and functional testing.
4. Adjudication Method for the Test Set
This information is not applicable/not provided for the reasons stated above. Adjudication methods (e.g., 2+1, 3+1) are used to resolve discrepancies in expert interpretation, which is not relevant for the performance assessment of a conductive glove.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
This information is not applicable/not provided. MRMC studies are typically used for diagnostic imaging or equivalent interpretation devices to assess human-in-the-loop performance and usually involve multiple human readers interpreting cases with and without AI assistance. This device is a conductive electrode, not an AI or diagnostic interpretation device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. This device is a physical electrode, not an algorithm, and therefore does not have a "standalone" algorithmic performance.
7. The Type of Ground Truth Used
For the Inspirstar Glove Electrode, the "ground truth" for its performance is based on physical property measurements, specifically:
- Resistance measurement: The resistance of the silver-coated nylon yarn (less than 7 ohms per inch).
- Functional performance: Its ability to act as a conductive electrode to deliver stimulation current when connected to a legally marketed TENS device.
8. The Sample Size for the Training Set
This information is not applicable/not provided. The Inspirstar Glove Electrode is a manufactured medical device, not an AI model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for this type of device.
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).