(67 days)
"For the symptomatic relief of chronic intractable pain"
A portable TENS device for pain relief.
Here's a breakdown of the acceptance criteria and study information based on the provided text, using the requested structure:
1. Table of Acceptance Criteria & Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No new questions of safety and effectiveness compared to predicate device | "The TensCare "Ulitima XL-A1" is substantially equivalent to the predicate device and any differences between the devices do not pose any new questions of safety and effectiveness." (Clinical testing was not necessary as no new or innovative aspects were introduced). |
| Output characteristics substantially equivalent to predicate devices | "The results of Bench Testing demonstrate that the output characteristics of the TensCare Ultima are substantially equivalent to those of the two predicate devices." |
| Performance as intended to specified requirements (post-market review) | "During this time [5 months on European Market] a review of Customer Complaints, Returned Product and the results of Post Market Feedback, has demonstrated that the product has performed as Intended, to it's Specified Requirements." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not applicable. The "test set" here refers to post-market surveillance data, not a formal clinical trial test set. The submission mentions a "review of Customer Complaints, Returned Product and the results of Post Market Feedback" over 5 months. The exact number of customer complaints, returned products, or feedback instances is not specified.
- Data Provenance: European Market (specifically, the product had been on the European Market for 5 months). The data is retrospective, gathered from existing market feedback.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. The "ground truth" for the post-market review was operational performance based on customer complaints and returns, not expert consensus on specific cases.
4. Adjudication Method for the Test Set
- Not applicable. As described above, this was a post-market review, not a clinical trial with case adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No MRMC comparative effectiveness study was done. The submission explicitly states: "Clinical Testing was not necessary as no new or innovative aspects have been introduced."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a TENS unit, not an AI algorithm. Its performance is inherent to the device's electrical output, not an algorithm's classification or diagnostic ability. The "standalone performance" was assessed via bench testing of its output characteristics.
7. The Type of Ground Truth Used
- Bench Test: Comparison against the output characteristics of the predicate devices.
- Post-Market Review: Actual product performance (customer complaints, returned products, post-market feedback).
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm that requires a "training set." Its design is based on established TENS technology and predicate devices.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this type of device.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).