Search Results
Found 1 results
510(k) Data Aggregation
(278 days)
The EPRT Bodihealth TENS System (Transcutaneous Electrical Nerve Stimulator for Pain Relief) with Silver Wrap is intended for temporary symptomatic relief and management of chronic intractable pain and as an adjunctive treatment in the management of post-surgical and post-traumatic pain.
The Bodihealth TENS system was previously described in K052836. The Silver Wrap is the component of the Bodihealth System that is used to transfer the energy from the Bodihealth device to the patient. It consists of a MediSponge foam 100 to which silver fabric is laminated, and then covered by urethane. The silver wrap is one-piece and consists of (a) a Urethane outer layer, (b) an adhesive layer, (c) a silver plated nylon conductive layer and (d) a foam layer that acts as the material that contacts the patient. The silver wrap functions as the means to conduct a maximum current of 3 milliamperes at 0.000732 Hz for 23 minutes. The electric currents produced are compatible with the natural electric currents of the human body.
The provided document describes a 510(k) premarket notification for a Class II medical device, the EPRT Bodihealth TENS System with Silver Wrap. This submission aims to demonstrate substantial equivalence to a predicate device (EPRT Bodihealth System with Foam and Rubber Wrap, K052836) due to a modification in the wrap component.
Here's an analysis of the acceptance criteria and study information, addressing your requested points:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical performance metrics (e.g., sensitivity, specificity). Instead, they are framed as design inputs that the new "Silver Wrap" component must meet to demonstrate equivalence to the predicate device's "Foam and Rubber Wrap." The reported device performance is described qualitatively and through engineering testing, indicating that these requirements were met.
| Acceptance Criteria (Design Input) | Reported Device Performance |
|---|---|
| Obtain foam component equivalent to that used in predicate wrap | Medi-Sponge 100 selected as a suitable replacement. "Engineering Testing meets the requirements as shown in this section." |
| Simplify the device from a two-piece system to a single-piece wrap | Successful development of a one-piece wrap. "Improved and simplified as described in User Preference Testing shown in this section." (Note: "User Preference Testing" is mentioned but details are not provided in the excerpt). |
| Reduce the resistance encountered in the previous rubber Strap/Conco foam. | One-piece silver wrap reduced the resistance as required in design input. "Engineering testing demonstrated that the silver wrap has over 1/24th the resistance as the predicate (see User Preference Testing shown in this section)." (Again, "User Preference Testing" details are missing). |
| Improve uniform energy transfer from the Bodihealth device to the patient. | Silver fabric is silver-plated over nylon, laminated to foam with a hot melt grid adhesive. The grid pattern allows a conductive path from the silver fabric through the wet foam. "See Engineering Testing meets the requirements as shown in this section." |
| Ensure that waveform and energy output of the improved device matches that of the predicate. | Equivalent to predicate. "See Engineering Testing shown in this section demonstrates equivalent waveforms to the predicate." |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not detail a study involving test subjects or a test set of data in the traditional sense of clinical performance for a diagnostic device. The evaluation focuses on bench testing and engineering comparisons of the new wrap component to the predicate. Therefore, there is no mention of sample size for a test set, country of origin, or whether the data was retrospective or prospective in the context of clinical performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The study described is primarily engineering/bench testing comparing device components, not a clinical study requiring expert-established ground truth on patient data.
4. Adjudication Method for the Test Set
Not applicable. As described above, there is no clinical test set that would require adjudication.
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 submission is for a TENS device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or reporting of improvement with AI assistance is not relevant or included.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm, but rather a physical component (wrap) for an existing TENS system. Its performance is evaluated through engineering testing of its conductive properties and energy transfer, not as a standalone algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is the performance and characteristics of the predicate device's wrap (K052836 with Foam and Rubber Wrap). The study's aim is to demonstrate that the new Silver Wrap achieves "equivalence" to this established performance. The methods used to establish this equivalence are primarily:
- Bench Testing/Engineering Testing: This involved direct measurement and comparison of physical and electrical properties (e.g., resistance, waveform, energy output) between the new Silver Wrap and the predicate wrap.
- User Preference Testing: Although details are sparse in the excerpt, this type of testing (if conducted, as stated in the table) would assess user perception or interaction with the simplified design, likely against the predicate's two-piece system.
- Biocompatibility Testing: To ensure the materials of the new wrap are safe for patient contact.
8. The Sample Size for the Training Set
Not applicable. There is no training set mentioned, as this is not an algorithm-based device.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set for an algorithm, there is no ground truth established for one.
Ask a specific question about this device
Page 1 of 1