(304 days)
The Wellness Pro 2010 is an Electrotherapy Unit that is used for the following:
- Relief of chronic, intractable pain.
- Adjunctive treatment of post surgical or post-traumatic acute pain
The Wellness Pro 2010 is designed to provide electrical stimulation, for the relief of chronic, intractable pain and as an adjunctive treatment of post-surgical or post-traumatic acute pain, in a single compact, lightweight user friendly package. Stimulation does not always cause sensation to relieve pain.
The WellnessPro 2010 has 2 modes of waveforms: Continuous and Premodulated. The device gives the clinician ability to store frequencies or to choose from a set of 250 frequencies that allow quick and easy selection, for prescription of stimulation regimens that can be later stored in any of the 1000 available memory slots.
The Wellness Pro 2010 package is comprised of the following items:
-
- 7.5 Volt medical power adapter, conforming to industry standards.
-
- Four industry standard wires for electrodes conforming to FDA standard,
-
- Four standard commercially available and FDA approved, round 50(mm) self adhesive electrodes.
-
- An instruction Manual.
The provided text describes a 510(k) premarket notification for the "Wellness Pro 2010" TENS device. However, it does not include any acceptance criteria or a study demonstrating the device's performance against such criteria. Instead, it focuses on establishing substantial equivalence to predicate devices based on similar indications for use and unit characteristics.
Therefore, many of the requested sections regarding acceptance criteria and a performance study cannot be filled from the provided document.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided from the text. The document does not define specific acceptance criteria (e.g., efficacy rates, pain reduction percentages) for the Wellness Pro 2010 itself, nor does it report the device's performance against such criteria in a clinical study. The basis for substantial equivalence is primarily through comparison to predicate devices, not through a new clinical performance study.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided from the text. No performance study or test set is discussed.
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)
- Cannot be provided from the text. No performance study or ground truth establishment is discussed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided from the text. No performance study or adjudication is discussed.
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
- Cannot be provided from the text. The Wellness Pro 2010 is a TENS device, not an AI-powered diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided from the text. As a TENS device, there is no "algorithm only" performance that would be evaluated in this context. The device's function is direct electrical stimulation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided from the text. No performance study is discussed, so no ground truth type is mentioned.
8. The sample size for the training set
- Cannot be provided from the text. There are no details of a training set as no new clinical performance study was conducted.
9. How the ground truth for the training set was established
- Cannot be provided from the text. There are no details of a training set or how ground truth for it would be established.
Summary of available information regarding the device's evaluation:
The substantial equivalence argument for the Wellness Pro 2010 is based on:
- Similar Indications for Use: Relief of chronic, intractable pain, and adjunctive treatment of post-surgical or post-traumatic acute pain.
- Similar Unit Characteristics: Both the Wellness Pro 2010 and its predicate devices (Medrelief ST-100, ST-150, ST-200, ST-300, and Fenzian Treatment System) are TENS devices that provide electrical stimulation for pain relief.
- Non-Clinical Data:
- Risk Analysis results (demonstrating acceptable and mitigated potential hazards).
- Compliance with various international and national safety and EMC standards (ISO 10993, UL 60601-1-1: 2003, IEC 60601-2-10: 1987, IEC 60601-1-1: 1998 + A1 + A2:1995, EN 60601-1-2:2001).
The document explicitly states: "The performance is equivalent to legally marketed predicate devices. Risk Analysis does not demonstrate any design or performance potential hazards that are not adequately mitigated." This indicates that no new clinical performance study was conducted or required for this 510(k) clearance. The clearance relies on the established safety and effectiveness of the predicate devices.
§ 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).