(256 days)
The NT2000 is indicated for:
- Transcutaneous Electrical Nerve Stimulation (TENS) for the symptomatic relief and a) management of chronic (long term) intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic acute pain problems.
- b) Electrical Neuromuscular Stimulation for the purposes of relaxation of muscle spasm, prevention or retardation of disuse muscle atrophy, muscle re-education, increase local blood circulation, maintain or increase range of motion, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
The NT2000 is a compact, battery powered transcutaneous electrical nerve and electronic muscle stimulator. Two channels are available on the NT2000. Each channel operates independently and if desired they may be used simultaneously. The clinician may set up to two prescribed programs from a list of defined programs for use by the patient. The parameters and options for two programs are variable. One option (dual program), the Rx and total treatment times may be set for all of the programs. The programmable parameters are frequency, pulse width, contraction time, relaxation time, ramp up time, ramp down time, amplitude limit and channel delay. The programmable options are synchronous or alternate mode, extended pulse or sub_pulse mode, monophasic or biphasic mode, single or dual frequency, load sensing on or off, audio off or on, trigger mode off or on and dual program off or on. The NT2000 is programmed using a detachable keypad connector called the NT2000C. The clinician may use the NT2000 with the NT2000C interlocked but it is generally designed for use without the NT2000C by the patient. The patient may use the selected program or another available program if provided. The patient may over ride the contraction/ relaxation cycle using an optional external trigger (if provided) or by using the override feature. The patient may also increase and decrease the amplitude of the stimulus. Use of the device is recorded internally, allowing the clinician to evaluate compliance with the prescribed treatment regimen.
The provided text describes a 510(k) premarket notification for a medical device called the NT2000, a Transcutaneous Electrical Nerve Stimulator (TENS) and electronic muscle stimulator.
Here's an analysis of the requested information based on the text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in terms of measurable performance metrics or thresholds for the NT2000. Instead, the "acceptance criteria" appear to be based on demonstrating substantial equivalence to a predicate device and adherence to recognized industry standards for safety and electrical performance.
| Acceptance Criterion (Implied) | Reported Device Performance (Summary) |
|---|---|
| Substantial Equivalence to Predicate Device (Bio Tens Model: ST-601) | Comparisons of stimulation outputs for the NT2000 and the predicate Bio Tens Model: ST-601 show similar results. The NT2000 is effectively a more user controllable device which indicates patient compliance. |
| Adherence to Electrical Standards | The NT2000 is designed and tested to the electrical requirements of IEC 601-1, the electromagnetic compatibility requirements of IEC 601-1-2. The NT2000 also conforms to AAMI/ANSI NS4 #3.2.3.2. 1985. |
| Safety & Effectiveness | Testing of the stimulation output parameters of the NT2000 indicate that the device is safe, that it provides appropriate stimulation output for effective relief of chronic pain and that it performs as well as or better than the legally marketed predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "No clinical testing was performed for the purpose of this 510(k) Premarket Notification." This means there was no "test set" in the context of clinical data. The evaluation was based on non-clinical tests (comparison of stimulation outputs and compliance with standards). Therefore, there is no sample size or data provenance information for a clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As no clinical testing was performed, no experts were used to establish ground truth for a clinical test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As no clinical testing was performed, there was no ground truth to adjudicate.
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 device is a TENS/EMS unit, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and "human readers" are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The NT2000 is a physical medical device, not a standalone algorithm. Its performance is evaluated based on its electrical output parameters and adherence to safety standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the "ground truth" was established by comparison to the a legally marketed predicate device (Bio Tens Model: ST-601) and adherence to recognized electrical and electromagnetic compatibility standards (IEC 601-1, IEC 601-1-2, AAMI/ANSI NS4 #3.2.3.2. 1985). The "ground truth" is therefore based on established engineering and safety standards, and performance characteristics consistent with a previously cleared device.
8. The sample size for the training set
Not applicable. The NT2000 is a hardware device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
§ 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).