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510(k) Data Aggregation
(29 days)
Inspirstar IS02 Microcurrent Stimulator is intended to be used for the symptomatic relief of chronic intractable pain.
Inspirstar IS02 Microcurrent Stimulator is a Microcurrent TENS device intended to be used for the symptomatic relief of chronic intractable pain. This product can generate low current intensity pulses at microampere level and frequency of pulses. The unit supports five pre-defined therapy programs. The current intensity, frequency, time, etc. are programmable by doctors.
The provided document describes a 510(k) premarket notification for the Inspirstar IS02 Microcurrent Stimulator, a TENS device intended for symptomatic relief of chronic intractable pain. This type of submission relies on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than conducting new clinical trials to establish de novo effectiveness against specific acceptance criteria.
Therefore, the document does not contain information on acceptance criteria for a novel device performance study, nor a study proving the device meets such criteria. Instead, its "performance data" section focuses on compliance with general safety and electromagnetic compatibility standards and software verification.
However, I can extract the information relevant to the substantial equivalence process which implicitly defines the "acceptance criteria" for a 510(k) submission and how the device "meets" them:
1. Table of Acceptance Criteria and Reported Device Performance (as applied to Substantial Equivalence):
| Acceptance Criteria (based on Predicate Device Equivalence) | Reported Device Performance (Inspirstar IS02) |
|---|---|
| Indications for Use: Same as legally marketed predicate device. | "Inspirstar IS02 Microcurrent Stimulator has the same indications for use as the legally marketed predicate device." (Section 6) |
| Indications for Use: "symptomatic relief of chronic intractable pain." (Section 4) | |
| Technological Characteristics: Same or comparable to predicate device without raising new questions of safety or effectiveness. | "Inspirstar IS02 Microcurrent Stimulator has the same technological characteristics as all of the predicate devices. All are battery-powered, current source pulse generator devices with two output channels." (Section 7) |
| "Inspirstar IS02 Microcurrent Stimulator has very close waveforms and output characteristics including frequency, current intensity, wave slope, etc with Precision Micro ('THERASTIM') and has comparable waveforms and output characteristics with Alpha-Stim 100('ALPHA-STIM CS')." (Section 7) | |
| "The user operating interfaces to setup values of frequency, current intensity, etc have some differences... But these differences do not affect the technology and do not affect the safety and effectiveness." (Section 7) | |
| Safety and Effectiveness: Demonstrated through compliance with recognized standards and software verification (where applicable). | "Inspirstar IS02 Microcurrent Stimulator conforms to applicable voluntary standards IEC 60601-1 for safety requirement, and IEC60601-1-2 for electromagnetic compatibility requirement. In addition, the software verification has been carried out according to FDA software guidance." (Section 8) |
The following information is NOT applicable or NOT available in the provided document, as it pertains to a different type of device evaluation (e.g., a clinical study with novel performance claims, not a substantial equivalence submission):
- 2. Sample size used for the test set and the data provenance: Not applicable. No test set for a performance study is described. The "test" is a comparison to predicate devices based on design and technical specifications.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" for a performance test set is described.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 unit, not an AI-assisted diagnostic tool requiring human reader performance studies.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic diagnostic device.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" in a 510(k) is the established safety and effectiveness of the predicate device(s).
- 8. The sample size for the training set: Not applicable. Not an AI/ML device requiring a training set.
- 9. How the ground truth for the training set was established: Not applicable.
Summary of the "Study" (Substantial Equivalence Demonstration):
The "study" undertaken for the Inspirstar IS02 Microcurrent Stimulator was a 510(k) premarket notification to the FDA. This regulatory pathway demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device.
- Nature of the "Study": A comparison of the new device's indications for use, technological characteristics, and performance data (safety and EMC standards, software verification) against one or more predicate devices.
- "Acceptance Criteria" for this "Study": The FDA's criteria for substantial equivalence, primarily:
- Same intended use as the predicate device(s).
- Same technological characteristics, OR
- Different technological characteristics that do not raise new questions of safety or effectiveness and are supported by appropriate data (e.g., performance testing as per standards).
- Conclusion: The FDA reviewed the submission and found the Inspirstar IS02 Microcurrent Stimulator to be substantially equivalent to the predicate devices (Precision Micro / THERASTIM and ALPHA-STIM CS). This determination allows the device to be legally marketed.
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