(123 days)
The i-lipo™ Ultra Vacuum Massage System is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite. The i-lipo™ Ultra Treatment Pads and Probes are indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasms, and temporary improvement of local blood circulation.
The i-lipo™ Ultra System consists of a main unit, and applied parts (massage head with rollers and various laser diode cluster probes and pads). The Main Unit contains the mains input, fuses, power supply, pump, relay, control circuits, LCD display, membrane function buttons, emergency stop, and key switch. The massage head, and cluster probes and pads, which are placed against the patients skin, contain the rollers, and Laser diodes, Laser light provides topical heating which increases tissue temperature, and the rollers in combination with the vacuum mechanically manipulate the tissue.
The provided text describes a 510(k) submission for the Chromogenex Technologies Limited i-lipo™ Ultra System. However, it does not contain the detailed information requested regarding specific acceptance criteria, study design parameters (like sample sizes for test/training sets, data provenance, expert qualifications, or adjudication methods), or comprehensive performance results.
The document states:
- Clinical Testing: "Skin temperature measurements were made to support the performance of pads and probes as thermal heating systems for pain relief." This is the only mention of a "study" related to performance. It doesn't elaborate on the specifics of this study, its results, or how these results relate to predefined acceptance criteria.
- Non-Clinical Testing: Safety testing was to be carried out to various IEC, UL, and CSA standards (e.g., IEC 60601-1, IEC 60601-2-22, CSA C22.2, IEC 60601-1-2) for electrical safety and electromagnetic compatibility. These are standards for device safety, not device performance against specific clinical efficacy claims or acceptance criteria.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | Skin temperature measurements were made to support performance as thermal heating systems for pain relief. (No specific values or metrics provided.) |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified (implicitly clinical data, but no country or retrospective/prospective status).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified, as there is no mention of ground truth established by experts for performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified.
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:
- No MRMC study was mentioned. The device is not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is a physical medical device, not an algorithm. Standalone performance as typically described for AI/software is not relevant. The device itself operates "standalone" in its intended use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the "skin temperature measurements," the implicit ground truth would be the temperature measurements themselves, considered direct evidence of heating. For other indications like pain relief, muscle spasms, blood circulation, and cellulite reduction, the document only mentions "support the performance" but does not detail how efficacy was measured or validated against a ground truth.
8. The sample size for the training set:
- Not applicable/Not specified as no training set for an algorithm is mentioned.
9. How the ground truth for the training set was established:
- Not applicable/Not specified as no training set for an algorithm is mentioned.
Summary of Device and Study Information:
- Device Name: i-lipo™ Ultra System
- Intended Use: Temporary relief of minor muscle aches and pain, temporary relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.
- Key Finding from Document: The device appears to have obtained 510(k) clearance based on substantial equivalence to predicate devices and non-clinical testing for safety (electrical, EMC) and limited clinical support for performance via skin temperature measurements. The document does not provide details of a rigorous clinical trial with defined acceptance criteria for efficacy or comprehensive performance data for each indicated use. The FDA letter confirms the 510(k) clearance based on substantial equivalence.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.