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510(k) Data Aggregation
(96 days)
PICORE Q-switched Nd : Y AG Laser System is indicated for the incision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.
532nm Wavelength
Tattoo removal light ink (red, tan, purple, orange, sky blue) Removal of Benign Epidermal Pigmented Lesions, Minor Benign Vascular Lesions. Talangiectasias Treatment of Lentigines, Cafe-Au-Lait, Sebrorrheic Keratoses, Becker's Nevi, Freckles Treatment of Post Inflammatory Hyperpigmentation (PIH)
1064nm Wavelength:
Tattoo removal: dark ink (black, blue, green) Removal of Nevus of Ota, Removal or lightening of unwanted hair with or without adjuvant preparation Treatment of Common Nevi, Melasma, Skin resurfacing procedures for the treatment of acne scars. wrinkle
The subject device PICORE is a picosecond Nd:Y AG laser instrument that uses Nd:YAG as a medium to emit a laser beam of 1064nm and 532nm wavelength. It has four non-fractional handpieces (Zoom handpiece, 7mm collimated handpiece, 3-5 mm handpiece, 6-8 mm handpiece). A physician can optimize the treatment effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam. Laser emission can be controlled by using a Foot Switch. Laser parameters and other system features are controlled from a display panel located on the front of the power supply unit.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device (BM.IRIS, K171648) by showing that its technical specifications are comparable and that it passed relevant non-clinical testing standards.
However, we can infer the "acceptance criteria" through the comparison to the predicate device and the non-clinical testing performed.
| Acceptance Criteria (Inferred) | Reported Device Performance (PICORE, K212082) |
|---|---|
| Technical Specifications Comparable to Predicate Device (BM.IRIS, K171648): | |
| Laser Type | Nd:YAG (Same as predicate) |
| Wavelength (nm) | 1064/532 (Same as predicate) |
| Operating Mode | Q-switched, Pulsed (Same as predicate) |
| Spot size (mm) | 2-10 @ 1064nm, 2-10 @ 532nm (Comparable to predicate's 2-10 @ 1064nm, 1.5-8 @ 532nm) |
| Maximum Pulse Energy (mJ) | 50-800 @ 1064nm (Q), 5-300 @ 532nm (Q), 50-800 @ Blue Fx, 50-800 @ Blue T (Different from predicate's 1200 @1064nm (Q), 400 @ 532nm (Q), etc., but noted as "different & subset" with an implication of maintaining safety/effectiveness). |
| Maximum Pulse Power (GW) | 800 mJ/450ps = 1.8 GW (Different from predicate's 1200 mJ/5ns = 0.24 GW, but deemed not to significantly alter safety/effectiveness). |
| Pulse Duration | 450 ps @ 1064nm, 380 ps @ 532nm, 450 ps @ Blue Fx, 450 ps @ Blue T (Different from predicate's 5-10ns, but deemed not to significantly alter safety/effectiveness). |
| Repetition Rate (Hz) | 1-10 (Different from predicate's 10-20, but noted as "different & subset" with an implication of maintaining safety/effectiveness). |
| Aiming Beam | <3 mW @ 655 nm (Same as predicate) |
| LCD Display | 10.4" touch screen (Same as predicate) |
| Cooling | Closed circuit water to air (Same as predicate) |
| Power Consumption | 3kVA (Same as predicate) |
| Dimensions | 290mmX794mmX934mm (Comparable to predicate's 295mmX740mmX1680mm) |
| Weight | 60 kg (Comparable to predicate's 70 kg) |
| Compliance with Non-Clinical Standards: | |
| Basic Safety & Essential Performance (IEC 60601-1) | Met (Test conducted) |
| Laser Product Safety (IEC 60825-1) | Met (Test conducted) |
| Electromagnetic Compatibility (IEC 60601-1-2) | Met (Test conducted) |
| Software Validation & Verification | Met (Test conducted) |
| Bench Testing to Verify Performance | Met (Test conducted) |
| Biocompatibility: (Not performed, rationale provided) | Not applicable: Handpieces do not touch patients and are identical to the predicate device. |
| No Significant Alteration in Safety and Effectiveness due to Technical Differences from Predicate | The document explicitly states: "The difference in technological parameters is not expected to significantly alter the safety and effectiveness of the subject device compared to the predicate device." This is the overarching acceptance criterion for substantial equivalence. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. No clinical or standalone performance studies were conducted that would involve a "test set" of patients/data in the typical sense for an AI/diagnostic device. The testing was non-clinical (bench testing, standards compliance).
- Data Provenance: Not applicable. The testing was primarily against hardware/software standards and direct comparison of specifications, not clinical data or patient samples.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. Since no clinical study or data-driven performance test was conducted on a "test set" requiring ground truth, no experts were used for this purpose in the context of this submission.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No clinical or data-driven test set requiring adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done.
- Effect Size of Human Readers with AI vs. without AI assistance: Not applicable, as no such study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Standalone Performance Study: No, a standalone performance study (algorithm only) was not conducted. The device is a laser system, not an AI or diagnostic algorithm, and its performance is evaluated through technical specifications and safety standards, not an "algorithm only" assessment.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable in the context of clinical outcomes or diagnostic accuracy. For the non-clinical testing, the "ground truth" was established by engineering specifications, recognized international safety and performance standards (IEC standards), and the technical characteristics of the legally marketed predicate device.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a laser system, not a machine learning or AI-driven diagnostic device that typically requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable, as no training set was used.
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