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The CO2-2B Galaxy CO2 Laser System is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery, general surgery.

Dermatology, Plastic Surgery and General Surgery procedures:

Laser skin resurfacing.

Treatment of furrows and wrinkles.

Removal of skin tags, actinic keratosis, acne scars, keloids, tattoos, telangiectasia, squamous and basal cell carcinoma, warts and uneven pigmentation.

Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications.

Blepharoplasty.

Site preparation for hair transplants.

The fractional scanner is for treatment of wrinkles and skin resurfacing.

Galaxy CO2 Laser System consists of Mainframe, Optical Delivery System, Protective Glasses and Footswitch. Mainframe consists of CO2 laser generator, laser power supply, control device, safety protection system and cooling system. Optical delivery system consists of articulated arm, aiming beam, normal handpiece and fractional scanner handpiece.

Galaxy CO2 Laser System produces a beam of coherent infrared light --- 10.6µm laser which is near the peak of tissue water absorption. When the water in the tissue absorbs the laser energy, it heats up. The heating causes instantaneous vaporization of the target issue. Equipped with the scanner, the system delivers a high-speed laser scan with micro spots for optional control of treatment area and depth.

The provided document is a 510(k) summary for the CO2-2B Galaxy CO2 Laser System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing extensive clinical trials with performance criteria. As such, the information you're requesting regarding acceptance criteria and a study proving those criteria are met, particularly in the context of AI performance, human-in-the-loop studies, and detailed ground truth establishment, is not present in this document.

Here's why and what information is available:

• Device Type: The CO2-2B Galaxy CO2 Laser System is a surgical laser, not an AI/ML diagnostic or prognostic device.
• 510(k) Process: The 510(k) pathway for medical device clearance primarily requires the manufacturer to demonstrate that their new device is "substantially equivalent" to an existing, legally marketed predicate device. This often involves non-clinical testing (bench testing, electrical safety, EMC, etc.) and comparison of technical characteristics, indications for use, and safety. Extensive clinical efficacy studies or performance comparisons against a human standard are typically not required, especially for devices with well-established technologies like CO2 lasers.
• "No Clinical Information is required.": The summary explicitly states this in the "Non-Clinical Conclusion" section, further indicating that the type of study you're asking about (with detailed performance metrics, test sets, ground truth, etc.) was not part of this submission.

Therefore, I cannot provide the requested table or detailed study information from the provided text for the following reasons:

1. No Acceptance Criteria for Performance Defined and Tested: The document does not specify performance acceptance criteria in terms of accuracy, sensitivity, specificity, AUC, or other metrics typically associated with AI/ML or diagnostic devices. The acceptance criteria relate to compliance with safety and performance standards (IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2, UL 60601-1:2003 R6.03).
2. No Performance Study in the Context of AI/ML: There is no mention of a performance study involving a test set, ground truth, or human readers, as this device is a surgical instrument, not a diagnostic AI.

However, I can still extract the information that is relevant to the "Testing" section and the overall submission:

1. Table of Acceptance Criteria and Reported Device Performance (as per document's scope):

• IEC 60601-1 (General requirements for safety)
• IEC 60601-2-22 (Safety of diagnostic and therapeutic laser equipment)
• IEC 60825-1 (Safety of laser products - Part 1: Equipment classification, and requirements)
• IEC 60601-1-2 (Electromagnetic compatibility)
• UL 60601-1:2003 R6.03 |
  | Design Specifications | Laboratory testing conducted to validate and verify that the device met all design specifications. |
  | Substantial Equivalence | Demonstrated to be substantially equivalent to predicate devices (eCO2 Laser System K091115, YouLaserCO2 Laser System K111592, Slim Evolution II CO2 Laser and Delivery Device Accessories K110984) in technology, indications for use, safety compliance, design features, and functional features. |

Missing Information (Not applicable or not provided in the document for this type of device/submission):

2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set as described for AI/ML performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable. No clinical ground truth establishment for a diagnostic AI.
4. Adjudication method 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 is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
7. The type of ground truth used: Not applicable. The "ground truth" for this device's clearance is its compliance with established engineering and safety standards, and its technical equivalence to predicate devices, verified through non-clinical laboratory testing.
8. The sample size for the training set: Not applicable. There is no AI training set.
9. How the ground truth for the training set was established: Not applicable. There is no AI training set.

In summary, the provided document outlines an engineering and regulatory compliance review (510(k) clearance) for a surgical laser, not a clinical validation study for an AI-powered diagnostic tool. The "testing" referred to is primarily non-clinical, demonstrating adherence to technical standards and specifications, and substantial equivalence to existing devices.

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• · Tattoo Removal
• · Treatment of Vascular Lesions
• · Treatment of Pigmented Lesions,
• · Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology

1064nm:
Tattoo Removal: Dark ink: blue and black
Treatment of Pigmented Lesions: Nevus of ota

532nm:
Tattoo Removal: Light ink: red, Light ink: sky blue and green
Treatment of Vascular Lesions: Port wine birthmarks, Telangiectasias, Spider angioma, Cherry angioma, Spider nevi
Treatment of Pigmented Lesions: Café-au-lait birthmarks, Solar lentiginos, Senile lentiginos, Becker's nevi, Freckles, Nevus spilus

The Nd: YAG Laser System is based on the Q-Switched Nd:YAG (1064 nm) and frequency doubled KTP Nd:YAG (532 nm) laser technology. There is one optical cavity containing the Nd:YAG crystal. The frequency doubled KTP Nd:YAG wavelength is achieved by directing the Nd:YAG laser beam through a frequency doubling non-linear crystal. The Nd:YAG laser is activated by means of the use of flashlamp. A red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided by articulated arm to a focusing handpiece.

Both laser wavelengths share a common power supply, control system, and cooling system. The internal microprocessor can be directed to select either the Nd:YAG or the KTP Nd:YAG laser wavelength. The physician is able to select the desired wavelength and the related output energy ,spot size ,fluence via control panel.

The provided text describes a 510(k) premarket notification for the Nd: YAG Laser System (Qmetrx 1000 (Victory 11)) and assesses its substantial equivalence to predicate devices. However, it does not include information about specific acceptance criteria related to device performance in a clinical context (e.g., efficacy rates for tattoo removal, lesion clearance), nor does it detail a study proving the device meets such criteria through clinical endpoints.

Instead, the document focuses on non-clinical testing to ensure safety and compliance with recognized standards.

Here's an analysis of the provided information, addressing your questions based on what is available:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, there are no specific performance acceptance criteria (e.g., target percentages for lesion clearance or tattoo fading) or a report of the device's clinical performance against such criteria. The "Testing" section focuses on compliance with international safety and electrical standards.

2. Sample size used for the test set and the data provenance

The document explicitly states: "No Clinical Information is required." Therefore, there was no clinical test set in the traditional sense of patient data. The testing mentioned refers to laboratory testing for safety and design specifications. There is no information about data provenance (country of origin, retrospective/prospective) for a clinical test set because none was used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

As no clinical test set was used, no experts were utilized to establish ground truth for a clinical test set. The grounding of the device's safety and effectiveness relies on compliance with engineering standards and comparison to previously approved predicate devices by the FDA.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical test set was used.

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 laser system, not an AI-based diagnostic or assistive tool for human readers. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device (laser system), not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical testing, the "ground truth" was established by adherence to the specified international and national safety and performance standards (e.g., IEC 60825-1, IEC 60601 series, UL 60601-1). The device's "effectiveness" from the perspective of this 510(k) is primarily established through its substantial equivalence to the predicate devices, which means it shares similar indications for use, design, and functional features, implying similar efficacy outcomes based on the predicate's established history.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable. There is no mention of a training set.

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The new device Speed 808 Diode Laser System is intended for use in dermatologic and general surgical procedures.

The Speed 808 Diode Laser System is indicated for hair removal, permanent hair reduction.

The permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

The Speed 808 Diode Laser System is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.

Speed 808 Diode Laser System are new devices for 510(k) submission and share the similar indication for use and safety compliance, similar design features and functional features with the predicate devices.

The complete system consists of a console, a handpiece connected to the system by an umbilical cord and a footswitch. There are two important components in the handpiece: a diode laser inserted in the handpiece and a sapphire-made aperture with an area of 10mmX10mm through which laser energy is emitted. A cooling system effectively works on the sapphire-made aperture and can ensure enough and continuous protection of skin. The handpiece is pressed against the patient's skin and a pulse of laser is delivered. To initiate energy output, the system requires the activation of the handpiece trigger or the footswitch. Laser specifications and other system features are controlled from the Operating Buttons and LCD screen on top of the console, which provide interface with the system computer.

The Speed 808 Diode Laser System is intended for hair removal and permanent hair reduction. The manufacturer states that the device is substantially equivalent to the predicate device, Modified Alma Lasers Family of Soprano XL™ Multi-Application Platforms.

Here's a breakdown of the information requested, based on the provided document:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for hair removal or permanent hair reduction. Instead, it relies on substantial equivalence to a predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "No Clinical Information is required." This indicates that no clinical test set with human subjects was used for this 510(k) submission. The evaluation was based on non-clinical testing and comparison to a predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Since no clinical test set was used, there were no experts used to establish a ground truth for a test set. The regulatory body (FDA) reviewed the non-clinical data and the claim of substantial equivalence.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The submission did not involve clinical studies with human readers or AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done

No, a standalone (algorithm only) performance study was not done. This device is a laser system, not an AI algorithm. The testing was non-clinical, focusing on design specifications and compliance with standards.

7. The Type of Ground Truth Used

The ground truth used for this submission is based on:

• Engineering and design specifications: The device was tested to meet its design specifications.
• Compliance with international and national standards: The device underwent testing to ensure it met relevant safety and performance standards (e.g., IEC, UL).
• Substantial equivalence to a legally marketed predicate device: The fundamental "ground truth" for regulatory clearance was the demonstration that the device is as safe and effective as the predicate device already approved for marketing, without raising new issues.

8. The Sample Size for the Training Set

Not applicable. This device is a physical laser system, not an AI model that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As noted above, this device does not utilize a training set in the AI sense.

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