Search Results

The Candela Cbeam Pulse Dye Laser is indicated for the following uses in:

General Surgery: Photocoagulation of benign cutaneous vascular lesion and benign cutaneous lesions.

Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesion, such as facial and leg telangiectasia, rosacea, port wine stains, hemangioma, angioma, spider angioma, Poikiloderma of Civatte, and benign cutaneous lesions, such as warts, scars, stries and psoriasis. Periorbital wrinkles and the treatment of wrinkles.

Gynecology: Photocoagulation of benign cutaneous lesion and benign vascular lesion in gynecology.

Podiatry: Treatment of benign cutaneous lesion, such as warts.

The Cbeam is a 585 nm flash-lamp excited pulse dye medical laser, controlled by an embedded microprocessor, to be used for the treatment of benign cutaneous vascular lesions, such as facial and leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma. Poikiloderma of Civatee and benign cutaneous lesions, such as warts, scars. striea and psoriasis. Photocoagulation of benign cutaneous lesion and benign vascular lesion in Gynecology. Treatment of periorbital wrinkles. The Cbeam laser may be used with the Candela Dynamic Cooling Device, which provides a short burst of cryogen spray prior to firing the laser pulse. The laser output energy is delivered via an optical fiber to a handpiece, which produces circular beams with diameters of 5, 7 or 10 millimeters on the skin. The cryogen, which is housed within the laser enclosure. is delivered via a hose to a nozzle located in the handpiece.

The Candela Cbeam Pulse Dye Laser is equipped with safety interlock systems to protect patients and operators. Users of the device make selections from an onboard control panel to regulate operation during treatment.

The provided text describes the Candela Cbeam Pulse Dye Laser System and its clearance via a 510(k) premarket notification. However, it does not contain information regarding a study with specific acceptance criteria and reported device performance in the format requested.

The document primarily focuses on:

• Device Description: What the Cbeam laser is, its operating principles, and its intended uses.
• Predicate Devices: Identification of similar devices already on the market (Candela Clearbeam Pulse Dye Laser (K013043) and SLS Biophile Ltd NLite (K013461)).
• Regulatory Compliance: Mention of adherence to laser performance standards (21 CFR 1040), electrical safety standards (UL 2601, EN 60601-1-2), and demonstrating substantial equivalence to predicate devices.
• Indications for Use: Specific clinical applications approved for the device.

Key takeaway: The submission for this 510(k) relies on demonstrating "substantial equivalence" to existing legally marketed devices rather than presenting a performance study with specific acceptance criteria as you've outlined. The FDA's decision letter explicitly states, "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices." This means the device met its acceptance criteria by being similar enough to already approved devices, not by achieving specific performance metrics in a new clinical study.

Therefore, I cannot populate the table or answer the specific questions about sample sizes, ground truth, experts, or adjudication methods based on the provided text, as this type of detailed performance study information is not included in this 510(k) submission.

Summary of missing information based on your request:

1. A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on substantial equivalence to predicate devices, not on meeting specific performance criteria from a new study.
2. Sample size used for the test set and the data provenance: Not provided, as no such test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method for the test set: Not provided.
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/not provided. This is a laser system, not an AI-assisted diagnostic tool, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/not provided. This is a physical medical device.
7. The type of ground truth used: Not provided.
8. The sample size for the training set: Not applicable/not provided, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable/not provided.

Ask a specific question about this device

The Candela Vbeam Pulse Dye Laser System is indicated for the following uses in:

General Surgery: Photocoagulation of benign cutaneous vascular lesions and benign cutaneous lesions.

Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesions, such as facial and leg telangiectasia, rosacea, port wine stains, hemangioma, angioma, spider angioma, poikiloderma of Civatte and benign cutaneous lesions, such as warts, scars, striae, and psoriasis. Treatment of periocular wrinkles.

Gynecology: Photocoagulation of benign cutaneous lesions and benign vascular lesions in gynecology.

Podiatry: Treatment of benign cutaneous lesions, such as warts.

The Vbeam Pulse Dye laser is a 595 nm, flash lamp excited pulsed dye medical laser, controlled by an embedded microprocessor. The Vbeam Pulse Dye Laser System is comprised of a power supply, optical delivery system, software control system and Dynamic Cooling Device. The laser output energy is delivered via an optical fiber to a handpiece, which produces circular or elliptical laser beams onto the skin. The Dynamic Cooling Device provides a short burst of cryogen spray during the laser treatment. The cryogen, which is housed within the laser enclosure, is delivered via a hose to a nozzle located in the handpiece. The Dynamic Cooling Device functions to cool the skin during the laser treatment minimizing thermal damage to skin during laser treatment and reducing pain associated with laser treatment.

The Candela Vbeam Pulse Dye Laser is equipped with a safety interlock system to protect patients and operators. Users of the device make selections from an onboard control panel to regulate operation during treatment.

This document describes the Candela Vbeam Pulse Dye Laser System, a medical device for the photocoagulation of benign cutaneous lesions and vascular lesions. The information provided is primarily focused on demonstrating substantial equivalence to predicate devices for regulatory purposes.

Here's an analysis of the provided text based on your request:

Acceptance Criteria and Device Performance

The provided document does not list specific acceptance criteria as quantitative thresholds that the device must meet (e.g., "device must achieve X accuracy"). Instead, the "acceptance criteria" are implicitly understood as demonstrating substantial equivalence to predicate devices. The "device performance" is described in terms of its characteristics and intended use being similar to these predicates.

Study Details

The provided document does not describe a clinical study or performance study in the way you've outlined. Instead, it's a 510(k) premarket notification for demonstrating substantial equivalence based on technical and intended use comparisons to existing predicate devices. Consequently, many of your requested details are not applicable or available in this type of submission.

Here’s a breakdown based on the provided text:

1. Sample size used for the test set and the data provenance:

   • N/A. No clinical "test set" and associated data provenance (e.g., country of origin, retrospective/prospective) are mentioned. The submission relies on comparative analysis with predicate devices and compliance with engineering standards.

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

   • N/A. No clinical "test set" requiring expert-established ground truth is described.

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

   • N/A. No clinical "test set" requiring an adjudication method is described.

4. 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. This device is a laser system, not an AI-assisted diagnostic or therapeutic tool that would involve "human readers" or "AI assistance." Therefore, an MRMC study is not applicable.

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

   • N/A. This is a hardware laser system with software controls, not a standalone algorithm.

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

   • N/A. Since no clinical performance study for the Vbeam Pulse Dye Laser System itself is detailed, there's no mention of ground truth establishment for a test set. The "ground truth" in this context is the established safety and efficacy of the predicate devices to which the Vbeam is compared.

7. The sample size for the training set:

   • N/A. No "training set" for an algorithm or AI model is applicable to this device type or submission.

8. How the ground truth for the training set was established:

   • N/A. See point 7.

In summary, the provided document is a 510(k) summary focused on demonstrating the substantial equivalence of the Candela Vbeam Pulse Dye Laser System to previously cleared predicate devices based on its intended use, operating principles, and design aspects. It does not contain information about a clinical performance study with defined acceptance criteria, test sets, ground truth establishment, or clinical efficacy data as one might find for a novel diagnostic or AI-powered device. The "testing" mentioned refers to compliance with laser performance and electrical safety standards.

Ask a specific question about this device