Search Results

The Palomar Aspire™ Laser Platform is indicated for laser assisted lipolysis.

The Palomar Aspire™ Laser Platform is a small transportable system which includes a cart, power supply, software, user interface panel, footswitch, cooling system and handpiece.

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and supporting study for the Palomar Aspire™ Laser Platform:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state specific quantitative acceptance criteria or detailed performance metrics for the Palomar Aspire™ Laser Platform. Instead, it relies on the concept of substantial equivalence to predicate devices.

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

The document does not specify a classic "test set" sample size for a clinical study in the way one might expect for a diagnostic or treatment efficacy device. The primary approach for demonstrating equivalence appears to have been through a comparison of the device's technical specifications and intended use against existing predicate devices.

• Sample Size: Not applicable in the context of a comparative clinical trial for this specific 510(k) submission. The "data" refers to the technical specifications and functional capabilities compared to predicates.
• Data Provenance: The document does not provide information about the country of origin or whether the data for the new device was retrospective or prospective. The "performance data" mentioned is generalized and suggests technical testing rather than a clinical trial with patient data.

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

This information is not provided and is likely not relevant to this type of 510(k) submission, which focuses on substantial equivalence rather than establishing a new clinical benefit or diagnostic accuracy against a ground truth standard via clinical experts.

4. Adjudication Method for the Test Set:

This information is not provided and is not applicable to the substantial equivalence framework used here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence to predicate devices, not on demonstrating an improvement in human reader performance with or without AI assistance. The device in question is a medical laser system for lipolysis, not an AI-powered diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Study Was Done:

No, a standalone (algorithm only) study was not done. The Palomar Aspire™ Laser Platform is a physical medical device (laser system), not a software algorithm or AI. Its performance is evaluated based on its physical and functional characteristics for performing laser-assisted lipolysis.

7. The Type of Ground Truth Used:

The concept of "ground truth" as typically used in diagnostic AI evaluation (e.g., pathology, outcomes data) is not directly applicable here. The "ground truth" in this context is implicitly the established safe and effective performance of the predicate devices for laser-assisted lipolysis. The new device demonstrates its equivalence to these known safe and effective devices.

8. The Sample Size for the Training Set:

This information is not applicable/not provided. The device is a hardware system, not a machine learning model, so there is no "training set" in the conventional sense.

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

This information is not applicable/not provided as there is no training set for a machine learning model.

Summary of the Study:

The "study" referenced in the 510(k) summary is not a traditional clinical trial or performance study with acceptance criteria in the sense of a new technology proving its efficacy. Instead, it is a technical and functional comparison of the Palomar Aspire™ Laser Platform against existing, legally marketed predicate devices. The "performance data" provided was sufficient to demonstrate that the new device shares:

• The same intended use (laser-assisted lipolysis).
• Similar technological characteristics.
• Similar principles of operation.

This demonstration led the FDA to conclude substantial equivalence to its predicate devices, implying that it is as safe and effective without requiring a full-scale clinical trial to prove new safety or efficacy. The predicates listed are other laser systems for lipolysis (e.g., Cynosure SmartLipo, Biolitec Ceralas, Sciton Profile ProLipo, New Star Lasers CoolLipo).

Ask a specific question about this device

1064 nm: Intended for the coagulation and hemostasis of benign vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and the treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos, solar lentigos, Café au lait macules, seborrheic keratoses, nevi, chloasma, verrucea, skin tags, keratoses, and plaques.

The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the laser is indicated for the removal of unwanted hair, for the stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment of pseudofolliculitis barbae. Indicated for use on all skin types (Fitzpatrick I-IV), including tanned skin.

1320 nm: For use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue. For use in the treatment of fine lines and wrinkles. It is also indicated for the treatment of back acne and atrophic acne scars.

The SKIN CLEAR SRVH Long Pulsed Nd:YAG Laser is a compact self-contained device that delivers a beam of laser energy at infrared wavelengths of 1064 nm and 1320 nm to the treatment site. The SKIN CLEAR SRVH Long Pulsed Nd: YAG Laser consists of six (6) primary components:

1. Laser console;
2. Internal computer;
3. Control panel and display;
4. Optical delivery system;
5. Hand set with integrated cooling (chilled sapphire optical window);
6. Foot switch
   The SKIN CLEAR SRVH Long Pulsed Nd: YAG Laser is not battery operated, but is controlled and operated with the aid of computer software.

The provided text does not describe specific acceptance criteria and a study proving the device meets those criteria. Instead, it is a 510(k) summary for the SKIN CLEAR SRVH Long Pulsed Nd:YAG Laser, which seeks to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving performance against predefined acceptance criteria through a clinical study.

Here's a breakdown of why this information is absent and what the document does provide:

• No Clinical Performance Data: The document explicitly states "Clinical Performance Data: None" and "Nonclinical Performance Data: None." This immediately tells us that no studies were conducted to gather performance metrics against acceptance criteria for this specific device.
• Substantial Equivalence: The conclusion states: "The SKIN CLEAR SRVH Long Pulsed Nd:YAG Laser shares the same indications for use, similar design features (including wavelengths, laser medium, power supply, cooling and control systems), functional features (including power output, repetition rate, energy, spot sizes and energy fluence), and is therefore substantially equivalent to the above legally marketed laser systems currently in commercial distribution." This is the core of a 510(k) submission – demonstrating similarity to a device already on the market, avoiding the need for new clinical trials in many cases.

Therefore, for the specific questions asked, the answers are largely "Not applicable" or "None provided" based on the nature of this 510(k) submission.

Here's how to answer based on the provided document, addressing each point:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size (Test Set): Not applicable, as no clinical or performance test set data specific to this device is provided.
• Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: 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

• MRMC Comparative Effectiveness Study: No, not applicable. This is a laser device, not an AI-assisted diagnostic tool for human readers.

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

• Standalone Performance Study: No, not applicable. This is a physical laser device, not an algorithm.

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

• Type of Ground Truth: Not applicable, as no clinical study or performance data generation for this specific device is described.

8. The sample size for the training set

• Sample Size (Training Set): Not applicable, as no algorithm training or clinical study for this device is described.

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

• Ground Truth Establishment for Training Set: Not applicable.

Summary based on the document:

This 510(k) submission for the SKIN CLEAR SRVH Long Pulsed Nd:YAG Laser relies entirely on demonstrating substantial equivalence to existing, legally marketed predicate devices. No new clinical performance data, nonclinical performance data, or studies (such as those involving test sets, training sets, experts, or multi-reader studies) were submitted for this specific device. The device's approval is based on its similar design, functional features, and indications for use as compared to the listed predicate devices.

Ask a specific question about this device