Search Results

The Isolaz™ is intended to treat benign vascular and pigmented lesions, permanent hair reduction, mild to moderate acne, including pustular acne, comedonal acne and mild to moderate inflammatory acne (acne vulgaris) in all skin types (Fitzpatrick I-VI).

The Isolaz™ System is a portable tabletop system used to deliver non-coherent 400-1200nm, 530-12000mm and 580-1200mm intense pulsed light via a delivery handpiece utilizing photpneumatic technology. The system consists of a main console, a treatment handpiece and a footswitch. The desired power and delivery time are set manually by the operator.

The provided text is a 510(k) summary for the Isolaz™ Intense Pulsed Light System. This document focuses on establishing substantial equivalence to a predicate device, rather than detailed clinical study results with acceptance criteria.

Therefore, the document does not contain the information requested to comprehensively describe the acceptance criteria and the study that proves the device meets them, according to your specific points.

Here's a breakdown of what is and isn't present in the provided text:

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

• Not present. The document states "Product testing was conducted to evaluate conformance to product specification. The results showed the system met specification." However, it does not elaborate on what those specifications or acceptance criteria were, nor does it provide a table of performance metrics.

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

• Not present. This document doesn't detail any clinical test sets or their characteristics.

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):

• Not present. There is no mention of ground truth establishment by experts for a test set.

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

• Not present.

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:

• The Isolaz™ is an Intense Pulsed Light system, not an AI-powered diagnostic device that would typically involve human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.

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

• The Isolaz™ is a physical medical device for treatment, not an algorithm. Therefore, a standalone algorithm performance study is not applicable and not mentioned.

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

• Not present.

8. The sample size for the training set:

• Not present. The document does not describe a training set as would be relevant for an AI/ML model.

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

• Not present.

In summary:

The provided K083730 510(k) summary is a regulatory filing for a medical device that demonstrates substantial equivalence to a predicate device. It focuses on the device's intended use, basic function, manufacturing methods, and materials, asserting that product testing confirmed conformance to general specifications. It does not include the detailed clinical study data, acceptance criteria, or ground truth establishment methodologies that would be required to answer your specific questions, which are more relevant to diagnostic devices, particularly those involving AI/ML.

Ask a specific question about this device

The Aesthera Photopneumatic™ (PPx™) System is intended for:

• The treatment of benign vascular and pigmented lesions: .
• Permanent hair reduction; .
• The treatment of mild to moderate acne, including pustular acne, comedonal acne, . and mild to moderate inflammatory acne (acne vulgaris).

The Aesthera Photopneumatic™ (PPx™) System is intended for use on all skin types (Fitzpatrick skin types I-VI).

The Aesthera Photopneumatic™ (PPx™) System is comprised of the following main components:

• . Main console
• PPx™ Treatment Handpiece .
• Optional coolant accessory cryogenic, water, or air spray for cooling the handpiece . tip; and
• . Treatment Footswitch.

The Aesthera Photopneumatic™ (PPx™) System (with treatment handpiece) is a portable tabletop system used to deliver intense pulsed light to the patient treatment site via a delivery handpiece utilizing Photopneumatic technology. Intense pulsed light is emitted through the IntelliTip™ only when the tip is sealed against the selected patient treatment All emitted light is contained within the IntelliTip™ during treatment. site. The handpiece is uniquely designed to promote increased ergonomics with all user interface and controls located on the handpiece.

The provided text is a 510(k) summary for the Aesthera Photopneumatic™ (PPx™) System. It describes the device, its indications for use, and its substantial equivalence to predicate devices. However, it does not contain detailed information about specific acceptance criteria, a formal study design with performance metrics, sample sizes for test sets, data provenance, expert qualifications, or adjudication methods typically found in clinical trial reports or detailed performance studies.

The document states: "Clinical data demonstrating the safety and effectiveness of the Aesthera Photopneumatic™ (PPx™) System for the treatment of mild to severe acne, including pustular acne, comedonal acne, and mild to moderate inflammatory acne (acne vulgaris) was provided." However, it does not elaborate on the specifics of this clinical data.

Therefore,Based on the provided text, I cannot complete the requested tables and information. The document is a 510(k) summary focused on substantial equivalence, and it lacks the detailed performance study information required to answer your questions.

Ask a specific question about this device

The AIP Intense Pulsed Light System is an intense pulsed light device intended for the following: the treatment of benign vascular and pigmented lesions, and permanent hair reduction.

The AIP Intense Pulsed Light System is intended for use on all skin types (Fitzpatrick skin types I-VI).

The AesThera AIP Intense Pulsed Light System is a 400—1200 nm intense pulsed light delivery system, powered by Photo-Pneumatic™ technology. It is a portable tabletop system with a hand piece connected by an umbilical to the main console. The hand piece incorporates an intelligent tip that is replaced with every patient treatment. A "sealed" intelligent tip is used to transmit light to the patient's skin. Light is emitted only through the tip and is always sealed with the patient's surrounding tissue during intense pulsed light emission. All emitted light is contained within the tip during treatment. The hand niece of the AIP Intense Pulsed Light System is uniquely designed to promote increased ergonomics with all user interface and controls located on the hand piece.

This 510(k) summary does not contain the information requested for acceptance criteria and a study proving the device meets those criteria.

This document is a regulatory submission for a new medical device (AesThera AIP™ Intense Pulsed Light System) seeking 510(k) clearance by claiming substantial equivalence to existing predicate devices.

Here's why the requested information is not present:

• Acceptance Criteria & Device Performance Table: This type of table, with specific performance metrics and acceptance thresholds, is typically found in a detailed clinical study report or a design verification and validation (V&V) report. The 510(k) summary focuses more on demonstrating equivalence to predicates in terms of intended use, technology, and safety features.
• Study Details (Sample Size, Data Provenance, Ground Truth, Adjudication, MRMC, Standalone Performance, Training Set): The document provided is the 510(k) summary itself, which is a high-level overview. While the approval letter mentions the device is "substantially equivalent...for the indications for use stated in the enclosure," it does not detail any specific clinical studies performed by the manufacturer of this new device to establish its performance against predefined acceptance criteria.

Key points from the provided document relevant to its clearance:

• Intended Use: Treatment of benign vascular and pigmented lesions, and permanent hair reduction on all skin types (Fitzpatrick I-VI).
• Mechanism: Intense Pulsed Light (IPL) system (400-1200 nm) with proprietary Photo-Pneumatic™ technology.
• Regulatory Approach: Substantial Equivalence to listed predicate devices (SkinStation™, StarLux™, MediLux™, EsteLux™, etc.). This means the manufacturer is asserting their device is as safe and effective as existing legally marketed devices, rather than submitting results from a de novo clinical trial with specific performance endpoints.
• No detailed performance data: The document does not describe the specific performance metrics (e.g., clearance rates, adverse event rates, scar formation rates for lesion treatment; hair reduction percentage for hair removal) that would typically be evaluated in a study with acceptance criteria.

To answer your request, if this were a document describing a clinical study (which it is not), I would be looking for:

1. A specific section detailing clinical study results.
2. Explicitly stated primary and secondary endpoints.
3. Statistical analyses establishing the device's performance against pre-defined thresholds.

Since this is a 510(k) summary, the "acceptance criteria" are effectively that the device is substantially equivalent to established predicate devices, and the "study" is the comparison made to those predicates, along with a declaration of its intended use and technological characteristics. No specific performance study with a defined test set, ground truth, or expert consensus is described within this document for the new device.

Ask a specific question about this device