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Alexandrite 755nm laser source:
Temporary hair reduction.
Stable long-term or permanent hair reduction through selective targeting of
melanin in hair follicles. 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 regime, on all skin types (Fitzpatrick I - VI) including tanned skin.
Treatment of benign pigmented lesions.
Treatment of wrinkles.
Photocoagulation of benign dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
Nd:YAG 1064nm laser source:
Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB . The lasers are indicated on all Skin Types Fitzpatrick I-VI including tanned skin.
Photocoagulation and hemostasis of benign pigmented and benign vascular lesions, such as but not limited to port wine stains, hemangioma, warts, teleangiectasia, rosacea, venus lake, leg veins and spider veins.
Coagulation and hemostasis of soft tissue.
Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, cloasma, verrucae, skin tags, keratosis and plaques.
The laser is indicated for benign pigmented lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Treatment of wrinkles.

Motus AZ is a medical device equipped with Alexandrite 755nm laser and Nd: YAG 1064nm laser.
The laser sources deliver the laser output through a lens coupled user replaceable optical fiber with a wide range of interchangeable, quick release laser handpieces with electronic spot recognition.
The modifications to the device consist on a restyling of the device (chassis, cover plastics and GUI) and on modifications to Moveo handpiece (new spot sizes available and new optional spacer). The spot size and the fluences are within the range of the already cleared device (K181486). The optional spacer is made of a biocompatible material (Anticorodal 6082), already used in previously cleared devices for the same type of contact (K192539, K172362, K172362, K133895).
The intended use of the modified devices, as described in the labelling, has not changed as a result of the modifications. Labelling itself has been updated also to include general improvements that have been implemented since predicate device clearance and considered as minor changes.

This document is a 510(k) summary for the DEKA Motus AZ device, a laser surgical instrument. It primarily focuses on demonstrating substantial equivalence to a predicate device (DEKA Motus AY, K181486) rather than providing extensive details about a specific clinical study for performance acceptance criteria.

The acceptance criteria presented are essentially that the proposed device (DEKA Motus AZ) maintains the same or equivalent specifications and performance characteristics as the predicate device (DEKA Motus AY). The submission asserts that the modifications are minor and do not affect safety or effectiveness.

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

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

The document does not explicitly state numerical acceptance criteria for clinical efficacy or specific performance metrics in the way one might expect from a clinical trial summary. Instead, the acceptance criteria are implicitly met by demonstrating that the DEKA Motus AZ's specifications and performance are identical to or within acceptable variations of the predicate device (DEKA Motus AY).

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

The document primarily relies on demonstrating substantial equivalence to a predicate device through engineering and performance comparisons, not on a prospective clinical trial with a "test set" as one might find for a novel device or AI algorithm. It's a "Special 510(k)" which generally indicates modifications to an already cleared device.

Therefore, there is no mention of a specific clinical "test set" sample size or data provenance in the context of efficacy for the modified DEKA Motus AZ device. The "data" refers to engineering and non-clinical performance data.

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 applicable. This submission is for a laser surgical instrument, and the performance testing mentioned (electrical safety, EMC, software validation) does not involve establishing ground truth by medical experts for image interpretation or diagnosis.

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

Not applicable. See #3.

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 a laser surgical instrument, not an AI-based diagnostic tool that would typically involve MRMC studies or human reader improvement with AI assistance.

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

Not applicable. See #5.

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

Not applicable in the context of clinical efficacy ground truth for a test set. The "ground truth" for this submission are the established safety and performance standards for laser medical devices and the characteristics of the predicate device.

8. The sample size for the training set

Not applicable. This document does not describe the development or testing of an AI algorithm with a training set.

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

Not applicable. See #8.

Summary of the Study Proving Acceptance Criteria:

The "study" proving the device meets its acceptance criteria, in this context, is the demonstration of substantial equivalence to the predicate device (DEKA Motus AY, K181486) through a combination of:

• Non-clinical performance testing:
  • Electrical safety and electromagnetic compatibility (EMC): Conducted according to ANSI AAMI ES60601-1 and IEC 60601-1-2 standards.
  • Software Validation and Verification Testing: Conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
  • Additional non-clinical testing: Conducted according to IEC 60601-2-22 (particular requirements for laser equipment) and IEC 60825-1 (safety of laser products).
• Comparison of technological characteristics: A detailed side-by-side comparison (as shown in the provided table) confirming that the proposed device (DEKA Motus AZ) shares the same intended use, fundamental technology (Alexandrite 755nm and Nd:YAG 1064nm lasers, wavelengths, fluences, pulse durations, repetition rates, skin cooling systems), and similar or identical essential design parameters within acceptable ranges as the predicate device. The changes (restyling, new Moveo handpiece spot sizes and optional spacer) were evaluated to ensure they do not introduce new questions of safety or effectiveness.

The conclusion states: "Based on the comparison of indications for use and the technological characteristics, we can conclude that DEKA Motus AZ is as safe, as effective, and performs as well as the legally marketed predicate device (K181486)." This statement serves as the proof that the device meets the implicit acceptance criteria of being substantially equivalent to the cleared predicate.

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Lumenis AcuPulse W CO2 Laser System, Delivery Devices and Accessories is indicated for incision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynaecology, neurosurgery, orthopaedics, general and thoracic surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

The subject AcuPulse W system is a new scaled-down version of the recently FDA cleared Lumenis AcuPulse CO2 Laser System, Delivery Devices and Accessories under K180597. It is based on the following hardware components in the AcuPulse:

• . A Laser Console with a Free Beam Port to which an articulated arm attached.
  • Identical to the AcuPulse, the Laser Console of the AcuPulse W System houses the laser O tube and optical system, the laser power source, console electronics, laser output ports, cooling system, purge air pump, control components (including touch screen, emergency stop button) and rear connector panel.
• . An articulated arm to guide laser output via a set of folding mirrors to the connected accessory for delivery of laser energy to the tissue.
• . A footswitch to activate the laser treatment beam and allow the selected laser energy to be transmitted via the delivery device to the target location.
• . A variety of Free Beam Delivery Device and accessories.

The AcuPulse and AcuPulse W systems have the same proprietary software, which is embedded in the Main Controller, Peripheral Controller units and PC. The differences between the two are the enabled or disabled software features, through a hardware key (HASP dongle), that reflects the capabilities of each laser system or the particular configuration of a given system. Importantly, both systems use the same Software version, which was already validated, verified and submitted under K180597.

The AcuPulse W is offered with a subset of the previously cleared AcuPulse Handpieces/Tips that connect to the articulated arm or/and scanners for controlled delivery of laser energy to the target tissue. In addition, Lumenis is adding a Titanium (Ti-6Al-4V) 90° Side-firing Handpiece design. Like the cleared handpieces, it has multiple uses. The 90° Side-firing handpiece connects to the cleared AcuScan 120 Microscanner through two adaptors (a Handpiece Adapter and Third Lens Adapter) for delivery of laser energy. The 90° Side-firing handpiece is comprised of the following components:

• Handpiece Adapter
• Tip (Standard or Fine)
• . Limiter ring (Standard or Fine)

This handpiece is based on the same technology and principles of operation of the cleared CO2 delivery devices and its introduction does not raise any new questions of safety and/or efficacy.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Lumenis AcuPulse W CO2 Laser System, Delivery Devices and Accessories:

Observation: The provided text is a 510(k) summary for a medical device. This type of document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific, novel acceptance criteria through a primary clinical study. It details changes from a previous version and outlines various verification and validation activities conducted. Therefore, it does not contain information about a traditional "study that proves the device meets acceptance criteria" in the sense of a standalone clinical trial with pre-defined performance endpoints. Instead, it indicates that the device was evaluated against existing standards and specifications to ensure it performs comparably to the predicate.

Given this context, I will extract relevant information to address your points, acknowledging that some fields might not be directly applicable as they pertain to clinical performance studies, which are not detailed here.

Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission, the "acceptance criteria" are primarily established by the successful demonstration of substantial equivalence to the predicate device and compliance with relevant industry standards for safety and performance. There isn't a table of specific clinical performance criteria (e.g., sensitivity, specificity for a diagnostic device) and reported device performance from a clinical trial in this document.

The document implicitly states that the device performs in accordance with its requirements and specifications similarly to its predicate device. The "reported device performance" is effectively its compliance with the listed standards and its functional equivalence to the cleared predicate.

• IEC 60601-1
• IEC 60601-1-2
• IEC 60825-1
• IEC 60601-2-22 | Testing performed and results indicated that the new configuration performs in accordance with its requirements and specifications similarly to its predicate device. This implies successful completion and compliance with these standards. |
  | 90° Side-firing Handpiece performance (functional) | Testing demonstrated that the accessory (90° Side-firing Handpiece) together with the AcuPulse W system performs in compliance with their specifications and requirements. This includes functional equivalence to existing cleared CO2 delivery devices based on the same technology and principles. |
  | 90° Side-firing Handpiece Cleaning Validation (AAMI TIR 30) | Validation activities performed. |
  | 90° Side-firing Handpiece Sterilization Validation (ISO 17665-1) | Validation activities performed. |
  | 90° Side-firing Handpiece Biocompatibility (ISO 10993) | Biocompatibility testing performed for materials. |
  | Software Validation | The AcuPulse and AcuPulse W systems use the same proprietary software version, which was already validated, verified, and submitted under K180597. The differences are enabled or disabled features via a hardware key. This implies the software continues to meet its previously established performance criteria as the core software remains unchanged. |
  | Substantial Equivalence to Predicate Device (K180597) | The device is deemed substantially equivalent. Test results indicated that the new configuration performs in accordance with its requirements and specifications, similarly to its predicate device, and does not raise new questions of safety and/or effectiveness. |

Study Details (as inferable from the 510(k) Summary):

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

   • Sample Size: Not applicable in the context of a clinical test set. The document describes engineering verification and validation activities (testing against standards, functional testing of accessories). For these engineering tests, sample sizes are not explicitly stated, but typically involve representative samples of the device and its components.
   • Data Provenance: Not applicable for a clinical test set. The studies are engineering and regulatory compliance tests.

2. 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 applicable. This device is not an AI/diagnostic device that requires expert-established ground truth for a test set. The "ground truth" for the engineering tests is compliance with established safety and performance standards and the functional specifications of the device.

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

   • Not applicable. This is not a study requiring adjudication of clinical outcomes or diagnostic interpretations.

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 surgical instrument, not an AI-based diagnostic or assistive system for human readers.

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

   • Not applicable. This is not an AI algorithm but a physical medical device. Software validation was done, but it pertains to the device's operational control, not a standalone diagnostic algorithm. The software is embedded and controls the laser device.

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

   • The "ground truth" for the evaluation documented here is primarily compliance with recognized electrical, laser safety, and biocompatibility standards (e.g., IEC 60601-1, IEC 60825-1, ISO 10993, ISO 17665-1, AAMI TIR 30), and the functional specifications set for the device and its accessories, evaluated through engineering tests, rather than clinical outcomes or expert consensus on patient data.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that involves a "training set."

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

   • Not applicable, as there is no training set for an AI model.

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The CO2 Laser Therapy System is used for body soft tissue vaporization and coagulation in dermatology and plastic surgery, general surgery, gynecology.

The CO2 Laser Therapy Systems generate a 10,600nm wavelength, which is absorbed by water in the tissue. The laser energy heats up the water until it reaches a boiling point causing the evaporation of the affected tissue. Some heat is absorbed by tissue adjacent to the ablated target area, causing tissue coagulation which induces hemostasis (the cessation of bleeding) as well as thermal stimulation of deep skin layers, which induces fibroblast stimulation and neocollagenesis (the formation of new collagen).

I'm sorry, but the provided text describes a medical device called "CO2 Laser Therapy System" and its FDA 510(k) clearance application. It details the device's indications for use, technological characteristics, and comparison to predicate devices, along with non-clinical testing performed to meet electrical safety and electromagnetic compatibility standards.

However, the document explicitly states in section "VIII Clinical Testing" that "It is not applicable." This means that no clinical studies, which would typically involve testing the device's performance against defined acceptance criteria on a test set with ground truth, were conducted or included in this submission for the purpose of demonstrating substantial equivalence.

Therefore, I cannot provide the information requested regarding acceptance criteria, device performance, sample sizes, data provenance, expert adjudication, MRMC studies, standalone performance, or ground truth establishment, as this type of information is not present in the provided text. The FDA clearance was based on substantial equivalence to predicate devices and non-clinical performance testing.

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