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The AI.ME System is indicated for fractional skin resurfacing.

The AI.ME system is a micro coring device controlled by a robot that removes skin by using a disposable punch assembly containing six (6), hollow needle punches inserted into the skin with a fixed maximum penetration depth of 3 mm to remove up to 10% of skin in the treatment area to excise and/or resurface skin.

The AI.ME system, which is similar in design and performance as the FDA cleared Venus Concept ARTAS system, consists of a cart, a coring mechanism, single-use vacuum assembly and a sterile single-use disposable punch assembly.

This document describes the FDA's 510(k) clearance for the AI.ME System, a microneedling device for aesthetic use. It details the device's substantial equivalency to predicate devices based on non-clinical performance data.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The document does not present a formal table of quantitative acceptance criteria with corresponding performance metrics like a typical study report might. Instead, it outlines various performance and safety tests conducted and states that they were successfully passed or demonstrated. The acceptance criteria are implicitly linked to compliance with relevant industry standards and guidance documents.

Here's a table constructed from the information provided, outlining the tested aspects and the stated outcome:

Study Details

This document describes a 510(k) premarket notification for a medical device that does not involve an AI algorithm for diagnostic or prognostic purposes, but rather a robotic system that incorporates an "AI.ME System" name. The AI aspect, as described, appears to relate to the robotic control for precision, rather than a data-driven AI model that makes clinical assessments or diagnoses. Therefore, many of the requested details about AI model studies (like sample size for test/training sets, ground truth establishment methods, expert adjudication, MRMC studies) are not applicable to the type of device and testing described in this 510(k) summary.

The "AI" in "AI.ME System" seems to refer to Artificial Intelligence in the sense of an intelligent, automated system (robotics), rather than a machine learning algorithm for image analysis or clinical decision support that would require extensive data for training and testing as per the typical questions.

However, based on the provided text, here's what can be inferred about the "performance data" that serves as the "study":

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

   • Test Set (Pre-Clinical Study): A "swine model" was used for the pre-clinical study. The exact number of animals is not specified.
   • Data Provenance: The study was "pre-clinical" (animal model), likely conducted in a controlled lab environment by the manufacturer or a contract research organization. The country of origin is not specified. It is a prospective study, as it describes an evaluation over time (7, 14, 28 days post-treatment).
   • Other Performance Data: For non-clinical tests like electrical safety, EMC, software validation, sterility, biocompatibility, etc., these are bench tests and lab validations. No patient data or image data sets were mentioned.

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

   • For the swine study, "macroscopical and histopathological analysis" was conducted. This implies expert evaluation (e.g., pathologists).
   • However, the number of experts and their specific qualifications are not specified.
   • Ground truth regarding the performance characteristics (e.g., accuracy of needle penetration depth) would have been established by engineering measurements using instruments like the Keyence Laser System, not clinical experts.

3. Adjudication Method for the Test Set:

   • For the pre-clinical (swine) study, the method of adjudication for macroscopic and histopathological analysis is not specified. It generally implies a consensus or independent review process by qualified personnel, but no details are provided.
   • For other performance tests, adjudication methods are not applicable as they involve objective measurements against standards.

4. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

   • No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging AI systems where human readers interpret medical images with and without AI assistance. The AI.ME system is a microneedling device, not a diagnostic imaging AI.

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

   • The document describes device performance characteristics and safety validations. While the "AI.ME System" implies an automated aspect (robotics), the testing detailed is on the physical device's mechanics, safety, and biological interaction. It's not a standalone AI algorithm in the sense of a software-only diagnostic tool being evaluated for its performance. The "performance data" reported is for the system as a whole, including its automated functions, but doesn't isolate an AI algorithm's performance in a way that is typically measured for diagnostic AI.

6. The Type of Ground Truth Used:

   • Pre-Clinical Swine Study: Ground truth was established through "macroscopical and histopathological analysis" of tissue from the treated areas at different time points (7, 14, 28 days). This is pathology-based ground truth indicating tissue response and healing.
   • Other Tests: Ground truth for other aspects (e.g., electrical safety, EMC, sterility, biocompatibility, accuracy of needle depth) was established through objective measurements against recognized industry standards and validated methods.

7. The Sample Size for the Training Set:

   • Not applicable / not specified. The document describes a medical device clearance based on substantial equivalence and non-clinical performance testing validated against standards. It does not describe the development or training of a machine learning model that would require a distinct "training set" of data in the typical AI sense. The "AI" in AI.ME likely refers to robotic automation/control, not a learned model from a dataset.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable. As no AI training dataset is explicitly mentioned, the concept of establishing ground truth for a training set does not apply.

Conclusion Summary from Document:

The document concludes that the AI.ME System is safe and effective as the legally marketed predicate and reference devices, and that the performance testing data supports the stated indications for use. It asserts that the AI.ME System did not raise new questions of safety or effectiveness.

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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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CO2 LASER Part: Fractional mode is indicated only for ablative skin resurfacing. Non-fractional mode is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery). otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery.

The Ilooda Fraxis CO2 Laser is comprised of the following major components:

• The main console unit 1.
• 2. Delivery handpieces (2)
• 3. Footswitch.
• 4. Accessories
     The device is re-usable and non-sterile; instructions for cleaning its components between uses are provided in the labeling.

The provided text details a 510(k) premarket notification for the Ilooda Fraxis CO2 Laser, showing its substantial equivalence to a predicate device (Fraxis Duo). However, the document does not contain any information about acceptance criteria, device performance testing against specific clinical endpoints, or related studies (such as MRMC, standalone, or ground truth establishment) typically associated with AI/ML-driven medical devices.

The performance testing section (VIII) only lists general safety and electrical standards (e.g., IEC 60601-1, IEC 60601-2-22) and mentions software verification/validation and biocompatibility. Crucially, Section IX explicitly states:

"Based on the similarities in the safety and effectiveness profiles of the subject, primary predicate and reference devices, no clinical studies were deemed needed to support this submission."

This indicates that the device's approval was based on demonstrating substantial equivalence to a legally marketed predicate device, rather than on demonstrating performance against specific clinical acceptance criteria in a dedicated study. The information required in your request, such as acceptance criteria, sample sizes, expert adjudication, MRMC studies, standalone performance, and detailed ground truth establishment, is typically associated with a more rigorous clinical validation process for novel devices or AI/ML components, which was not performed or submitted for this particular 510(k).

Therefore, I cannot fulfill your request for the specific details within the given document because the document does not contain that information.

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SECRET RF is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis.

Secret RF's High Frequency(=Radio Frequency) includes the system main body, a bipolar handpiece(Two type) with disposable micro-needle type electrodes, footswitch and an LCD touch screen control panel. The HF energy is delivered to the target tissue using a handpiece and disposable tip(micro needle electrode tip), the tip being placed in light contact with the epidermis and the handpiece being held at right angles to the target tissue. As the HF energy passes through the skin, it generates an electro thermal reaction, which is capable of coagulating the tissue. Using the micro needle tip, the Secret RF system creates heat within the target dermal tissue via micro-needles inserted from the tip.

The provided text describes a 510(k) summary for a medical device called "Secret RF". This document focuses on demonstrating substantial equivalence to a predicate device, "FRAXIS DUO_RF PART" (K160312), rather than providing detailed acceptance criteria and studies for independent device performance.

Therefore, many of the requested categories cannot be directly addressed from this document because it's a submission for substantial equivalence based on similar technology and intended use, not a clinical trial evaluating specific performance metrics against pre-defined acceptance criteria.

However, I can extract information related to the device's technical specifications and the non-clinical testing performed to establish safety and effectiveness for a 510(k) submission.

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

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

The document does not explicitly state acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the "performance" demonstrated is that the device's technological characteristics and non-clinical test results are comparable or compliant with established standards, supporting its substantial equivalence to the predicate device.

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

• Non-Clinical Testing (IEC Standards): Not applicable for "sample size" in the conventional sense of a clinical test set. These are engineering and electrical safety tests typically performed on a device unit.
• Animal Testing: Micropig models were used. The document does not specify the number of animals (sample size).
• Data Provenance: The document implies these tests were conducted by the manufacturer or accredited labs for the purpose of the 510(k) submission. No country of origin for the "test set" data is explicitly stated beyond the manufacturer being in Korea. The animal study results are not presented in a way that would indicate retrospective or prospective, but animal studies for regulatory submissions are typically prospective.

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

This is not applicable to the non-clinical and animal testing described. Ground truth in a clinical context (e.g., expert consensus on image interpretation) is not part of this 510(k) summary, which focuses on device safety and technical equivalence. The animal study generated histological data, which would typically be analyzed by veterinary pathologists, but this detail and the number of experts are not provided.

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

This is not applicable. Adjudication methods are typically used in clinical studies involving interpretation of data by multiple human readers, which is not described here.

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 510(k) submission for a non-AI electrosurgical device, not an AI-powered diagnostic or assistive tool.

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

Not applicable. This device is an electrosurgical tool, not an algorithm. Its performance is directly tied to its physical and electrical characteristics and how it interacts with tissue.

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

• For Non-Clinical Testing (IEC standards): "Ground truth" is compliance with the defined parameters and limits of the specific international standards (e.g., electrical safety, EMC).
• For Animal Testing: The ground truth for evaluating tissue effects was histological data obtained from micropig models, presumably interpreted by pathologists.

8. The sample size for the training set

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

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

Not applicable. There is no training set for this device.

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