Search Results

Ask a specific question about this device

Ask a specific question about this device

The IPL Treatment Device (Model: MDSQMC-01) is intended for use in surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions.
Mild to moderate inflammatory Acne (Acne vulgaris)

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 regimen.

The IPL Treatment Device is an intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 400nm-1200nm, Intense Pulsed Light (IPL) systems work on the principles of selective thermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin. IPL Systems are different from lasers in that they deliver many wavelengths in each pulse of light instead of just one wavelength. Generally, IPL enhances penetration without using excessive energy levels and enables targeting of specific chromophores. Based on this, the IPL Treatment Device (inclusive of the handpiece used to deliver pulsed-light energy) is indicated for use in surgical and aesthetic applications in permanent hair removal, and reduction of benign pigmented lesions and benign vascular lesions.

The provided FDA 510(k) clearance letter and summary for the IPL Treatment Device (Model: MDSQMC-01) primarily focus on demonstrating substantial equivalence to a predicate device through technical specifications, safety, and biocompatibility testing. It does not contain information about acceptance criteria and clinical study results that would typically prove a device meets those criteria for performance-based claims.

Specifically, the document states:

• "The following performance data were provided in support of the substantial equivalence determination."
• It then lists Biocompatibility Testing, Electrical Safety and EMC, Eye Safety, Software Verification and Validation, and Usability.

These are non-clinical performance data related to the device's safety and fundamental operation, not its clinical efficacy or diagnostic performance as would be demonstrated in studies with acceptance criteria for patient outcomes or diagnostic accuracy.

Therefore, many of the requested details about acceptance criteria and clinical study types (like MRMC studies, ground truth establishment, expert qualifications, sample sizes for test/training sets, effect sizes) are not present in the provided text.

Based on the information available:

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

The document does not explicitly state performance-based acceptance criteria for its indicated uses (permanent hair removal, reduction of benign pigmented/vascular lesions, mild to moderate inflammatory Acne) nor does it provide clinical study results against such criteria. The "Performance Data" section details safety and engineering tests, not clinical performance outcomes.

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

This information is not provided in the document. The document lists non-clinical testing (biocompatibility, electrical safety, etc.) but does not describe any clinical test sets, their sizes, or provenance.

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)

This information is not provided. As no clinical test set is detailed, there's no mention of experts or ground truth establishment relevant to clinical performance.

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

This information is 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

This information is not provided. The device is an IPL treatment device, not a diagnostic AI device that would typically participate in MRMC studies to evaluate human reader improvement with AI assistance.

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

This information is not provided. The device is a physical IPL treatment device, not a standalone algorithm.

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

This information is not provided for clinical performance. The "ground truth" for the non-clinical tests would be the established standards (e.g., ISO, IEC norms) that the device successfully met.

8. The sample size for the training set

This information is not provided. As no clinical efficacy study is described, there is no mention of a training set.

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

This information is not provided.

Summary of available "Performance Data" which are non-clinical:

The study that proves the device meets these acceptance criteria are the laboratory and engineering tests listed under "Performance Data," demonstrating compliance with the referenced international standards (ISO, IEC) for safety and software functionality, and adherence to FDA guidance for usability. These studies were performed by the manufacturer as part of their submission without specific mention of external labs or detailed methodologies beyond the standard references.

Ask a specific question about this device

• The DEKA LOTUS 570mm pulsed light handpiece is indicated for photocoagulation of dermatological benign vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions.
· The DEKA LOTUS 500G pulsed light handpiece is intended for treatment of benign pigmented lesions, including lentigines, nevi, melasma, and cafe-au-lait; and treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, telangiectasias, rosacea, facial and leg veins.
· The DEKA LOTUS RF handpiece is indicated for use in dermatologic and general surgical procedures for the noninvasive treatment of mild to moderate facial wrinkles and rhytides.

The DEKA LOTUS is a device provided with two pulsed light handpieces and a RF handpiece.
The two pulsed light handpieces have a built-in cooled waveguide which differ in emission spectrum, connected to the main unit through a flexible multifunctional cable.
The handpiece uses a linear Xenon flashlamp, emitting a broad spectrum of electromagnetic radiation (light) when energized.
The RF handpiece produces a particular electric current at 1MHz that induces a molecular oscillation on the cells, raising their temperature locally. The RF current flows through the special electrodes, forming a homogeneous heat area.
The modifications to the device respect to DEKA LOTUS (K233473) consist of replacement of the filter of 590nm Intensed Pulsed Light Handpiece with a 570nm filter. The intended use of modified device, as described in the labelling, has changed as a result of the modifications. Labelling itself has been updated accordingly.

The provided text is a 510(k) summary for the DEKA LOTUS device, which is an intense pulsed light (IPL) and radiofrequency (RF) system. This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a performance study with detailed acceptance criteria and validation results for an AI algorithm.

Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found within the provided text.

The document states:

• Clinical Performance Data: None. This explicitly indicates that no clinical studies were performed to prove the device meets acceptance criteria in a clinical setting.
• Non-Clinical Performance Data: "Test according to IEC 60601-2-57:2011 for the modified IPL Handpiece." This refers to electrical safety and electromagnetic compatibility standards, not performance criteria for a specific medical outcome or AI algorithm.

The core of this 510(k) submission is a comparison of the device's technical specifications and intended use against a predicate device (Quanta Chrome K202503 and existing DEKA LOTUS K233473) to establish substantial equivalence. The "Acceptance Criteria" here are implicitly linked to demonstrating that the new device variant (specifically, a 570nm filter change for an IPL handpiece) is as safe and effective as the predicate, based on technical similarity, without requiring new clinical performance studies.

Ask a specific question about this device

The Intense Pulsed Light Treatment System (Model: LK-PT) is indicated for use in surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions.

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 regimen.

The LK-PT device is an intense pulsed light system which delivers intense pulsed light at wavelengths ranging from 560mm ~ 1200nm. Intense Pulsed Light(IPL) system work on the principles of selective thermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin.

IPL systems are different from lasers in that they deliver many wavelengths in each pulse of light instead of just one wavelength. Generally, IPL enhances penetration without using excessive energy levels and enables targeting of specific chromophores.

The provided text does not contain any information about acceptance criteria or a study that proves the device meets those criteria, as typically seen for AI/ML-enabled devices.

Instead, this document is a 510(k) Premarket Notification from the U.S. FDA, indicating that the device, an Intense Pulsed Light Treatment System (Model: LK-PT), has been reviewed and determined to be substantially equivalent to a legally marketed predicate device (Intense Pulsed Light Treatment System, Model: HM-IPL-B8, K192521).

The type of analysis performed here is a comparison to a predicate device to show substantial equivalence, not a performance study against predefined acceptance criteria for an AI/ML algorithm.

Here's why the requested information cannot be extracted and what the document does discuss:

• No AI/ML Component: The device described is an "Intense Pulsed Light Treatment System." The description focuses on its physical parameters (wavelength, energy density, pulse width, spot size, power) and its working principle (selective thermolysis). There is no mention of any AI or machine learning component in the device. Therefore, questions 1, 3, 4, 5, 6, and 7, which relate to AI/ML study design, ground truth, and reader studies, are not applicable.
• No Acceptance Criteria for Performance: The document doesn't define acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) because it's not demonstrating de novo performance; it's demonstrating equivalence to an already cleared device.
• No Specific Performance Study: Section 10 explicitly states: "No clinical study is included in this submission." This means there was no clinical performance study conducted to prove the device meets specific acceptance criteria.
• Basis for Equivalence: The determination of substantial equivalence (SE) is based on:
  • Same intended use: Permanent hair removal, reduction of benign pigmented lesions, and benign vascular lesions.
  • Similar technological characteristics: Both are Intense Pulsed Light (IPL) systems.
  • Non-clinical performance tests: These tests are for safety and essential performance (e.g., electrical safety, electromagnetic compatibility, photobiological safety, biocompatibility), not for clinical efficacy or diagnostic accuracy.
  • Comparison of technical parameters: Wavelength, energy density, pulse delay, pulse width, spot size, and max power are compared to the predicate, with minor differences deemed not to negatively affect safety and effectiveness.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, AI performance studies, sample sizes for AI, ground truth establishment, or expert adjudication, as this information is not present in the provided 510(k) document for this non-AI/ML device.

Ask a specific question about this device

MULA is intended for aesthetic and dermatological skin procedure applications by using multi-filtered Intense Pulsed Light/ Dye Pulsed Light. Intended Use for the 400-1200mm (including 8 filters) Light:

1. Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, and ephelides (freckles).

2. Cutaneous lesions, including warts, scars and striae.

3. Benign cutaneous vascular lesions, including port wine stains, hemoangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas, poikiloderma of Civatte, facial and leg veins and venous malformations.

4. Removal of unwanted hair and to effect stable long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles.

5. Mild to moderate inflammatory Acne (Acne vulgaris)

Note: Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after completion of treatment regime.

The MULA is a multi-application, multi-technology system, with an IPL&DPL handpiece and 8 different filters: 515nm/ 560mm/ 615nm/ 640mm/ 695nm/ Acne Filter (Notch filter 400-600 and 800-1200) and Vascular Filter (Notch filter 530-650 & 900-1200), and it also equips two precision treatment heads (38x10mm and 8mm diameter).

This document is a 510(k) summary for the MULA (K2-A1) device, a multi-filtered Intense Pulsed Light/Dye Pulsed Light (IPL/DPL) system. The document states that clinical testing was "Not applicable," meaning a study demonstrating the device meets specific acceptance criteria was not included in this submission.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them from the provided text. The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.

Ask a specific question about this device

The Intense Pulsed Light System is intended for medical use in the treatment of the following conditions:

1. Moderate inflammatory acne vulgaris;
2. Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
3. Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial truncal and leg telangiectasias, erythema of rosacea, leg veins, spider angiomas and venous malformations;
4. Permanent hair reduction-long-term stable reduction in number of hairs re-growing after a treatment regimen.

Intense Pulsed light (IPL) System is a type of intensive, broadband, coherent light source which has a wavelength spectrum of 420 nm -1200 nm. There are six optical filters that can be using in this system listed in table. With these special properties, the IPL System has a wide application in non-ablative therapies based on theory of human skin tissue's selective absorption.

The provided FDA 510(k) summary (K240482) for the Smedtrum Medical Technology Co., Ltd. Intense Pulsed Light System (ST-690) indicates that the device's acceptance criteria are based on bench testing for optical energy output and electrical safety, and its performance is demonstrated by compliance with relevant IEC standards.

Here's an analysis of the requested information:

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

• IEC 60601-1: 2005+corr.1:2006+Corr.2.2007+A1:2012 (General requirements for basic safety and essential performance)
• IEC 60601-1-2:2020 (Electromagnetic disturbances)
• IEC 62471 First edition 2006-07 (Photobiological safety)
• IEC 60601-2-57 Edition 1.0 2011-01 (Particular requirements for non-laser light source equipment) |
  | Bench Testing (Optical Energy Output): Spatial variation of the LS equipment output over the treatment area shall not deviate from the average irradiance or radiant exposure by more than ±20%. | The product fulfills the requirements of IEC 60601-2-57 (which includes parameters for optical energy output and spatial variation). Specifically, the document states "The Intense Pulsed Light system... has been determined through engineering testing to verify optical energy output... The product fulfills the requirements of IEC 60601-2-57." |
  | Intended Use and Indications for Use: Equivalence to the predicate device. | The device has the same intended use and indications for use as the predicate device (K231394). |
  | Technological Characteristics and Operating Principles: Equivalence to the predicate device. | The device has the same technological characteristics, energy used, and operating principles as the predicate device (K231394), with minor differences in form factor (tabletop vs. standing, single handpiece vs. potentially more on predicate). |

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 does not specify a patient-based test set sample size or data provenance (country, retrospective/prospective). The performance data cited is based on engineering and bench testing to verify hardware and software functionality and safety, not clinical trial data with human subjects.

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)

This information is not applicable to this submission. The ground truth relies on engineering and safety standards compliance, not expert consensus on clinical data.

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

This information is not applicable. There was no clinical test set requiring human adjudication.

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

This is not applicable. The device is an Intense Pulsed Light System, a physical medical device for treatment, not an AI-powered diagnostic or assistive tool for human readers.

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

This is not applicable. The device is a physical therapeutic system, not an algorithm. Performance assessment is based on physical and electrical output specifications.

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

The ground truth used for this submission is compliance with established international engineering and electrical safety standards (IEC 60601-1, IEC 60601-1-2, IEC 62471, IEC 60601-2-57) and verification of optical energy output specifications.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of an algorithm or AI model for this type of medical device submission. The device is evaluated based on its physical and electrical performance against predefined engineering standards.

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

This is not applicable as there is no training set. The "ground truth" for the device's performance relies on engineering measurements and adherence to specified performance ranges outlined in the electrical and optical standards.

Ask a specific question about this device

· The DEKA LOTUS 590nm pulsed light handpiece is indicated for permanent hair removal. 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.

· The DEKA LOTUS 500G pulsed light handpiece is intended for treatment of benion pigmented lesions, including lentigines, nevi, melasma, and cafe-au-lait; and treatment of benign vascular lesions, including port wine stains, hemangiomas, telangiectasias, rosacea, facial and leg veins.

· The DEKA LOTUS RF handpiece is indicated for use in dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides.

The DEKA Lotus is a device provided with two pulsed light handpieces and a RF handpiece. The two pulsed light handpieces have a built-in cooled waveguide which differ in emission spectrum, connected to the main unit through a flexible multifunctional cable. The handpiece uses a linear Xenon flashlamp, emitting a broad spectrum of electromagnetic radiation (light) when energized. The RF handpiece produces a particular electric current at 1MHz that induces a molecular oscillation on the cells, raising their temperature locally. The RF current flows through the special electrodes, forming a homogeneous heat area.

This document is a 510(k) Summary for the DEKA LOTUS device, which is an intense pulsed light and radiofrequency (RF) system. It focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than proving specific performance metrics against pre-defined acceptance criteria for a novel AI/software component in a diagnostic context.

Therefore, the information required to answer your specific questions about acceptance criteria, ground truth, sample sizes for training/testing, expert adjudication, and MRMC studies is not present in this document. This is because the DEKA LOTUS is a medical device (pulsed light and RF system), and the 510(k) submission primarily relies on demonstrating equivalence to existing devices through non-clinical performance data (electrical safety, EMC) and comparisons of technical specifications and indications for use, rather than clinical performance studies involving AI algorithms.

Here's a breakdown of why this information is missing and what is provided:

Why the requested information is absent:

• Nature of the Device: The DEKA LOTUS is a physical medical device (laser/light/RF system), not an AI/software-based diagnostic tool. Its performance is assessed through its physical characteristics and safety, not through diagnostic accuracy or interpretation of images/data by an algorithm.
• 510(k) Pathway: The 510(k) substantial equivalence pathway typically does not require extensive clinical trials or performance studies if the device is similar enough to existing ones. It focuses on comparing the new device to predicates in terms of indications for use, technological characteristics, and safety/EMC.
• No AI/Software Component for Interpretation: There's no mention of a software component that interprets medical images, diagnoses conditions, or assists human readers in a diagnostic task. The software validation mentioned refers to the general control software for the device's operation, not an AI for diagnostic purposes.

What information is provided in the document (and how it relates to your questions, or why it doesn't):

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

   • Acceptance Criteria: Not explicitly stated in the context of device performance metrics for an AI. The "acceptance criteria" here are implicitly met by demonstrating substantial equivalence to the predicate devices through identical or similar technical specifications and parameters (e.g., fluence, pulse duration, frequency for light/RF) and demonstrating compliance with safety standards (IEC 60601 series).
   • Reported Device Performance: The document provides comparative tables showing the technical specifications of the DEKA LOTUS against its predicate devices (Quanta Chrome, Palomar Icon, Pollogen Legend+™ System) for pulsed light (590nm, 500G) and RF handpieces. Examples include:
     • Pulsed Light (590nm): Fluence (Up to 25 J/cm² - identical to predicate), Spot Size (20x17 mm vs. predicates' 48x13 mm/25x13mm - difference noted as not affecting safety/effectiveness), Pulse Duration (Up to 40 ms - identical), Repetition Rate (3 Hz max. - identical).
     • Pulsed Light (500G): Fluence (Up to 80 J/cm² - identical), Spot Size (17x20 mm vs. predicate's 10x15 mm - difference noted as not affecting safety/effectiveness), Pulse Duration (1-100 ms - identical).
     • RF Handpiece: Frequency (1 MHz - identical), Waveform (Sinusoidal - identical), Maximum output power (50W or 15W - identical).
   • Safety and EMC testing: The document states that electrical safety and electromagnetic compatibility (EMC) testing were conducted according to ANSI AAMI ES60601-1 and IEC 60601-1-2. There were also tests according to IEC 60601-2-57 for non-laser light source equipment. This implies these standards' requirements serve as "acceptance criteria" for basic safety and performance, which were met.

2. Sample sizes used for the test set and the data provenance: Not applicable. This refers to an AI/software's performance test set. The document mentions non-clinical testing (electrical safety, EMC, thermal profiles) but these don't involve test "samples" in the sense of patient data for a diagnostic algorithm. No clinical data or test sets are described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This relates to ground truth for diagnostic AI.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This relates to ground truth for diagnostic AI.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. The document explicitly states "Clinical Performance Data: None." This type of study (MRMC) is relevant for assessing human reader performance with and without AI assistance, which is not the purpose of this submission for a light/RF device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no diagnostic algorithm to perform in a standalone manner.

7. The type of ground truth used: Not applicable. Ground truth typically refers to validated diagnostic labels for training/testing AI models.

8. The sample size for the training set: Not applicable. There is no AI model being trained on patient data.

9. How the ground truth for the training set was established: Not applicable. There is no AI model being trained on patient data.

In summary, this 510(k) submission for the DEKA LOTUS device demonstrates substantial equivalence based on the device's technical specifications and compliance with relevant safety and performance standards for physical medical devices, rather than a clinical performance study of an AI-powered diagnostic tool.

Ask a specific question about this device

The Intensity Pulsed Light Therapy System is intended for medical use in the treatment of the following conditions: -Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles); -Cutaneous lesions including scars; - Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial truncal and leg telangiectasias, erythema of rosacea, leg veins, spider angiomas and venous malformations. -Permanent hair reduction-long-term stable reduction in number of hairs re-growing after a treatment regimen.

Not Found

I apologize, but the provided text from the FDA 510(k) clearance letter for the "Intensity Pulsed Light Therapy System" (K233307) does not contain any information regarding acceptance criteria, device performance studies, or details about the validation of an AI/algorithm-based medical device.

The document is a standard FDA clearance letter confirming substantial equivalence to a predicate device. It outlines:

• The device name and regulation details.
• The FDA's determination of substantial equivalence.
• General controls and regulatory requirements the manufacturer must adhere to (e.g., Quality System regulation, adverse event reporting, labeling).
• Indications for Use for the device.

There is no mention of:

• Specific performance metrics or acceptance criteria for the device (e.g., sensitivity, specificity, accuracy).
• Any study data, sample sizes, data provenance.
• Expert involvement for ground truth, adjudication methods.
• Multi-reader multi-case (MRMC) studies or standalone algorithm performance.
• Details about training sets or how ground truth was established for "AI" or "algorithm" components.

Therefore, I cannot fulfill your request for a table of acceptance criteria, study details, or information about AI/algorithm validation, as this information is not present in the provided text.

Ask a specific question about this device

The Intense pulsed light therapy device is indicated for use in surgical and aesthetic applications in permanent hair removal. 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 regimen.

The Intense pulsed light therapy device is an intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 650-1200nm. Intense Pulsed Light (IPL) systems work on the principles of selective thermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin. IPL Systems are different from lasers in that they deliver many wavelengths in each pulse of light instead of just one wavelength. Generally, IPL enhances penetration without using excessive energy levels and enables targeting of specific chromophores. Based on this, the Intense pulsed light therapy device is indicated for use in surgical and aesthetic applications in permanent hair removal.

The document is a 510(k) Summary for an Intense Pulsed Light (IPL) therapy device (Model: FI-L06) seeking FDA clearance for permanent hair removal. It compares the proposed device to a predicate device (K192519) to establish substantial equivalence.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a numerical or pass/fail format for clinical performance. Instead, it relies on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technical specifications. The key performance comparison is presented in tables 6-2 and 6-3.

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

• Sample Size: Not applicable. The submission explicitly states: "No clinical study is included in this submission." The evaluation for substantial equivalence relies on non-clinical (bench) testing and comparison to the predicate device's established performance and specifications.
• Data Provenance: Not applicable, as no clinical data was submitted. Non-clinical tests were conducted by the manufacturer, Hebei Zhemai Technology Co., Ltd., in China.

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

• Not applicable. No clinical test set requiring expert ground truth was created for this submission. The submission relies solely on non-clinical testing and comparison to an existing predicate device.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set requiring adjudication was used.

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 device is an Intense Pulsed Light therapy device for hair removal, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or is relevant for this device type.

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

• Not applicable. This device is a physical IPL therapy machine; it does not involve an algorithm running in a standalone mode without human interaction, nor an AI component to evaluate. Its operation is managed by a user.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Not applicable. No clinical ground truth was established or used as no clinical studies were performed. The "ground truth" for demonstrating substantial equivalence was based on bench testing and comparison against recognized industry standards (IEC 60601-1-2:2020, AAMI/ANSI ES 60601-1: 2012, IEC 60601-2-57: 2011, ISO 10993-5: 2009, ISO 10993-10: 2010, ISO 14971: 2019) and the established specifications and indications for use of the predicate device.

8. The Sample Size for the Training Set

• Not applicable. No AI model or algorithm requiring a training set was part of this submission.

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

• Not applicable. No training set was used.

Ask a specific question about this device