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Olo is intended for vaporization and photocoagulation of benign vascular and benign pigmented lesions in soft tissues.

Olo is a device which emits laser radiation with a wavelength of 532 nm, which is delivered to the tissue through a transfer fiber and a handpiece or a scanner.

The Olo device electrical specifications are: 100-240V~, 50/60Hz, 600VA.

The provided FDA 510(k) clearance letter for the El.En. S.p.A. Olo Laser Device does not contain information about acceptance criteria or a study proving that the device meets specific performance acceptance criteria for a diagnostic AI/ML device.

The document describes a laser surgical instrument, and its clearance is based on substantial equivalence to an existing predicate device (QuadroStar PRO). The "performance data" section explicitly states "Clinical Performance Data: None" and "Non-Clinical Performance Data" which refers to electrical safety, EMC, and software validation for the device's operational functions, not its diagnostic or an AI/ML component's performance.

Therefore, I cannot extract the requested information concerning acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, or training set specifics from the provided text. The device described appears to be a physical medical device (laser) and not a software as a medical device (SaMD) or an AI/ML-powered diagnostic tool as indicated by the nature of the questions.

If the "Olo Laser Device" does incorporate AI/ML for diagnostic purposes, the provided FDA clearance letter is insufficient to detail how its performance was evaluated against specific diagnostic acceptance criteria. This type of information would typically be found in a separate Premarket Submission for AI/ML-enabled Medical Devices Guidance document or within the full submission details, which are not provided here.

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The DEKA BlueBeam is a medical device intended for incision, excision, vaporization, ablation, hemostasis and coagulation of body soft tissue.

The DEKA BLUEBEAM is a diode laser engineered to enhance performance in surgical applications. The DEKA BLUEBEAM electrical specifications are: 100-230V~, 50/60Hz, 300VA.

The FDA 510(k) Clearance Letter for the DEKA BLUEBEAM laser device explicitly states that no clinical performance data was submitted or used for its clearance. The clearance was based solely on non-clinical performance data and a comparison to a predicate device.

Therefore, the following information cannot be provided based on the given document:

• A table of acceptance criteria and the reported device performance: This document does not contain specific acceptance criteria or performance metrics derived from clinical (human) studies. The assessment was based on equivalence to a predicate device and adherence to safety and electromagnetic compatibility standards.
• Sample size used for the test set and the data provenance: No clinical test set.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there was no clinical test set.
• Adjudication method for the test set: Not applicable.
• 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-assisted diagnostic device for human readers.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a laser surgical instrument.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical performance. The ground truth for non-clinical testing refers to the specifications and performance against established safety and technical standards (e.g., electrical safety, EMC, laser safety).
• The sample size for the training set: Not applicable. This is not a machine learning device that requires a training set in the context of clinical performance.
• How the ground truth for the training set was established: Not applicable.

However, I can provide information on the non-clinical acceptance criteria and the study that proves the device meets these criteria, based on the provided document:

Non-Clinical Acceptance Criteria and Study Details:

The DEKA BLUEBEAM device clearance was based on its substantial equivalence to a predicate device (Wolf 445nm, K192272) and its compliance with relevant non-clinical performance and safety standards.

1. Non-Clinical Acceptance Criteria and Reported Performance:

The primary acceptance criterion was demonstrating that the DEKA BLUEBEAM is "as safe, as effective, and performs as well as the legally marketed predicate device (K1992272)." This was assessed through:

• Comparison of Technical Specifications: Demonstrating close similarity or subset relationship of key laser parameters to the predicate.
• Compliance with Recognized Standards: Meeting specific electrical safety, electromagnetic compatibility (EMC), and laser safety standards.
• Software Verification and Validation: Ensuring the software functions as intended and is safe.

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

• Test Set Sample Size: For the non-clinical testing, the "sample size" refers to the specific DEKA BLUEBEAM device(s) subjected to the electrical safety, EMC, and laser safety tests, and the software itself for V&V. The document does not specify the exact number of physical units tested, but it implies a sufficient number were tested to demonstrate compliance.
• Data Provenance: The testing was conducted by or for El.En. S.p.A. based in Italy. The data is generated from laboratory testing of the device itself against international and national standards. This is prospective testing specifically for regulatory submission.

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

• Number of Experts/Qualifications: This is not applicable in the sense of human interpretation of medical images or data. The "ground truth" for non-clinical testing is established by the definitions and requirements of the referenced international and national standards (e.g., IEC 60601 series, IEC 60825 series). The experts involved would be certified testing engineers and regulatory affairs professionals who interpret and apply these standards.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. Non-clinical compliance is typically a pass/fail determination against pre-defined limits or requirements set by the standards, not a consensus or adjudicated reading process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• MRMC Study: No, an MRMC study was not conducted. This type of study is relevant for diagnostic devices where human readers interpret outputs (e.g., medical images) with and without AI assistance. The DEKA BLUEBEAM is a laser surgical instrument.

6. Standalone Performance (Algorithm Only):

• Standalone Performance: Not applicable. This refers to the performance of a software algorithm without human interaction, typically in diagnostic or analytical AI. The DEKA BLUEBEAM is a medical device incorporating software, but its primary function is physical intervention (laser surgery), not analytical output. Its "performance" is assessed overall as a system meeting safety and functional specifications.

7. Type of Ground Truth Used:

• Ground Truth: For non-clinical performance, the "ground truth" is defined by the internationally recognized performance and safety standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1) and the technical specifications of the predicate device. The device's performance (e.g., output power, wavelength, electrical safety parameters, EMC emissions/immunity) is measured directly and compared against the specific limits and requirements set forth in these standards and the predicate's known performance.

8. Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. The DEKA BLUEBEAM is not an AI/machine learning device in the context of requiring training data to learn diagnostic or predictive patterns. Its software is for controlling the hardware and ensuring safe operation, verified through traditional software validation methods.

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

• Ground Truth for Training Set: Not applicable, as there is no "training set" in the machine learning sense for this device. Software verification and validation involve testing the software against its functional and non-functional requirements, which serve as the "ground truth" for whether the software performs as designed and safely.

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• 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.

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MOTUS PRO family is a medical laser family intended for:

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) included tanned skin.

• Treatment of benign pigmented lesions.

• 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 laser are indicated on all Skin Types Fitzpatrick I-VI including tanned skin.

• Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to, port wine stains, hemangioma, warts, teleangiectasias, 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), cafè au lait macules, seborrheic keratosis, nevi, cloasma, verrucae, skin tags, keratosis and plaques.

• The laser is indicated for benign pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patient with lesions that have not responded to other 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 PRO family is a medical laser family equipped with Alexandrite 755mm 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 device available with Alexandrite source only has the brand name MOTUS PRO AX.

The modifications to the device respect to DEKA Motus AZ (K211821) consist of a restyling of the device (chassis, cover plastic and GUI) and on modification to spot size ranges (new spot size available), pulse duration, 755mm maximum fluence and maximum pulse repetition rate. The modified specifications are within the range of the already cleared reference device (K233090).

The intended use of modified device, 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 clearance of predicate device and reference device and considered as minor changes.

This FDA 510(k) Premarket Notification document for the MOTUS PRO Family laser device outlines the basis for substantial equivalence to predicate devices, but does not contain a detailed study report with specific acceptance criteria and performance data in the format typically used for AI/ML device evaluations.

The provided document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices (DEKA Motus AZ (K211821) and DEKA AGAIN PRO family (K233090)) based on identical or within-range technical specifications and indications for use.

Therefore, I cannot extract the specific information requested in the prompt regarding a detailed study with acceptance criteria and device performance metrics, sample sizes, ground truth establishment, or expert involvement as these details are not present in the provided text.

However, I can provide what is available regarding performance data and testing:

Summary of Performance Data (as reported in the document):

The document mentions that electrical safety, electromagnetic compatibility (EMC), and software verification and validation testing were conducted.

There is no specific clinical study data provided in this document that would allow for the construction of a "table of acceptance criteria and reported device performance" in the context of clinical efficacy or diagnostic accuracy. The substantial equivalence is based on the device's technical specifications and intended use being comparable to existing devices.

Regarding the specific questions you asked:

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

   • Not provided in the document. The document details technical specifications of the device and compares them to predicate devices, stating they are "identical" or "within the range" of the reference device. It does not present a formal table of clinical acceptance criteria and the device's performance against them.

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

   • Not provided in the document. The document does not describe a clinical test set or its 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 provided in the document. No information about ground truth establishment or expert involvement for a test set is mentioned.

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

   • Not provided in the document. No information about adjudication methods is mentioned.

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 provided in the document. This document is for a laser device, not an AI/ML device for interpretation, so an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and not mentioned.

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

   • Not applicable. This device is a laser surgical instrument, not an algorithm.

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

   • Not provided in the document. No information about ground truth for clinical efficacy is mentioned. The "performance data" section focuses on engineering safety and software validation, not clinical outcomes.

8. The sample size for the training set:

   • Not applicable/provided. As this is a laser device and not an AI/ML algorithm, there isn't a "training set" in the conventional sense of machine learning.

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

   • Not applicable/provided.

What the document does state regarding performance data:

• Electrical safety and electromagnetic compatibility (EMC): Tested according to AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1. This ensures the device meets fundamental safety and performance requirements for medical electrical equipment and laser products.
• Software Validation and Verification Testing: Conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submission for Device Software Functions." This ensures the software components of the device are reliable and function as intended.

Conclusion stated by the manufacturer:

Based on the comparison of indication for use and the technological characteristics (which are identical or within the range of predicate devices), the manufacturer concludes that the MOTUS PRO family device is safe, effective, and performs as well as the legally marketed predicate devices. This implies that compliance with the listed safety standards and software validation are sufficient for demonstrating substantial equivalence given the nature of the modifications (restyling, modifications to spot size ranges, pulse duration, maximum fluence, and maximum pulse repetition rate, all within the range of already cleared devices).

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· 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.

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785 nm laser source

Intended for removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue.

1064 & 532 nm laser sources in Q-Switched, nanosecond mode

Intended for treatment of benign vascular lesions, benign pigmented lesions, and for hair, tattoo removal and the incision, excision, ablation, vaporization of soft tissue for General dermatology such as, but not limited to:

532 nm (Q-Switched, nanosecond mode), including microbeam handpieces:

• · Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos
• · Treatment of benign vascular lesions including, but not limited to:
  • port wine birthmarks
  • telangiectasias
  • spider angioma
  • Cherry angioma
  • Spider nevi
• · Treatment of benign pigmented lesions including, but not limited to:
  • cafe-au-Iait birthmarks
  • Ephalides, solar lentigines
  • senile lentigines
  • Becker's nevi
  • freckles
• common nevi
• nevus spilus
• Ota Nevus
• · Treatment of seborrheic keratosis
• · Treatment of post inflammatory hyperpigmentation
• · Skin resurfacing procedures for the treatment of acne scars and wrinkles.

1064 nm (Q-Switched, nanosecond mode), including microbeam handpieces:

• · Removal of dark ink (black, blue and brown) tattoos
• · Removal of benign pigmented lesions including;
  • nevus of Ota
  • Café au lait spot
  • Ephalides, solar lentigo (lentigines)
  • Becker Nevus
  • Nevus spilus
• · Treatment of common nevi
• · Removal or lightening of unwanted hair
• · Skin resurfacing procedures for the treatment of acne scars and wrinkles

1064nm laser source in thermal mode (long-pulse) Intended for:

• Treatment of wrinkles
• · Treatment of mild to moderate inflammatory acne vulgaris

TORO device is a DEKA laser system with a wide choice of emission modes, ranging from picosecond to hundreds of microseconds of pulse duration.

The available sources are Nd:YAG lasers at 532 nm and 1064 nm, operating in Q-switched mode, and Ti:Sapphire laser at 785 nm operating in the Picosecond pulse mode.

The Q-switched laser at 1064 nm can also operate in Thermal mode, delivering pulses of hundreds of microseconds.

The laser beam generated by the source is then optically coupled to the articulated arm with a handpiece plugged at its end and delivered to the Patient.

The provided text does not contain information about acceptance criteria for a medical device's performance or a study proving that a device meets those criteria. The document is a 510(k) premarket notification decision letter from the FDA regarding the "Deka Toro" laser system.

Instead, it focuses on demonstrating substantial equivalence to predicate devices through comparisons of indications for use, technological characteristics (e.g., wavelength, pulse duration, energy, fluence, spot size, repetition rate), and compliance with electrical safety, EMC, and software validation standards.

Therefore, I cannot fulfill your request for the following information:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The document explicitly states under "Clinical Performance Data: None," and presents "Non-Clinical Performance Data" which pertains to electrical safety, EMC, and software validation, not clinical performance or efficacy studies against defined acceptance criteria.

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The Nirvana device is indicated for hair removal and permanent hair reduction.

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 NIRVANA is a diode laser device indicated for hair removal and permanent hair reduction. The device is provided with two different handpieces that deliver the laser energy to the patient. The NIRVANA electrical specifications are: 100-115V~, 50/60Hz, 1600VA.

The provided document is a 510(k) premarket notification for a medical device called "Nirvana," a diode laser indicated for hair removal and permanent hair reduction. It details the device's characteristics, its comparison to predicate devices, and non-clinical performance data.

However, the document does not contain information about acceptance criteria or a study that proves the device meets those criteria in a clinical performance context. Specifically, there is no mention of:

• Clinical performance data: The document explicitly states "Clinical Performance Data: None."
• Acceptance criteria for device performance: There is no table or description of specific metrics (e.g., accuracy, sensitivity, specificity, reduction percentage) that the device must achieve to be considered effective or safe, especially in terms of hair reduction.
• Study design for clinical evaluation: No information on sample size, data provenance, ground truth establishment, expert involvement, or statistical analysis for clinical effectiveness is provided.
• AI/Algorithm performance metrics: This device is a laser hair removal system, not an AI-driven diagnostic or assistive device. Therefore, metrics like MRMC studies, standalone algorithm performance, or human-in-the-loop improvement with AI assistance are not applicable.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on:

• Intended Use/Indications: The Nirvana device's indications for use are a subset of or identical to the predicate and reference devices.
• Technical Specifications: Comparison of wavelengths, spot sizes, fluence, pulse duration, and power to predicate devices.
• Non-Clinical Performance Data: Electrical safety, EMC, and software validation testing to relevant standards.

Therefore, I cannot fulfill your request for: "A table of acceptance criteria and the reported device performance" (clinical performance), "Sample sized used for the test set and the data provenance," "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," "Standalone performance," "Type of ground truth," "Sample size for the training set," and "How the ground truth for the training set was established" because this information is not present in the provided 510(k) summary.

The manufacturer has demonstrated substantial equivalence through non-clinical means and comparison to legally marketed predicate devices, rather than through a new clinical performance study. This is a common pathway for 510(k) clearances when a device is sufficiently similar to existing ones.

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The SMARTXIDE PRO is a medical device indicated for incision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

SmartXide PRO is a 10.6um carbon dioxide laser (CO2 laser), which is highly absorbed by water. Since tissue is comprised mostly of water, this invisible wavelength is highly effective in the surgical treatment of soft tissues. Moreover, SmartXide PRO device can be equipped with a scanning unit, called HiScan DOT, which can be connected to the arm to provide high performance in specific fields. The scanning unit is intended for fractionated skin resurfacing or traditional skin resurfacing. The modifications to the device consist of a restyling of the device (chassis, cover plastic, dimensions, weight, plastic cover, CPU and GUI), a restyling of HiScan DOT unit. The intended use of the modified device, 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.

The provided text is a 510(k) summary for the SmartXide PRO device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a rigorous clinical study with novel performance metrics.

Therefore, the document does not contain the detailed information typically found in a clinical study report that directly addresses acceptance criteria and device performance in the way you've outlined. Specifically:

• There is no table of acceptance criteria and reported device performance. The "Performance Data" section only mentions electrical safety, EMC, and software validation, which are technical standards tests, not clinical performance metrics against specific acceptance criteria for efficacy or diagnostic accuracy.
• No sample size for a test set, data provenance, or details on ground truth establishment are provided because a clinical performance study (e.g., an MRMC study or standalone algorithm performance study) was not conducted or required for this type of submission (a Special 510(k) for device modifications where the intended use has not changed).
• Information on experts, adjudication methods, MRMC studies, or standalone performance is absent for the same reason.
• No training set size or ground truth establishment for a training set is mentioned, as this is related to AI/ML model development, which is not described nor a primary focus of this device's submission.

The core of this 510(k) submission is to demonstrate substantial equivalence to a predicate device based on identical (or nearly identical) indications for use and technological characteristics. The "Substantial equivalence discussion" table (part of section {5}) is the primary "proof" for this submission, showing feature-by-feature comparison to the predicate device.

Given the provided text, I cannot complete the table or answer the specific questions about acceptance criteria and study design as they relate to a clinical performance study. The document focuses on regulatory compliance through substantial equivalence, not on establishing a new performance claim for the device against pre-defined clinical acceptance criteria.

If the request implies that I should infer what such a study would look like for a hypothetical AI/ML device where the provided text is a template, that is outside the scope of merely extracting information from the given document.

In summary, the provided document does not contain the information required to answer your prompt because it is a 510(k) summary demonstrating substantial equivalence, not a report of a clinical performance study against specific acceptance criteria.

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Incision, excision, ablation, vaporization, and coagulation of body soft tissue including intraoral tissue, in medical specialities including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

The SMARTXIDE TETRA PRO DEVICE consists of a 10,600nm carbon dioxide laser (CO2) laser with 40W of maximum power. The laser energy is delivered to the treatment area via an articulated arm and a delivery accessory connected to its distal end. The articulated arm is an optical assembly that delivers free beam laser radiation. It is made up of seven mirrors placed on rotating knuckles: the mechanical accuracy of the articulated arm allows the CO2 laser beam to travel inside it and along its axis regardless of the arm orientation. The device may be used in combination with scanning units in order to achieve greater predictability and reproducibility. The use with the scanning units is indicated for layer-by-layer char-free ablation, enhancing the safety of the treatment with more uniform, accurate and controllable impact such as ablative skin resurfacing.

The overall weight is approximately 62 kg and the sizes are 42 x 122 x 54cm (W x H x D) with folded articulated arm.

Electrical requirements: 100-230V ~ 50/60Hz, 1200VA (max).

This document is a 510(k) summary for a medical device called SMARTXIDE TETRA PRO, a CO2 laser surgical instrument. As such, it does not describe acceptance criteria and a study that proves the AI/ML device meets the acceptance criteria. The document explicitly states "Clinical Performance Data: None".

Instead, it focuses on demonstrating substantial equivalence to a predicate device (DEKA Smartxide family) through non-clinical performance data, primarily electrical safety, electromagnetic compatibility, and software validation.

To directly answer your request based on the provided text, the relevant information regarding acceptance criteria and device performance is as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance: Not applicable. This document refers to non-clinical testing of the device hardware and software, not a study involving patient data or test sets in the context of an AI/ML device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML device is not relevant for the type of non-clinical testing described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: 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: Not applicable. This device is not an AI-assisted device for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this type of device and testing. The "ground truth" for the non-clinical tests would be the specifications and requirements defined by the relevant electrical safety, EMC, and laser safety standards.

8. The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.

9. How the ground truth for the training set was established: Not applicable.

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The LILY device is indicated for muscle conditioning to stimulate healty muscles.

The device is not intended to be used in conjunction with therapy or treatment of medical disease or medical conditions of any kind.

The device is intended to be operated by a trained professional who is present to monitor treatment.

The DEKA LILY device consists of a main unit that generates electrical pulses and delivers rectangular biphasic waveforms via electrodes incorporated in an EMS applicator connected to the main unit.

The delivery of the electrical energy is controlled by a footswitch.

The DEKA LIL Y is provided with an applicator to perform EMS (Electrical Muscle Stimulation).

The applicator is provided with two different tips: Large and Medium, used to treat areas having different sizes, which include 3 stainless-steel equidistant electrodes.

The Applicator is directly applied on the area to be treated and moved by the operator across the skin.

The overall weight is approximately 62 kg and the sizes 47cm x 56cm x 106cm (L x W x H).

Electrical requirements: 115V, 50/60Hz, 2300VA.

Here's a breakdown of the acceptance criteria and study information for the DEKA LILY device, based on the provided FDA 510(k) summary:

Important Note: The provided document is a 510(k) summary for a Powered Muscle Stimulator (DEKA LILY). For this type of device, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are primarily focused on safety and electrical performance to demonstrate substantial equivalence to a predicate device, rather than diagnostic accuracy or clinical efficacy studies that would typically involve AI/ML models. Therefore, many of the questions related to AI/ML model evaluation (e.g., ground truth, expert adjudication, MRMC studies) are not applicable in this context.

1. Table of Acceptance Criteria and Reported Device Performance

For the DEKA LILY, acceptance criteria are generally defined by compliance with recognized electrical safety and performance standards for muscle stimulators, and a comparison to a legally marketed predicate device.

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