Search Results

Regulation Number

Type

Panel

EL.EN Electronic Engineering Spa

Reference & Predicate Devices

K101573

Intended Use

The LipoAI is indicated for the surgical incision, vaporization, ablation, and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The LipoAI is further indicated for laser assisted lipolysis.

Device Description

The LipoAl is medical laser equipped with a short pulse 1444 nm Nd:YAG laser source. The device delivers the laser energy through a 600 um optical fiber. The fiber is protected by a small stainless-steel cannula (max. 1.4mm) and is inserted in the tissue through a small aperture in the skin. The DEKA LipoAl device consists of: An AC/DC power supply unit, CPU controller, LASER source, Cooling system, User interface with LCD touch screen, Beam delivery system. Laser activation is controlled by footswitch. Electrical specifications are: 200-240V ~ single phase, 50/60 Hz, Absorbed electric power 3200 VA (max)

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically seen for AI-driven diagnostic devices.

The document describes a 510(k) premarket notification for a medical laser device, DEKA LipoAI. The core of this submission is to demonstrate substantial equivalence to an existing predicate device (Lutronic AccuSculpt II Laser system), not to prove performance against specific acceptance criteria for an AI algorithm.

Here's a breakdown of why the requested information is absent and what is present:

No AI-driven diagnostic or analytical capabilities: The DEKA LipoAI is a "Laser Surgical Instrument" for physical procedures like surgical incision, vaporization, ablation, and coagulation of soft tissue, and laser-assisted lipolysis. It does not appear to have any AI components that perform diagnosis, image analysis, or provide analytical outputs requiring performance metrics like sensitivity, specificity, or AUC. The "AI" in "LipoAI" might refer to "Artificial Intelligence" in a product branding sense, but its function as described is that of a laser delivery system, not an intelligent analytical tool requiring performance criteria to classify medical conditions.
Focus on Substantial Equivalence: The document explicitly states the purpose is to "demonstrate substantial equivalence" to a predicate device. This process primarily involves comparing specifications, indications for use, and safety standards rather than proving novel performance capabilities of an AI system.
Non-Clinical Performance Data: The "Non-Clinical Performance Data" section discusses:
- Electrical safety and electromagnetic compatibility (EMC): Tested against standards like ANSI AAMI ES60601-1 and IEC 60601-1-2.
- Software Validation and Verification Testing: Conducted "as recommended by FDA's Guidance for Industry and FDA Staff, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.'" This likely refers to the software controlling the laser's operation, not an AI for diagnosis.
- Additional non-clinical testing: Against standards like IEC 60601-2-22 and IEC 60825-1 (laser safety standards).
  These are all engineering and safety compliance tests, not performance studies for an AI algorithm.
"Clinical Performance Data: None": This explicitly states that no clinical performance data was provided for this submission. This further confirms that no studies were conducted to assess the diagnostic or analytical performance of an AI component, as such studies would be considered clinical performance.

Therefore, I cannot provide a table of acceptance criteria or details about an AI performance study because the provided document does not indicate the device has AI capabilities that would require such performance evaluation in the context of diagnostic accuracy.

The information requested would typically be found in a submission for an AI/ML-driven diagnostic medical device. This document details a laser surgical instrument, where the "AI" likely does not translate to diagnostic or analytical artificial intelligence.

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K Number

K211091

Device Name

Deka Tiac II

Manufacturer

Date Cleared

2021-10-15

(186 days)

Product Code

PBX

Regulation Number

878.4400

Type

Panel

El.En. Electronic Engineering Spa

Reference & Predicate Devices

K183371

Intended Use

The DEKA TIAC II RF device is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The DEKA TIAC II massage device is intended to provide a temporary reduction in the appearance of cellulite.

Device Description

The DEKA TIAC II is a medical device that used high frequency RF currents to produce a localized increase in temperature in subcutaneous tissue, for temporary relief of pain and muscle spasm and increase local circulation. The device has integrated massaging handpieces intended to provide a temporary reduction in the appearance of cellulite.

The DEKA TIAC II consists of the following main components:

microprocessor-driven control unit
high-frequency electromagnetic energy generator
user interface with 10.4" color touch screen
2 RF handpieces for application of radiofrequency
2 integrated massaging balls handpieces

Contact quality monitoring system is present for monitoring of the contact quality under the RF handpiece electrodes.

The electrical specifications are 100-240Vac, 50/60Hz, 1500VA.

AI/ML Overview

This document describes the DEKA TIAC II device, a medical radio frequency and massage device intended for temporary relief of pain, muscle spasms, increased local circulation, and temporary reduction in the appearance of cellulite. The study proving the device meets acceptance criteria is detailed in the Non-Clinical Performance Data section on pages 6 and 7 of the provided document.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Test Performed	Acceptance Criteria	Reported Device Performance
Non-clinical - Tissue heating performance	- The sample temperature in the range 40-43°C for at least for 10 minutes in the active zone of the handpieces (hot spots);

Skin surface increase in temperature not greater than 3°C;
Temperature outside the hot spot never exceeding 40°C;
Dissipation phase not increasing the temperature at the end of the treatment. | - Number of planned tests: 2
Number of tests executed: 2
Number of positive outcome: 2 (100%)
Device able to heat the target tissue maintaining the tissue temperature in the range 40°C - 43°C for at least 10 minutes in the active zone, with no significant temperature increase out of depth. |
| Non-clinical – Human skin temperature maintaining performance | - Skin temperature is maintained in the range 40-45°C for at least 10 minutes;
Skin temperature doesn't exceed 45°C over the entire test period. | - Number of planned tests: 36
Number of tests executed: 36
Number of positive outcome: 36 (100%)
Device able to keep the skin surface temperature in the range 40º-45ºC for at least 10 minutes. |

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

Non-clinical Tissue heating performance:
- Sample Size: Ex-vivo pig muscle sample (20x20x5 cm). Two tests were executed (2 for Deep handpiece and 2 for Shallow handpiece).
- Data Provenance: Not explicitly stated, but "ex-vivo pig muscle sample" implies a laboratory setting, likely in Italy where the submitter is located. This is retrospective as the tests were performed before submission.
Non-clinical Human skin temperature maintaining performance:
- Sample Size: 3 people of different skin types (Fitzpatrick I, III, IV). 36 tests were executed (e.g., each handpiece on each person, across three body areas at different power settings).
- Data Provenance: Not explicitly stated, but likely conducted in Italy. This is retrospective as the tests were performed before submission.

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

This information is not provided in the document. The tests performed are objective measurements of temperature, not subjective evaluations requiring expert consensus for ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable as the tests performed are objective measurements with pre-defined acceptance criteria, not subjective assessments requiring 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 information is not applicable. The DEKA TIAC II is a medical device for heating tissue and massage, not an AI-powered diagnostic or interpretive tool that would involve human readers. The document states "Clinical Performance Data: None."

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

This information is not applicable. The DEKA TIAC II is a physical medical device. The "tests performed" are evaluations of the device's physical output and effect on tissue/skin, not autonomous algorithmic performance.

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

Non-clinical Tissue heating performance: The ground truth was direct temperature measurement within the tissue and on the skin surface.
Non-clinical Human skin temperature maintaining performance: The ground truth was direct skin surface temperature measurement.

8. The Sample Size for the Training Set:

This information is not applicable/not provided. This device is not an AI/machine learning device that requires a training set in the conventional sense. The "training" for the device's design and engineering would be based on general biophysics, engineering principles, and potentially prior device development, rather than a specific labeled dataset.

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

This information is not applicable/not provided for the reasons stated above.

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K Number

K203396

Device Name

DEKA SMARTPERIO

Manufacturer

Date Cleared

2021-08-23

(278 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K124003,K200234,K952006,K030290

Intended Use

The DEKA SmartPerio system is intended to perform the following types of intraoral procedures: soft tissue dental, general, oral maxillofacial, and cosmetic surgery. The DEKA SmartPerio is intended for ablating, incising, excising, vaporization and coagulation of soft tissues using a contact fiber-optic delivery system. The device is intended to be used in dentistry. The following are the oropharyngeal indications for use: Abscess Incision and Drainage Apthous Ulcers Treatment Biopsies Excision and Incision Crown lengthening Hemostatic assistance Fibroma Removal Frenectomy Frenotomy Gingival Incision and Excision Gingivectomy Gingivoplasty Operculectomy Oral Papillectomy Tissue retraction for Impression Vestibuloplasty. Selective ablation of enamel (first degree) caries Exposure of unerupted / partially erupted teeth Implant recovery Lesion (tumor) removal Leukoplakia Pulpotomy Pulpotomy as adjunct to root canal therapy Removal of filling material such as gutta percha or resin as adjunct treatment during root canal retreatment Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment level and tooth mobility tooth mobility. Laser assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium.)

Device Description

The DEKA SmartPerio is a Nd:YAG laser device for soft-tissues intraoral treatments. The DEKA SmartPerio system delivers laser through an optical fiber that is guided to the target tissue with the aid of an handpiece and a tip. The DEKA Smartperio device consists of: An AC/DC power supply unit CPU controller LASER source Cooling system User interface with LCD touch screen Beam delivery system Laser activation is controlled by footswitch.

AI/ML Overview

The provided document is a 510(k) summary for the DEKA SmartPerio laser device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria with quantifiable performance metrics.

Therefore, much of the requested information cannot be extracted directly from this document. However, I can provide what is available, noting where information is absent.

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

This document does not specify quantitative acceptance criteria typically seen in performance studies for new medical devices, nor does it report specific device performance metrics in detail beyond a comparison of technical specifications with a predicate device.

Instead, the document's primary "acceptance criteria" appear to be meeting electrical safety and electromagnetic compliance standards, as well as demonstrating substantial equivalence to a legally marketed predicate device.

Acceptance Criteria (Inferred from regulatory context)	Reported Device Performance (Summary from comparison)
Substantial Equivalence:
- Indications for use	DEKA SmartPerio's indications are a subset of the predicate device's indications.
- Technological Characteristics (Laser Wavelength, Energy per Pulse, Pulses per Second, Pulse duration, Average Power, Aiming Beam wavelength, Aiming beam power, Delivery system, Power Requirements, Weight, Dimensions)	Most are identical or similar, with differences noted as not affecting safety and effectiveness.
Safety Standards Compliance:
- AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012, cl:2009/(R)2012 and a2:2010/(R)2012 (Medical Electrical Equipment)	Compliant
- IEC 60601-1-2 Ed. 4 (Electromagnetic disturbance)	Compliant
- IEC60601-2-22 Ed 3.1 (Laser equipment safety)	Compliant
- IEC 60825-1 Ed. 3.0 (Safety of laser products)	Compliant
Biocompatibility:	Subject device relies on biocompatibility of already FDA-cleared accessories.

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 explicitly states "Clinical Performance Data: None" and "Non-Clinical Performance Data" only refers to compliance with electrical and laser safety standards. This implies there was no "test set" of patient data in the sense of a clinical trial or performance study. The data provenance and sample size for such a test set are therefore not applicable or not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable, as no clinical test set or ground truth adjudication using experts is mentioned.

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

Not applicable, as no clinical test set or ground truth adjudication 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 applicable. The DEKA SmartPerio is a laser surgical instrument, not an AI-powered diagnostic or assistive device that would involve human readers or AI assistance.

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

Not applicable. The DEKA SmartPerio is a physical medical device (laser surgical instrument), not an algorithm or AI system.

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

Not applicable, as no clinical performance study requiring a "ground truth" (e.g., for diagnostic accuracy) was performed or reported.

8. The sample size for the training set

Not applicable, as the DEKA SmartPerio is a physical laser device and not an AI or machine learning algorithm that requires a "training set."

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

Not applicable, as the DEKA SmartPerio is a physical laser device and not an AI or machine learning algorithm.

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K Number

K211821

Device Name

DEKA Motus AZ

Manufacturer

El.En Electronic Engineering SPA

Date Cleared

2021-07-06

(25 days)

Product Code

Regulation Number

Type

Special

Panel

K192539,K172362,K133895,K181486

Reference & Predicate Devices

Intended Use

Alexandrite 755nm laser source:
Temporary hair reduction.
Stable long-term or permanent hair reduction through selective targeting of
melanin in hair follicles. Permanent hair reduction is defined as the long-term,
stable reduction in the number of hairs regrowing when measured at 6,9, and 12 months after the completion of a
treatment regime, on all skin types (Fitzpatrick I - VI) including tanned skin.
Treatment of benign pigmented lesions.
Treatment of wrinkles.
Photocoagulation of benign dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
Nd:YAG 1064nm laser source:
Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB . The lasers are indicated on all Skin Types Fitzpatrick I-VI including tanned skin.
Photocoagulation and hemostasis of benign pigmented and benign vascular lesions, such as but not limited to port wine stains, hemangioma, warts, teleangiectasia, rosacea, venus lake, leg veins and spider veins.
Coagulation and hemostasis of soft tissue.
Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, cloasma, verrucae, skin tags, keratosis and plaques.
The laser is indicated for benign pigmented lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Treatment of wrinkles.

Device Description

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

AI/ML Overview

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

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

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

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

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

Characteristic	Acceptance Criterion (Predicate Device DEKA MOTUS AY, K181486)	Reported Device Performance (Proposed Device DEKA Motus AZ)	Comment
General Specifications
Weight	Approx. 90 kg	Approx. 100 kg	The variation to the weight does not affect safety and effectiveness of the device.
Dimensions (cm)	95x51x83 (HxWxD)	114x45x94 (HxWxD)	The variation to the dimensions does not affect safety and effectiveness of the device.
Mains voltage	230 V~single phase, 50-60 Hz	230 V~single phase, 50-60 Hz	Identical
Breaker	16 A	16 A	Identical
Operating environmental conditions	15-35 °C; 30%-75% rel. humidity, 700-1060 hPa	15-35 °C; 30%-75% rel. humidity, 700-1060 hPa	Identical
Transport and storage conditions	5-50 °C; 10-90% humidity, 700-1060 hPa	5-50 °C; 10-90% humidity, 700-1060 hPa	Identical
Indications for Use (Alexandrite 755nm)	Temporary hair reduction; Stable long-term or permanent hair reduction on all skin types (Fitzpatrick I - VI) including tanned skin; Treatment of benign pigmented lesions; Treatment of wrinkles; Photocoagulation of benign dermatological vascular lesions.	Identical	Identical
Indications for Use (Nd:YAG 1064nm)	Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB on all Skin Types Fitzpatrick I-VI including tanned skin; Photocoagulation and hemostasis of benign pigmented and benign vascular lesions; Coagulation and hemostasis of soft tissue; Benign pigmented lesions (various types); Reduction of red pigmentation in hypertrophic and keloid scars; Treatment of wrinkles.	Identical	Identical
Regulation number	21 CFR 878.4810: Laser surgical instrument for use in general and plastic surgery and in dermatology	Identical	Identical
Product Code	GEX	Identical	Identical
Alexandrite 755nm Laser Source
Laser Type	Alexandrite	Alexandrite	Identical
Wavelength (nm)	755 nm	755 nm	Identical
Fluence (J/cm²)	2-200 J/cm²	2-200 J/cm²	Identical
Handpiece Spot Sizes (diameter mm)	2.5, 5, 7, 10, 12, 14, 15, 16, 18, 20 mm (Moveo: 14 mm)	2.5, 5, 7, 10, 12, 14, 15, 16, 18, 20 mm (Moveo: 7, 14 mm)	Identical overall spot size range (note: new Moveo spot size available, but within range)
Pulse Duration (milliseconds)	2 to 50 ms	2 to 50 ms	Identical
Pulse Repetition Rate (Hz)	up to 10 Hz	up to 10 Hz	Identical
Skin Cooling System	Yes (handpiece integrated and external)	Yes (handpiece integrated and external)	Identical
Skin Cooling Temperature	15°C	15°C	Identical
Nd:YAG 1064nm Laser Source
Laser Type	Nd:YAG	Nd:YAG	Identical
Wavelength (nm)	1064 nm	1064 nm	Identical
Fluence (J/cm²)	2-600 J/cm²	2-600 J/cm²	Identical
Handpiece Spot Sizes (diameter mm)	2.5, 5, 7, 10, 12, 14, 15, 16, 18, 20 mm (Moveo: 14 mm)	2.5, 5, 7, 10, 12, 14, 15, 16, 18, 20 mm (Moveo: 5, 14 mm)	Identical overall spot size range (note: new Moveo spot size available, but within range)
Pulse Duration (milliseconds)	0.2 to 50 ms	0.2 to 50 ms	Identical
Pulse Repetition Rate (Hz)	up to 10 Hz	up to 10 Hz	Identical
Skin Cooling System	Yes (handpiece integrated and external)	Yes (handpiece integrated and external)	Identical
Skin Cooling Temperature	15°C	15°C	Identical

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

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

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

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

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

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

Not applicable. See #3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

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

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

Not applicable. See #5.

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

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

8. The sample size for the training set

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

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

Not applicable. See #8.

Summary of the Study Proving Acceptance Criteria:

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

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

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

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K Number

K202258

Device Name

ERISE Laser handpiece

Manufacturer

EL.EN. Electronic Engineering Spa

Date Cleared

2021-04-26

(259 days)

Product Code

Regulation Number

Type

Panel

El.En Electronic Engineering Spa

Reference & Predicate Devices

K192539,K173002

Intended Use

ERISE Laser Handpiece is indicated for use in soft tissue (skin and cutaneous tissue) such as, but not limited to: Dermatology and plastic Surgery: Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectas; Actinic chelitis; Keloids; Verrucae; Skin tags; Keratoses; Scar revision (including acne scars). With microbeam end piece it is indicated for Skin resurfacing.

Device Description

ERISE is an Erbium:YAG laser handpiece delivering laser radiation at 2940nm. It is intended to be used with DEKA LUXEA platform, cleared by FDA with K192539. The Erise laser handpiece includes: - . A connector to connect to the console - A cord where electrical cables and hydraulic tubes pass in - A plastic shell - . A Laser cavity - . A mechanical shutter - . An optical guide - . An ending tip which provides different spot sizes (diameter 2, 4, 9mm), including microbeam output (diameter 9mm) The 2940 nm Erbium:YAG laser handpiece is controlled by the DEKA LUXEA console which it is connected to, through the connector.

AI/ML Overview

The provided FDA 510(k) summary for the ERISE Laser Handpiece does not contain information about acceptance criteria for a device performance study or any study proving such criteria are met.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Quanta System 2940 nm Er:YAG laser handpiece) based on technological characteristics and non-clinical performance data.

Here's a breakdown of why the requested information cannot be provided from this document:

No Clinical Performance Data: The document explicitly states under "Clinical Performance Data:" "None". This means no studies were conducted to evaluate the device's clinical effectiveness in terms of specific outcomes or meeting pre-defined acceptance criteria for efficacy.
Focus on Substantial Equivalence: The primary goal of a 510(k) submission is to show that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing technological features, safety standards, and non-clinical performance, rather than conducting new clinical trials with acceptance criteria.
Non-Clinical Data for Safety and Compatibility: The "Non-Clinical Performance Data" section describes tests related to:
- Safety and electromagnetic compatibility (EMC): Compliance with standards like IEC 60601-2-22, IEC 60825-1 (for safety) and IEC 60601-1-2 (for EMC) for the DEKA LUXEA platform (which the ERISE handpiece connects to). These are regulatory compliance tests, not performance studies with acceptance criteria for specific clinical outcomes.
- Software Verification and Validation: This ensures the software of the DEKA LUXEA platform (with the ERISE handpiece) functions as intended. Again, this is a form of regulatory compliance and quality assurance, not a performance study evaluating clinical efficacy.

Therefore, it is not possible to complete the requested table or answer the specific questions about acceptance criteria and performance studies because such information is not present in this 510(k) submission. The device's approval is based on its similarity to an already cleared device and adherence to relevant safety and software standards, not on new clinical performance data demonstrating specific efficacy outcomes against predefined acceptance criteria.

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K Number

K181867

Device Name

Deka Smartxide2 Trio

Manufacturer

Date Cleared

2018-10-02

(82 days)

Product Code

Regulation Number

Type

Special

Panel

El.En Electronic Engineering Spa

Reference & Predicate Devices

K112166,K113504

Intended Use

The DEKA SmartXide2 Trio CO2 laser 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 (including open and endoscopic), dental and oral surgery and genitourinary surgery.

The DEKA Smartxide2 Trio 940nm diode laser is incision, excision, vaporization ablation and coagulation of soft tissues (open surgery), cutting, vaporization of soft tissues (endoscopic surgery) in medical specialties including: plastic surgery, dermatology, ENT, gynaecology, urology, general surgery, gastroenterology and dental procedures.

The DEKA SmartXide2 Trio 980mm diode laser is incision, excision, vaporization ablation and coagulation of soft tissues (open and endoscopic surgery) in medical specialties including plastic surgery, dermatology, ear, nose and throat and oral surgery (otolaryngology), gynaecology, neurosurgery, general and thoracic surgery, gastroenterology and dental procedures.

Device Description

The DEKA SmartXide2 Trio is a medical laser system equipped with a 80W CO2 laser source and an (optional) 980nm or 940nm 50W diode laser source.

The CO2 laser radiation has a wavelength of 10600nm and is delivered to the treatment area through an articulated arm and a delivery accessory (handpiece/scanner/micromanipulator) connected to its distal end, or through a hollow waveguide.

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 waveguide consists of a flexible silica capillary whose inside wall has been coated with a durable coating which is highly reflective at the intended wavelength of use.

The waveguides used with DEKA Smartxided Trio are manufactured by Laser Engineering and have been cleared by FDA with K112166.

The diode laser source can be provided in two alternative wavelengths: 940nm and 980mm.

The diode laser radiation is delivered to the treatment area through optical fibers, which are guided to the target tissue with the aid of handpieces. The spot size is effectively the diameter of the fiber being connected to the system.

Emission parameters are selected on the front panel while laser emission is activated by a footswitch. The on-off switch and emergency switch are also located on the front panel of the svstem.

A warning light is located on the top cover, close to the control panel. Light ON state indicates that the system is enabled and ready.

Overall weight of the device is 100 kg, and the size is 240 cm x 59 cm x 56 cm (H x W x D). Electrical requirement is 100-120Vac 50/60Hz, 220-230Vac 50Hz, 16A.

The modification to the device is the addition of a hollow waveguide delivery system as an alternative to the articulated arm for the CO2 laser beam . It allows easier delivery of laser energy to the targeted tissue in some surgical procedures.

The intended use of the modified devices, as described in the labelling, has not changed as a result of the modification.

AI/ML Overview

The provided document is a 510(k) summary for the DEKA Smartxide2 Trio, a medical laser system. The purpose of this document is to demonstrate "substantial equivalence" to a predicate device, not necessarily to provide a detailed study proving the device meets specific acceptance criteria in the format requested.

Therefore, the information required for a comprehensive answer regarding acceptance criteria and a detailed study proving the device meets these criteria is largely not present in this type of FDA submission.

Here's an attempt to answer the questions based only on the provided text, highlighting what is available and what is missing:

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

The document does not provide a specific table of acceptance criteria linked to reported device performance metrics in the way one might expect from a detailed clinical or performance study. Instead, it focuses on demonstrating equivalence in features and specifications between the proposed device and the predicate device.

The Feature table on pages 4 and 5 implicitly shows the "performance" by comparing the specifications of the new device to the predicate. The "acceptance criteria" for this submission appear to be that the new device's specifications (including the new delivery system) are within an acceptable range or identical to the predicate, and that the "Intended Use" and "Principle of operation" remain the same.

Feature Type	Acceptance Criteria (Implied from Predicate)	Reported Device Performance (DEKA SmartXide2 Trio)
CO2 Laser
Laser type	CO2 laser - sealed off - RF excited	CO2 laser - sealed off - RF excited
Wavelength	10.6 µm	10.6 µm
Delivery system	Articulated arm	Articulated arm, Waveguide
Output power	0.1 W to 80 W	0.1 W to 80 W
Spot size	0.125 mm - 1.5 mm (articulated arm)	0.125 mm - 1.5 mm (articulated arm), 0.3 -0.5 mm (waveguide)
Pulse length	0.04ms to 0.9s	0.04ms to 0.9s
Pulse Rate	5 to 800 Hz	5 to 800 Hz
Aiming beam	635 nm, 5mW max	635 nm, 5mW max
Surgical scanning system	Integrated (HiScan Surg., Endoscan)	Integrated (HiScan Surg., Endoscan)
Diode Laser
Laser type	Semiconductor Diode Laser	Semiconductor Diode Laser
Wavelength (nm)	940, 980 nm	940, 980 nm
Output power	0.5W - 50W	0.5W - 50W
Spot size (mm)	0.2, 0.3, 0.6 mm	0.2, 0.3, 0.6 mm
Laser Operating Modes	CW, pulsed	CW, pulsed
Pulsed mode Ton	5ms to 2s	5ms to 2s
Delivery system	Optical Fiber	Optical Fiber
Aiming beam	630-670mm, 3mW max	630-670mm, 3mW max

The key change is the addition of a hollow waveguide delivery system for the CO2 laser. The "acceptance criteria" for this modification would be that its performance (e.g., CO2 laser output characteristics when using the waveguide) is safe and effective for the stated indications, and equivalent to the existing articulated arm delivery or the predicate device's capabilities.

2. Sample size 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. The document explicitly states "Clinical Performance Data: None" and describes "Non-Clinical Performance Data" as verification and validation activities. These are typically in-house engineering and bench tests, not studies with patient samples.

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 "Clinical Performance Data: None" and the data being non-clinical verification/validation, there would be no ground truth established by medical experts in this context.

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

This information is not provided. Not applicable given the type of data presented.

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. This device is a surgical laser system, not an AI-powered diagnostic tool. Therefore, an MRMC study with AI assistance is not relevant to this submission.

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

This information is not provided. As mentioned, this is not an AI algorithm. The performance evaluation focuses on the physical device's specifications.

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

For the "Non-Clinical Performance Data," the "ground truth" would be established by engineering specifications, technical standards, and internal test procedures. For example, a laser power meter would provide the "ground truth" for laser output power, or precise measurement tools for spot size. This is not derived from medical expert consensus or patient outcomes.

8. The sample size for the training set

This information is not provided. The device is a physical laser system, not an AI model, so there is no "training set."

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

This information is not provided. Not applicable as there is no training set.

Summary of Study that Proves the Device Meets Acceptance Criteria:

The document broadly refers to "Non-Clinical Performance Data" as the study proving the device meets acceptance criteria. These activities included:

Verification of CO2 laser output using the waveguide: This would involve testing the power, wavelength, beam stability, and other characteristics of the CO2 laser when delivered through the new waveguide. The acceptance criteria would be that these outputs meet predefined engineering specifications and are comparable to or within the established range of the predicate device's articulated arm delivery.
Verification and validation of modified software: This ensures that any software changes related to the new waveguide or other aspects of the device operate correctly, safely, and as intended. Acceptance criteria would be based on software requirements and testing protocols.

The document explicitly states that "The test methods, acceptance criteria and test results are documented in the Design History File of Smartxide2 Trio," but these specific details are not included in this 510(k) summary. The overarching "proof" is that these non-clinical tests confirmed the modified device (including the new waveguide) performs equivalently and safely to the predicate device, allowing it to maintain the same indications for use.

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K Number

K181510

Device Name

ECHOLASER X4

Manufacturer

Date Cleared

2018-09-04

(88 days)

Product Code

Regulation Number

Type

Panel

EL.EN Electronic Engineering Spa

Reference & Predicate Devices

K080959

Intended Use

The ECHOLASER X4 laser system is intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, bronchoscopes, gastroscopes, cystoscopes and colonoscopies), in incision/excision, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), and in the treatment and/or removal of vascular lesions (tumors).

Device Description

The ECHOLASER X4 is a medical device equipped with a diode laser source emitting at 1064nm wavelength in CW mode. The laser beam is transmitted via 1 to 4 optical fibres. The operator can use 1 to 4 fibres simultaneously, one independent from the other in both activation and power adjustment. Laser activation is controlled by footswitch.

AI/ML Overview

The provided text describes a medical laser system, the ECHOLASER X4, and its substantial equivalence to a predicate device for the purpose of FDA 510(k) clearance. However, it does not include information about acceptance criteria or a study proving the device meets specific performance criteria in terms of clinical or algorithmic efficacy.

The document focuses on regulatory compliance and comparison with a predicate device (DORNIER MEDILAS D 1064 laser system) based on technical specifications and intended use.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to clinical or algorithmic performance, which is not detailed here.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Cannot be fully provided. The document lists technical specifications of the device and compares them to a predicate device. It doesn't define explicit "acceptance criteria" in terms of clinical performance metrics (e.g., accuracy, sensitivity, specificity for a diagnostic device, or a specific outcome measure for a therapeutic device) or detailed "reported device performance" against such criteria. The performance shown is primarily technical parameters.

Acceptance Criteria (Implied for Substantial Equivalence to Predicate)	Reported Device Performance (ECHOLASER X4)	Predicate Device Performance (DORNIER MEDILAS D 1064)
Indications for Use: Cutting, vaporization, ablation, coagulation of soft tissue (endoscopic, open surgery), treatment/removal of vascular lesions (tumors)	Same	Same
Laser Type: DIODE	DIODE	DIODE
Wavelength: 1064 nm ± 10%	1064 nm ± 10%	1064 nm ± 10%
Output Mode: Multimode	Multimode	Multimode
Maximum Delivered Power: Comparable	28W	30W
Stability of Output Power Level: ±20%	±20%	±20%
Beam Diameter: 0.3 mm	0.3 mm	0.3 mm
Mode of Operation: Continuous wave	Continuous wave	Continuous wave
Aiming Beam Laser Type: Diode	Diode	Diode
Aiming Beam Wavelength: Comparable	630-670 nm	632 nm
Aiming Beam Maximum Delivered Output Power: Comparable

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K Number

K172362

Device Name

DEKA SMARTXIDE TOUCH

Manufacturer

Date Cleared

2017-11-17

(105 days)

Product Code

Regulation Number

Type

Panel