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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.)

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.

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.

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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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.

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.

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:

1. 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.

2. 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.

3. 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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The SmartXide UltraSpeed laser is incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, endoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology, neurosurgery, oculoplastic, orthopedic, pulmonary/thoracic urgery, and urology for surgical and aesthetic applications.

Also, the SmartXide UltraSpeed laser is indicated for periodontal applications such as, but not limited to:

• · Removal of diseased or Inflamed soft tissue in the periodontal pocket (sulcular debridement)
• · Biopsies
• Frenectomy, Frenum release
• Gingivoplasty
• Papillectomy
• · Vestibuloplasty
• · Hyperplasia
• Operculectomy
• · Drainage (abscess)
• · Flap surgerv
• · Fibroma (nonmalignant tumor, mucosa, tongue)
• Epulis
• · Aphthous ulcers
• · Removal of soft tissue, cysts, and tumors

· Laser assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long iunctional enithelium).

DEKA SmartXide UltraSpeed is a 10,600 nm CO2 laser devices whit a maximum power of 40W. The laser source delivers the laser output through interchangeable laser handpieces. Handpiece activation is by footswitch.

The provided text is a 510(k) summary for a medical device, the DEKA SmartXide UltraSpeed laser. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

It's crucial to understand that a 510(k) submission primarily focuses on substantial equivalence to a predicate device, not necessarily extensive clinical performance studies or AI model validation. Therefore, the information requested in your prompt regarding acceptance criteria, training/test sets, expert ground truth, and AI performance metrics will likely not be present in this type of document because the device in question is a laser surgical instrument, not an AI-driven diagnostic or therapeutic device. No AI or machine learning components are mentioned for this device.

Based on the provided document, here's an attempt to address your points, highlighting where the information is not applicable or not provided:

The DEKA SmartXide UltraSpeed is a 10,600 nm CO2 laser device for incision, excision, ablation, vaporization, and coagulation of body soft tissues. The 510(k) submission establishes its substantial equivalence to a predicate device (DEKA Smart US 20D/UltraSpeed and Smart Clinic laser, K081181) based on similar indications for use, principle of operation, and performance characteristics.

Regarding Acceptance Criteria and Device Performance (as requested for an AI/diagnostic device):

Since this is a laser surgical instrument and not an AI/diagnostic device, the concept of "acceptance criteria" in the context of sensitivity, specificity, or similar performance metrics for an AI model is not applicable. The "device performance" instead refers to its physical specifications and its ability to perform its intended surgical functions safely and effectively.

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

For a laser surgical instrument, acceptance criteria are generally related to its technical specifications and compliance with safety standards rather than diagnostic performance metrics.

Study Proving Device Meets Acceptance Criteria:

The document states: "Tests results demonstrated compliance to related standards." This indicates that non-clinical performance tests were conducted according to the listed international standards (ISO 10993-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1) to ensure the device operates safely and effectively as designed.

The following points are largely N/A (Not Applicable) or N/P (Not Provided) in this 510(k) summary for a laser surgical instrument, as they pertain to AI/diagnostic model validation:

2. Sample size used for the test set and the data provenance: N/A. No test set of patient data (images, etc.) is mentioned as this is not an AI diagnostic device. The "tests" mentioned are non-clinical engineering and safety compliance tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. No "ground truth" derived from expert review of patient data is relevant for this type of device.

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

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: N/A. This is a surgical laser, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. There is no algorithm mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A. The "ground truth" for this device would be its adherence to established engineering, electrical, and laser safety standards, and its consistent output of specified laser parameters.

8. The sample size for the training set: N/A. No AI model or training set is mentioned.

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

In summary, this 510(k) document is for a medical laser, not an AI or diagnostic device. Therefore, the detailed questions about AI model validation, test/training sets, and expert ground truth are not relevant to the information presented in this regulatory submission. The "study" proving the device meets criteria consists of non-clinical, engineering, and safety compliance tests against recognized international standards.

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The DEKA Motus AX laser system is indicated for:

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).

The DEKA Motus AX is a medical device equipped with a 755nm solid state laser source. The laser source delivers 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. Handpiece activation is either by footswitch or fingerswitch.

The provided document is a 510(k) summary for the DEKA Motus AX medical laser system. The purpose of a 510(k) summary is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove that the device meets specific acceptance criteria through a clinical study in the way an AI/ML device would.

Based on the content of this document, here's an analysis of the requested information:

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

This document does not present specific acceptance criteria in terms of clinical performance metrics (like sensitivity, specificity, accuracy, or reduction percentages common in clinical trials for new medical treatments and AI/ML devices). Instead, it focuses on demonstrating substantial equivalence to a predicate device by comparing technical specifications and ensuring safety and regulatory compliance.

The "device performance" reported is primarily in terms of technical specifications compared to the predicate device and conformance to electrical/safety standards.

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". This means there was no clinical test set (i.e., human subject data) used to demonstrate performance against specific clinical acceptance criteria in the context of an effectiveness study.

The non-clinical performance data included "ex-vivo performance data on three different tissue types". This refers to laboratory testing, not human patient data. The provenance of this ex-vivo data is not specified (e.g., country of origin). It would be considered prospective for the device under review, as these tests were conducted for this submission.

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

Since no clinical performance data was presented, there was no test set requiring multi-expert ground truth establishment.

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

Not applicable, as no clinical test set was used for performance evaluation that would require 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

Not applicable. This is not an AI/ML device, and no MRMC comparative effectiveness study was conducted.

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

Not applicable. This is a laser system, not an algorithm.

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

For the ex-vivo non-clinical performance data, the "ground truth" would be the measured thermal energy distribution and adversely affected tissue regions, as assessed by the scientific methods used in the laboratory setting. There is no mention of expert consensus, pathology, or outcomes data as ground truth for clinical performance, as no clinical studies were performed.

8. The sample size for the training set

Not applicable. This is a hardware device (laser system), not a machine learning model that requires a training set.

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

Not applicable, as there is no training set for this device.

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The DEKA Synchro Repla:Y family of laser systems is indicated for:

755mn laser:
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 dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).

l 064nm laser:
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 pigmented and 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 pigmented lesions to reduce 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.

Pulsed light FT handpiece:
Permanent hair reduction, photocoagulation of vascular lesions, photothermolysis of blood vessels, treatment of benign pigmented lesions.
Different wavelength ranges of Pulsed Light attachment are indicated for the various treatments and skin types, as indicated in the following table: -

The Deka Synchro Repla: Y family of lasers is a platform which can be equipped with two separate solid state laser heads (755nm and 1064nm) and a pulsed light handpiece (FT handpiece).
The two laser heads can only be activated separately and they deliver the laser output through the same single laser delivery system, consisting of a lens coupled user replaceable optical fiber with a wide range of interchangeable, quick release laser handpieces with electronic spot recognition.
The FT handpiece delivers the pulsed light to the treatment area by means of a sapphire lightguide: it is provided with has an integrated skin cooling system and is equipped with five different emission spectra interchangeable filters.
The system allows to switch from one of the three available sources to the other by pressing a key on touch panel.
Handpiece activation is either by footswitch or fingerswitch.

This document is a 510(k) summary for a medical laser system and does not contain information about acceptance criteria or a study proving its performance in the context of an AI/algorithm-based device as typically presented in such studies. The device is a physical laser system, not an AI or software algorithm that provides diagnostics or interpretations.

The document discusses "Clinical Performance Data: None" and "Non-Clinical Performance Data: Performance data has been provided in order to show that the Deka Synchro Repla: Y Software complies with the Requirements of the 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' issued by the FDA on May 11, 2005. Moreover, performance data has been provided in order to show that the Deka Synchro Repla: Y complies with the EMC requirements of the FDA Recognized Standard IEC 60601-1-2 and with the FDA/CDRH Recommendations for EMC/EMI in Healthcare Facilities."

This statement indicates that the software performance data is primarily about compliance with regulatory guidance for medical device software and EMC standards, not about clinical effectiveness as you would expect for an AI algorithm making diagnostic predictions.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, sample sizes, expert ground truth, or AI performance metrics because this information is not present in the provided text for this type of device. The provided text is a 510(k) summary for a physical medical laser device establishing substantial equivalence to predicate devices based on technical specifications and intended use, not clinical performance data for an AI-powered diagnostic or assistive tool.

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The DEKA SmartXide2 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 940nm diode laser is indicated for incision, excision, vaporization ablation and coagulation of soft tissues (open surgery), cutting, vaporization, ablation and coagulation of soft tissues (endoscopic surgery) in medical specialties including: plastic surgery, dermatology, ENT, gynaecology, urology, general surgery, gastroenterology and dental procedures.

The DEKA SmartXide2 980nm diode laser is indicated for 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, urology, neurosurgery, general and thoracic surgery, gastroenterology and dental procedures.

The DEKA SmartXide" system 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 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.

An air flow is provided by an internal pump in order to avoid dust and particles deposition on the optics during laser operations.

The DEKA SmartXide2 CO2 laser can be used with DEKA CO2 scanning units and the DEKA EasySpot Hybrid micromanipulator.

The scanning units move the beam on the tissue with controlled velocity and defined patterns to optimize the laser ablation.

The CO2 laser focalized on very little spots by the micromanipulator and moved by scanning systems is useful to fasten the surgical procedures and limit the thermal damage to the tissues surrounding the ablation.

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

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 system.

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 95 kg, and the size is 210 cm x 59 cm x 56 cm (H x W x D).

Electrical requirement is 100-120Vac 50/60Hz, 220-230Vac 50Hz, 16A.

Analysis of Acceptance Criteria and Device Performance for DEKA SmartXide2 Laser System

Based on the provided 510(k) summary (K113504), the DEKA SmartXide2 laser system is a medical laser system intended for various surgical applications. The submission's primary focus is demonstrating substantial equivalence to predicate devices rather than proving performance against specific quantitative acceptance criteria established by the manufacturer and validated through a standalone study.

1. Table of Acceptance Criteria and Reported Device Performance

As the submission is for substantial equivalence, formal quantitative acceptance criteria are not explicitly stated in the document in the way they would be for a novel device proving its safety and efficacy de novo. Instead, the "acceptance criteria" are implicitly met by demonstrating that the device performs "as well as, or better than" the predicate devices. The performance is assessed through non-clinical bench testing and historical literature data.

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

• Sample Size for Test Set: Not explicitly stated as a number of "cases" or "patients" in the context of a clinical trial. The testing involved "histological evaluations... on three different animal tissues." The number of samples or specimens within those animal tissues is not specified.
• Data Provenance: The data is non-clinical bench test data conducted on "three different animal tissues." It is retrospective in the sense that existing scientific literature was used to support claims. The country of origin for the animal tissue studies is not specified, but the submitter is based in Italy.

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

• The document does not mention the use of experts to establish a "ground truth" for the non-clinical histological evaluations in the manner it would be done for diagnostic imaging or a comparative clinical study. The histological evaluations likely involved standard laboratory protocols and analyses by trained histologists or pathologists, but no specific number or qualifications of "experts" for ground truth establishment are provided.

4. Adjudication Method for the Test Set

• Given the nature of the non-clinical bench testing (histological evaluations and literature review), there was no mention of an adjudication method like 2+1 or 3+1 typically used in clinical studies with human readers. The results of the histological assessments would be based on scientific measurement and interpretation protocols within a laboratory setting.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. The submission explicitly states "Clinical Performance Data: None." The evaluation was based on non-clinical bench testing and literature review to demonstrate substantial equivalence, not a direct comparison of human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• This question is not applicable to the DEKA SmartXide2 laser system. This device is a surgical laser system controlled by a human operator, not an AI algorithm. There is no "algorithm only" performance to evaluate.

7. The Type of Ground Truth Used

• For the non-clinical performance data, the "ground truth" was derived from histological evaluations of ablated animal tissues, measuring parameters like ablation depth and lateral thermal damage. This is a direct physical measurement/assessment rather than expert consensus, pathology report (though pathology methods are used), or outcomes data in humans.

8. The Sample Size for the Training Set

• Not applicable. The DEKA SmartXide2 is a physical medical device, not an AI/ML algorithm that requires a "training set" of data.

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

• Not applicable. As a physical medical device, there is no "training set" for which ground truth needs to be established.

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The ASA laser SH1 is intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of muscle and joint pain and stiffness, arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.

The ASA laser SH1 is a medical laser system equipped with a Nd: Y AG laser source. The Nd:YAG laser radiation has a wavelength of 1064nm and is delivered to the treatment area through a fiber optics and a delivery handpiece connected to its distal end. 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 13 kg, and the size is 38 cm x 22 cm x 42 cm (H x W x D). Electrical requirement is 115Vac 50/60Hz, 750VA.

The provided 510(k) summary (K122125) describes the ASA laser SH1, a medical device for topical heating. The study provided focuses on the device's ability to achieve and maintain a specific skin temperature. Here's a breakdown based on your request:

Acceptance Criteria and Reported Device Performance

Study Details

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

• Sample Size: Three live human subjects.
• Data Provenance: Prospective (clinical study performed), country of origin not explicitly stated but the applicant is El.En. S.p.A. from Italy.

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

• Number of Experts: Not applicable. The "ground truth" here is the objective measurement of skin temperature.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

• Not applicable. The study involved objective temperature measurement, not subjective interpretation 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:

• Not applicable. This device is not an AI-assisted diagnostic tool and no MRMC study was performed.

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

• Not applicable. This is a medical laser device, not an algorithm, and its performance directly involves human subjects for therapeutic effect, not as an "algorithm-only" assessment.

7. The type of ground truth used:

• Objective Measurement (Skin Temperature): The "ground truth" was the direct measurement of skin temperature achieved and maintained on human subjects.

8. The sample size for the training set:

• Not applicable. This study does not involve an AI algorithm with a training set. The clinical study was a direct performance test on a small cohort of subjects.

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

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

Summary of the Study and its purpose for this 510(k):

The clinical study described was a clinical performance trial involving three human subjects with different skin phototypes. The primary purpose of this study was to demonstrate the device's ability to achieve its intended physiological effect (elevating and maintaining tissue temperature within a specific range). This type of study supports the substantial equivalence claim by showing that the device performs as expected and similarly to its predicate device in terms of its therapeutic mechanism. It is important to note that this is a very small study primarily focused on demonstrating direct physiological action rather than complex diagnostic or intervention outcomes.

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The Deka Synchro FT is indicated for the following treatments:

Nd: YAG laser: Removal of unwanted hair, for stable long term or permanent hair reduction (Skin Types Fitzpatrick I-VI), photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to warts, teleangiectasia, leg veins and spider veins, treatment of benign pigmented lesions.

Pulsed light attachment: Permanent hair reduction, photocoagulation of vascular lesions, photothermolysis of blood vessels, treatment of benign pigmented lesions.

Different wavelength ranges of Pulsed Light attachment are indicated for the various treatments and skin types, as indicated in the following table:

The Deka Synchro FT is a platform which can be equipped with an internal hi-power long pulse Nd:YAG laser module and a pulsed light handpiece (FT handpiece). SynchroFT with the long pulse Nd:YAG module comes with a wide range of interchangeable, quick release handpieces with electronic spot recognition. The FT handpiece is equipped with five different emission spectra interchangeable filters. The system allows to switch from one of the two available sources to the other by pressing a key on keyboard. Handpiece activation is either by footswitch or fingerswitch.

Overall weight of the device is 65 kg, and the size is 100 cm x 50 cm x 83 cm (H x W x D).

Electrical requirement is 230VAC, 16A, 50-60 Hz, single phase.

The provided 510(k) summary for the Deka Synchro FT device does not include any acceptance criteria or a study demonstrating the device meets such criteria.

Instead, the submission relies on substantial equivalence to predicate devices (El.En. Synchro HP Platform and El.En. Minisilk FT) for its approval. This means that the device's safety and effectiveness are asserted to be similar to those of devices already legally marketed, rather than being proven through new performance data against specific acceptance criteria.

Therefore, most of the information requested in your prompt regarding acceptance criteria and a study to prove device performance cannot be extracted from this document.

Here's a breakdown of what can be stated based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

No test set was used for a performance study. The submission explicitly states:

• Nonclinical Performance Data: None
• Clinical Performance Data: None

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

Not applicable, as no test set or clinical performance data was provided.

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

Not applicable, as no test set or clinical performance data was 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

Not applicable. This device is a laser and pulsed light system, not an AI-assisted diagnostic or interpretation tool. No MRMC study was conducted.

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

Not applicable. This device is a physical medical device (laser/pulsed light system), not an algorithm.

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

Not applicable, as no performance study was conducted requiring ground truth establishment.

8. The sample size for the training set

Not applicable, as no training set was used for an algorithm.

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

Not applicable, as no training set was used for an algorithm.

Summary of Device Approval Approach:

The Deka Synchro FT device gained 510(k) clearance based on its substantial equivalence to previously cleared predicate devices (El.En. Synchro HP Platform for Nd:YAG laser aspects and El.En. Minisilk FT for pulsed light attachment). The manufacturer states that the Deka Synchro FT has the same indications for use, principle of operation, and "essentially the same performances" as these predicate devices. No new nonclinical or clinical performance data were submitted to demonstrate safety or effectiveness by meeting specific acceptance criteria for this new device.

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The SmartXide 50 HS/MS system with its delivery accessories is a medical device indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery and genitourinary surgery.

SmartXide 50 HS/MS is a surgical CO2 laser with 50W of maximum power in continuous mode. The laser system is produced and sold with an internal predisposition for scanning system (HiScan Surgical for SmartXide HS, MiniScan Plus for SmartXide MS). Laser activation is by footswitch. Overall weight of the laser is 43 kg, and the size is 160 cm x 48 cm x 55 cm (H x W x D). Electrical requirement is 115VAC, 6A, 50-60 Hz, single phase. The wavelength of this laser is 10.600nm. This wavelength is mostly absorbed by water and that makes this laser particularly suitable for soft tissue surgery. The CO2 laser radiation is delivered to the treatment area through the handpiece. The handpiece is attached to the distal end of the articulated arm, which is a permanently mounted laser delivery system of the system. 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 however the arm is oriented. The field of action of the articulated arm covers a radius of approximately 80 cm, the transfer efficiency of power is greater than 85%. The loss of 15% is balanced by a suitable calibration of the internal power meter. An air flow is provided by an internal pump in order to avoid dust and particles deposition on the optics during laser operations. Emission parameters are selected on the front panel while emission activation is by the footswitch. The on-off switch and emergency switch are also located on the front panel of the system. 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. The CO2 laser microsurgery is done with microspot micromanipulators and scanning systems. The CO2 laser focalized on very little spots (140-250um) and moved by scanning systems is useful to fasten the surgical procedures and limit the thermal damage to the tissues surrounding the ablation. In the SmartXide 50 HS/MS series, the electronic controller of the scanner has been integrated in the laser system with touch screen settings. The scanning systems move the beam on the tissue with controlled velocity and defined patterns to optimize the laser ablation. The high Power Density reached though little spots and typical of the cutting, are thus well controlled by the operator, and the tissue destruction happens in a very quick, delicate and precise way, reducing drastically the surgery time and limiting the lateral thermal damage and the negative phenomenon of carbonisation, with evident advantage for the patient and for the surgeon as well. Both scanning units can be used together with Deka micromanipulator EasySpot. Easyspot has a single ring nut rapid focalization system that allows to focalize the beam to the same focal length of the microscope and fix the position with a mechanical block. In this way the micromanipulator "remembers" the focus position, still allowing eventually the surgeon to defocus the beam from the same ring nut. Thanks to its joystick, it is possible to regulate the mechanical tension and the maximum work field in order to easily control and never "loose" the beam even inside small size faryngoscopes. On top of the joystick Easyspot can mount a remote control specially conceived to command top level scanning systems (HiScan Surgical). It allows the surgeon to have under direct control the more useful electronic scanning functions (rotation and dimension of the figures, scan off-scan on, centering) without moving his eyes from the microscope.

This submission describes a CO2 laser system (Smartxide 50 HS/MS) for soft tissue surgery. The key aspect of this 510(k) is that no acceptance criteria or studies proving performance were conducted or are required for this type of device.

Here's why:

• Predicate Device Equivalence: The safety and effectiveness of the Smartxide 50 HS/MS are established by demonstrating substantial equivalence to previously cleared predicate devices: Lumenis Acupulse30 ST/40 ST (K082809), DEKA Smart CO2 (K072159), and Lumenis UltraPulse Surgitouch (K030147).
• "Nonclinical Performance Data: None" & "Clinical Performance Data: None": The document explicitly states that no nonclinical or clinical performance data was provided or deemed necessary for this 510(k) submission. This is common for devices that are "substantially equivalent" to existing, cleared devices and do not introduce new technology or indications that would necessitate new performance testing.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone studies, and training set information is not applicable to this 510(k) submission.

Summary of Device and Regulatory Context (based on the provided text):

1. Acceptance Criteria & Reported Device Performance: Not applicable. Performance is established through substantial equivalence to predicate devices, not by meeting specific acceptance criteria or through a new performance study.

2. Sample Size & Data Provenance (for test set): Not applicable, as no dedicated performance study using a test set was conducted for this submission.

3. Number of Experts & Qualifications (for ground truth): Not applicable, as no new ground truth determination was required for a performance study.

4. Adjudication Method (for test set): Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. No such study was performed or required.

6. Standalone (Algorithm Only) Performance Study: Not applicable. This is a physical medical device (CO2 laser), not an algorithm.

7. Type of Ground Truth Used: Not applicable. Safety and effectiveness are based on the known performance and predicate devices.

8. Sample Size for Training Set: Not applicable, as no machine learning algorithm was developed or tested for this device.

9. How Ground Truth for Training Set was Established: Not applicable.

Conclusion from the 510(k) Summary:
"The Smartxide 50 HS, Smartxide 50 MS lasers with delivery accessories are safe and effective devices for incision, excision, ablation, vaporization and coagulation of body soft tissue, including intraoral tissue." This conclusion is based on substantial equivalence to predicate devices.

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The Minisilk FT pulsed light device is indicated for permanent hair reduction, photocoagulation of vascular lesions, photothermolysis of blood vessels and treatment of benign pigmented lesions.

The Minisilk_FT is a pulsed light system having a Xenon flashlamp located in the handpieces. It is a light source emitting in the wavelength range 500-1200 nm. Emission activation is by footswitch. Overall weight of the system is 16 kg, and the size is 22x37x45 cm (H x W x D). Electrical requirement is: 115 VAC, 10A, 50-60 Hz, single phase.

This 510(k) summary explicitly states: "Nonclinical Performance Data: None; Clinical Performance Data: None."

Therefore, based on the provided document, the following information regarding acceptance criteria and a study to prove the device meets them cannot be detailed:

1. A table of acceptance criteria and the reported device performance: No acceptance criteria or performance data are provided.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable as no clinical study was conducted.
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 study was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no clinical study was conducted.
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 document describes a pulsed light system, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document describes a pulsed light system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no clinical study was conducted.
8. The sample size for the training set: Not applicable as no clinical study was conducted, and the device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

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