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The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are indicated for use in medicine and surgery, in the following medical specialties: Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, Pulmonary Surgery, Gastroenterology, ENT, and Radiology.

The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopies), in incision/excision, vaporization, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), in the treatment and/or removal of vascular lesions (tumors) and removal of unwanted hair, for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux and treatment of reticular veins and branch varicosities.

The Dornier Medilas D Family Lasers, specifically the Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are intended for use in the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral lobes ranging in total volume from 28-85 cc.

Device Description

The Dornier Medilas D Family Lasers are continuous-wave diode laser emitting laser radiation in the invisible range of 940 nm. Each is calibrated during the manufacturing process and during service calls. The end-user does not calibrate fibers for this system. The Medilas D Family Lasers incorporate a graphic display panel, which shows laser operating parameters, application modes, time functions, system status and messages for the user. The Medilas D Family Lasers feature several operating modes, including Standard, Fibertom, LITT and LPS. The lasers can be used in contact or non-contact open surgery with or without handpieces.

AI/ML Overview

The provided document is a 510(k) summary for the Dornier Medilas D Family Lasers. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense of a novel device proving its efficacy or accuracy.

Therefore, the requested information elements such as acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC/standalone studies, are not explicitly present in this type of regulatory submission. This document describes the device, its intended use, and its technological characteristics as compared to a predicate device, ultimately stating its compliance with established electrical and laser safety standards rather than clinical performance metrics.

Here is a summary of what can be extracted from the document, with explanations for the missing information:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Safety and Effectiveness through Substantial Equivalence: The primary "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a legally marketed predicate device, ensuring the new device is as safe and effective.	The submission concludes that the Dornier Medilas D Family Lasers and the predicate device (Biolitec Ceralas Diode 100 W 980 nm Laser System K050824) are "substantially equivalent" from a clinical perspective and based on design specifications. "No significant differences exist between the proposed diode lasers and the predicate devices."
Compliance with Safety Standards: Compliance with relevant international electrical and laser safety standards.	The lasers are in compliance with Class IV performance standards for light-emitting products promulgated under the Radiation Control for Health and Safety Act of 1968 (21 C.F.R. §1040.10 and §1040.11). They also comply with IEC 60601-1, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1, and European Medical Device Directive (CE).
Technological Characteristics Comparison: The new device's technological characteristics should not raise new issues of safety or effectiveness compared to the predicate device.	The "minor differences" between the Medilas D Family Lasers and its predicates "should not raise any concerns regarding the overall safety or effectiveness."

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. As this is a 510(k) for a laser system built on substantial equivalence to an existing device, it relies on design comparisons and compliance with safety standards rather than new clinical outcome data or a specific "test set" in the context of AI/diagnostic device performance.

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. This type of detail is relevant for diagnostic devices or those requiring expert interpretation for ground truth, which is not the primary focus of this laser system's 510(k) submission.

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

This information is not provided. See point 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

This information is not provided. MRMC studies are typically for evaluating the impact of AI on human diagnostic performance, which is not applicable to a laser system device focused on tissue manipulation.

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

This information is not provided. This refers to AI algorithm performance and is not relevant for this device.

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

This is not specified because the submission relies on the established safety and efficacy of the predicate device and compliance with general device standards, not on a new clinical study generating specific ground truth. The "ground truth" for this type of submission is essentially the proven safety record and performance of the predicate device and the adherence to recognized safety standards.

8. The sample size for the training set

This information is not applicable/provided. There is no mention of "training set" as this is not an AI/machine learning device.

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

This information is not applicable/provided. See point 8.

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K Number

K083258

Device Name

MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE

Manufacturer

DORNIER MEDTECH AMERICA, INC.

Date Cleared

2009-01-30

(87 days)

Product Code

GEX

Regulation Number

878.4810

Type

Traditional

Panel

General & Plastic Surgery

Reference & Predicate Devices

N/A

Intended Use

The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are indicated for use in medicine and surgery, in the following medical specialties: Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, Pulmonary Surgery, Gastroenterology, ENT, and Radiology.

The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopies), in incision/excision, vaporization, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), in the treatment and/or removal of vascular lesions (tumors) and removal of unwanted hair, for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux and for use in the treatment of incompetence and reflux of superficial veins in the lower extremity.

Device Description

AI/ML Overview

This submission describes the Dornier Medilas D Family Lasers. The provided text indicates that the device's performance was evaluated against technological characteristics and overall performance, rather than specific quantitative acceptance criteria or a clinical study demonstrating statistically significant improvements.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
No significant differences existing between the proposed diode lasers and the predicate devices (Diomed D15 plus and D30 plus)	Dornier MedTech America, Inc. believes that no significant differences exist and that minor differences should not raise concerns regarding overall safety or effectiveness.
Compliance with Class IV performance standards for light-emitting products (promulgated under the Radiation Control for Health and Safety Act of 1968)	The Dornier Medilas D Family Lasers are in compliance with 21 C.F.R. §1040.10 and §1040.11.
Compliance with applicable voluntary standards: IEC 60601-1, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1, and European Medical Device Directive (CE).	The lasers also comply with these standards.
Substantial Equivalence for Safety and Effectiveness (compared to predicate devices)	Dornier MedTech America, Inc. believes the devices are substantially equivalent, and differences are minor, not raising new issues of safety or effectiveness.

Study Information

The provided text does not describe a clinical study with a test set, ground truth, or expert review for the device's performance in its intended clinical applications. Instead, it focuses on demonstrating substantial equivalence to existing predicate devices based on technological characteristics and compliance with regulatory and voluntary standards.

Here's what can be inferred or stated as absent based on your questions:

Sample size used for the test set and the data provenance: Not applicable. No clinical test set described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set or ground truth established by experts is mentioned for device performance.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical test set described.
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 system, not an AI-assisted diagnostic tool for human readers. No MRMC study was conducted.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device (laser system), not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this submission revolves around compliance with engineering and safety standards, and technological similarity to predicate devices, rather than clinical outcomes verified by independent means.
The sample size for the training set: Not applicable. This device is a laser system, not a machine learning algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable.

In summary: The provided 510(k) summary is for a medical laser system and focuses on demonstrating substantial equivalence to predicate devices through a review of technological characteristics and compliance with established safety and performance standards. It does not contain information about a clinical study involving a test set, ground truth, or expert review in the manner typically associated with submissions for diagnostic or AI-driven devices.

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K Number

K073427

Device Name

MEDILAS D FAMILY LASERS

Manufacturer

DORNIER MEDTECH AMERICA, INC.

Date Cleared

2008-08-20

(258 days)

Product Code

GEX

Regulation Number

878.4810

Type

Traditional

Panel

General & Plastic Surgery

Reference & Predicate Devices

K982629,K003993,K000072,K020339

Intended Use

The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are indicated for use in medicine and surgery, in the following medical specialties: Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, Pulmonary Surgery, Gastroenterology, ENT, and Radiology.

The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopies), in incision/excision, vaporization, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), in the treatment and/or removal of vascular lesions (tumors) and removal of unwanted hair, for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.

Device Description

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Dornier Medilas D Family Lasers. However, it does not contain information about acceptance criteria for device performance, nor does it detail a study proving the device meets such criteria.

The document primarily focuses on:

Intended Use and Indications for Use: Delineating the medical specialties and specific procedures for which the lasers are intended.
Technological Characteristics: Stating that the device is substantially equivalent to predicate devices.
Regulatory Compliance: Listing the performance standards and voluntary standards with which the device complies (e.g., 21 C.F.R. §1040.10 and §1040.11, IEC 60601-1, etc.). These are regulatory compliance standards, not performance acceptance criteria from a clinical study.
Administrative Information: Submitter details, device trade names, common names, classification, and predicate devices.
FDA Clearance Letter: Confirming substantial equivalence to predicate devices based on the information provided.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided document.

The document does not include any details on:

A table of acceptance criteria and reported device performance.
Sample sizes for test sets, data provenance.
Number of experts or their qualifications for ground truth.
Adjudication methods.
Multi-reader multi-case (MRMC) comparative effectiveness studies.
Standalone (algorithm only) performance studies.
Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
Sample size for the training set.
How ground truth for the training set was established.

The "Performance Data" section explicitly states: "While no performance standards have been established for Diode lasers under Section 514 of the Federal Food, Drug, and Cosmetic Act, the Dornier Medilas D Family Lasers are in compliance with class IV performance standards for light emitting products promulgated under the Radiation Control for Health and Safety Act of 1968. See 21 C.F.R. §1040.10 and §1040.11. The lasers also comply with the applicable requirements of the following voluntary standards: IEC 60601-1, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1, and European Medical Device Directive (CE)."

This indicates compliance with electrical safety and laser product performance standards, which are different from acceptance criteria for clinical efficacy or diagnostic accuracy that would be proven in a clinical study.

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K Number

K070536

Device Name

MEDILAS D FAMILY LASERS

Manufacturer

DORNIER MEDTECH AMERICA, INC.

Date Cleared

2007-05-21

(84 days)

Product Code

GEX

Regulation Number

878.4810

Type

Traditional

Panel

General & Plastic Surgery

Reference & Predicate Devices

K982629,K003993,K021724,K000072,K020339

Intended Use

The Dornier Medilas D Family Lasers, specifically the Medilas D LiteBeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, and Medilas D FlexiPulse are indicated for use in medicine and surgery, in the following medical specialties: Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, Pulmonary Surgery, Gastroenterology, ENT, Radiology.

The Dornier Medilas D Family Lasers, specifically the Medilas D LiteBeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, and Medilas D FlexiPulse, are intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopies), in incision/excision, vaporization, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), in the treatment and/or removal of vascular lesions (tumors) and removal of unwanted hair, and for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.

The Dornier Medilas D Family Lasers, specifically the Medilas D UroBeam, Medilas D MultiBeam, and Medilas D FlexiPulse, are intended for use in the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral lobes ranging in total volume from 28-85 cc.

Device Description

AI/ML Overview

The provided text describes the 510(k) summary for the Dornier Medilas D Family Lasers. It outlines the device, its intended use, and claims of substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria or a detailed study proving the device meets particular performance metrics beyond regulatory compliance.

Instead, the submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, a common pathway for medical device clearance in the US.

Here's an analysis based on the information provided, highlighting what is present and what is absent:

Acceptance Criteria and Device Performance Study for Dornier Medilas D Family Lasers

This submission for the Dornier Medilas D Family Lasers (including Medilas D Litebeam, Medilas D Litebeam +, Medilas D Urobeam, Medilas D Multibeam, and Medilas D FlexiPulse) relies on demonstrating substantial equivalence to predicate devices rather than independent performance studies with specific acceptance criteria. Therefore, a table of acceptance criteria and reported device performance, in the typical sense of quantitative clinical or analytical performance, cannot be extracted directly from this document.

The "acceptance criteria" can be inferred as compliance with existing regulatory standards and the demonstration of equivalent technological characteristics and overall performance to the identified predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category (Inferred)	Reported Device Performance (Inferred from Submission)
Regulatory Compliance	Complies with Class IV performance standards for light-emitting products (21 C.F.R. §1040.10 and §1040.11). Complies with voluntary standards: IEC 60601-1, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1, and European Medical Device Directive (CE).
Technological Characteristics	"From a clinical perspective and comparing design specifications, the Dornier Medilas D Family Lasers and the predicate devices are substantially equivalent." Minor differences exist that "should not raise any concerns regarding the overall safety or effectiveness."
Overall Performance	"Based on the technological characteristics and overall performance of the devices... no significant differences exist between the proposed diode lasers and the predicate devices." Implied performance is equivalent to predicate devices for stated indications.
Safety and Effectiveness	Believed to be "substantially equivalent" to predicate devices, and differences "do not raise new issues of safety or effectiveness."

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

The document does not describe a specific "test set" for a performance study as it relies on substantial equivalence. It does not mention any sample sizes for tests, nor does it specify data provenance in terms terms of country of origin or retrospective/prospective nature. The assessment is based on a comparison of design specifications and regulatory compliance.

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

This information is not provided as there is no described test set or ground truth establishment relevant to the performance metrics of an AI/algorithm-based device. The submission focuses on the engineering and regulatory equivalence of a laser system.

4. Adjudication Method for the Test Set

This information is not provided as there is no described test set that would require an adjudication method.

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

A MRMC comparative effectiveness study was not conducted or reported for this device, as it is a laser hardware system, not an AI or imaging diagnostic tool that would typically involve human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study, as understood for AI/algorithmic devices, was not conducted or reported. The device is an energy-based surgical tool. Its performance is assessed through compliance with electrical, laser radiation, and medical device safety standards, and by demonstrating equivalence in its operational specifications to previously cleared devices.

7. Type of Ground Truth Used

The concept of "ground truth" as typically applied to AI image analysis or diagnostic algorithms is not relevant or discussed in this 510(k) submission. The "truth" in this context is the fulfillment of regulatory standards and the demonstration that the device's technical specifications and intended uses are analogous to legally marketed predicate devices.

8. Sample Size for the Training Set

This information is not applicable and not provided as this submission is for a laser surgical instrument, not an algorithm that requires a training set.

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

This information is not applicable and not provided for the reasons stated in point 8.

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