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The Dornier Medilas D LiteBeam + 1470 is a diode laser that is intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures. The device is intended for the treatment of reflux of saphenous veins associated with varicose veins and varicosities.

The Dornier Medilas D Lite Beam + 1470 Laser is a continuous-wave diode laser emitting laser radiation in the invisible range of 1470 nm. The Medilas D LiteBeam+ 1470 incorporates a graphic display panel, which shows laser operating parameters, application modes, time functions, system status and messages for the user. The Medilas D LiteBeam+ 1470 features several operating modes, including Standard, Fibertom and LPS.

The provided text describes a laser surgical instrument (Dornier Medilas D LiteBeam+ 1470) and its substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically understood for an AI/algorithm-based medical device.

The document is a 510(k) summary for a physical medical device (a diode laser system), not a software or AI device. Therefore, the questions related to AI/algorithm performance, such as test sets, ground truth, expert adjudication, MRMC studies, and standalone performance, are not applicable to this submission.

Here's a breakdown of what is available and what is not:

1. Table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the laser's clinical application. The submission focuses on compliance with general safety standards and equivalence to a predicate device.
• Reported Device Performance:
  • The device is a continuous-wave diode laser emitting at 1470 nm.
  • It complies with Class IV performance standards for light-emitting products (21 C.F.R. §1040.10 and §1040.11).
  • It complies with IEC 60601-1, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1, and European Medical Device Directive (CE).
  • The core argument is substantial equivalence to the predicate device (Biolitic 15W Ceralas Diode 1470nm Laser, K073063) based on technological characteristics and overall performance.

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. This submission for a physical laser device does not involve a "test set" in the context of an algorithm's performance on a dataset. The "performance data" refers to compliance with safety and electrical standards for the device itself, not an evaluation of its clinical effectiveness through a study with a test set of patients/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. See point 2. There's no ground truth established by experts for a test set in this type of device submission.

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

• Not applicable. See point 2.

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 physical laser device, not an AI or imaging diagnostic tool that would involve human readers or MRMC studies.

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

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

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

• Not applicable. The "ground truth" for this device relates to its adherence to manufacturing specifications, safety standards, and functional parameters, which are verified through engineering tests and quality control, not clinical data ground truth.

8. The sample size for the training set:

• Not applicable. This device does not use machine learning or require a training set.

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

• Not applicable. See point 8.

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The Dornier Medilas D 1064 Laser model (trade name Medilas D30) is indicated for use in medicine and surgery, in the following medical specialties: Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, ENT, Radiology. The Dornier Medilas D 1064 Laser model (trade name Medilas D30) is 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), and in the treatment and/or removal of vascular lesions (tumors).

The Dornier Medilas D 1064 Laser is a continuous-wave diode laser emitting laser radiation in the invisible range of 1064 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 1064 Laser incorporate a graphic display panel, which shows laser operating parameters, application modes, time functions, system status and messages for the user. The Medilas D 1064 Laser features several operating modes, including Standard, Fibertom, LITT and LPS. The laser can be used in contact or non-contact open surgery with or without handpieces.

The provided document is a 510(k) summary for the Dornier Medilas D 1064 Laser. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new device meets specific de novo acceptance criteria through rigorous clinical studies for performance metrics like sensitivity, specificity, etc.

Therefore, the document does not contain the information requested in points 1-9 regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/diagnostic device.

Here's why and what information is available:

• Type of Device: The Medilas D 1064 Laser is a surgical laser, not an AI or diagnostic device that would typically have performance metrics like those for image analysis, disease detection, or treatment efficacy quantified by sensitivity, specificity, F1-score, etc.
• Regulatory Pathway: The 510(k) pathway focuses on demonstrating "substantial equivalence" to a predicate device. This means showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to a device already on the market.
• Performance Data (as presented): 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 1064 Laser is in compliance with class IV performance standards for light emitting products promulgated under the Radiation Control for Health and Safety Act of 1968... The laser also complies 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 safety and electrical standards for laser devices, not clinical performance metrics on patient outcomes or AI accuracy.

In summary, the requested information (performance acceptance criteria, study details, sample sizes, ground truth methodology, expert qualifications, MRMC studies, standalone performance) is not applicable to this type of device and regulatory submission.

The document confirms that:

• The Medilas D 1064 Laser emits laser radiation at 1064 nm.
• It operates in continuous-wave mode.
• It is calibrated during manufacturing and service.
• It has a graphic display and several operating modes (Standard, Fibertom, LITT, LPS).
• It can be used in contact or non-contact open surgery, with or without handpieces.
• Its intended use is for cutting, vaporization, ablation, and coagulation of soft tissue in various medical specialties, including with endoscopic equipment, and for treating/removing vascular lesions.

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The Dornier Medilas D Laser is intended to be used in cutting, vaporization, ablation, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or in incision/excision, vaporization, ablation and coagulation of soft tissue in contact or non-contact open surgery (with or without hand piece).

The Dornier Medilas D is 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 laser is a 50 W diode laser that emits laser radiation in the invisible range of 940 nm. It offers laser power of 0-50 W at the distal tip of the light guide, adjustable in 1 W steps, and offers adjustable pulse duration. It has software controlled operating modes including Standard, Fibertom, LITT and LPS. It uses a 0.1mW Diode laser aiming beam with a wavelength of 645 nm. It incorporates a graphic display showing laser operating parameters, application modes, time functions, system status and messages for the user. It has a cooling system which includes an air-cooled, temperature controlled internal closed circuit water system. It is based on a single shutter with two parallel running microprocessors.

The provided text describes a 510(k) submission for the Dornier Medilas D Laser, which asserts substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a formal study.

Therefore, most of the requested information regarding acceptance criteria, study details, and data provenance cannot be extracted from this document, as such a study was not conducted or reported for this 510(k) submission.

Here's what can be inferred for the relevant points:

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

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics from a dedicated study. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices. The reported "performance" is a comparison of technological characteristics to those predicate devices.

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. No "test set" or clinical study data were provided in this 510(k) submission to demonstrate performance against specific criteria. The submission relies on a comparison of technological characteristics to already cleared devices.

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. No "ground truth" establishment by experts was detailed as no specific performance study was presented.

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

Not applicable. No "adjudication method" was detailed as no specific performance study was 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

Not applicable. This device is a laser for surgical procedures, not an AI-assisted diagnostic tool, and no MRMC study was conducted or described.

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

Not applicable. This device is a laser, not an algorithm, and performance was established by demonstrating substantial equivalence to predicate devices, not through standalone algorithm performance.

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

Not applicable. The "ground truth" in this context is the safety and effectiveness of the predicate devices as previously determined by the FDA. The Medilas D Laser's "performance" is its similarity in function and safety profile to these established devices.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this 510(k) is not for an AI algorithm or a device requiring a training phase from data.

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

Not applicable. As no training set was used, no ground truth needed to be established for it.

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