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The Dornier Scanner handpiece is intended to be used in general and surgical procedures for incision / excision, vaporization, ablation, and coagulation of soft tissue and cartilage. The Dornier Scanner may also be used for skin resurfacing.

The Dornier Scanner is for use as an accessory for the Dornier Medilas E Laser (K981438). It is indicated for use in medicine and surgery in the medical specialties as listed in the Indication for Use Statement for the Dornier Medilas E Laser System.

No new indications are being requested.

The Dornier Scanner handpiece is intended to be used in general and surgical procedures for incision / excision, vaporization, ablation, and coagulation of soft tissue and cartilage. The Dornier Scanner may also be used for skin resurfacing. The Dornier Scanner is for use as an accessory for the Dornier Medilas E Laser (K981438).

This looks like a 510(k) summary for a medical device submitted to the FDA, rather than a study report detailing acceptance criteria and performance data.

Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth, expert qualifications, and multi-reader multi-case studies cannot be extracted from the provided text.

The document states that the safety and effectiveness of the Dornier Scanner is based on "substantial equivalence" to predicate devices (Dornier VarioSpot 90 handpiece and Coherent's Computerized Pattern Generator). It does not describe a new study with explicit acceptance criteria and performance metrics for the Dornier Scanner itself.

Here's a breakdown of why the requested information is not present based on the provided text:

1. Acceptance Criteria and Device Performance Table: Not provided. The document makes a claim of "substantial equivalence" rather than presenting specific performance metrics against pre-defined acceptance criteria.
2. Sample Size and Data Provenance: Not applicable, as no new study is described where data was collected. The comparison is based on the characteristics of existing predicate devices.
3. Number and Qualifications of Experts for Ground Truth: Not applicable. Ground truth typically refers to validated outcomes in a clinical study; since no such study for the Dornier Scanner is described, no experts were needed to establish ground truth.
4. Adjudication Method: Not applicable for the same reasons as above.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned and not applicable. This type of study involves human readers interpreting data, often with AI assistance, which is not relevant to a laser handpiece accessory.
6. Standalone Performance Study: Not mentioned and not applicable. "Standalone" performance usually refers to an algorithm's performance without human intervention, which again, is not relevant to a laser handpiece.
7. Type of Ground Truth Used: Not applicable.
8. Sample Size for Training Set: Not applicable, as this is not an AI/algorithm-based device requiring a training set.
9. How Ground Truth for Training Set was Established: Not applicable.

In summary, the provided text is a regulatory submission for premarket notification (510(k)) that focuses on demonstrating "substantial equivalence" of a new device (Dornier Scanner) to existing predicate devices, rather than presenting a detailed study report of the new device's performance against specific acceptance criteria.

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The Domier Lasertrode fiber is intended to be used for vaporization, cutting, ablation and coagulation of soft tissue in conjunction with or without endoscopic equipment including laparoscopes, hysteroscopes, bronchoscopes, cystoscopes, gastroscopes, colonoscopes, or for open surgery for contact or non-contact surgery with or without handpiece for use in coagulation, incision/excision, ablation and vaporization of soft tissue.

The Dornier Lasetrode is indicated for use in medicine and surgery in the following specialties: Urology, Plastic Surgery, Radiology, Dermatology, Pulmonology, Gastroenterology, Gynecology, ENT and General Surgery.

Not Found

The provided text is a 510(k) summary for the Dornier Lasertrode Fiber, seeking substantial equivalence to a predicate device. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring new clinical studies with acceptance criteria, test sets, or expert evaluations. Therefore, the document does not contain information regarding acceptance criteria, device performance from a new study, sample sizes, ground truth establishment, or clinical effectiveness studies in the way you've described.

Instead, the submission argues for substantial equivalence based on technological characteristics and intended use being the same as the predicate device (Dornier Light Guide with Bare Fiber Tip, K982629).

Here's why the requested information cannot be extracted from this document:

• No new clinical study: The document explicitly states, "The safety and effectiveness of the Dornier Lasertrode is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices..." This means no new clinical trials were conducted to establish performance against acceptance criteria for this specific 510(k) submission.
• Focus on substantial equivalence: The core of a 510(k) is to show that a new device is "substantially equivalent" to one already on the market. This often involves comparing design, materials, intended use, and performance data from previous studies on the predicate device, or bench testing to show similar performance, but not typically a new, large-scale clinical trial with acceptance criteria for the new device itself.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, and expert opinions because the provided 510(k) summary does not contain this information for the Dornier Lasertrode Fiber.

The document's statement: "Dornier Surgical Products, Inc. believes the minor differences of the Dornier Lasertrode fiber and its predicate laser accessories should not raise any concerns regarding the overall safety or effectiveness" further supports this, indicating a comparison rather than a de novo performance evaluation.

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The Dornier Medilas H/2 Laser is intended to be used in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparascopes, 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 H/2 Laser is indicated for use in medicine and surgery in the following specialties: Urology, Pulmonology, Arthroscopy, Lithotripsy, Gastroenterology, Gynecology, ENT, and General Surgery.

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I am sorry, but the provided text is a 510(k) summary for a medical device (Dornier Medilas H/2 Laser) and does not contain the kind of study information (acceptance criteria, sample sizes, expert qualifications, ground truth, etc.) that you are asking for.

The 510(k) summary focuses on establishing "substantial equivalence" of the new device to a predicate device already on the market, rather than presenting a performance study with detailed acceptance criteria and study data. It primarily discusses:

• Device Name, Submitter, and Contact Information: Basic identification details.
• Classification Name and Predicate Devices: How the device is categorized and which existing device(s) it is compared to for regulatory purposes.
• Intended Use and Indications for Use: What the device is designed to do and for which medical conditions/procedures. In this case, it's for cutting, vaporization, ablation, and coagulation of soft tissue in various surgical specialties.
• Technological Characteristics and Substantial Equivalence: The core of a 510(k), where the manufacturer argues that their new device is similar enough to an already legally marketed device (the predicate) that it does not raise new questions of safety or effectiveness. The key point here is that the only minor difference mentioned is the replacement of a contraindication with a precaution statement regarding kidney and bladder stone fragmentation.

Therefore, I cannot extract the requested information from this document. To answer your questions, I would need a clinical study report or a pre-market approval (PMA) application summary, which typically include detailed performance data, acceptance criteria, and study methodologies.

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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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The Dornier Medilas E Laser is intended to be used in small and large joint arthroscopy, laparoscopic procedures, general and all surgical procedures for incision/excision, vaporization, ablation, and coagulation of soft tissue and cartilage. All soft tissues encountered in all surgical procedures are included in this indication such as, skin, cutaneous tissue, subcutaneous tissue, straited and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The Dornier Medilas E may also be used for skin resurfacing.

The Dornier Medilas E is indicated for use in medicine and surgery, in the following medical specialties:

• Dermatology
• Plastic Surgery
• General Surgery
• Urology
• Gynecology
• Pulmonary Surgery
• Gastroenterology
• ENT
• Thoracic Surgery
• Oral & Maxillofacial Surgery
• Ophthalmology
• Podiatry

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The provided document is a 510(k) Summary for the Dornier Medilas E Laser, dated July 20, 1998. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific acceptance criteria through clinical studies in the way a new medical algorithm would.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not present in this document. The 510(k) process for this device focused on technological characteristics and intended use in comparison to existing, legally marketed lasers.

Instead of a table of acceptance criteria and reported performance, the document states:
"The safety and effectiveness of the Dornier Medilas E Laser is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices which includes the following: Schwartz Electro-Optics, Inc. CRL 2940 Erbium CR Laser (K9971404 / K974039); Sharplan Model 4020 Erbium YAG Laser (K971648)."

And further:
"From a clinical perspective and comparing design specifications, the Dornier Medilas E laser and the predicate devices are substantially equivalent and have the same intended use. Based on the technological characteristics and overall performance of the devices, Dornier Surgical Products, Inc. believes that no significant differences exist between the Dornier Medilas E and the predicate devices, SEO CRL 2940 Erbium CrystaLase and the Sharplan Model 4020 Erbium YAG laser."

Summary of unavailable information from the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable/not provided. The document focuses on substantial equivalence based on technological characteristics and intended use, not on specific performance metrics or acceptance criteria for a novel device.
2. Sample sized used for the test set and the data provenance: Not applicable/not provided. There is no mention of a test set or data from a clinical study to assess 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): Not applicable/not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/not 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/not provided. This device is a laser, not an AI-powered diagnostic tool, so MRMC studies are irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable/not provided. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/not provided.
8. The sample size for the training set: Not applicable/not provided.
9. How the ground truth for the training set was established: Not applicable/not provided.

The document is a regulatory submission demonstrating substantial equivalence of a physical medical device (a laser) to existing predicate devices, rather than a clinical study report for an algorithm or a device requiring specific performance metrics against acceptance criteria.

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The Dornier Medilas H 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, and colonoscopes), or in incision/excision, vaporization, ablation and coagulation of soft tissue in contact or non-contact open surgery. The Dornier Medilas H Laser is indicated for use in medicine and surgery, in the following specialities: Urology, Pulmonology, Arthroscopy, Lithotripsy, Gastroenterology, Gynecology, ENT, and General Surgery.

The Dornier Medilas H Pulsed Holmium YAG Laser is a compact pulsed HO:Yag laser emitting laser radiation in the invisible range of 2080 nm. The Medilas H provides a temperature controlled method for contact cutting and non contact coagulation and vaporization with a bare fiber.

This document describes a 510(k) submission for the Dornier Medilas H Pulsed Laser. The provided text is a summary seeking clearance for the device, and as such, it does not detail a study proving the device meets specific performance acceptance criteria in the manner one might find for a diagnostic or AI-based device. Instead, it focuses on demonstrating substantial equivalence to predicate devices and compliance with relevant safety standards.

Therefore, many of the requested elements regarding acceptance criteria, sample sizes, ground truth establishment, expert adjudication, and comparative effectiveness studies are not applicable or not present in this type of submission.

Here's an analysis based on the provided text, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for a laser device demonstrating substantial equivalence, explicit "acceptance criteria" for a specific disease or diagnostic task are not provided in the same way they would be for a clinical diagnostic device.

The "performance" is primarily focused on demonstrating that the device operates safely and effectively within established laser standards and is technologically similar to predicate devices.

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

This is not applicable. The submission does not describe a clinical study in the traditional sense involving a "test set" of patient data. It relies on technological comparison and compliance with standards rather than clinical performance data against a specific disease outcome.

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

This is not applicable. No ground truth for a test set was established as no such study is described.

4. Adjudication Method for the Test Set

This is not applicable. No test set requiring expert adjudication is described.

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 is not applicable. This is not an AI-assisted diagnostic device, but a surgical laser. No MRMC study was performed.

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

This is not applicable. This is a surgical laser, not an algorithm.

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

This is not applicable. The submission is based on demonstrating substantial equivalence to predicate devices and compliance with safety and performance standards for laser devices, not on a ground truth related to a specific disease diagnosis or outcome in a study. The closest concept to "ground truth" here would be the established safety and efficacy profiles of the predicate devices and the regulatory standards themselves.

8. The Sample Size for the Training Set

This is not applicable. This is not a machine learning device that requires a training set.

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

This is not applicable. As above, this is not a device requiring a training set with established ground truth.

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