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The GreenLight HPS™ Surgical Laser System and Accessories are intended for the surgical incision/excision, vaporization, ablation and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.

532nm Applications: General Surgery, Gastroenterology, Gynecology, Head and Neck/Otorhinolaryngology (ENT), Neurosurgery, Opthamology, Plastic Surgery, Spinal Surgery, Thoracic Surgery, Urology.

1064nm Applications: Endoscopic/Laparoscopic General Surgery, Gastroenterology, General Surgery, Gynecology, Head and Neck/Otorhinolaryngology (ENT), Hemostasis during Surgery, Neurosurgery, Oculoplastics, Orthopedics, Plastic Surgery, Pulmonary Surgery, Thoracic Surgery, Urology.

The Laserscope Gemini™ Surgical Laser System and Accessories consists of four major subsystems: The Optical and Laser resonator System, The Electronics and Electrical System, Operator Interface, A variety of Delivery Devices and Accessories, A Cooling Sub-system.

The provided document K062719 is a 510(k) summary statement for the GreenLight HPS™ Series Surgical Laser System & Accessories. It establishes substantial equivalence to predicate devices and describes the intended uses of the device. However, it does not contain any information about specific acceptance criteria, outcomes of efficacy studies, or performance metrics in the way often seen for diagnostic or AI-driven devices.

The document states that the device conforms to:

• Federal Regulations
• Performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems
• International Harmonized Standards

The basis for clearance is substantial equivalence to previously cleared predicate devices, not through a prospective clinical study demonstrating specific performance metrics.

Therefore, most of the requested information (acceptance criteria, reported device performance, sample size for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance) is not present in this type of 510(k) submission for a surgical laser system.

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

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

• Acceptance Criteria: Not explicitly stated as pass/fail metrics within the document for a specific study. The device is expected to conform to general laser performance standards (21 CFR 1040.10, 1040.11) and International Harmonized Standards.
• Reported Device Performance: No specific performance metrics (e.g., accuracy, sensitivity, specificity, or surgical outcome rates) are reported as part of a formal study in this submission. The device is described as capable of incision/excision, vaporization, ablation, and coagulation of soft tissue, which is its intended function.

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

• Not Applicable. This 510(k) relies on substantial equivalence to predicate devices, not on a new clinical study with a test set of patient data to assess performance.

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

• Not Applicable. No ground truth establishment by experts for a test set is described.

4. Adjudication method for the test set

• Not Applicable. No test set or associated adjudication method 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

• Not Applicable. This document is for a surgical laser system, not an AI-driven diagnostic or assistive device that would involve human readers or AI interaction in that manner. 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 hardware surgical device, not an algorithm.

7. The type of ground truth used

• Not Applicable (in the context of clinical performance data). The "ground truth" for this 510(k) is implicitly established by the regulatory standards and the performance of predicate devices against which it is compared for substantial equivalence. There is no mention of a specific clinical ground truth (e.g., pathology, outcomes data) being used to validate the performance of this specific device in a new study mentioned in the summary.

8. The sample size for the training set

• Not Applicable. This is a hardware device submission, not an AI/machine learning algorithm that requires a training set.

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

• Not Applicable. Same as above.

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The Laserscope GDD Cystourethroscope Hardware System is intended to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples of use of the product include the visualization and manipulation of anatomy, ablation, biopsy, incision, and resection of tissue, and/or as the surgeon deems appropriate. The system is intended for use in general urological surgery through minimally invasive approach by utilizing natural orifices to access the surgical site. The system's use is intended for, but not limited to the following types of procedures: Dilation of the urethra and cold slitting strictures Trans-urethral incision, vaporization, and resection of the prostrate Trans-urethral removal of bladder tumors

The 24 Fr GDD Cystourethroscope is designed with a continuous flow outer sheath, a separate inner sheath/bridge, and an obturator. The outer sheath has the inflow and outflow Stopcocks attached to it. The inner sheath/bridge has one integral accessory port and can accommodate one accessory up to 9 Fr in size. The obturator is designed to allow atromatic introduction of the outer sheath in a natural orfice. The true continuous flow design washes away blood and small tissue particles to ensure a clear operative field. The working length is 23.2 cm to allow access to the entire lower urinary tract. The dedicated operative channel stabilizes accessories including laser fibers. The Continuous Flow Laser Cystourethroscope is designed to be used with low viscosity fluids, including normal saline, Glycine, Sorbitol, or Ringer's Lactate, and standard surgical accessories.

The provided document is a 510(k) summary for the Laserscope Guided Delivery Device (GDD) Cystourethroscope & Accessories. It explicitly states in section "K. Clinical Data" that "No clinical tests were performed." This means that the submission for this device did not include any studies proving the device meets specific acceptance criteria based on clinical performance.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found within this document.

The manufacturer, Laserscope, based their rationale for substantial equivalence and safety on the device sharing "the same Indications For Use, similar design, materials, component features, and functional features" with the predicate device, the Stryker Urology and Gynecology Hardware System. They concluded that "There are no new issues raised regarding the safety or effectiveness of the device."

In summary, the document does not contain the information needed to answer your questions because no clinical studies were conducted for this 510(k) submission.

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The Laserscope Gemini™ Laser System & Accessories is indicated for: KTP/532 Applications: Dermatology: To treat moderate inflammatory Acne vulgaris. ND:YAG/1064 Applications: Dermatology: For use in the Dermatological Applications for the treatment of facial wrinkles. It is also intended to effect stable long-term, or permanent hair reduction in skin types I - VI through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term, stable, reduction in the number of hairs re-growing after a treatment regimen.

The Laserscope Gemini™ Surgical Laser System and Accessories consists of four major subsystems: The Optical and Laser resonator System. The Electronics and Electrical System Operator Interface. A variety of Delivery Devices and Accessories A Cooling Sub-system

Acceptance Criteria and Study Details for Laserscope Gemini™ Surgical Laser System & Accessories

This document describes the acceptance criteria and supporting study details for the Laserscope Gemini™ Surgical Laser System & Accessories, based on the provided 510(k) summary.

The 510(k) summary does not contain specific acceptance criteria with performance metrics, nor does it detail a standalone clinical study to prove the device meets such criteria. Instead, the submission relies on the concept of substantial equivalence to legally marketed predicate devices.

Therefore, the "acceptance criteria" presented below are inferred from the stated claims of substantial equivalence and the device's intended uses. The "reported device performance" is essentially the claim that its performance is equivalent to the predicate devices for the specified indications.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided 510(k) summary does not contain information about a test set or a dedicated study with a specific sample size. The submission relies on demonstrating substantial equivalence to predicate devices, rather than presenting new clinical study data with a test set. Therefore, there is no mention of data provenance (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

As there is no new clinical study presented in the 510(k) summary, there is no information regarding experts used to establish ground truth.

4. Adjudication Method

Without a new clinical study or test set, there is no adjudication method mentioned in the summary.

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

The 510(k) summary does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The focus is on demonstrating equivalence of the device itself, not on comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

The Laserscope Gemini™ Surgical Laser System & Accessories is a physical medical device (laser system), not an AI algorithm. Therefore, a standalone performance study for an algorithm without human-in-the-loop performance is not applicable and not presented in this 510(k) summary.

7. Type of Ground Truth Used

Given the reliance on substantial equivalence, the "ground truth" for the device's efficacy is implicitly the established safety and effectiveness of the predicate devices for their respective indications. The summary does not refer to new pathology, expert consensus, or outcomes data specifically for the Gemini™ system in a standalone study.

8. Sample Size for the Training Set

The 510(k) summary does not refer to a training set. This is because the submission is for a physical medical device, not an AI/ML algorithm that would undergo a "training" phase with data.

9. How Ground Truth for the Training Set Was Established

As there is no training set for this type of device, this question is not applicable.

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The Laserscope Aura i Laser System & Accessories is indicated to treat moderate inflamatory acne vulgaris.

The Laserscope Aura i Surgical Laser System & Accessories are comprised of the following main components:

• A Laser Console
• A Fiber Port (for Delivery Devices)
• Control and Display Panels
• Operating Software
• Footswitch and Handswitch Delivery Controls
• Accessories
• A Cooling Sub-system

This document is a 510(k) summary for the Aura™ i Surgical Laser System & Accessories, indicating it's a submission for market clearance rather than a detailed study report. Therefore, it does not contain the acceptance criteria or a study proving the device meets specific performance criteria in the way you've outlined for clinical performance studies.

Instead, this document focuses on establishing substantial equivalence to predicate devices based on shared indications for use, design, and functional features, and adherence to performance standards for medical laser systems (21 CFR 1040.10 and 1040.11).

Therefore, I cannot provide a table of acceptance criteria or details about a study proving the device meets that criteria based on the provided text. The document is essentially a regulatory filing for market clearance, not a clinical trial report.

However, I can extract information related to the device and its intended use:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as clinical performance metrics (e.g., reduction in lesion count by X% in Y% of patients). Instead, the regulatory acceptance criteria for this 510(k) submission are that the device is substantially equivalent to legally marketed predicate devices and conforms to federal regulations and performance standards for medical laser systems (21 CFR 1040.10 and 1040.11).
• Reported Device Performance: The document states the device is "indicated to treat moderate inflammatory acne vulgaris." No specific clinical performance statistics (e.g., efficacy rates, adverse event rates, or comparative outcomes) are provided in this summary.

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

• Not applicable. This document does not describe a clinical study with a test set of patients for evaluating the device's efficacy or performance in a clinical setting. It's a regulatory submission for substantial equivalence.

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

• Not applicable. See point 2.

4. Adjudication Method for the Test Set:

• Not applicable. See point 2.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:

• No. This document does not mention any MRMC study or any comparative effectiveness study with human readers (as would be relevant for diagnostic AI).

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

• No. This device is a physical surgical laser system, not an AI algorithm.

7. The type of ground truth used:

• Not applicable. As this is a medical device and not a diagnostic AI tool, the concept of "ground truth" for a test set in the same way is not relevant here. The "truth" for its claims relies on its physical and functional similarity to already cleared devices and adherence to laser safety standards.

8. The sample size for the training set:

• Not applicable. This document describes a physical medical device, not an AI model that requires a training set.

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

• Not applicable. See point 8.

In summary: This 510(k) submission establishes the regulatory pathway for marketing the Aura™ i Surgical Laser System by demonstrating substantial equivalence to predicate devices and compliance with relevant safety standards. It does not present clinical trial data or performance against specific clinical acceptance criteria in the format you requested.

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The Laserscope Lyra TM Laser Systems & Accessories are indicated for use in the Dermatological applications for the treatment of facial wrinkles.

The Lyra™ Series Surgical Laser Systems are Nd: YAG lasers producing laser emission @ 1064nm. The Laserscope Lyra Surgical Laser System consists of four major subsystems: The Optical and Laser Resonator system; The Cooling system; The Electronics and Electrical system; The Operator interface.

The provided text describes the Laserscope Lyra™ Surgical Laser System & Accessories 510(k) Premarket Notification. However, it does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a study proving the device meets those criteria from an AI/algorithm perspective.

This document is a traditional medical device 510(k) summary for a physical laser system, not for a software or AI-driven diagnostic device. Therefore, the concepts of "test set," "ground truth," "MRMC study for AI improvement," and "standalone algorithm performance" are not applicable in the context of this specific regulatory submission.

Here's what can be extracted and what cannot:

Information from the provided text:

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

• Acceptance Criteria: The document only broadly states that "Clinical studies produced results that indicate the Laserscope Lyra™ Laser Systems & Accessories is safe and effective for the treatment of facial wrinkles." Specific quantitative acceptance criteria (e.g., a certain percentage reduction in wrinkles, or a specific patient satisfaction score) are not provided.
• Reported Device Performance: Similarly, specific performance metrics are not provided. The document only offers a general statement about safety and effectiveness.

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

• Test Set Sample Size: Not provided.
• Data Provenance: The document mentions "Clinical studies," implying prospective data collection on human subjects, but does not specify country of origin or whether it was retrospective.

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

• This concept of "experts establishing ground truth" is typically associated with AI model validation where human experts label data. For a physical laser device for wrinkle treatment, the "ground truth" would likely be direct clinical observation by physicians, patient self-assessment, or possibly photographic analysis by a panel of evaluators. However, none of this detail is provided.

4. Adjudication method for the test set:

• 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. This is a physical laser device, not an AI system being evaluated to assist human readers.

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

• Not applicable. This is a physical laser device.

7. The type of ground truth used:

• The document implies the ground truth was based on clinical outcomes relevant to "safety and effectiveness for the treatment of facial wrinkles." This would likely involve physician assessment, possibly patient questionnaires, and potentially photographic evidence, but specifics are not given. It is not pathology or genetic data.

8. The sample size for the training set:

• Not applicable / not provided. The concept of a "training set" applies to machine learning models, not typically to the direct development and testing of a physical medical device. While there were clinical studies, they are not referred to as a "training set" in this context.

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

• Not applicable / not provided.

In summary of what is available from the document:

• Device Type: Laserscope Lyra™ Surgical Laser System & Accessories (Nd:YAG laser)
• Intended Use: Dermatological applications for the treatment of facial wrinkles.
• Performance Claim: "Clinical studies produced results that indicate the Laserscope Lyra™ Laser Systems & Accessories is safe and effective for the treatment of facial wrinkles."
• Nonclinical Data: None mentioned for this specific submission, likely relying on prior predicate device data for engineering performance.
• Clinical Data: Yes, clinical studies were performed to support safety and effectiveness. However, no details about the study design, sample size, specific endpoints, or results are included in this 510(k) summary.

This 510(k) summary serves to establish substantial equivalence to predicate devices, and as such, often omits the granular detail of clinical study results that would typically be found in a full clinical study report or a PMA submission requiring more extensive evidence.

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The Orion Series Surgical Laser System (Q-Switched Nd:YAG configuration) is intended for the removal and reduction of unwanted hair.

The Crion Series Surgical Laser System and the Lyra Surgical Laser System are intended for the lightening and removal of unwanted body hair in Fitzgatrick Skin Ty I to VI using 1064 nm, Nd:YAG.

The Orion Series Surgical Laser System consists of a movable console containing power supplies, a treatment laser on a solid optical deck, and a cooling system to dissipate the heat generated by the system. A keypad control panel with CRT enables the user to control the laser system operating parameters. Surgical power is controlled via a footswitch. Laser power is emitted only when the footswitch is depressed. The delivery system is through fiber optics.

Here's an analysis of the provided text to extract the requested information about acceptance criteria and the study that proves the device meets them:

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

• 38% at 7 days post-treatment
• 86% at 30 days post-treatment
• 58% at 90 days post-treatment |
  | Safety: No adverse events or complications reported beyond the time of treatment | Safety: One adverse event (extended erythema and burning sensation resolved within 10 minutes of treatment) reported at the time of treatment (1.4%). No adverse events or complications reported beyond the time of treatment. |

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

• Sample Size (Test Set): 70 patients, with 139 treated sites among them.
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the study was described as "multi-center" with "three geographically dispersed investigational centers," and the 510(k) summary is submitted to the US FDA, implying US-based data.
  • Retrospective or Prospective: Prospective (described as a "multi-center, randomized, unblinded design with an active, parallel control" and treatments were performed between specific dates: June 8 and October 12, 1998).

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)

• Number of Experts: At least one "investigator" at each of the three study centers. The text refers to "the investigator" (singular) in the context of effectiveness evaluation, implying a single expert per site making the primary visual assessment.
• Qualifications of Experts: Not specified. The text only refers to "the investigator" without detailing their professional background or experience (e.g., dermatologist, physician, etc.).

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

• Adjudication Method: None explicitly described for the "investigator" estimates. The text primarily relies on the investigator's visual estimation and the patient's self-reported satisfaction/estimate. The success criteria combine these two subjective measures. There is no mention of an independent panel or multiple expert readers for agreement.

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

• MRMC Study: No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done.
• Effect Size of AI Assistance: Not applicable, as this is a device study for a surgical laser, not an AI diagnostic algorithm.

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

• Standalone Performance: Not applicable. This study evaluates a physical laser device operated by a human, not a standalone algorithm.

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

• Type of Ground Truth: The ground truth for effectiveness was a combination of:
  • Expert Visual Estimation: "The investigator was to visually estimate percent reduction in hair density." (Subjective)
  • Patient Self-Reported Visual Estimation: "The patient was also queried as to her or his visual estimate of percent reduction in hair density." (Subjective)
  • Patient Satisfaction Ranking: "The patients were asked to rank their treatments on a scale from 1 to 5." (Subjective outcomes data)

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This study describes a clinical trial for a physical medical device, not a machine learning model that requires a training set. The 70 patients used are for the prospective clinical study itself.

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

• Ground Truth for Training Set: Not applicable, as there is no training set in the context of this device evaluation.

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