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The device is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures including via endoscopes. The Evolve HPD Multiwavelength 980/ 1470 Diode Laser (up to 150W) is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, cardiothoracic surgery, dental applications, and endovenous occlusion of the saphenous veins in patients with superficial vein reflux. The Multiwavelength laser is further indicated for laser assisted lipolysis. Power from 151W to 200W is indicated in the vaporization of the prostate to treat Benign Prostatic Hyperplasia (BPH).

The device is specifically indicated for use as follows:

Ear, Nose and Throat and Oral Surgery (Otolaryngology)
Arthroscopy
Gastroenterology
General Surgery, Dermatology, Plastic Surgery and Podiatry
Endovenous Occlusion of the Saphenous Veins in Patients with Superficial Vein Reflux Associated with Varicose Veins and Varicosities
Urology
Gynecology
Neurosurgery
Cardiac Surgery
Pulmonary Surgery
Dental Applications
Powers from 151W to 200W

The Evolve HPD 980/ 1470nm Multiwavelength Diode Laser contains the same basic components as the cleared Ceralas 150W 980/ 1470mm Diode Laser (K090164). The purpose of this submission is to increase the energy from 150W to 200W for application in the vaporization of the prostate to treat Benign Prostatic Hyperplasia. (BPH)

The provided text is a 510(k) summary for the Evolve® HPD 980/ 1470nm Multiwavelength Diode Laser. It primarily focuses on demonstrating substantial equivalence to predicate devices and expanding the power range for a specific indication. The document does not contain the level of detail typically found in a clinical study report that would establish specific acceptance criteria and detailed performance metrics.

Therefore, many of the requested fields cannot be directly extracted or inferred from this document. However, based on the information provided, here's what can be answered:

Acceptance Criteria and Device Performance:

The document states that the device complies with several voluntary consensus standards, implying that meeting these standards served as acceptance criteria for certain aspects (e.g., electrical safety, electromagnetic compatibility, biocompatibility).

Study Details:

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

   • The document mentions "studies using 200W 980nm lasers on human cadaver prostates" and "50W 1470nm lasers on prostates of patients with bladder outlet obstruction." However, specific sample sizes for these studies are not provided.
   • Provenance: "human cadaver prostates" and "prostates of patients." The country of origin is not specified but given it's a US FDA submission, US data is implied or preferred, but not explicitly stated.
   • Retrospective or prospective: Not specified.

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

   • This information is not provided in the document. The document refers to "published clinical data" and "studies," but doesn't detail the methodology for establishing ground truth within those studies.

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

   • This information is not provided.

4. 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 device is a surgical laser, not an AI diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.

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

   • This device is a surgical laser, and its performance is inherently tied to its use by a human in a surgical setting. Therefore, a "standalone algorithm only" performance study is not applicable. The "performance data" refers to the physical effects of the laser (ablation rates).

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

   • For the ablation studies on prostates, the "ground truth" would likely involve objective measurements of tissue ablation, such as volume of tissue removed, depth of penetration, or other physical/histological evaluations of the treated tissue. The document does not explicitly state the specific type of measurement.

7. The sample size for the training set:

   • The document primarily relies on "published clinical data" and studies on cadaver/patient prostates. There is no mention of a "training set" in the context of an algorithm or AI model, as this is a hardware device.

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

   • As there is no "training set" in the context of an AI model for this hardware device, this question is not applicable. The "ground truth" related to the laser's physical performance (e.g., ablation rates) would be established through direct measurement and observation in experiments.

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The Ceralas 1470nm Fiber-Coupled Diode Laser family (and its delivery accessories used to deliver optical energy) is indicated for use in general surgical applications for incision, excision, ablation, cutting, vaporization, hemostasis, and coagulation of soft tissue contact or non-contact, open or closed endoscopic applications where incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue vaporization, hemostasis and/or coagulation may be indicated. Endovenous Occlusion of the Saphenous Veins in Patients with Superficial Vein Reflux Associated with Varicose Veins and Varicosities. Laser Assisted Lipolysis.

The Ceralas 1470nm family for Biolitec Medical Devices, Inc. is identical (contains the same components, technology and principles of operation and assembled by the same manufacturer) as the cleared Ceralas 1470nm family for Biolitec, Inc..

Here's an analysis of the provided text regarding the Ceralas 1470nm Diode Laser Family, focusing on acceptance criteria and study information:

Acceptance Criteria and Device Performance

This submission is a 510(k) for substantial equivalence, not a premarket approval (PMA) application. Therefore, it focuses on demonstrating that the device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific clinical efficacy endpoints. The "acceptance criteria" here are compliance with recognized standards and demonstrating identical characteristics to the predicate.

Table of Acceptance Criteria and Reported Device Performance

Study Details

This submission does not present a clinical study in the traditional sense of evaluating device performance on patients or human readers. Instead, it relies on demonstrating substantial equivalence to already cleared predicate devices. The "study" here is a comparison exercise rather than a performance trial.

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

   • Test Set Sample Size: Not applicable. This is a substantial equivalence submission based on device characteristics, not a clinical performance study with a test set of data.
   • Data Provenance: Not applicable. The "data" consists of device specifications and confirmed manufacturing processes, not patient data.

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

   • Not applicable. Ground truth for a clinical test set is not established in this type of submission. The "ground truth" for substantial equivalence is the established safety and effectiveness of the predicate device.

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

   • Not applicable. There is no test set or adjudication process for clinical outcomes.

4. 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:

   • No. This device is a surgical laser, not an AI-assisted diagnostic tool.

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

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

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

   • The "ground truth," implicitly, is the regulatory approval and a history of safe and effective use of the predicate devices (K073063, K082225, and K102755). The substantial equivalence argument states that because the new device is identical in all relevant aspects to these predicates, it shares their established safety and effectiveness.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of an AI/machine learning model. The device's design, manufacturing, and testing (to meet standards like IEC 601-2-22) are the relevant "data" for its own performance, and these are compared to the predicate.

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

   • Not applicable. As there is no training set for an AI model, there is no ground truth established for it. The ground truth for this submission hinges on the regulatory history and proven performance of the predicate devices.

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The Radial-Emitting Shaped Fiber Optic Delivery System, is intended for use as a fiber delivery system in conjunction with any surgical laser with an SMA 905 compatible connector. It is indicated for use in general surgical applications for incision, ablation, cutting, vaporization, hemostasis, and coagulation of soft tissue contact or non-contact, open or closed endoscopic applications where incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue vaporization, hemostasis and/or coagulation may be indicated. The fiber is indicated for use in general surgery, urology, gastroenterology, gynecology, dermatology, neurosurgery, plastic surgery, ENT/ otolaryngology, endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux and laser assisted lipolysis with a compatible laser marketed for use in the desired application.

The Radial-Emitting Shaped Fiber Optic Delivery System contains the same basic components and design as the cleared Megabeam Radial fiber and theCeralas diode laser family is substantially similar in performance and technology to the cleared Nd: YAG laser.

The provided document is a 510(k) summary for the Radial-Emitting Shaped Fiber Optic Delivery System. It explicitly states that no performance testing was included in the submission because "the performance... is well established and documented on soft tissue."

Therefore, based on the provided text, it is not possible to provide a table of acceptance criteria or details about a study proving the device meets acceptance criteria. The submission relies on substantial equivalence to predicate devices, rather than new performance data.

Here's an attempt to answer the questions based only on the provided information, noting the lack of specific study data:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. A table of acceptance criteria and the reported device 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 / Not provided. The submission explicitly states: "Since the performance of the Radial-Emitting Shaped Fiber Optic Delivery System is well established and documented on soft tissue no performance testing is being specifically included in this submission." Therefore, no new test set was used or data provenance specified.

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. No new test set requiring expert ground truth establishment was described.

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

• Not applicable / Not provided. No new test set requiring adjudication was 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

• No. This is a medical device (fiber optic delivery system), not an AI-based diagnostic tool. No MRMC study was performed or is relevant to this submission.

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

• No. This is a medical device (fiber optic delivery system), not an algorithm. No standalone algorithm performance study was done.

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

• Not applicable / Not provided. The submission relies on substantial equivalence to predicate devices whose performance is "well established and documented on soft tissue," rather than new studies with a defined ground truth.

8. The sample size for the training set

• Not applicable / Not provided. This is a medical device. There is no mention of a "training set" as would be used for AI/ML models.

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

• Not applicable / Not provided. As there is no training set for this type of device submission, this question is not relevant.

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The Ceralas Fiber-Coupled 1470nm Diode Laser family (and their delivery accessories used to deliver optical energy) are indicated for use in general surgical applications for incision, excision, ablation, cutting, vaporization, hemostasis, and coagulation of soft tissue contact or non-contact, open or closed endoscopic applications where incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue vaporization, hemostasis and/or coagulation may be indicated. Added Indication for Use: Laser Assisted Lipolysis

The Ceralas 1470nm contains the same basic components as the cleared Ceralas 980nm family and substantially similar technologies to the cleared Quanta 980 and 1470nm families.

The provided text does not contain information about specific acceptance criteria or a study that evaluated the device's performance against such criteria for the added indication of Laser Assisted Lipolysis. Instead, this document is a 510(k) summary and an FDA clearance letter, which focus on demonstrating substantial equivalence to predicate devices rather than primary clinical performance data.

Therefore, I cannot populate the table or answer the questions as requested, as the necessary information is not present in the given text.

The document indicates that the Ceralas 1470nm Diode Laser family is considered "as safe and effective for this additional Indication for Use as the Ceralas 980nm Family and the Quanta System 980nm & 1470nm laser family" based on having "the same intended uses, indications, technological characteristics, and principles of operation as its predicate devices." This is a statement of substantial equivalence, not a report of a new performance study.

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The device is intended for endovascular coagulation of blood vessels. The device is indicated for the endovascular coagulation of the greater saphenous vein in the thigh in patients with superficial vein reflux.

The ELVeS kit with Radial Fibers contain the following components: (1) radial fiber; (2) access needle; (3) introducer sheath/ dilator; and (4) a guidewire.

The provided text describes a 510(k) submission for the "Endo Laser Vein System Kit with Radial Fiber," and it focuses primarily on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document. The document states that "The device complies with the following voluntary consensus standards: 21 C.F.R. §§ 1040.10 & 1040.11; ANSI/AAMI ES1; IEC 601-1; IEC 601-2-22; EN 60825-1, and ANSI/AAMI/ISO 10993-7." However, it does not specify acceptance criteria derived from these standards, nor does it report device performance against specific metrics.

The document's central argument for substantial equivalence is based on:

• The use of previously cleared radial fiber technology (K924258).
• Having the same intended use and indications for use as cleared predicate devices (Ceralas D 1470, 980 and 810nm ELVeS kits).
• The ELVeS kit not representing a new technological characteristic for diode lasers in endovascular coagulation of the greater saphenous vein.

Here's a breakdown of the other requested information based on the provided text:

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

   • Not provided in the document. The submission relies on substantial equivalence to predicate devices and compliance with general consensus standards, not on specific performance data against defined acceptance criteria.

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 / Not provided. The document does not describe a performance study with a test set.

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. No performance study with a test set is described.

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

   • Not applicable / Not provided. No performance study with a test set 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:

   • No. This device is a laser system for endovascular coagulation, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or mentioned.

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

   • No. This is a medical device (laser system), not an algorithm. Standalone performance for an algorithm is not applicable.

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

   • Not applicable / Not provided. No performance study requiring ground truth is described.

8. The sample size for the training set:

   • Not applicable / Not provided. This device is a laser system, not a machine learning algorithm requiring a training set.

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

   • Not applicable / Not provided. As above, no training set for an algorithm is relevant here.

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The Ceralas Fiber-Coupled Diode Laser family 980nm (and their delivery accessories used to deliver optical energy) are indicated for use in general surgical applications for incision, excision, ablation, cutting, vaporization, hemostasis, and coagulation of soft tissue contact or non-contact, open or closed endoscopic applications where incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue vaporization, hemostasis and/or coagulation may be indicated.

Added Indication for Use:

Percutaneous Lumbar Disc Decompression/ Diskectomy in soft and cartilaginous tissue.

Ceralas Fiber-Coupled Diode Laser 980 nm Family

The request implicitly asks for a detailed description of acceptance criteria and the study proving the device meets them, but the provided text (K100726 Biolitec Inc.'s Ceralas Fiber-Coupled Diode Laser 980nm Family) does not contain typical acceptance criteria tables or detailed study results like those found in clinical efficacy trials for AI/ML devices.

Instead, this 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices for an additional indication of use (Percutaneous Lumbar Disc Decompression/Diskectomy). The performance "data" discussed is not about numerical accuracy or sensitivity/specificity but about confirming the safety and efficacy of the 980nm laser for a new application, primarily by comparing its technological characteristics to already-cleared devices.

Therefore, many of the requested categories (like sample size, ground truth, experts, MRMC study, standalone performance) are not applicable to the type of submission presented here.

Here's a breakdown of what can be extracted and why other parts are not present:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The "acceptance criteria" here are implicitly meeting the standards of safety and effectiveness as demonstrated by the predicate devices for the target anatomical location and procedure. "Device performance" is stated as being "substantially equivalent" rather than reporting specific metrics like sensitivity or accuracy.

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

• Not Applicable. This submission is for substantial equivalence based on technological characteristics and prior clearances, not a clinical study involving a "test set" of patients or data in the typical sense for AI/ML device evaluations. No patient-specific data or cohorts are mentioned for this particular submission.

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

• Not Applicable. As no specific data "test set" requiring ground truth by external experts is detailed in this 510(k) summary, this information is not provided. The assessment of substantial equivalence is done by the manufacturer (Biolitec) and reviewed by the FDA, based on engineering data, technological comparisons, and established principles of laser surgery.

4. Adjudication method for the test set

• Not Applicable. There is no "test set" discussed in the context of clinical data requiring an adjudication method.

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 surgical instrument, not an AI/ML-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and AI-related performance metrics are irrelevant to this submission.

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

• Not Applicable. This is a hardware device (laser), not an algorithm.

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

• Not Applicable. For this type of 510(k) – substantial equivalence for an added indication for a physical device – "ground truth" as typically defined for diagnostic or AI/ML devices is not explicitly stated or required in this summary. The "truth" is based on the established safety and efficacy of the predicate devices and the technological comparison demonstrating the new device performs similarly for the new indication.

8. The sample size for the training set

• Not Applicable. This is a physical medical device (laser), not an AI/ML algorithm that requires a "training set."

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

• Not Applicable. As above, no training set or its ground truth is relevant or discussed for this device.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as per this 510(k) Summary):

The "study" presented in this 510(k) summary is not a traditional clinical trial with patient cohorts and statistical outcomes. Instead, it is a design and performance comparison study demonstrating the Ceralas Fiber-Coupled Diode Laser 980nm Family's substantial equivalence to legally marketed predicate devices for the added indication of Percutaneous Lumbar Disc Decompression/Diskectomy.

Key components of this "study":

• Technological Characteristics Comparison: The submission details that the Ceralas 980nm family has "substantially similar technological characteristics" (e.g., wavelength, power output, delivery accessories, fundamental principle of operation) to several predicate devices already cleared for similar applications, including other Ceralas models (G15 532nm, D1950) and lasers from Quanta System and INTERmedic.
• Performance Data Assessment: The document states that "Performance testing of the Ceralas 980nm family demonstrates no significant difference as compared to the cleared Ceralas G15 532nm Frequency-Doubled Nd:YAG and D1950 lasers." While the specifics of this "performance testing" are not detailed in this summary, it would typically involve bench testing (e.g., power output stability, beam profile, tissue ablation rates in ex vivo models, thermal effects) to confirm the new device performs within expected parameters and similarly to the predicates for the intended use.
• Safety and Effectiveness Argument: The core of the submission is the argument that because the technological characteristics are similar and performance testing shows no significant difference, the Ceralas 980nm family is as safe and effective for Percutaneous Lumbar Disc Decompression/Diskectomy as its predicate devices, which are already deemed safe and effective for similar uses. The minor technological differences are argued not to raise new issues of safety or effectiveness.

Conclusion from the document: The FDA's review agreed with this assessment, issuing a letter stating that the device is "substantially equivalent" to legally marketed predicate devices for the stated indications for use. This substantial equivalence determination is the primary "proof" for this type of regulatory submission, rather than a clinical trial report with numerical performance metrics.

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The device is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures including via endoscopes. The Ceralas Multiwavelength 980/1470nm Diode Laser is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, cardiothoracic surgery, dental applications, and endovenous occlusion of the greater saphenous vein. The Multiwavelength laser is further indicated for laser assisted lipolysis.

The device is specifically indicated for use as follows:

Ear, Nose and Throat and Oral Surgery (Otolaryngology)
Hemostasis, incision, excision, ablation, coagulation, and vaporization of tissue from the ear, nose, throat and adjacent areas including soft tissue in the oral cavity. Examples include:

• Removal of benign lesions from the ear, nose and throat
• Excision and vaporization of vocal cord nodules and polyps
• Incision and excision of carcinoma in situ
• Ablation and vaporization of hyperkeratosis
• Excision of carcinoma of the larynx
• Laryngeal papillomectomy
• Excision and vaporization of herpes simplex I and II
• Neck dissection

Arthroscopy
Hemostasis, incision, excision, coagulation, vaporization and ablation of joint tissues during arthroscopic surgery. Examples include:

• Menisectomy
• Synovectomy
• Chondromalacia

Gastroenterology
Hemostasis, incision, excision, ablation, coagulation and vaporization of tissue in the upper and lower gastrointestinal tracts and also with endoscopic procedures. Examples include:

• Hemostasis of upper and lower GI bleeding
• Excision and vaporization of colorectal carcinoma
• Excision of polyps

General Surgery, Dermatology, Plastic Surgery and Podiatry
Excision, ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue and dermabrasion. Examples include:

• Matrixectomy
• Excision of neuromas
• Excision of periungual and subungual warts
• Excision of plantar warts
• Excision of keloids
• Liver resection
• Excision of cutaneous lesions
• Hemorrhoidectomy
• Appendectomy
• Debridement of decubitus ulcers
• Hepatobiliary tumors
• Mastectomy
• Dermabrasion
• Vaporization and hemostasis of capillary hemangioma
• Excision, vaporization and hemostasis of abdominal tumors
• Excision, vaporization and hemostasis of rectal pathology
• Pilonidal cystectomy
• Herniorapphy
• Adhesiolysis
• Parathyroidectomy
• Laparoscopic cholecystectomy
• Thyroidectomy
• Resection of organs
• Debridement of wounds
• Photocoagulation of teleangectasia of the legs and face
• Photocoagulation of vascular lesions of the face and extremities
• Endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
• Treatment of reticular veins and branch varicosities

Urology
Excision, vaporization, incision, coagulation, ablation and hemostasis of urological tissues. Examples include:

• Vaporization of urethral tumors
• Release of urethral stricture
• Removal of bladder neck obstruction
• Excision and vaporization of condyloma
• Lesions of external genitalia
• Vaporization of the prostate to treat benign prostatic hyperplasia (BPH)

Gynecology
Ablation, excision, incision, coagulation, hemostasis and vaporization of gynecological tissue. Examples include:

• Endometrial ablation
• Excision or vaporization of condylomata acuminate
• Vaporization of cervical intraepithelial neoplasia
• Cervical conization
• Menorrhagia

Neurosurgery
Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. Examples include: hemostasis in conjunction with menigiomas

Cardiac Surgery
Hemostasis and coagulation of soft tissue, including cardiac tissue.

Pulmonary Surgery
Hemostasis, vaporization, coagulation, incision, excision and ablation of soft tissue in the pulmonary system. Examples include:

• Tracheobronchial malignancy or stricture
• Benign and malignant pulmonary obstruction
• Endoscopic pulmonary applications

Dental Applications
Indicated for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingival and epithelial lining of free gingival): frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, pulpotomy as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening.

Endovenous Occlusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux
Indicated for use with the ELVes Procedure Kit in the endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.

The Ceralas Multiwavelength 980/1470 Diode Laser emits laser energy at the 980nm and 1470nm wavelengths in a manner substantially similar to the Ceralas 980 and Ceralas 1470.

The provided text is a 510(k) summary for the Biolitec Ceralas Multiwavelength 980/1470nm Diode Laser System. It outlines the device's intended use, indications, technological characteristics, and a statement of substantial equivalence to predicate devices. However, it does not contain the specific information required to complete most of your request regarding acceptance criteria and a detailed study proving performance.

Here's an analysis based on the available text:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of numerical performance metrics (e.g., accuracy, sensitivity, specificity, or specific physical parameters with defined thresholds). Instead, it relies on the concept of substantial equivalence to predicate devices.

The "Performance Data" section merely states:
"Performance testing of the Ceralas Multiwavelength 980/1470 Diode Laser demonstrates no significant difference as compared to the cleared predicate devices."

This implies that the device's performance characteristics (e.g., power output stability, wavelength accuracy, safety features) were tested and found to be sufficiently similar to those of the predicate devices. However, the exact metrics and their values are not provided.

Table of Acceptance Criteria and Reported Device Performance:

Study Details Based on the Provided Text:

Based on the provided 510(k) summary, the device passed its regulatory review by demonstrating substantial equivalence to previously cleared devices. This type of submission generally does not involve a detailed clinical trial with efficacy endpoints in the same way a PMA submission would, nor does it typically involve AI-specific evaluation criteria.

Here's a breakdown of the requested information, indicating where the document lacks specific details:

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

   • The document does not describe a specific "test set" in the context of clinical or performance data for the device. The evaluation was based on demonstrating that the new device has "no significant difference" in performance compared to predicate devices, which likely involved engineering and bench testing rather than a large clinical study with a defined test set of imaging data. Therefore, details about data provenance, retrospective/prospective nature, or sample size are not applicable as described in the document.

2. 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. The document does not describe a "test set" requiring human expert-established ground truth. The comparison is based on the technical specifications and operational characteristics of the laser system relative to its predicates.

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

   • Not applicable for the same reasons as above.

4. 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 diode laser system for surgical procedures, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant to this submission.

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

   • Not applicable. This is a medical device (a laser system), not an algorithm.

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

   • Not applicable in the context of clinical image assessment or AI performance. The "ground truth" for this device would be its adherence to established engineering specifications and safety standards, and its functional similarity to predicate devices, verified through various physical and functional tests (not explicitly detailed in the summary).

7. The sample size for the training set:

   • Not applicable. This device is not an AI algorithm that requires a "training set."

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

   • Not applicable.

In summary: The provided 510(k) summary focuses on demonstrating "substantial equivalence" of the new Ceralas Multiwavelength 980/1470nm Diode Laser System to existing predicate devices (Cynosure Smart Lipo Multiwavelength Laser, Biolitec Ceralas 980nm Diode Laser, and Biolitec Ceralas 1470nm Diode Laser). This regulatory pathway relies on showing that the new device has the same intended use, similar indications for use, similar technological characteristics, and similar principles of operation, and that any minor technological differences do not raise new issues of safety or effectiveness. The "performance data" mentioned refers to testing done to confirm these similarities, not to a clinical study with specific acceptance criteria or ground truth establishment as would be common for AI/diagnostic devices.

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The device is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures including via endoscopes. The 180W Ceralas D 980 is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, cardiothoracic surgery, dental applications, and endovenous occlusion of the greater saphenous vein.

The device is specifically indicated for use as follows:

Ear, Nose and Throat and Oral Surgery (Otolaryngology)
Hemostasis, incision, excision, ablation, coagulation, and vaporization of tissue from the ear, nose, throat and adjacent areas including soft tissue in the oral cavity. Examples include:

• Removal of benign lesions from the ear, nose and throat
• Excision and vaporization of vocal cord nodules and polyps
• Incision and excision of carcinoma in situ
• Ablation and vaporization of hyperkeratosis
• Excision of carcinoma of the larynx
• Laryngeal papillomectomy
• Excision and vaporization of herpes simplex I and II
• Neck dissection

Arthroscopy
Hemostasis, incision, excision, coagulation, vaporization and ablation of joint tissues during arthroscopic surgery. Examples include:

• Menisectomy .
• Synovectorny .
• Chondromalacia .

Gastroenterology
Hemostasis, incision, excision, ablation, coagulation and vaporization of tissue in the upper and lower gastrointestinal tracts and also with endoscopic procedures. Examples include:

• Hemostasis of upper and lower GI bleeding
• Excision and vaporization of colorectal carcinoma
• Excision of polyps

General Surgery, Dermatology, Plastic Surgery and Podiatry
Excision, ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue and dermabrasion. Examples include:

• . Matrixectomy
• Excision of neuromas .
• Excision of periungual and subungual warts
• Excision of plantar warts .
• Excision of keloids ●
• Liver resection .
• Excision of cutaneous lesions ●
• Hemorrhoidectomy .
• Appendectomy
• Debridement of decubitus ulcers
• Hepatobiliary tumors
  Mastectomy
  Dermabrasion
• Vaporization and hemostasis of capillary hemangioma
• Excision, vaporization and hemostasis of abdominal tumors
• Excision, vaporization and hemostasis of rectal pathology
• Pilonidal cystectomy
• Herniorapphy
• Adhesiolysis
• Parathyroidectomy
• Laparoscopic cholecystectomy
• Thyroidectomy
• Resection of organs
• Debridement of wounds
• Photocoagulation of teleangectasia of the legs and face
• Photocoagulation of vascular lesions of the face and extremities
• Endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
• Treatment of reticular veins and branch varicosities

Urology
Excision, vaporization, incision, coagulation, ablation and hemostasis of urological tissues. Examples include:

• Vaporization of urethral tumors .
• Release of urethral stricture
• Removal of bladder neck obstruction
• Excision and vaporization of condyloma
• Lesions of external genitalia
• Vaporization of the prostate to treat benign prostatic hyperplasia (BPH)

Gynecology
Ablation, excision, incision, coagulation, hemostasis and vaporization of gynecological tissue. Examples include:

• Endometrial ablation .
• Excision or vaporization of condylomata acuminate
• Vaporization of cervical intraepithelial neoplasia
• Cervical conization
• Menorrhagia

Neurosurgery
Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. Examples include: hemostasis in conjunction with menigiomas

Cardiac Surgerv
Hemostasis and coagulation of soft tissue, including cardiac tissue.

Pulmonary Surgery
Hemostasis, vaporization, coagulation, incision, excision and ablation of soft tissue in the pulmonary system. Examples include:

• . Tracheobronchial malignancy or stricture
• Benign and malignant pulmonary obstruction .
• Endoscopic pulmonary applications

Dental Applications
Indicated for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingival and epithelial lining of free gingival): frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, pulpotomy as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening.

Endovenous Occlusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux
Indicated for use with the ELVes Procedure Kit in the endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.

The 180W Ceralas D 980 has the same technological characteristics as the cleared 150W Ceralas D 980.

The provided text is a 510(k) summary for the Biolitec Inc.'s 180W Ceralas Diode 980nm Laser System (Model D180). This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not a study proving the device meets specific acceptance criteria in the way one would for novel AI or diagnostic devices.

The laser device described is a surgical tool, and its "acceptance criteria" are related to its safety and effectiveness in achieving its intended surgical functions, which are demonstrated through its technological characteristics and intended uses being substantially equivalent to a predicate device that has already been cleared by the FDA.

Therefore, the requested information about acceptance criteria and a study proving the device meets them, particularly regarding sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, does not apply to this 510(k) summary for a surgical laser.

Instead, the "study" demonstrating its acceptance is the comparison to the predicate device as outlined in the "Substantial Equivalence" section.

Here's how to interpret the provided information in the context of a medical device submission demonstrating substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:
This concept is not applicable here. There is no "test set" in the sense of a dataset for an AI or diagnostic algorithm. The "test" is the comparison against the predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
This concept is not applicable. "Ground truth" for this type of device is established by the existing regulatory clearance and long-term clinical use of the predicate device, and the general understanding of laser physics and surgical applications. There isn't a specific set of experts adjudicating performance for this submission in the way one would for a diagnostic study.

4. Adjudication Method:
Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. This type of study is for evaluating human performance, often with and without AI assistance for interpretation tasks. This is a surgical laser, not an interpretive device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is a surgical device requiring human operation, not a standalone algorithm.

7. The Type of Ground Truth Used:
For this submission, the "ground truth" for demonstrating substantial equivalence is established based on the prior FDA clearance of the predicate device (Biolitec's 150W Ceralas D 980nm Diode Laser, K072106). The assumption is that the predicate device is already deemed safe and effective for its indicated uses.

8. The Sample Size for the Training Set:
Not applicable. This is not a machine learning device.

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

In summary: The provided 510(k) summary is for a surgical laser system seeking clearance based on substantial equivalence to an already approved predicate device. The "study" demonstrating its acceptability is not a clinical trial in the traditional sense, but rather a comparative analysis of its technical specifications and intended uses against those of the predicate device. The evidence presented focuses on showing that the new device does not raise new issues of safety or effectiveness compared to the predicate, due to their similar characteristics and principles of operation.

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The Ceralas D1470 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 indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.

The Ceralas D1470 is a diode laser that is intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures. The Ceralas D1470 contains an ELVeS Kit for gaining access to the vasculature to treat varicose veins and varicosities associated with superficial reflux of the saphenous veins.

This document describes the 510(k) summary for Biolitec's 15W Ceralas D 1470nm Diode Laser (Model D1470). It is a special 510(k) notice for a modification to a previously cleared device. The primary claim is substantial equivalence to predicate devices, rather than a de novo clinical study proving novel performance. Therefore, many of the typical acceptance criteria and study details for a new device are not explicitly present in this summary.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

No specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) are provided in this 510(k) summary. The basis for clearance is "substantial equivalence" to existing legally marketed devices.

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

This document does not describe a test set or clinical study with a specific sample size designed to prove the device meets acceptance criteria. The clearance is based on substantial equivalence to predicate devices. This typically involves demonstrating that the modified device does not raise new questions of safety or effectiveness compared to a device already on the market, often through bench testing, engineering analysis, and a comparison of design specifications. Therefore, there is no explicit test set data with a sample size or data provenance mentioned.

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

Not applicable. As no explicit clinical test set or study is described, there's no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set

Not applicable, as no explicit clinical test set or study is described.

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

No MRMC study is mentioned. This 510(k) summary focuses on demonstrating substantial equivalence of a modified device, not on comparative effectiveness against human readers or other devices in an MRMC setting.

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

Not applicable. The Ceralas D1470 is a surgical laser, not an diagnostic algorithm or AI system. Its performance is related to its physical properties and clinical application by a surgeon.

7. Type of Ground Truth Used

Not explicitly stated in terms of a clinical ground truth for a study. The "ground truth" for the substantial equivalence claim is the established safety and effectiveness of the existing predicate devices (Biolitec's previously cleared Ceralas D1470 and Cool Touch CTEV 1320 Nd: YAG Laser).

8. Sample Size for the Training Set

Not applicable. This device is a laser, not a machine learning algorithm.

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

Not applicable. This device is a laser, not a machine learning algorithm.

In summary:

The provided 510(k) summary for the Biolitec Ceralas D 1470nm Diode Laser demonstrates substantial equivalence to predicate devices (Biolitec's previously cleared Ceralas D1470 and the Cool Touch CTEV 1320 Nd: YAG Laser) for its safety and effectiveness. This strategy for regulatory clearance does not typically involve the detailed clinical study methodologies (e.g., test set sample sizes, expert ground truth, MRMC studies) that would be common for novel diagnostic devices incorporating AI or requiring de novo clinical validation. The acceptance criteria essentially revolve around demonstrating that the modified device does not introduce new safety or effectiveness concerns compared to its predicates.

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The Ceralas E15/980, E30/980 is intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The Ceralas E15/980, E30/980 is generally indicated for incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, cardiothoracic surgery, and ophthalmology. This Ceralas E15/980, E30/980 is specifically indicated for hemostasis and coagulation of soft tissue (including cardiac tissue) and laser assisted lipolysis.

The Ceralas E15/980, E30/980 has the same technological characteristics as the cleared Ceralas D. The laser has an additionally incorporated RFID sensor/antenna in the fiber port so as to recognize fibers with an RFID chip in their connectors. The fibers used with the Ceralas E have been previously cleared by FDA (K951775, K964497, K060050) for use with its other laser products and have an RFID chip incorporated into the proximal connector end.

The provided document is a 510(k) summary for a medical device (Ceralas E 980nm Diode Laser). It does not contain information about acceptance criteria or a study proving device performance against such criteria.

The document primarily focuses on:

• Device Identification and Regulatory Information: Name, manufacturer, classification, predicate device.
• Purpose of the Submission: Explaining that the Ceralas E is a modification of a previously cleared device (Ceralas D).
• Intended Use and Specific Indications for Use: A comprehensive list of surgical procedures and tissues for which the device is intended (e.g., incision, excision, vaporization, hemostasis in various medical specialties).
• Technological Characteristics: Stating that it has the same characteristics as the cleared Ceralas D, with an added RFID sensor to recognize fibers.
• Substantial Equivalence Claim: Asserting that the minor differences do not raise new safety or effectiveness questions, making it substantially equivalent to its predicate.
• FDA Clearance Letter: Confirming the FDA's review and their determination of substantial equivalence.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets them, as this information is not present in the provided text.

In absence of the requested information, the following response will indicate that the information is not available in the document.

1. A table of acceptance criteria and the reported device performance
Not provided in the document. The document lists the intended uses and indications for the device, but does not specify quantifiable acceptance criteria or performance metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided in the document. The submission is for substantial equivalence to a predicate device, and it does not detail new clinical or performance studies with specific test sets.

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 in the document. Ground truth establishment is typically relevant for studies validating diagnostic or AI-driven devices, which is not the case for this laser device submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided in the document. Adjudication methods are typically relevant for studies validating diagnostic or AI-driven devices, which is not the case for this laser device submission.

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 in the document. This is not an AI-assisted diagnostic device, so an MRMC study is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/Not provided in the document. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable/Not provided in the document. Ground truth is typically relevant for studies validating diagnostic or AI-driven devices.

8. The sample size for the training set
Not applicable/Not provided in the document. This is not an AI algorithm, and no specific training set for performance evaluation is mentioned.

9. How the ground truth for the training set was established
Not applicable/Not provided in the document. Ground truth establishment for a training set is typically relevant for AI/ML device development.

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