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The Ceralas D 980 nm Diode Lasers are intended for endovascular coagulation of blood vessels. The Ceralas D 980 nm Diode Lasers are indicated for use in endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.

Ceralas D 980 nm Diode Laser System (Model D50)

Here's a breakdown of the acceptance criteria and study details for the Ceralas Diode Laser System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a numerical value, but described as "a single arm, open study at a single site." The number of patients is not directly provided, only the percentage of success.
• Data Provenance: Single site, described as a "single arm, open study." No explicit country of origin is mentioned, but the submitter is based in Massachusetts, USA. The study was prospective as it involved enrolling patients to determine the device's ability to treat reflux.

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

• Number of Experts: "Two clinical investigators" were involved in the study.
• Qualifications: Their specific qualifications (e.g., medical specialty, years of experience) are not specified in the provided text.

4. Adjudication Method for the Test Set

• The text does not specify an adjudication method. It only mentions the involvement of "two clinical investigators," but doesn't detail how they made decisions or resolved disagreements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The study was a "single arm, open study" to determine the device's ability to treat vein reflux, not to compare human reader performance with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• The Ceralas Diode Laser System is a physical medical device, not an AI algorithm. Therefore, a standalone performance study in the context of an algorithm is not applicable to this device. The study evaluated the device's performance directly on patients.

7. The Type of Ground Truth Used

• The ground truth was established by clinical observation and assessment by the two clinical investigators, specifically focusing on "complete closure of the vein" and "adverse events" in patients. This aligns with patient outcomes data and expert clinical assessment.

8. The Sample Size for the Training Set

• This information is not applicable/not provided. The Ceralas Diode Laser System is a physical laser device, not an AI model that requires a training set. The clinical study described is for evaluating the device's efficacy.

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

• This information is not applicable/not provided as the device is not an AI model with a training set.

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See the attached pages 1-3 for a list of indications for use.

The attached list of indications is in addition to the already cleared indications.

Ear, Nose and Throat and Oral Surgery: 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; Phototcoagulation of teleangectasia of the legs and face; Photocoagulation of vascular lesions of the face and extremities.

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.

Gynecology: Ablation, excision, incision, coagulation, hemostasis and vaporization of gynecological tissue. Examples include: Endometrial ablation; Excision or vaporization of condylomata acuminata; Vaporization of cervical intraepithelial neoplasia; Cervical conization; Menorrhagia.

Neurosurgery: Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. Example includes: Hemostasis in conjunction with menigiomas.

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.

The Cerals D Diode Laser operates with a power range of 1-50W in the CW or pulsed mode. The delivery systems for the Ceralas D Laser System consist of optical fiber fitted with an SMA 905 connector at the proximal end. There is no difference between the laser that is subject of this 510(k) and the previously cleared Ceralas D Diode laser.

The provided text is a 510(k) summary for the Ceralas Diode Laser System. This type of submission to the FDA is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the safety and effectiveness of a novel device through clinical trials and performance data in the same way.

Therefore, the document explicitly states: "Performance Data: None required."

This means that the manufacturer did not conduct a study to demonstrate the device meets acceptance criteria as would be done for a new device requiring such validation. Instead, the substantial equivalence is based on the device being identical to a previously cleared device (the Ceralas D Diode Laser System) and having the same intended use.

Consequently, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, or MRMC studies because these were not part of this 510(k) submission. The FDA cleared the device based on its substantial equivalence to an already cleared device, which implies that the predicate device had previously established its safety and effectiveness.

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