Search Results

Ask a specific question about this device

Ask a specific question about this device

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.

Ask a specific question about this device

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

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

Indications for Use:

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 .

Ophthalmology
Retinal photocogulation Diabetic retinopathy

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 D10 Diode Laser operates with a power range of 1-10W 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.

The Ceralas Diode Laser System (Model D10) is a surgical laser.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

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

   Acceptance Criteria	Reported Device Performance
   Not specified.	Not specified.

   Explanation: The document explicitly states "None required" under the "Performance Data" section. This indicates that specific acceptance criteria and performance data were not deemed necessary for this 510(k) submission, likely due to substantial equivalence to already cleared predicate devices. The submission relies on demonstrating that the device has principles of operation, function, and intended use similar to predicate devices, and that it raises no new questions of safety or effectiveness.

2. Sample sizes used for the test set and the data provenance:
   No test set data is provided, as performance data was not required.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable, as no performance data based on a test set was required or provided.

4. Adjudication method for the test set:
   Not applicable, as no performance data based on a test set was required or 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 device is a surgical laser, not an AI-assisted diagnostic tool.

6. 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.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   Not applicable, as no performance data requiring ground truth was presented.

8. The sample size for the training set:
   Not applicable, as this is neither an AI/ML device nor is a training set mentioned.

9. How the ground truth for the training set was established:
   Not applicable, as this is neither an AI/ML device nor is a training set mentioned.

Ask a specific question about this device

Intended for light activation of bleaching materials for teeth whitening. Note: This is an additional indication to the already cleared indications for use.

The Ceralas D Laser System that is the subject of this 510(k) notice is identical to the Ceralas D Laser System, which has already been cleared by FDA. The cleared Ceralas D Laser System is a complete self-contained compact surgical laser that utilizes gallium aluminum arsenide (GaALAs) semiconductor diodes to generate near-infrared laser radiation. The laser employs a modular design comprised of: (1) a laser diode: (2) a cooling module containing the laser diode, thermoelectric coolers, heat sink fins and fans; (3) an optics module containing a beamsplitter for control of optical power; (4) front control and display panel; and (5) RFIshielded, transformer power supply and control electronics. Interchangeable fiber optic delivery systems are coupled to the laser via an SMA 905 connector to deliver laser radiation to the target tissues. The diode laser is enclosed in a rugged, factory aligned, environmentally protective module. The wavelength for the Ceralas D Laser System is 980 ± 30nm, and its laser aiming beam wavelength is 635mm+10mm. The delivery systems for the Ceralas D Laser System consist of optical fiber fitted with an SMA 905 connector at the proximal end. The optical fiber is composed of quartz fiber core with a coaxially mounted protective sheath.

The provided text describes a 510(k) submission for the Ceralas Diode Laser System, seeking to add an indication for light activation of bleaching materials for tooth whitening. The submission focuses on demonstrating substantial equivalence to a predicate device for this specific intended use.

Here's an analysis of the acceptance criteria and study information, 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: The document does not specify the sample size for the "bench studies."
• Data Provenance: The document does not specify the country of origin. It indicates the studies were "bench studies," which are laboratory-based, not clinical, and thus do not typically involve human subjects or retrospective/prospective data collection in the clinical sense.

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

• This information is not provided in the document. Bench studies typically rely on physical measurements and established protocols rather than expert consensus on images or clinical outcomes.

4. Adjudication Method for the Test Set

• This information is not applicable and not provided. Bench studies for physical devices primarily involve direct measurement and quantification of performance characteristics against a standard or predicate, not adjudication of interpretations as seen in diagnostic imaging.

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 information is not applicable and not provided. This device is a laser system for tooth whitening, not an AI-powered diagnostic tool requiring human reader interpretation or MRMC studies.

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

• Not directly applicable in the context of an AI algorithm. However, the "bench studies" assess the laser system's direct performance (its ability to activate bleaching materials) in a standalone manner, without human intervention in the mechanism of activation. The system itself is the "standalone" entity being evaluated for its physical function.

7. The Type of Ground Truth Used

• The ground truth for the bench studies would be based on physical measurements and established scientific principles related to the activation of bleaching materials. This would likely involve quantifiable metrics of bleaching effectiveness or energy transfer, compared against the predicate device's known performance. It is not expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

• This information is not applicable and not provided. The Ceralas Diode Laser System is a physical device, not an AI algorithm that requires a training set.

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

• This information is not applicable and not provided for the same reason as point 8.

Ask a specific question about this device

The Ceralas D10 Laser System that is the subject of this 510(k) notice is intended for the following dental indications on intraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva): frenctomy, frenotomy, biopsy, operculectorny, 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, vestibuloplasty, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy and pulpotomy as an adjunct to root canal therapy.

The Ceralas DlO Diode laser is indicated for the following dental indications on intraoral and extraoral soft tissue (including marginal and interdental gingiva : and epithelial lining of free gingiva); frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor sites, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasty, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, and pulpotomy as an adjunct to root canal therapy.

The Cerals D10 Diode Laser operates with a power range of 1-10W 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.

The provided 510(k) submission for the Ceralas D10 Diode Laser System states "None required" for "Performance Data." This indicates that the device's acceptance criteria were not established through a specific performance study in this submission, but rather through a claim of substantial equivalence to a predicate device. Therefore, most of the requested information regarding acceptance criteria and performance studies cannot be extracted from this document.

However, based on the provided text, here's what can be stated:

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

Not applicable. The document explicitly states "Performance Data: None required." The acceptance was based on substantial equivalence to a predicate device, not on specific performance metrics demonstrated in a study for this device.

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 performance study was conducted.

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 performance study was conducted.

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

Not applicable. No performance study was conducted.

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 system, not an AI diagnostic tool. No MRMC study was conducted.

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

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

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

Not applicable. No performance study requiring ground truth was conducted for this device.

8. The sample size for the training set

Not applicable. No performance study involving a training set was conducted for this device.

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

Not applicable. No performance study involving a training set was conducted for this device.

Explanation from the document:

The 510(k) submission explicitly states:

• "Performance Data: None required."
• "There are no technological differences between the Ceralas D10 Laser System and the Premier Laser Systems Aurora Diode Laser.. The Ceralas D10 Laser System's principles of operation, function and intended use are similar to Premier Laser System's Aurora Diode Laser System and no new questions of safety or effectiveness are raised."

This indicates that the FDA's acceptance of the Ceralas D10 Diode Laser System was based on its substantial equivalence to the legally marketed Premier Laser System's Aurora Diode Laser, meaning it operates on the same principles and has the same intended use, and therefore, no new performance data or separate clinical studies were deemed necessary for this specific submission.

Ask a specific question about this device

The Ceralas D Laser System that is the subject of this 510(k) notice is identical to the Ceralas D Laser System that has already been cleared by FDA (K983058) for use in the following dental indications: draining fistulas, coagulation and decontamination of extraction sites, frenectomy, excisional biopsy, operculectomy, implant uncovering, gingivectomy, gingivoplasty, degranulation of infrabony defects, enucleate apical troughing for crown and bridge, apthus ulcers, crown lengthening, hemostasis of donor sites, removal of granulation tissue, laser assisted flap surgery, exposure of enamel for orthodontic brackets, and surgical exposure to aid in eruption. The purpose of this submission is to expand the indications for use to include pulpotomy and pulpotomy as an adjunct to root canal therapy.

The Cerals D Diode Laser operates with a power range of 1-15W 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.

Here's an analysis of the provided text regarding the Ceralas Diode Laser System and its performance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states: "Performance Data: None required." This indicates that no new empirical test set data was used to demonstrate performance for this particular 510(k) submission. The device relies on demonstrating substantial equivalence to a predicate device and technological identity to a previously cleared version of itself for the expanded indications.

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

Since no performance data was required or submitted, there was no test set for which ground truth needed to be established by experts.

4. Adjudication Method for the Test Set

Not applicable, as no test set was used.

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

No, an MRMC comparative effectiveness study was not done. The submission explicitly states "Performance Data: None required."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device is a hardware laser system, not an algorithm. Therefore, a standalone performance study in the context of AI algorithms is not applicable.

7. The Type of Ground Truth Used

No new ground truth was established or used for this 510(k) submission as no performance data was submitted. The grounds for approval are based on predicate device comparison and the lack of technological differences from a previously cleared device.

8. The Sample Size for the Training Set

Not applicable. As a hardware device, there is no "training set" in the context of machine learning. The device's design and operating parameters would have been established through engineering and potentially prior clinical testing, but this 510(k) does not detail such information.

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

Not applicable, as there is no "training set" in this context. The core assertion is that the device, being technologically identical to a previously cleared one and similar to a predicate, is safe and effective for the expanded indications without requiring new performance data.

Ask a specific question about this device

The Ceralas H Laser System is a surgical instrument indicated to treat leg veins in dermatology and plastic surgery procedures. Specific indications for the Ceralas H Laser System include the treatment of leg veins.
The Ceralas H 808nm Diode Laser System is indicated to treat leg veins in dermatology and plastic surgery procedures.

The Ceralas H Laser System is a complete, self-contained compact surgical laser that utilizes gallium alumnum arsenide (GaAlAs) semiconductor diodes to generate near-infrared laser radiation. The laser system consists of a console, footswitch, and handpiece which are connected to the device's console. The diode laser is enclosed in a rugged, factory aligned, environmentally protective module. The handpiece is placed against the patient's skin and a pulse of light is delivered to the skin surface when the footswitch and handpiece trigger are depressed.

The wavelength for the Ceralas H Laser System is 808 ± 20nm. The laser delivers pulsed light with a selectable pulse duration of 5-30 millsseconds and a fluence of 10-40J/cm2. The corresponding pulse energy delivered through the 9x9mm handpiece is 8-32 Joules. The laser pulses are generated at a maximum pulse repetition frequency of up to 1 Hz. Additionally, the software and software development activities are in accordance with FDA's guidance document. "Reviewer Guidance For Computer Controlled Medical Devices Undergoing 510(k) Review."

The provided text does NOT describe acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) summary for the Ceralas Diode Laser System, which focuses on establishing substantial equivalence to a predicate device (StarLight™ Pulsed Diode Array Laser System) for regulatory clearance.

Specifically, the "Performance Data" section states: "None required." This indicates that for this particular 510(k) submission, the FDA did not require the applicant to submit performance data from a clinical or human-based study to demonstrate the device's efficacy or safety against specific acceptance criteria. The clearance was based on technological characteristics and a declaration of substantial equivalence to a legally marketed predicate device.

Therefore, I cannot provide the requested information because it is not present in the given text.

Ask a specific question about this device

The Ceralas D Laser System is indicated for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva): 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: vestibuloplasty; 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).

The Ceralas D Laser System is a complete self-contained compact surgical laser that utilizes gallium aluminum arsenide (GaAlAs) semiconductor diodes to generate near-infrared laser radiation. The laser employs a modular design comprised of: (1) a laser diode; (2) a cooling module containing the laser diode, thermoelectric coolers, heat sink fins and fans; (3) an optics module containing a beamsplitter for control of optical power; (4) front control and display panel; and (5) RFI-shielded, transformer power supply and control electronics. Interchangeable fiber optic delivery systems are coupled to the laser via an SMA 905 connector to deliver laser radiation to the target tissues. The diode laser is enclosed in a rugged, factory aligned, environmentally protective module. The wavelength for the Ceralas D Laser System is 980 ± 30nm, and its laser aiming beam wavelength is 635nm+10nm. The power output ranges from 1-15 Watts. The delivery systems for the Ceralas D Laser System consist of an optical fiber fitted with an SMA 905 connector at the proximal end. The optical fiber is composed of quartz fiber core with a coaxially mounted protective sheath.

The Ceralas Diode Laser System (Model D15) received 510(k) clearance based on substantial equivalence to predicate devices, without requiring new performance data. The provided document does not contain explicit acceptance criteria or a study demonstrating the device meets such criteria in terms of analytical or clinical performance (e.g., sensitivity, specificity, accuracy). Instead, the submission focuses on establishing equivalence based on technological characteristics and previously cleared indications for use.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria or provide a table of performance metrics (like sensitivity, specificity, accuracy, etc.) for the Ceralas Diode Laser System. The submission states "Performance Data: None required." This indicates that for this 510(k) submission, the FDA did not mandate a new study demonstrating specific performance metrics for the expanded indications, relying instead on the established safety and effectiveness of the predicate devices and the lack of significant technological changes.

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

No test set or associated data is described in the provided document. The submission explicitly states "Performance Data: None required," indicating that a study with a test set was not conducted or submitted for this specific 510(k).

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

Not applicable, as no test set or ground truth establishment process is described.

4. Adjudication Method for the Test Set:

Not applicable, as no test set or adjudication process is described.

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

No, an MRMC comparative effectiveness study was not done or reported. The submission focuses on establishing substantial equivalence based on technological characteristics and predicate device performance, not on demonstrating improved human reader performance with or without AI assistance.

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

Not applicable. The Ceralas Diode Laser System is a surgical instrument, not an AI or algorithm-based device that would require standalone performance evaluation in the context of diagnostic accuracy.

7. The Type of Ground Truth Used:

Not applicable, as no ground truth for a performance study is described. The "ground truth" for this 510(k) submission appears to be implicit in the established safety and effectiveness of the predicate devices and the scientific understanding of diode laser technology for the stated indications.

8. The Sample Size for the Training Set:

Not applicable, as the Ceralas Diode Laser System is a physical medical device (laser system), not an AI algorithm that requires a training set.

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

Not applicable, as there is no training set for an AI algorithm.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

There is no specific "study" described in the provided document that proves the device meets explicit acceptance criteria in terms of performance metrics. The basis for clearance is substantial equivalence to predicate devices. The document highlights that:

• No significant changes have been made to the Ceralas D Laser System hardware or software since its previous FDA clearances (K951775, K964497).
• The device's technological characteristics (e.g., wavelength, power output, delivery system) are similar to its predicate devices. While there are minor differences (e.g., wavelength compared to Premier Laser Systems' Aurora Diode Dental Laser), the submission argues these "do not raise new questions of safety and efficacy."
• The expanded intended uses for intraoral and extraoral soft tissue are comparable to the uses for which predicate devices (including earlier versions of the Ceralas D Laser System and other dental diode lasers) have already been cleared.

Therefore, the "proof" for meeting acceptance criteria in this specific 510(k) relies on the established safety and effectiveness of the predicate devices and the demonstration that the Ceralas Diode Laser System, with its expanded indications, is substantially equivalent and does not introduce new questions of safety and effectiveness compared to these previously cleared devices. The FDA's concurrence letter confirms this by stating, "we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976."

Ask a specific question about this device

Intended to be used as a fiber optic delivery system handpiece with the capability to be reused with a disposable optical fiber.

The MegaBeam Reusable Fiber Optic Handpiece and Needles are designed to be used with the company's cleared disposable MegaBeam Fiber Optic Delivery Systems which are intended to vaporize, coagulate, incise and excise tissue and which are designed for any indication for which compatible laser systems have been cleared by FDA. The needle is available with 0°, 15°, 30° and 70° angles. They are designed to fit 400 micron, 600 micron, 800 micron and 1000 micron disposable optical fibers. The labeling includes instructions for sterilizing the devices using EtO or steam. The needle is attached to the handpiece by a threaded connector. The fiber optic is then threaded through the handpiece and needle. At the end of the procedure, the fiber optic is discarded and the handpiece and needle are reusable.

The provided text is a 510(k) summary for the CeramOptec's MegaBeam Reusable Fiber Optic Handpiece and Needles. It describes the device, its intended use, technological characteristics, and substantial equivalence to predicate devices. However, it explicitly states:

"Performance Data: None provided."

Therefore, based on the input text, there is no information available regarding:

1. Acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How the ground truth for the training set was established.

The 510(k) cleared the device based on its substantial equivalence to predicate devices, rather than on new performance data demonstrating meeting specific acceptance criteria through a study.

Ask a specific question about this device