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The Evolve HPD 980/ 1470nm Multiwavelength Diode Laser (Evolve Dual) (and its 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.

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 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.

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
Urology
Gynecology
Neurosurgery
Cardiac Surgery
Pulmonary Surgery
Dental Applications

The Biolitec Medical Device, Inc. Evolve HPD 980/ 1470nm Multiwavelength Diode Laser contains the same identical components as the cleared Biolitec, Inc. Evolve HPD 980/ 1470nm Multiwavelength Diode Laser (K112013).

The provided document is a 510(k) summary for the Evolve® HPD 980/ 1470nm Multiwavelength Diode Laser. It explicitly states that the device is determined to be substantially equivalent to a predicate device (K112013).

In the context of 510(k) submissions, the acceptance criteria for a new device are typically met by demonstrating that it is as safe and effective as a legally marketed predicate device. This is primarily done by showing identical or highly similar technological characteristics, intended use, indications for use, and principles of operation, and by demonstrating compliance with relevant voluntary consensus standards.

Therefore, the "study that proves the device meets the acceptance criteria" in this case is the substantial equivalence determination by the FDA, based on a comparison to the predicate device and compliance with established standards. There is no clinical study, comparative effectiveness study, or standalone algorithm performance study described in these documents that would provide information on sensitivity, specificity, or other performance metrics typically associated with AI/software devices.

Here's the breakdown of why certain requested information cannot be provided from this document:

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

   • Acceptance Criteria (Implied by Substantial Equivalence): The device must be "as safe and effective" as the predicate device (Evolve HPD 980/ 1470nm Multiwavelength Diode Laser, K112013). This implicitly means it must perform within the same safety and effectiveness parameters as the predicate.
   • Reported Device Performance: The document states, "The Evolve HPD 980/ 1470mm Multiwavelength Diode Laser is as safe and effective for these Indication for Use as the cleared predicate device." and "The Evolve HPD 980/ 1470nm Multiwavelength Diode Laser has the identical same intended uses, indications, technological characteristics, and principles of operation as its predicate device." No specific quantitative performance metrics (e.g., accuracy, sensitivity, specificity, or other clinical outcomes) are provided for either 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 / Not provided: No test set or clinical study data is described in this 510(k) summary. The submission relies on demonstrating substantial equivalence to a predicate device through technological and intended use comparisons, and compliance with recognized standards.

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 test set or ground truth establishment is described.

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

   • Not applicable / Not provided: No test set or adjudication process 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: No MRMC study was done, nor is this device an AI-assisted device. The device is a multiwavelength diode laser for general surgical applications.

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

   • No: This is a physical medical device (laser), not an algorithm or software. Therefore, a standalone performance assessment in the sense of an algorithm is not applicable.

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

   • Not applicable / Not provided: No ground truth used for a performance study is described as no performance study was conducted for this 510(k). The "ground truth" for this submission is the established safety and effectiveness of the existing predicate device.

8. The sample size for the training set

   • Not applicable / Not provided: This is not a machine learning or AI device. No training set is involved.

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

   • Not applicable / Not provided: No training set is involved.

In summary, this 510(k) submission for the Evolve® HPD 980/ 1470nm Multiwavelength Diode Laser is based on demonstrating substantial equivalence to a predicate device and compliance with relevant voluntary consensus standards. It does not involve performance studies in the context of diagnostic or AI devices, and therefore, most of the requested information regarding independent performance testing, sample sizes, and ground truth is not present in the provided text.

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The MegaBeam Reusable Fiber Optic Delivery System is intended for use as an accessory to any surgical laser system to vaporize, coagulate, incise and excise tissue for any application for which the lasers are cleared.

The MegaBeam Reusable Fiber Optic Delivery System for Biolitec Medical Devices, Inc. contains the identical same components and design as the device cleared under K980838 for Biolitec Inc.

The provided text describes a 510(k) summary for the MegaBeam Reusable Fiber Optic Delivery System. It explicitly states that no performance testing was included in this submission because the performance of the device "is well established and documented on soft tissue."

Therefore, based on the provided text, I cannot complete a table of acceptance criteria or describe a study that proves the device meets specific criteria, as such information is not present in the document.

Here's an attempt to answer the questions based on the absence of the requested information:

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)

• Sample Size: Not applicable, as no new performance testing was conducted for this submission.
• Data Provenance: Not applicable, as no new performance testing was conducted for this submission.

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, as no new performance testing with a test set requiring ground truth establishment was conducted for this submission.

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

Not applicable, as no new performance testing with a test set requiring adjudication was conducted for this 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. This device is a fiber optic delivery system, not an AI-powered diagnostic tool, and no MRMC study was mentioned.

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

Not applicable. This device is a fiber optic delivery system, not an algorithm, and no standalone performance study was mentioned.

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

Not applicable, as no new performance testing with a test set requiring ground truth was conducted for this submission.

8. The sample size for the training set

Not applicable, as this is a medical device, not an AI model, and no training set was mentioned.

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

Not applicable, as this is a medical device, not an AI model, and no training set with ground truth establishment was mentioned.

Summary based on the provided text:

The submission for the MegaBeam Reusable Fiber Optic Delivery System (K113688) relies on a substantial equivalence pathway. The document explicitly states: "Since the performance of the MagaBeam Reusable Fiber Optic Delivery System is well established and documented on soft tissue no performance testing is being specifically included in this submission." Therefore, there is no information in the provided text regarding acceptance criteria or a study proving the device meets them because new performance data was not presented. The device's safety and efficacy are asserted through its identical nature to its predicate device (K980838).

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The MegaBeam Endo-ENT Probe is a fiber optic delivery system intended as an aid for otologic procedures, for use in incision, excision, coagulation and vaporization of soft and fibrous tissue including osseous tissue. It is indicated for ENT surgery for use with compatible lasers cleared for use in the desired application.

The MegaBeam Endo ENT Probe for Biolitec Medical Devices, Inc. contains the identical same components and design as the device cleared under K952772 for Biolitec Inc. There are no differences in technology and as such does not raise any new questions on safety or efficacy.

This 510(k) summary states that the MegaBeam Endo-ENT Probe is substantially equivalent to a previously cleared device (MegaBeam Endo ENT Probe, K952772). Therefore, it relies on the predicate device's established performance without new studies.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. No new performance testing was conducted for this submission (K113858). The device is asserted to be identical to its predicate (K952772).

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

Not applicable. No new performance testing was conducted for this submission.

4. Adjudication Method for the Test Set

Not applicable. No new performance testing was conducted for this submission.

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

No. An MRMC study was not done for this submission.

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

Not applicable. This device is a physical medical probe, not an algorithm.

7. The Type of Ground Truth Used

Not applicable for this submission as no new performance data was generated. The "ground truth" for demonstrating equivalence relies on the predicate device's historical clearance and established safe and effective use.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical probe, not an AI/ML algorithm that requires training.

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

Not applicable. This device is a physical medical probe, not an AI/ML algorithm that requires training.

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The MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece is intended for use as an accessory to any surgical laser system to vaporize, coagulate, incise and excise tissue for any application for which the lasers are cleared.

The MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece for Biolitec Medical Devices, Inc. contains the identical same components and design as the device cleared under K946336, K923953 and K943445 for Biolitec Inc. There are no differences in technology and as such does not raise any new questions on safety or efficacy. Additional flat/ bare (no tips) fiber optic sizes of 230µ, 365µ, 400µ and 550u are included for clearance in this submission.

The provided text is a 510(k) summary for the MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece. This document primarily focuses on establishing substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria for a new, independent device evaluation.

Therefore, many of the requested sections about acceptance criteria, detailed study parameters, and ground truth establishment are not applicable or not present in this type of submission.

Here's a breakdown based on the provided text, indicating where information is present or absent:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: No specific quantifiable acceptance criteria are provided in the document.
• Reported Device Performance: The document states: "Since the performance of the MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece is well established and documented on soft tissue no performance testing is being specifically included in this submission."

Therefore, a table cannot be created as the submission explicitly states no new performance testing was conducted.

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

• Sample Size for Test Set: Not applicable, as no new performance testing was conducted or submitted.
• Data Provenance: Not applicable.

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

• Not applicable, as no new performance testing requiring ground truth establishment was conducted or submitted.

4. Adjudication Method for the Test Set

• Not applicable, as no new performance testing requiring adjudication was conducted or submitted.

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

• Was an MRMC study done?: No.
• Effect size of improvement with AI vs. without AI assistance: Not applicable, as this is a physical medical device (fiber optic delivery system), not an AI/software device, and no MRMC study was conducted.

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

• Not applicable, as this is a physical medical device, not an algorithm, and no standalone performance study was conducted.

7. The Type of Ground Truth Used

• Not applicable, as no new performance testing requiring ground truth establishment was conducted or submitted.

8. The Sample Size for the Training Set

• Not applicable, as this is a physical medical device, not a machine learning algorithm, and therefore no training set was used.

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

• Not applicable, as this is a physical medical device, not a machine learning algorithm, and therefore no training set with ground truth was established.

Summary of the Study that Proves the Device Meets Acceptance Criteria

The submission does not describe a study to prove the device meets acceptance criteria in the traditional sense of novel performance testing. Instead, the basis for approval is Substantial Equivalence (SE) to legally marketed predicate devices.

The key points of the argument for SE are:

• Predicate Devices: MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece (K946336, K923953, and K943445).
• Technological Characteristics: The MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece for Biolitec Medical Devices, Inc. contains "the identical same components and design" as the predicate device(s). The only difference mentioned is the inclusion of "Additional flat/bare (no tips) fiber optic sizes of 230µ, 365µ, 400µ and 550u for clearance."
• Safety and Efficacy: The submission explicitly states, "There are no differences in technology and as such does not raise any new questions on safety or efficacy."
• Intended Use: The intended use is identical: "to vaporize, coagulate, incise and excise tissue for any application for which the lasers are cleared."
• Performance Data: The submission states, "Since the performance of the MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece is well established and documented on soft tissue no performance testing is being specifically included in this submission."

In essence, the "study" that proves the device meets (implicitly understood) acceptance criteria is the accumulated evidence and historical performance data of the predicate device, combined with the argument that the new device is technologically identical and shares the same intended use. The FDA agreed with this assessment by issuing a substantial equivalence determination.

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The MegaBeam Endocular Probe and Aspirating Endocular Probe are intended for intraocular photocoagulation with or without simultaneous aspiration/ irrigation as an adjunct to vitrectomy surgery. Specific indications include the treatment of proliferative vitreoretinopathy, tractional retinal detachments, proliferative diabetic retinopathy, and various retinal vascular tumors.

The MegaBeam Endocular Probe and Aspirating Endocular Probe for Biolitec Medical Devices. Inc. contains the same components and design as the devices cleared under K935747 and K952340 for Biolitec Inc. except for a small change in tip size. (19 gauge to 25 gauge).

The provided text explicitly states that no performance testing was included in the submission for the MegaBeam Endocular Probe and Aspirating Endocular Probe. The submission relies on the established and documented performance of its predicate devices due to similar components, design, and only a small change in tip size (19 gauge to 25 gauge).

Therefore, there is no information available in the provided document to answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, or ground truth establishment for this particular device submission.

The relevant sentence is: "Since the performance of the MegaBeam Endocular Probe and Aspirating Endocular Probe is well established and documented no performance testing is being specifically included in this submission."

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The Twister™ Side Fire Fiber Optic Delivery System is a delivery accessory used to deliver optical energy and is indicated for use in general surgical applications in combination with any SMA-compatible laser system also indicated for the same applications. It is indicated for use in hemostasis, ablation and vaporization of soft or fibrous tissue in any surgical discipline in contact or non contact mode with a compatible laser marketed for the desired application. The system can be used with or without a standard viewing scope. It can be inserted through the working channel of a cystoscope. urethroscope, or any other viewing scope.

The Biolitec Medical Devices, Inc. Twister™ Side-Fire Fiber Optic Delivery System contains equivalent components and identical patient-contact materials as the cleared Biolitec Inc. Megabeam Lateral/ Side Fire Fiber Optic Delivery Systems.

The provided text does not contain detailed acceptance criteria and a study proving the device meets those criteria. Instead, it describes a 510(k) submission for a medical device (Twister™ Side-Firing Fiber Optic Delivery System) and states that no specific performance testing was included because its performance on soft tissue is "well established and documented."

Therefore, most of the requested information cannot be extracted from the given text.

Here's a breakdown of what can and cannot be answered:

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

• Cannot be provided. The document explicitly states: "Since the performance of the Twister™ Side-Fire Fiber Optic Delivery System is well established and documented on soft tissue no performance testing is being specifically included in this submission." This indicates that no new performance data or acceptance criteria for this specific submission were presented or needed due to relying on prior established performance.

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

• Cannot be provided. No new test set data was included in this submission.

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)

• Cannot be provided. No new test set data was included in this submission.

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

• Cannot be provided. No new test set data was included in this 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

• Cannot be provided. This device is a fiber optic delivery system, not an AI-powered diagnostic tool, so an MRMC study related to AI assistance is not applicable.

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

• Cannot be provided. This device is a fiber optic delivery system, not an algorithm.

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

• Cannot be provided. No new performance study generating ground truth was conducted for this submission. The submission relies on "well established and documented" performance of similar predicate devices, implying that any ground truth would have been established during the development and clearance of those previous devices.

8. The sample size for the training set

• Cannot be provided. This device is a physical delivery system, not a machine learning model, so there is no "training set."

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

• Cannot be provided. Same as above, no training set applies.

Summary from the provided text:

The submission for the Twister™ Side-Firing Fiber Optic Delivery System is based on substantial equivalence to existing predicate devices (Megabeam® Lateral/ Side Fire Fiber Optic Delivery System). The core argument is that the Twister system has "equivalent components and identical patient-contact materials" and its "performance... on soft tissue is well established and documented." Therefore, no new performance testing or specific studies were included in this submission to demonstrate acceptance criteria for this particular device. The acceptance criteria are implicitly met by its substantial equivalence to previously cleared devices whose performance was already deemed acceptable.

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The device is intended for endovascular coagulation of blood vessels. The device is indicated for endovascular coagulation of the Greater Saphenous vein of 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 and is identical to that cleared under K101712.

This 510(k) summary does not contain any performance data or a study describing acceptance criteria for the Endo Laser Vein System Kit with Radial Fiber.

Instead, the document states:

• Technological Characteristics: The device is "identical to that cleared under K101712."
• Performance Data: "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 ANSI/AAMI/ISO 10993-7." These are general safety and performance standards for medical electrical equipment and laser products, not specific clinical performance criteria.
• Substantial Equivalence: The primary argument for clearance is based on the device being "identical to that cleared under K101712 and uses previously cleared radial fiber technology (K924258) and has the same intended use and indications for use as the cleared Ceralas 1470, 980 and 810nm ELVeS kits."

Therefore, I cannot provide the requested table and study details because the provided text does not include information about acceptance criteria or a study proving the device meets them, in the typical sense of clinical or diagnostic performance.

The FDA cleared this device based on its substantial equivalence to previously cleared devices and compliance with relevant safety standards, rather than new clinical performance data in this specific submission.

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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, 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. 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 for Biolitec Medical Devices. Inc. contains the identical same components and design as the device cleared under K110080 for Biolitec Inc. There are no differences in technology and as such does not raise any new questions on safety or efficacy.

The provided document does not contain acceptance criteria or a study proving the device meets acceptance criteria.

Instead, it's a 510(k) premarket notification for a medical device (Radial-Emitting Shaped Fiber Optic Delivery System). The key takeaway from the "Performance Data" section (Page 1) is:

"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."

This statement indicates that the submission relies on the established performance of a predicate device (K110080) and asserts that the new device has "identical same components and design" and "no differences in technology." Therefore, it raises no "new questions on safety or efficacy" and is considered "substantially equivalent" to the predicate device.

Given this, I cannot fill out the requested table or answer most of your detailed questions about acceptance criteria and a study.

However, I can extract what limited information is available related to the request:

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

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

• Test set sample size: Not applicable. No new performance testing was conducted for this submission.
• Data provenance: Not applicable. The submission relies on the established performance of a predicate device, but no specific data or its provenance is detailed.

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 new performance testing was conducted that would require establishing ground truth by experts.

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

• Not applicable. No new performance testing 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 fiber optic delivery system, not an AI or imaging device involving human readers. No MRMC study was mentioned.

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

• Not applicable. This device is a physical medical device (fiber optic delivery system), not an algorithm.

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

• Not applicable. No new performance testing or ground truth establishment was conducted for this submission. The submission relies on the performance of a predicate device.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that would have a training set.

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

• Not applicable. This is not an AI/machine learning device.

In summary, this 510(k) submission leverages the concept of "substantial equivalence" to a predicate device. It explicitly states that no new performance testing was conducted or included in the submission because the device is identical in components and design to a previously cleared device, and its performance is considered "well established."

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The Ceralas Fiber Coupled 980nm 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. Indications include: General Surgery, Urology, Gynecology, Gastroenterology, Otolaryngology, Plastic Surgery, Dermatology, Podiatry, Neurosurgery/ Peripheral. Pulmonary Surgery, Arthroscopy, Cardiothoracic Surgery, Laser Assisted Lipolysis. Ophthalmology, Dental Applications, Endovenous Occlusion of the Greater Saphenous Vein.

The Ceralas 980nm 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 980nm family for Biolitec. Inc..

The provided submission is for a Ceralas 980nm Diode Laser Family for general surgical applications. This is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies to prove effectiveness or safety. Therefore, the information requested about acceptance criteria and a study proving device performance in the context of, for example, AI/ML device evaluations, is not directly applicable here.

Here's an analysis based on the provided text, addressing the points where information is available or noting its absence:

1. Table of Acceptance Criteria and 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)

This information is not applicable and not provided. This submission is for substantial equivalence of a physical medical device (laser) to a predicate device, not for a data-driven AI/ML model that would use a test set from patient data. The "test" here refers to demonstrating compliance with standards and equivalence, not evaluating performance on a clinical dataset.

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)

This information is not applicable and not provided. Ground truth in the context of clinical data interpretation by experts is not relevant to this type of device submission. The "ground truth" here is the established safety and efficacy of the predicate device, and the current device's compliance with established engineering and performance standards.

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

This information is not applicable and not provided. Adjudication methods are used in studies involving expert interpretation of data, which is not the nature of this 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

This information is not applicable and not provided. This type of study is for evaluating observer performance with or without AI assistance, which is not relevant to a laser device submission focused on substantial equivalence.

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

This information is not applicable and not provided. This refers to AI algorithm performance studies, which are not relevant here.

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

The "ground truth" in this context is the established regulatory compliance, safety, and efficacy of the predicate device, as well as compliance with recognized voluntary consensus standards for electrical safety, electromagnetic compatibility, and biocompatibility. There is no clinical "ground truth" derived from patient data or pathology in this type of submission.

8. The sample size for the training set

This information is not applicable and not provided. There is no "training set" in the context of an AI/ML algorithm for this physical device submission.

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

This information is not applicable and not provided. As there is no training set mentioned, the establishment of its ground truth is irrelevant.

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

The "study" proving the device meets the acceptance criteria is primarily a substantial equivalence comparison and compliance demonstration against recognized standards.

• Substantial Equivalence Study: The core of the submission relies on demonstrating that the Ceralas 980nm Diode Laser Family is "as safe and effective as" its predicate device (the Ceralas 980nm family by Biolitec, Inc.). The proof is based on the assertion that the devices are "identical in all aspects except labeling relating to the manufacturer/distributor." Specifically, it's stated they contain "the same components, technology and principles of operation and assembled by the same manufacturer." This direct identity is the primary evidence for substantial equivalence in this context.
• Compliance with Voluntary Consensus Standards: The device's performance is shown to meet acceptance criteria through compliance with a list of voluntary consensus standards:
  • 21 C.F.R. §§ 1040.10 & 1040.11 (likely related to radiation control for laser products).
  • ANSI/AAMI ES1 (likely electrical safety).
  • IEC 601-2-22 (likely specific safety requirements for surgical lasers).
  • EN 60825-1 (likely laser safety classification and requirements).
  • ANSI/AAMI/ISO 10993-7 (likely biocompatibility evaluation relevant to medical devices).

The FDA's review and subsequent "substantial equivalence" determination (K112324) confirms that the evidence provided was sufficient to meet the regulatory requirements for this 510(k) submission. This is a regulatory review process, not a clinical trial or AI performance study.

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