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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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