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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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The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, Ho: YAG, KTP and Diode lasers have been cleared.

Fiber Optic Delivery Systems and Handpieces 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. Similarly, the predicate devices are also components of delivery systems designed to deliver laser radiation to a specified point. FiberTech's Fiber Optic Delivery System's fiber optical Handpiece and Tip has a similar material composition as its predicate devices. Third, the Fiber Optic Delivery System is available in sizes between 200 micron and 1000 micron. Ceramoptec's and Coherent Laser Delivery Systems is available also in sizes ranging from 200 micron to 1000 micron. Fourth, the reusable and the disposable Fiber Optic Delivery Systems are available in the same tip shapes and handpiece configurations. Further, both the reusable and the disposable devices are prepackaged sterile and fit lasers which employ SMA 905 connectors or lasers which have suitable adapters to allow SMA 905 connectors to be used. Finally, the reusable Fiber Optic Delivery System can be reused only once the optical fiber tip is properly cleaned, inspected, stripped and cleaved.

The provided text is a 510(k) summary for the FiberTech's USA Fiber Optic Delivery System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the way typically associated with AI/ML-based device performance evaluations (e.g., accuracy, sensitivity, specificity studies).

Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, which is the standard for 510(k) clearances. The "Performance Data" section primarily refers to certifications, not clinical performance metrics.

Therefore, I cannot fulfill your request for the specific points about acceptance criteria and study details because the provided document does not contain that type of information. It's a regulatory document for a physical medical device, not an AI/ML software as a medical device.

Here's a breakdown of why the requested information is absent:

1. A table of acceptance criteria and the reported device performance: Not provided. The document states "no new questions of safety and effectiveness raised by the introduction of this devices" based on similarity to predicates, rather than quantifiable performance metrics against specific acceptance criteria.
2. Sample sized used for the test set and the data provenance: Not applicable. Performance is established through comparison to predicate devices and existing certifications, not through a separate clinical test set in the traditional sense for an AI/ML device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The "Performance Data" section (Section 2) mentions:

• CE marking (Medical Device Directive 95.E.02)
• Certification under EN ISO 19407:2009
• Certification for Quality EN ISO 9001:2000

These are quality management system and regulatory compliance certifications, not direct performance metrics of the device itself (like accuracy of an AI algorithm). The basis for clearance is substantial equivalence to the predicate devices listed (Ceramoptec's Fiber Optic Delivery Sytems, InnovaQuartz Fiber Optic Delivery System, Laser Peripherals Fiber Optic Delivery System, Trymedyne Inc., Fiber Optic Delivery System). The argument for substantial equivalence is based on:

• Intended Use
• Technological Characteristics (material composition, available sizes, tip shapes, handpiece configurations, sterile packaging, connector types, reusability)

In summary, this document is a 510(k) submission for a physical medical device. It relies on demonstrating similarity to already cleared devices and adherence to manufacturing and quality standards, rather than presenting a performance study with acceptance criteria and ground truth, as would be expected for an AI/ML-based medical device.

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