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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, 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 contains the same basic components and design as the cleared Megabeam Radial fiber and theCeralas diode laser family is substantially similar in performance and technology to the cleared Nd: YAG laser.

The provided document is a 510(k) summary for the Radial-Emitting Shaped Fiber Optic Delivery System. It explicitly states that no performance testing was included in the submission because "the performance... is well established and documented on soft tissue."

Therefore, based on the provided text, it is not possible to provide a table of acceptance criteria or details about a study proving the device meets acceptance criteria. The submission relies on substantial equivalence to predicate devices, rather than new performance data.

Here's an attempt to answer the questions based only on the provided information, noting the lack of specific study data:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

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)

• Not applicable / Not provided. The submission explicitly states: "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." Therefore, no new test set was used or data provenance specified.

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 new test set requiring expert ground truth establishment was described.

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

• Not applicable / Not provided. No new test set requiring adjudication was 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. This is a medical device (fiber optic delivery system), not an AI-based diagnostic tool. No MRMC study was performed or is relevant to this submission.

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

• No. This is a medical device (fiber optic delivery system), not an algorithm. No standalone algorithm performance study was done.

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

• Not applicable / Not provided. The submission relies on substantial equivalence to predicate devices whose performance is "well established and documented on soft tissue," rather than new studies with a defined ground truth.

8. The sample size for the training set

• Not applicable / Not provided. This is a medical device. There is no mention of a "training set" as would be used for AI/ML models.

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

• Not applicable / Not provided. As there is no training set for this type of device submission, this question is not relevant.

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The device is intended for endovascular coagulation of blood vessels. The device is indicated for the endovascular coagulation of the greater saphenous vein in 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.

The provided text describes a 510(k) submission for the "Endo Laser Vein System Kit with Radial Fiber," and it focuses primarily on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document. The document states that "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 60825-1, and ANSI/AAMI/ISO 10993-7." However, it does not specify acceptance criteria derived from these standards, nor does it report device performance against specific metrics.

The document's central argument for substantial equivalence is based on:

• The use of previously cleared radial fiber technology (K924258).
• Having the same intended use and indications for use as cleared predicate devices (Ceralas D 1470, 980 and 810nm ELVeS kits).
• The ELVeS kit not representing a new technological characteristic for diode lasers in endovascular coagulation of the greater saphenous vein.

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

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

   • Not provided in the document. The submission relies on substantial equivalence to predicate devices and compliance with general consensus standards, not on specific performance data against defined acceptance criteria.

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. The document does not describe a performance study with a test set.

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 performance study with a test set is described.

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

   • Not applicable / Not provided. No performance study with a test set 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. This device is a laser system for endovascular coagulation, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or mentioned.

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

   • No. This is a medical device (laser system), not an algorithm. Standalone performance for an algorithm is not applicable.

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

   • Not applicable / Not provided. No performance study requiring ground truth is described.

8. The sample size for the training set:

   • Not applicable / Not provided. This device is a laser system, not a machine learning algorithm requiring a training set.

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

   • Not applicable / Not provided. As above, no training set for an algorithm is relevant here.

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