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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 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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