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Omni-Guide Holdings, Inc. single-use OmniGuide PRIMA Surgical Laser fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500nm – 2200nm have received regulatory clearance.
Omni-Guide Holdings, Inc. single-use OmniGuide PRIMA Surgical Laser fibers devices are intended for use with any cleared surgical laser with an SMA 905 connector, SMA 906 connector, or manufacturer specific connectors and adapters

Omni-Guide Holding, Inc. OmniGuide Prima Surgical Laser Fibers are individually packed sterile devices indicated to provide high quality surgical laser fiber optic delivery systems for laser surgery. The Fibers are intended for use in laser surgical procedures including, but not limited to open, laparoscopic, or endoscopic ablation, coagulation, incision, and excision or vaporizing in any soft/hard-tissue application for which compatible lasers are applicable. Product description, length, laser wavelength compatibility can be found in Section 15 of this 510(k) Premarket Notification. The key components of this system are the SMA-905, SMA-906 with RFID and Manufacturer's specific RFID connectors and the Fiber Optic, these fibers may be used in a variety of laser-based surgical cases. Per [807.92(a)(4)].

The provided text describes the OmniGuide RFID Surgical Laser Fibers and seeks to establish substantial equivalence to a predicate device, the OmniGuide LISA Laser Family of Surgical Laser Fibers (K220189). The document outlines various performance tests and compliance with recognized standards.

However, it's crucial to understand that this document describes a 510(k) submission, which is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. This is different from a typical clinical study with a detailed description of acceptance criteria, statistical analysis, and ground truth establishment you might expect for a novel AI device.

Let's break down the information available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present acceptance criteria in the traditional sense of numerical thresholds for a specific clinical outcome for the new device itself. Instead, it outlines a comparison between the subject device (OmniGuide Prima Surgical Laser Fibers) and the predicate device (OmniGuide LISA Laser Surgical Fibers) to demonstrate substantial equivalence. The "acceptance criteria" here are essentially that the new device performs as well as or similarly to the predicate device across various technical and safety characteristics.

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

The document describes "bench testing" and "performance testing" rather than a clinical test set with human subjects.

• Sample Size: The exact sample size for each specific bench test (e.g., how many fibers were subjected to pull testing) is not explicitly stated in the provided text. It generally refers to "the subject device" and "the predicate device."
• Data Provenance: The testing appears to be retrospective in the sense that it's evaluating a product against established benchmarks and a predicate device. The testing was conducted by or for Omni-Guide Holdings, Inc. (the device manufacturer) and its contract manufacturer, LightGuide Optics International Ltd. No specific country of origin for the data is mentioned beyond this, but given the company's address is in Massachusetts, USA, and the FDA submission, the testing would generally align with US regulatory context.

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

This information is not applicable in the context of this 510(k) submission. For devices like laser fibers, "ground truth" is typically established through engineering specifications, material science properties, and performance standards, not through expert clinical consensus as would be the case for an AI diagnostic tool.

4. Adjudication Method for the Test Set:

This is not applicable. The evaluation of laser fiber performance is based on physical measurements, technical specifications, and adherence to engineering standards, not on subjective interpretations requiring an adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI devices that assist human readers in tasks like image interpretation. This document describes a medical device (laser fibers), not an AI diagnostic or assistance tool. The study focuses on the physical and performance equivalence of the laser fibers themselves.

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

Not applicable. This device is a physical surgical tool (laser fiber), not an algorithm or software. It requires a human operator (surgeon) to use it with a laser system.

7. The Type of Ground Truth Used:

The "ground truth" for evaluating these laser fibers is based on engineering specifications, material science properties, and compliance with recognized industry standards. This includes:

• Documented chemical and physical properties of materials (silica, fluoropolymer, etc.).
• Performance measures like power output, beam homogeneity, bend radius tolerance, and pull strength, measured against design specifications.
• Compliance with various ISO and ASTM standards for sterilization, packaging, biocompatibility, and risk management.
• Comparison data from the predicate device (OmniGuide LISA Laser Surgical Fibers, K220189), which serves as a benchmark for "safe and effective" performance.

8. The Sample Size for the Training Set:

The concept of a "training set" is not applicable here. This device development does not involve machine learning or AI models that require training data.

9. How the Ground Truth for the Training Set was Established:

Not applicable for the same reason as point 8.

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