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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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Omni-Guide Holdings, Inc. single-use LISA Laser Surgical 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 LISA Laser Surgical 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. LISA Laser Surgical Fibers are individually packed sterile devices to provide high quality surgical laser fiber optic delivery systems for laser surgery. The Fibers are for use in laser surgical procedures, including open, laparoscopic, or endoscopic ablation, coagulation, incision, and excision or vaporizing, in soft/hard-tissue application for which compatible surgical lasers are applicable. The key components are the fiber optic, and either an SMA-905, SMA-906, or manufacturer's specific connector. The fibers allow energy to be delivered to the surgical site through the use of glass fiber optic cable. Propagation of the light energy through the glass provides users the ability to direct the energy to the appropriate areas in the body. The Omni Guide Surgical Holding, Inc. single-use LISA Laser Surgical Fibers family of fibers are marketed to physicians as a sterile device within a typical Tyvek/poly pouch. Internally, the fiber is either secured in a wound circle with a Tyvek band, backer-card, or placed in a polyethylene tubing hoop to allow ease of removal. The construction of the fibers is dependent of the application to which it's marketed. There are two main methods of attaching the connector : crimp and adhesive. The crimp offers a reliable connection that will not be affected by heat whereas the epoxy allows a lower cost alternative where high temperatures are not an issue. All fibers offer various connector nuts, heat shrinks, abrasion jackets, strain reliefs or caps that best serve the environment where they are utilized.

The provided document is a 510(k) Premarket Notification for the Omni-Guide LISA Laser Surgical Fibers, determining its substantial equivalence to a predicate device. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive clinical trials and establishing new acceptance criteria based on human performance. Therefore, many of the typical elements of a study proving a device meets acceptance criteria for an AI/CAD system (like sample sizes for test/training sets, expert consensus, MRMC studies, standalone performance, etc.) are not applicable to this document.

The document focuses on demonstrating substantial equivalence through a comparison of technological characteristics and non-clinical performance data, primarily bench testing and adherence to recognized standards.

Here's an analysis based on the provided text, addressing the points where information is available and indicating where it's not applicable:

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

The document includes a "Substantial Equivalence Comparison Table" which compares the subject device (LISA Laser Surgical Fiber) with the predicate device (Laser Peripherals surgical fiber optic laser delivery devices K170366) across various characteristics and lists non-clinical performance data. Since this is a substantial equivalence submission for a traditional medical device (laser surgical fibers), the "acceptance criteria" are implicitly met by demonstrating equivalence to the predicate and compliance with relevant performance standards through bench testing.

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. This submission is for a traditional medical device, relying on bench testing and adherence to standards, not a diagnostic AI/CAD system that would typically have a "test set" of clinical data. The non-clinical performance data section describes "bench testing" without specifying sample sizes in this summary. The data provenance is laboratory-based testing conducted by the manufacturer, Omni-Guide Holdings, Inc.

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. Ground truth in the context of clinical expert review or diagnostic accuracy is not relevant for this device's submission type. Testing focused on engineering and material performance.

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

• Not Applicable. Adjudication methods are relevant for clinical studies involving human interpretation or diagnostic agreement, which is not the case here.

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 is not an AI/CAD device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

• Not Applicable. The device is a laser surgical fiber, not an algorithm.

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

• Not Applicable / Indirect. The "ground truth" for this type of device is implicitly defined by the safety and performance requirements of the predicate device and the relevant international and national standards (e.g., ISO, ASTM) that the device must meet through bench testing. For example, a successful bond strength test (per ASTM F88-09) or successful sterilization (per ISO 11135-1) serves as the "truth" that the device performs as intended in that particular aspect.

8. The sample size for the training set:

• Not Applicable. This refers to machine learning algorithms, which are not involved here.

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

• Not Applicable. This refers to machine learning algorithms, which are not involved here.

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