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The Laser Peripherals Laser Fiber is indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500nm – 2200nm have received regulatory clearance. Laser Peripherals surgical fiber optic laser delivery devices are intended for use with any cleared surgical laser with an SMA 905 connector, SMA 906 connector, or manufacturer specific connectors and adaptors.

The Family of 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 open, laparoscopic ablation, coagulation, incision, and excision or vaporizing in any soft/hard-tissue application for which compatible lasers are applicable. The key components of this system are the SMA-905, SMA-906 and Manufacturer's specific connectors and the Fiber Optic. The fiber optic in the laser fiber is the main component in the assembly and is what allows for delivering the energy to the patient. The fiber portion of the laser fiber is comprised of several different materials; these can be thought of as: 1) the fiber core, 2) fiber cladding and coating layers, and 3) the outside coating or the jacket. All fibers featured in this submission have a core consisting of a silica (glass) material. The core is the main light pipe which offers a path for the light energy. The fiber cladding and coating layers are placed over the core and shield the fiber from losing energy over the length of the fiber and guide the energy to exit the distal tip. The material of the cladding and coating layer has a different index of refraction, which directs the light back into the core. This is typically another layer of silica, but may include a chemical layer (e.g., Fluoropolymer). Fiber selection is based on the ability to transmit the light wavelength that the laser is producing. The outside of the laser fiber is coated with a flexible material to offer abrasion and breakage resistance. This coating is typically an ETFE, but some models offer a Polyimide coating for superior resistance. The distal tip of the laser fiber offers the user an opportunity to configure the output energy to suit the needs of the application. The most predominate distal tip configuration is a flat, polished surface. The flat end face of the fiber allows the energy to exit the fiber unaltered. Other configurations manage the light in different ways. This allows the user to use the fiber where a different method of treatment is appropriate. Fibers can be divided into two categories: Contact and Non-contact. This refers to whether the distal tip is touching the subject matter at the worksite or whether it is held back, away from the target. Contact fibers are generally shaped into configurations intended to maximize the effectiveness of the procedure. These shapes include cone tips, ball tips, spherical tips, etc. A third type of distal tip offers further treatment of the laser energy as it exits the fiber. These distal tips utilize added components to either direct the laser light (i.e., ScatterFree™ (SideFire)) or lens the light (focus or dispersed).

The provided text describes a 510(k) premarket notification for "Laser Peripherals, Llc Family Of Bare Laser Fibers." It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a new, innovative device with a primary clinical outcome. Therefore, many of the requested details about acceptance criteria for device performance, especially in a comparative effectiveness study or involving expert ground truth, are not directly applicable or available in this document.

However, I can extract information related to what constitutes "acceptance" in the context of this 510(k) submission, which is primarily demonstrating substantial equivalence and meeting non-clinical performance and safety standards.

Here's an interpretation based on the provided text:

Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are implicitly tied to demonstrating substantial equivalence to the predicate devices and meeting relevant safety and performance standards. The reported device performance is that it meets these standards and is comparable to the predicates.

Study Details (as inferred from the 510(k) submission):

This submission primarily relies on non-clinical performance testing to demonstrate substantial equivalence, rather than a clinical study with diagnostic outcomes.

1. Sample Size used for the test set and the data provenance:

   • The document does not specify a "test set" in the sense of a clinical or expert-reviewed dataset. The testing was bench testing on physical device samples.
   • The sample sizes for the various non-clinical engineering and bench tests (e.g., power output, bend radius, pull testing, biocompatibility, packaging) are not explicitly stated in this summary. These quantities would be detailed in the full test reports referenced (e.g., Section 18).
   • Provenance: This is entirely laboratory/bench test data, likely conducted internally by Laser Peripherals, LLC, or by accredited labs per standards. It is retrospective in the sense that the test results confirm the design's performance.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. This submission focuses on non-clinical engineering and performance testing, not on diagnostic accuracy requiring expert interpretation or ground truth establishment in a clinical context. The "ground truth" for these tests are objective measurements against defined engineering specifications and standard requirements.

3. Adjudication method for the test set:

   • Not applicable. There was no expert adjudication process involved, as the "test set" consists of objective measurements from physical bench tests.

4. 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, an MRMC comparative effectiveness study was not done. This device is a bare laser fiber, a surgical instrument, not an AI-assisted diagnostic tool or an imaging device. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.

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

   • Not applicable. This is a physical medical device (laser fiber), not an algorithm or software. Its performance is inherent in its physical properties and how it delivers laser energy.

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

   • The "ground truth" for this device's evaluation is primarily based on engineering specifications, compliance with recognized consensus standards (ISO, ASTM), and objective physical measurements from bench testing. For biocompatibility, it's defined by the outcomes of standard biological tests. For sterilization, it's meeting validated sterilization parameters.

7. The sample size for the training set:

   • Not applicable. This is a physical device, not a machine learning model, so there is no "training set" in the AI sense. The design and manufacturing process would involve internal development and verification cycles, but not a dataset for algorithm training.

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

   • Not applicable. As there is no training set, there is no ground truth establishment for one.

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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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