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Indicated for incision/excision, ablation, and coagulation (homeostasis) when attached to cleared laser systems such as KTP, Nd:YAG, Argon, Diode, Ho:YAG and ER:YAG wavelengths for the indications for which the lasers have been cleared.

The OptiLite™ Holmium Laser Fibers are intended to be used with legally cleared laser systems to deliver laser energy. The fiber delivery system is typically used in conjunction with a rigid or flexible endoscope to access the surgical site. The laser fibers work on the principle of total internal reflection. Laser energy is focused into a glass silica fiber at the proximal end and traverses the length of the fiber by means of total reflection. The fiber is able to contain the laser beam and funnels the laser energy from the proximal end to the distal end.

The provided text describes the 510(k) submission for the OptiLite™ Holmium Laser Fibers. However, it does not contain the detailed information necessary to answer all parts of your request, particularly regarding specific acceptance criteria for device performance, the study design for such performance, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies.

The document indicates that the device's substantial equivalence is based on its similarity to existing predicate devices regarding "indications for use and technology," and that "Biocompatibility, sterility and performance testing were performed in accordance to Food and Drug Administration quidance's and recognized international standards." However, the details of these performance tests and their specific acceptance criteria are not included in the provided text.

Therefore, I can only provide information based on what is explicitly stated or can be inferred from the text. Many sections of your request will be answered with "Not provided in the text."

Acceptance Criteria and Study Details for OptiLite™ Holmium Laser Fibers

1. Table of Acceptance Criteria and Reported Device Performance

   Acceptance Criteria	Reported Device Performance
   Functionality:
   - Deliver laser energy from proximal to distal end for incision/excision, ablation, and coagulation.	"The fiber is able to contain the laser beam and funnels the laser energy from the proximal end to the distal end." No specific quantitative metrics for energy delivery or efficacy are provided. Performance testing was done, but specific results or acceptance thresholds are not detailed.
   Biocompatibility:	"Biocompatibility...testing were performed in accordance to Food and Drug Administration guidance's and recognized international standards." No specific acceptance criteria or results reported.
   Sterility:	"Sterility...testing were performed in accordance to Food and Drug Administration guidance's and recognized international standards." No specific acceptance criteria or results reported.
   Compatibility: (with specific laser systems)	"Indicated for incision/excision, ablation, and coagulation (homeostasis) when attached to cleared laser systems such as KTP, Nd:YAG, Argon, Diode, Ho:YAG and ER:YAG wavelengths for the indications for which the lasers have been cleared." No specific performance metrics or acceptance criteria for this compatibility are detailed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not provided in the text. The document only states that "Performance testing were performed," but no details on the sample size (e.g., number of fibers tested, number of procedures simulated), type of data, or provenance are given.

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 in the text. This type of information is typically relevant for AI/imaging devices involving interpretive tasks. For a laser fiber, the "ground truth" would be established through engineering and biological performance standards, not expert adjudication of images. The text does not mention any expert involvement in establishing ground truth for performance testing.

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

   • Not applicable / Not provided in the text. Adjudication methods are typically used for establishing ground truth in diagnostic studies involving human interpretation. This is not relevant for the described performance testing of a laser fiber.

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 / Not provided in the text. An MRMC study is relevant for AI-assisted diagnostic or interpretive tasks. The OptiLite™ Holmium Laser Fiber is a medical device for delivering laser energy, not an AI or imaging device, so such a study would not be applicable.

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

   • Not applicable / Not provided in the text. This question is also relevant for AI/algorithm-based diagnostic devices. The OptiLite™ Holmium Laser Fiber is a physical medical device. Its "standalone performance" refers to its ability to function as designed (deliver laser energy, biocompatibility, sterility) which was stated as having been tested.

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

   • Based on engineering and biological performance standards. The text indicates "Biocompatibility, sterility and performance testing were performed in accordance to Food and Drug Administration quidance's and recognized international standards." This implies that the "ground truth" for evaluating the device's performance would be established by predefined engineering specifications (e.g., laser energy transmission efficiency, damage thresholds) and biological safety standards (e.g., cytotoxicity, irritation). No mention of expert consensus, pathology, or outcomes data for establishing the performance 'ground truth' is made.

8. The sample size for the training set

   • Not applicable / Not provided in the text. Training sets are used in machine learning and AI. This device is a physical, non-AI medical device; therefore, no training set in the AI sense would be used. The text does not mention any data sets used for "training" the device.

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

   • Not applicable / Not provided in the text. As explained above, this device does not involve a training set in the context of AI.

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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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The Optical Integrity General Shaped Fiber is intended to be used for vaporization, cutting, ablation and coagulation of soft tissue in conjunction with or without endoscopic equipment including laparoscopes, hysteroscopes, arthroscopes, cystoscopes, cystoscopes, gastroscopes, and colonoscopes, or for contact or non-contact surgery with or without handpieces for use in coagulation, incision/excision, ablation and vaporization of soft tissue.

The Optical Integrity GS Fiber is indicated for use in medicine and surgery in the following specialties: Urology, Plastic Surgery, Radiology, Dermatology, Pulmonology, Gastroenterology, Gynecology, ENT, General and Vascular Surgery, Lithotripsy, Arthroscopy, Podiatry, Orthopedics and Neurosurgery.

The Optical Integrity General Shaped (GS) Fiber is a fiber optic laser delivery system consisting of a 3 meter long silica fiber, clad in fluorinated doped silica, buffered with a fluorinated acrylate and a shaped tip. As an integral part of a laser system, the GS fiber may be used for a wide variety of surgical procedures.

The provided text for K022338 describes a medical device, the Optical Integrity General Shaped (GS) Fiber, and its intended use. However, it does not contain detailed information regarding acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth establishment.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a comprehensive clinical study report with detailed performance metrics against predefined acceptance criteria.

Based only on the provided text, I can infer the following about how the device meets its claims:

1. Acceptance Criteria and Reported Device Performance: This information is not
   explicitly stated in the provided document. The document states "Bench testing was performed to demonstrate that the device will perform as intended," but it does not specify what those "intentions" (i.e., acceptance criteria) were, nor does it list specific performance results like accuracy, sensitivity, specificity, etc., that would typically be found in a performance table. The focus of the 510(k) is on the technological characteristics and comparison to predicate devices, not on quantitative performance metrics against specific criteria.

2. Sample Size and Data Provenance for Test Set: This information is not provided in the document. The text mentions "Bench testing," which implies laboratory-based tests, but no details on the number of samples used or if any human-derived data was involved. Given it's "bench testing," it's likely physical or engineering tests on the fiber itself, not a clinical test set with patient data.

3. Number of Experts and Qualifications: This information is not provided. Bench testing typically involves engineers or technicians, not medical experts in the way clinical studies do for ground truth establishment.

4. Adjudication Method: This information is not applicable or provided. Adjudication methods like 2+1 or 3+1 are used in clinical trials involving human readers/interpreters to establish ground truth from discrepancies. Bench testing does not involve this type of adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: An MRMC comparative effectiveness study was not mentioned in the document. This type of study would be relevant for evaluating the impact of AI on human reader performance, which is not the focus of this 510(k) for a laser delivery fiber.

6. Standalone Performance Study (Algorithm Only): A standalone performance study was not mentioned. This device is a physical fiber optic laser delivery system, not an algorithm.

7. Type of Ground Truth Used: For "bench testing," the "ground truth" would be engineering specifications, physical measurements, and performance benchmarks relevant to the fiber's function (e.g., optical power transmission, durability, beam profile, heat dissipation). The document does not specify the exact type of ground truth used for these bench tests.

8. Sample Size for Training Set: This information is not applicable or provided. The device is a physical product, not an AI/ML algorithm that requires a training set.

9. How Ground Truth for Training Set was Established: This information is not applicable or provided for the reasons mentioned above.

Summary based on available information:

The 510(k) summary (K022338) for the Optical Integrity General Shaped Fiber primarily focuses on establishing substantial equivalence to existing predicate devices through technological characteristic comparison and general bench testing, rather than presenting detailed clinical performance data against specific acceptance criteria.

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