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The VaporMax LDD® family of laser fibers, which includes VaporMAX LDD, Mega/OULE LDD and MoJO LDD, are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500 nm and 2200 nm have received regulatory clearance. The VaporMAX LDD family of laser delivery fibers are intended for use with any cleared surgical laser having a SMA 905 connector or manufacturer specific connectors and adaptors.

VaporMAX LDD® family of fibers, which includes VaporMAX LDD®, MegaJOULE LDD, and MoJo LDD, are fiber optic surgical laser energy delivery devices consisting of a stainless steel laser connector, e.g. SMA 905 or Trimedyne OmniPulse™ MAX, an anodized aluminum extension sleeve or polymer overnut for accommodating recessed laser ports, fiber/connector strain relief, and a transmitting optical fiber consisting of a low [OH-], fused silica core fiber with fluorine-doped, fused silica cladding, a fluoropolymer secondary cladding and an ethylene tetrafluorethylene copolymer (ETFE, e.g. DuPont Tefzel 210™) protective jacket. The distal tip is laser polished and is disposed within a fused quartz capsule (cap) containing a beam conditioning lens and a prism for redirecting the output at nearly right angles to the fiber longitudinal axis.

The dimensional difference between the optical fiber and the distal cap is equalized with a Udel tube covering the distal length of fiber that may be tasked to pass a cystoscope bridge working channel, sized to match the cap diameter and upon which is dispose a green visual indicator of the fiber rotational orientation. The proximal end of the diameter matching tube is terminated within a patent pending control knob for ergonomic rotational control (aiming). Some models of the VaporMAX LDD, those with subscripted "e", where e" indicates "ergonomic") exploit severing the connection between the redirection prism from the transmitting fiber by providing for free rotation of the cap about the fiber, vial the control knob, thereby aiming the fiber output without torquing the transmitting fiber.

VaporMAX LDD fibers are packaged as a coil upon a coated fiberboard or dense polymer carrier card that is intended to provide for ease of dispensing within the surgical field while immobilizing the product within the sterile pouch. The working end (distal section) of the fiber is maintained in a straight configuration to avoid "fiber jumping" when rotated in surgery (due to the device's "memory" of being stored in a coil). Carrier cards are sealed within non-woven/impermeable pouches, e.g., Tyvek/paper or Tyvek/Mylar, currently validated by IQ for a three-year shelf life. Sealed sterile pouches are protected by an outer, nonsterile fiberboard carton. Both the sterile pouch and carton are labeled with the product information per FDA labeling requirements. All tissue contacting VaporMAX LDD materials of construction, and any materials in fluidic communication with tissue, are USP Class VI biocompatible and are compatible with ethylene oxide (EO) sterilization.

The provided document does not contain acceptance criteria or a study that rigorously proves the device meets specific acceptance criteria in the format typically used for medical device efficacy studies (e.g., clinical trials).

Instead, it's a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than direct proof of meeting defined acceptance criteria through a specific study. The "Performance Testing (Bench and User Evaluation)" section describes bench tests to compare performance with predicate devices.

However, based on the information provided, here's an attempt to extract and infer information relevant to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Since explicit "acceptance criteria" (e.g., target accuracy, sensitivity, specificity, or specific performance metrics with defined thresholds) are not provided, I've inferred performance goals based on the comparison to predicate devices and the described testing.

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

• Sample Size: Not explicitly stated. The document refers to "subject fibers" (plural) meaning multiple units were tested, but no specific number is given.
• Data Provenance: The tests are described as "simulated surgery" and "bench tests" performed within the InnovaQuartz manufacturing facility in Phoenix, Arizona. This indicates these are prospective bench studies (laboratory-based testing). Country of origin is the USA.

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

• This information is not provided. The document describes bench testing and performance comparisons, not studies involving expert evaluation of clinical data or images to establish a "ground truth."

4. Adjudication Method for the Test Set

• This information is not applicable/provided. The "tests" described are physical and mechanical performance tests, not those requiring expert adjudication of subjective outcomes.

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. The document describes bench testing comparing the device's physical and optical performance to predicate devices, not human reader performance with or without AI assistance.

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

• This question is not applicable. The device (laser fiber) is a physical medical device, not an algorithm or AI software. Therefore, an "algorithm only" performance study is not relevant.

7. The Type of Ground Truth Used

• The "ground truth" for the performance tests was based on physical measurements and defined operational characteristics (e.g., energy delivery, beam profiles, mechanical strength, output angle, divergence) in a controlled laboratory setting against known predicate device performance and design specifications. There is no mention of expert consensus, pathology, or outcomes data as "ground truth" for these specific tests.

8. The Sample Size for the Training Set

• This question is not applicable. The device is a physical laser fiber, not an AI or machine learning model that requires a training set.

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

• This question is not applicable as there is no training set for this type of device.

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ProFlex CO2 Laser Fiber is indicated for the ablation, coagulation, incision, and vaporization of soft tissue in open, endoscopic, and laparoscopic surgical procedures.

ProFlex CO2 Laser Fibers are fiber optic energy delivery devices consisting of a stainless steel laser connector, e.g. SMA 905, an anodized aluminum expansion nut, strain relief, a hollow glass tube having a dielectric coating (silver/silver iodide) in the bore and a fluoropolymer outer coating and an ethylene tetrafluoroethylene copolymer (ETFE, Tefzel™) protective jacket.

ProFlex CO2 Laser Fibers are packaged in a coiled and tubular, high-density polyethylene (HDPE) carrier providing improved ease of dispensing within the surgical field while maintaining sterility. Coils are contained within non-woven/impermeable polymer, e.g. Tyvek/Mylar, sterile pouches, validated for three-year shelf life, and protected with an outer, nonsterile fiberboard carton. Both sterile pouch and carton are labeled.

All ProFlex CO2 Laser Fiber materials of construction are USP Class VI biocompatible and are compatible with ethylene oxide (EtO) sterilization.

ProFlex CO2 Laser Fibers are for prescription use only.

The provided document is a 510(k) Premarket Notification from the FDA for the ProFlex CO2 Laser Fiber. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving independent performance against acceptance criteria in the manner typically associated with novel AI/ML medical devices or complex diagnostic tools.

Therefore, the document does not contain the information requested regarding acceptance criteria, specific study designs (like MRMC or standalone performance), sample sizes for test/training sets, expert qualifications, ground truth establishment, or effect sizes for human reader improvement.

The document primarily shows:

• Device Name: ProFlex CO2 Laser Fiber (Model: S-COF500)
• Intended Use: Ablation, coagulation, incision, and vaporization of soft tissue in open, endoscopic, and laparoscopic surgical procedures.
• Predicate Device: CO2 Laser WaveGuide (K100384) from Lumenis Ltd.
• Demonstration of Substantial Equivalence: Achieved through a comparison of technical characteristics and non-clinical bench testing.

Specifically, regarding the requested information:

1. A table of acceptance criteria and the reported device performance: This document does not present acceptance criteria or reported device performance in the context of a clinical study or specific performance metrics typically associated with AI/ML or diagnostic devices (e.g., sensitivity, specificity, AUC). It focuses on physical and functional characteristics matching the predicate.
2. Sample sizes used for the test set and the data provenance: Not applicable. The "testing" referred to is non-clinical bench testing, not clinical studies with "test sets" in the diagnostic sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic accuracy is not relevant for this type of device and submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 laser fiber, not an AI-powered diagnostic tool.
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. This device does not involve machine learning or AI with training sets.
9. How the ground truth for the training set was established: Not applicable.

Instead, the document details:

• Non-Clinical Testing (Section 8): This "testing" served to verify that the proposed device met design specifications and was substantially equivalent. It included:
  • Bench Testing for labeling and performance verification (e.g., Instructions for Use, Fiber Design Verification, Packaging Design Verification).
  • Performance Qualification for sterility (ISO 11135:2014) and ethylene oxide sterilization residuals (ISO 10993-7:2008).
• Clinical Testing (Section 9): "No clinical study is included in this submission." This explicitly states that clinical performance data was not part of this 510(k).

In summary, the provided document is a regulatory clearance for a physical medical device (laser fiber), not a study report for an AI/ML or diagnostic device that would feature the requested criteria.

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ProFlex® Laser Fibers are intended for use in laser-based surgical applications including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary) and surgical procedures involving vaporization, ablation, hemostasis, excision, resection and incision and of soft and cartilaginous tissues. While designed primarily for holmium (Ho:Y AG) lasers, ProFlex laser fibers may be used with any laser wavelength between 500 nm and 2200 nm that have been cleared for surgical use including, but not limited to frequency doubled Nd: Y AG (KTP) lasers, argon lasers, alexandrite lasers, ruby lasers, dye lasers, Nd:YAG lasers and Tm:YAG lasers.

Subject devices and primary predicate devices are fiber optic energy delivery devices consisting of a stainless steel laser connector, e.g. SMA 905, an anodized aluminum expansion nut, strain relief, doubly step index clad optical fiber (fluoroacrylate over fluorine doped fused silica) with an ethylene tetrafluorethylene (ETFE, Tefzel™) protective jacket and are available in five nominal fiber core diameters (200 um, 273 µm, 365 µm, 550 um, 910 um, and 940 um), three nominal lengths (3 meters, 3.5 meters and 4.25 meters) and two laser-formed working tips (flat and orb). Subject devices and primary predicate devices are equipped with spatial and angular laser launch overfill protection -- a protective and guiding quartz ferrule, fused about the fiber input face upon which an input lens is laser-formed for high laser and physical damage threshold and for collimation of the laser focus energy within the optical fiber - and ruggedized output tips designed for ease of transit in flexible ureteroscopes and stone basket channels. Smaller fibers (where base fiber cores are smaller than laser foci) are equipped with tapered inputs where larger fibers are straight terminations.

Subject devices are packaged in a coiled high density polyethylene (HDPE) tube carrier providing ease of dispensing within the surgical field while maintaining sterility. All materials of construction are USP Class VI biocompatible and are compatible with flash autoclave and ethylene oxide (EtO) sterilization.

This document is a 510(k) Premarket Notification from the FDA for a medical device called "ProFlex® Laser Fibers." It's a regulatory clearance letter, not a study report demonstrating the device meets acceptance criteria.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" cannot be fully provided from this document. This letter states that the device is substantially equivalent to a predicate device, meaning it has similar indications, technological characteristics, and performs as well as a legally marketed device. It does not contain a detailed report of a study designed to prove specific acceptance criteria against a defined performance metric.

However, I can extract the relevant information that is present regarding performance and comparison:

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

This document does not specify quantitative acceptance criteria. Instead, it relies on substantial equivalence. The reported performance is a comparative statement.

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

• Sample Size: Not explicitly stated. The document mentions "Subject and predicate fibers were laser power tested," implying a sample of fibers was used, but the quantity is not provided.
• Data Provenance: The testing was conducted by InnovaQuartz, whose manufacturing facility is in Phoenix, Arizona, USA. The document doesn't specify if the testing was prospective or retrospective, but typically, premarket testing for substantial equivalence would be prospective.

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. This is a technical performance study of a physical device (laser fibers), not an assessment requiring expert interpretation of medical images or patient outcomes for ground truth establishment.

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

Not applicable. This is a technical performance study, not a ground truth establishment process involving multiple readers.

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 laser fiber, not an AI-powered diagnostic tool. No MRMC study was conducted or is relevant for this type of device.

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

Not applicable. This device is a physical medical instrument, not an algorithm.

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

The "ground truth" here is the measured performance of the laser fibers (e.g., laser power delivery) compared to a predicate device. This is based on bench testing/empirical measurements of physical characteristics, not medical "ground truth" typically established in diagnostic studies.

8. The sample size for the training set:

Not applicable. This is a physical device, not a machine learning algorithm that requires a training set.

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

Not applicable. (See #8)

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Proflex™ Laser Fibers are intended for use in laser-based surgical applications including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary) and surgical procedures involving vaporization, ablation, hemostasis, excision, resection and incision and of soft and cartilaginous tissues. While designed primarily for holmium (Ho: YAG) lasers, ProFlex™ fibers may be used with any laser wavelength between 500nm and 2200mm that have been cleared for surgical use including, but not limited to frequency doubled Nd: YAG (KTP) lasers, argon lasers, alexandrite lasers, ruby lasers, dye lasers, Nd:YAG lasers and Tm:YAG lasers.

The ProFlex™ Laser Fibers are fiber optic energy delivery devices consisting of a stainless steel laser connector, e.g. SMA 905, an anodized aluminum expansion nut, strain relief, doubly step index clad optical fiber (fluoroacrylate over fluorine doped fused silica) with an ethylene tetrafluorethylene (ETFE, Tefzel™) protective jacket and are available in two fiber core diameters: 200µm & 273µm. The ProFlex™ Laser Fibers are equipped with laser launch overfill protection (spatial and angular) -- a protective, transmissive quartz ferrule, fused about the fiber input face and laser polished for high damage threshold (laser and physical), and ruggedized output tips designed for ease of transit in flexible ureteroscopes. All materials of construction are USP Class VI biocompatible and compatible with flash autoclave and EtO sterilization.

The given text is a 510(k) premarket notification for a medical device (ProFlex™ Laser Fibers). It describes the device, its intended use, technological characteristics, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in terms of clinical outcomes or diagnostic accuracy.

The "Performance Testing" section (page 7) briefly mentions:

• Bench and User Evaluation: "subject and predicate fibers were power tested in relaxed and strained (bending) configurations using a cleared surgical holmium laser."
• Results: "ProFlex™ Laser Fibers performed better than the predicate devices in all four cases... individually, on average and in consistency."
• OEM evaluation: "ProFlex has also been evaluated by one OEM holmium laser manufacturer and found to perform well."

However, this is bench testing of the device's physical properties (power transmission under stress), not a clinical study to establish diagnostic performance, human reader improvement, or stand-alone AI performance. The document focuses on demonstrating substantial equivalence to existing predicate devices based on materials, intended use, technological characteristics, and some performance characteristics (power output, damage resistance).

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving that the device meets those criteria, as the provided text does not contain the necessary details for a clinical performance or diagnostic accuracy study. It specifically states that "ProFlex™ Laser Fibers are as safe, as effective and perform as well as the predicate devices," which refers to technical and material performance, not a clinical trial with human subjects or an AI component.

To answer your prompt, the document would need to describe a study with a test set, ground truth, human readers (if applicable), and diagnostic metrics like accuracy, sensitivity, specificity, AUC, etc., along with predefined acceptance criteria for these metrics. This information is absent.

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