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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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The VAPORMAX II is intended for surgical use including: incision, vaporization, vaporization, in ablation, and coagulation of soft tissue.

The VAPORMAX II is indicated for use with any cleared Holmium:YAG 2.1 micrometer laser with a compatible connector for that laser's cleared indications for use.

The VAPORMAX II is a single use, disposable, side firing, fiber optic energy delivery device for use with cleared Holmium:YAG lasers.

The provided document K053457 describes a 510(k) premarket notification for the VAPORMAX™ II Side Firing Fiber. It explicitly states that no nonclinical data and no clinical tests were submitted. Instead, the device's substantial equivalence was established by comparing its technological characteristics to a predicate device. Therefore, a study demonstrating the device meets acceptance criteria as typically understood in a clinical or performance study context was not performed or submitted.

Here's a breakdown based on your requested information, highlighting what is not applicable due to the nature of this 510(k):

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and data provenance

• Test Set Sample Size: Not applicable. No test set was used for a performance study.
• Data Provenance: Not applicable. No clinical or non-clinical study data were provided.

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

• Not applicable. No test set was used, and therefore no ground truth was established by experts in the context of a performance study.

4. Adjudication method for the test set

• Not applicable. No test set was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of human improvement with vs. without AI assistance

• Not applicable. This device is a laser fiber and does not involve AI or human-in-the-loop performance measurement.

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

• Not applicable. This device is a laser fiber and does not involve an algorithm.

7. The type of ground truth used

• Not applicable. No ground truth in the context of a performance study was established. The "ground truth" for this 510(k) relies on the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

• Not applicable. This device is a physical medical device (laser fiber) and does not involve machine learning or a training set.

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

• Not applicable. No training set was used.

Summary of the Study (as presented in the 510(k)):

The "study" in this context is a substantial equivalence comparison to predicate devices, not a performance study with clinical or non-clinical data generation.

• Predicate Devices:

  • VAPORMAX™ Side Firing Fiber (K050412)
  • UROLASE® Right Angle Laser Fiber (K944204, K954597, K970422)

• Methodology: The submission relies on demonstrating that the VAPORMAX™ II Side Firing Fiber has the "same technological characteristics" and "intended use" as the predicate devices.

  • Technological Characteristics: The VAPORMAX™ II shares most of its design characteristics and all materials with its VAPORMAX™ predicate. It emits laser energy at an approximately 90-degree angle by way of direct reflection, like the UROLASE® predicate. This allows it to be used with up to 100 watts of laser power, consistent with its predicate.
  • Intended Use: The intended use for incision, excision, ablation, vaporization, and coagulation of soft tissue with cleared Holmium:YAG lasers is the same as for its predicates.

• Conclusion: Based on this comparison, it was concluded that the VAPORMAX™ II performs as intended and has acceptable mechanical properties when used in accordance with its labeling, implying that it is as safe and effective as the legally marketed predicate devices. No new performance data was generated to prove specific acceptance criteria for the new device itself.

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The VAPORMAX is intended for surgical use including: incision, excision, vaporization, ablation, and coagulation of soft tissue.

The VAPORMAX is indicated for use with any cleared Holmium:YAG 2.1 micrometer laser with a compatible connector for that laser's cleared indications for use.

The VAPORMAX is a single use, disposable, side firing, fiber optic energy delivery device for use with cleared Holmium:YAG lasers.

Due to the nature of the provided document, which is a 510(k) premarket notification summary for a medical device (VAPORMAX™ Side Firing Fiber), the information requested about acceptance criteria and a study proving the device meets those criteria is not present in the document.

Here's why and what can be extracted based on your request:

• No Acceptance Criteria or Performance Study: This document states explicitly in sections "VII. Nonclinical Data" and "VIII. Clinical Data" that "No nonclinical data were submitted in this Premarket Notification" and "No clinical tests were submitted in this Premarket Notification."
• Predicate Device Equivalence: The 510(k) process primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than submitting extensive de novo acceptance criteria and performance data for a new technology. The VAPORMAX™'s submission focuses on its technological characteristics (increased power handling) compared to existing Trimedyne side firing fibers and the Lumenis DUOTOME SIDELITE™.
• Intended Use Statement: The "Conclusions Drawn From Testing" (Section IX) simply states, "The VAPORMAX performs as intended and has acceptable mechanical properties when used in accordance with its labeling." This is a general statement, not a detailed report of specific performance metrics against defined acceptance criteria.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, experts, or ground truth as this information was not part of this 510(k) submission.

Summary based on available information:

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