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Any surgical procedure within the nasal cavity, the oral cavity or the oropharynx, which requires laser surgery and suction capability to remove smoke.

This device is constructed from an Exmoor Single Use Suction Tube (MP17291), 510K 892504, a piece of stainless steel needle tubing (MP170288) identical to that used in MP170291, covered by the same 510K 892504, and a piece of silicone rubber tubing (MP180163) which is used to hold the two pieces of stainless steel tubing together in the correct position. It uses locally supplied suction tubing to connect the device to suction by pushing the tubing over the ball feature at the proximal end of the handle. The laser fibre is passed down the exposed end of the stainless steel tubing adjacent to the handle until it emerges from the distal end. The laser fibre protruding from the distal end of the instrument should be stripped and cleaved and adjusted to the required length.

The provided document is a 510(k) premarket notification for a medical device called "Dilkes Laser/Suction Cannulae". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, the information requested in your prompt regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is generally not part of a 510(k) submission unless there are specific performance claims that require such data.

Based on the provided text, I can extract the following relevant information and infer the absence of the requested study details:

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

The document does not specify quantitative acceptance criteria or a formal study reporting direct device performance metrics against such criteria. The basis for clearance is substantial equivalence to predicate devices. The implicit "acceptance criterion" is that the device is as safe and effective as the predicate devices for its intended use.

2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

These points are not applicable to this 510(k) submission. A 510(k) mainly relies on a comparison of technological characteristics, materials, and intended use with existing legally marketed devices, rather than a clinical trial demonstrating performance against specific metrics or involving human readers/AI. There is no mention of a clinical study, test set, ground truth experts, or comparative effectiveness.

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

As no clinical study is described, there is no "ground truth" established in this context. The demonstration of safety and effectiveness relies on the comparison with predicate devices.

8. The sample size for the training set

This is not applicable. The device is not an AI/ML algorithm that requires a training set.

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

This is not applicable. The device is not an AI/ML algorithm that requires a training set with established ground truth.

Summary of what the document does provide regarding the device and its clearance:

• Device Name: Dilkes Laser/Suction Cannulae
• Intended Use: Any surgical procedure within the nasal cavity, the oral cavity or the oropharynx, which requires laser surgery and suction capability to remove smoke.
• Predicate Devices:
  1. House Suction/Irrigation Tube 55-0207, manufactured by Richards
  2. Microstat hand-piece from Laserscope
• Comparison with Predicate Devices (Basis for Substantial Equivalence):
  • Size of the Dilkes Laser/Suction Cannulae is very similar to the House Suction/Irrigation Tube.
  • One predicate device (Microstat hand-piece) is currently being used for suction/Laser delivery, implying the combined function is already marketed.
  • Materials are similar (stainless steel in both cases).
  • The handle of the subject device is polyethylene (single-use), while the predicate is re-usable, which is a material difference but likely considered acceptable for a single-use device.
• Regulatory Outcome: The FDA determined the device is substantially equivalent to legally marketed predicate devices for its stated indications for use, allowing it to be marketed.

In essence, the "study" demonstrating this device meets criteria is a substantially equivalent comparison to existing devices, not a clinical performance study with quantitative acceptance criteria.

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