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The family of "THD disposable Anoscope/Proctoscope" is intended for physician use to examine the anal sphincter, anus, rectum, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

The family of "THD disposable Anoscope/Proctoscope" are designed for examination and treatment of the anal (Anoscope) and recture (Proctoscope) examination and consists of transparent plastic disposable anoscopes and proctoscopes in sterile and non sterile conditions, for diagnostic or therapeutic use. The family of THD disposable Anoscopes and Proctoscopes is made by 2 categories of devices: Diagnostic Anoscopes and Proctoscopes, Surgical Proctoscopes. Illumination is provided by a PenLight or by the "Shining Light" illuminator both supplied and manufactured by THD Spa. A PenLight is a battery powered illuminator while the "Shining Light" is AC powered. Both of these accessories are light sources employed to optimize the use of the anoscopes and proctoscopes.

The provided text is a 510(k) summary for a medical device, the "THD disposable Anoscope/Proctoscope." This type of document is filed with the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than to prove device performance against specific acceptance criteria through a clinical study or direct performance testing.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets them.

Specifically, the document does not provide:

• A table of acceptance criteria and reported device performance.
• Sample sizes for a test set, data provenance, number of experts for ground truth, or adjudication methods for performance evaluation.
• Information about a multi-reader multi-case (MRMC) comparative effectiveness study or any effect sizes of AI assistance.
• Details on standalone algorithm performance.
• The type of ground truth used for performance evaluation.
• Sample size for a training set or how ground truth for a training set was established, as this is not an AI/ML device.

Instead, the document focuses on:

• Substantial Equivalence: The core of this 510(k) is to demonstrate that the "THD disposable Anoscope/Proctoscope" is substantially equivalent to existing predicate devices (Sapimed Self Light Disposable Anoscope K070913 and Sapimed Disposable Sigmoidoscope/Proctoscope K070915). This is a regulatory pathway that relies on showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness as the predicate device.
• Device Description: It describes the device's components, variations (diagnostic vs. surgical), and illumination methods.
• Indications for Use: Clearly states the intended purpose for examining the anal sphincter, anus, rectum, and for diagnostic/therapeutic procedures.
• Supporting evidence for safety and identity:
  • Shelf Life: Accelerated aging testing was performed to substantiate a 5-year expiration date. (This is a form of performance testing, but not directly related to accuracy or clinical effectiveness in the way an AI would be evaluated).
  • Biocompatibility: The devices are compliant with ISO10993 standards. (This is safety testing, not performance criteria for a diagnostic/therapeutic outcome).

In summary, the provided text is a regulatory submission demonstrating substantial equivalence based on device characteristics, intended use, and safety standards, not a performance study as you've outlined for an AI/ML or diagnostic device.

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