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1. EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT
   This implant is designed to aerate the attic and mastoid antrum following tympanomastoid surgery. This silastic implant is designed to be placed in the attic and back into the mastoid antrum following mastoidectomy/ tympanoplasty surgery. The narrow end is placed under the head of the malleus when present and back into the mastoid antrum to enhance mucosa regrowth.
2. EXMOOR MIDDLE EAR AERATION SHEETING
3. This implant is designed to reduce adhesions in the middle ear following tympanoplasty surgery.
4. Made with medical grade silicone, this implant was designed to be used following middle ear surgery to prevent middle ear adhesions, especially from the malleus to the promontory, or from the ear drum to the inner ear.

The devices are small, shaped pieces of silicone rubber sheet. They are intended for long term use, i.e. it is not necessary for this material to be removed.

The provided text describes a 510(k) premarket notification for the "Exmoor Attic and Mastoid Antrum Middle Ear Implant" and "Exmoor Middle Ear Aeration Sheeting." This regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study with specific acceptance criteria and detailed device performance results.

Therefore, the document does not contain the information needed to fill out a table of acceptance criteria and reported device performance or address most of the requested points.

Here's what can be extracted and what is missing:

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

• Not available. The document does not describe specific performance metrics, acceptance criteria, or the results of a study designed to meet such criteria. It primarily focuses on the device description, intended use, and comparison to a predicate device for substantial equivalence.

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

• Not available. No test set or data provenance is mentioned.

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

• Not available. No ground truth establishment is described.

4. Adjudication method for the test set:

• Not available. No adjudication method is described.

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 available. This device is a physical implant (silicone rubber sheeting), not an AI-assisted diagnostic tool. Therefore, an MRMC study with human readers and AI assistance would not be relevant.

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

• Not applicable/Not available. As mentioned above, this is a physical implant, not an algorithm.

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

• Not available. No ground truth information is provided as there's no diagnostic study described. The basis for approval is "substantial equivalence" to a predicate device already on the market.

8. The sample size for the training set:

• Not available. No training set is mentioned as this is not an AI/algorithmic device.

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

• Not available. No training set or ground truth establishment is described.

Summary of what is present in the document:

• Trade Name: Exmoor Attic and Mastoid Antrum Middle Ear Implant, Exmoor Middle Ear Aeration Sheeting
• Common Name: Attic and Mastoid, Aeration Sheeting
• Classification Name: Prosthesis, Ear, Internal
• Predicate Devices: Exmoor Plastics SRS/1, 510K number K911503/A
• Description of Device: Small, shaped pieces of silicone rubber sheet intended for long-term use.
• Intended Use:
  • Attic and Mastoid: Following tympano-mastoid surgery, placed into the attic and mastoid to improve aeration from the middle ear.
  • Aeration Sheeting: Following middle ear surgery (adhesion removal, tympanic membrane/ossicular chain reconstruction), inserted into the mouth of the eustachian tube, covering the promontory, under the handle of the malleus, and covering the middle ear, to reduce adhesions.
• Comparison with Predicate Devices: "All these devices are cut from exactly the same implantable silicone rubber sheeting as the Exmoor Plastics SRS/1." The convenience for the surgeon (saving time and material) is highlighted as the primary difference.
• Regulatory Outcome: Found "substantially equivalent" to predicate devices marketed prior to May 28, 1976.

In conclusion, the provided document is a 510(k) summary for a physical medical device. It focuses on regulatory approval through substantial equivalence, not on detailed performance studies against specific acceptance criteria.

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