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The Invotec Laryngeal Electrodes are intended to be used as a sterile, single use, selfadhesive electrode attached to an endotracheal tube and positioned for continuous EMG monitoring of larynx during surgical procedure. This electrode is not to be adhesively attached to silicone endotracheal tubes.

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The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is an FDA 510(k) clearance letter for the Invotec Laryngeal Electrode, stating its substantial equivalence to legally marketed predicate devices. It lists the indications for use but does not include any performance metrics, study designs, sample sizes, or ground truth establishment relevant to the questions asked.

Therefore, I cannot provide the requested information based on the input text.

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The ClearView™ Endoscope Cover System is indicated as a one time use sterile jacket, placed over a medical Otolaryngology or Rhinological endoscope, during examination procedures, conducted by trained medical professional. It is designed and sized to fit on to specific manufactures' endoscope models.

Flexible Endoscope Barrier Sheath.

The provided text is a 510(k) premarket notification approval letter for the "Clearview Endoscope Cover" and does not contain detailed information about acceptance criteria or specific study results that prove the device meets such criteria. A 510(k) summary (which is a separate document typically submitted with the 510(k) application) would generally contain this type of performance data if it were required for substantial equivalence.

Based on the provided text, the device is a Flexible Endoscope Barrier Sheath (ClearView™ Endoscope Cover System). The FDA's letter indicates that they have reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices, meaning it does not require a full Premarket Approval (PMA). This type of approval often relies on demonstrating that the new device meets the same performance characteristics as an already approved predicate device, or that any differences do not raise new questions of safety and effectiveness.

Therefore, I cannot provide the requested information from the given text alone. The document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size for the test set or data provenance.
3. Number or qualifications of experts used for ground truth.
4. Adjudication method for the test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect sizes.
6. Information about a standalone (algorithm only) performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The letter explicitly states that the FDA "reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This implies that the application likely contained information (e.g., in a 510(k) summary) that demonstrated the device's performance, but those details are not present in this approval letter itself.

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Reconstruction of the sound conduction chain between the base of stapes and the tympanic membrane level by replacing the missing middle ear bones with a total implant in the sense of a tympanoplasty of type IIIC given an existing intact base of stapes with normal mobility and without luxation.

Titanium Ossicular Replacement System

The provided text is a 510(k) clearance letter from the FDA for the "Titanium Ossicular Replacement System." It indicates that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance, or any studies conducted.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, not on detailed performance evaluation against specific criteria or study results.

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THE INVOTEC CLEAN PAD may be used during any surgical procedure as an instrument wipe.

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The provided document is a 510(k) clearance letter from the FDA for a device called "Clean Pad." It indicates that the device has been found substantially equivalent to a predicate device and can be marketed. However, this document does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.

The letter is a regulatory approval document and does not detail the technical or clinical performance studies that might have been conducted to support the 510(k submission. Therefore, I cannot provide the requested information based on the given input.

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The Invotec Ear Tampon ( wick ) w/ string, is indicated for use as a ear packing for use after internal ear surgery. The packing is to be used in the ear canal as a surgical packing.

Invotec Ear Tampon (Wick) w/String

The provided documentation pertains to a 510(k) premarket notification for an Invotec Ear Tampon (Wick) w/String and does not contain information about acceptance criteria, device performance metrics, or study details typically associated with demonstrating performance against such criteria for a novel device, especially one involving AI or complex analytical methods.

The document is a letter from the FDA to Invotec International, Inc., confirming that their Ear Tampon (Wick) w/String is substantially equivalent to a legally marketed predicate device. This determination is based on the device's indications for use: "as an ear packing for use after internal ear surgery. The packing is to be used in the ear canal as a surgical packing."

Since this is a 510(k) clearance for a relatively simple medical device (an ear tampon/wick) where substantial equivalence to a predicate device is the basis for market clearance, a detailed study proving performance against specific acceptance criteria, as one would find for an AI-powered diagnostic device, is not presented or required in this type of regulatory submission. The focus is on demonstrating that the new device is as safe and effective as existing, similar devices.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies because this information is not part of the provided FDA 510(k) clearance letter.

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Ask a specific question about this device