(56 days)
KURZ Silicone Strips are placed over the tympanic membrane after surgical procedures in the middle ear to reduce the risk of adhesion to the surgical packing and to aid in the prevention of canal granulation and polyp formation.
KURZ Silicone Strips are designed to temporarily cover the tympanic membrane after surgical procedures in the middle ear.
KURZ Silicone Strips are manufactured from a medical grade silicone elastomer cut to size specifically for use within the external ear canal following ear surgery. The pliable, soft consistency of the silicone strips adapts itself to the shape of the auricular canal without further shaping by the physician, which saves valuable time in the operating room. KURZ Silicone Strips are intended for single use and are provided sterile. They require no further processing. They will be supplied transparent, white or transparent with blue stripes. Application, use and technical characteristics of the three presentations are identical. Choice of one or the other is entirely a matter of personal preference of the operating surgeon. Some surgeons prefer the transparent silicone strip, since the healing process can be checked without removing the dressing. Others prefer the white silicone strip, since they find it easier to see and handle. The transparent strips imprinted with blue stripes combine both advantages. The healing process can be observed through the transparent parts of the silicone, while the blue stripes make the silicone strips easily visible.
The provided document does not describe any acceptance criteria or the results of a study that proves the device meets specific performance criteria.
Instead, the document is a 510(k) Premarket Notification Summary for the KURZ Silicone Strips. This type of submission to the FDA focuses on demonstrating substantial equivalence to a previously legally marketed device (predicate device), rather than presenting new clinical study data with acceptance criteria for device performance.
Therefore, I cannot provide the requested information, as it is not present in the provided text.
Here's why the document doesn't contain the requested information:
- 510(k) Substantial Equivalence: The core of a 510(k) submission is to show that a new device is as safe and effective as another legally marketed device. This is typically done by comparing technological characteristics, intended use, and materials.
- No Clinical Performance Studies: For devices like these silicone strips (classified as Class II, Elastomer, Silicone Block), a detailed clinical performance study with acceptance criteria, sample sizes, expert ground truth, and statistical analysis is generally not required for 510(k) clearance. The comparison is primarily based on material properties, dimensions, and intended use as compared to the predicate.
- Biocompatibility Testing: The document mentions biocompatibility testing, but this is a safety test and not a performance study as would be described in terms of diagnostic accuracy or therapeutic efficacy with clear acceptance criteria for a device's functional performance.
To answer your specific points, this document indicates:
- A table of acceptance criteria and the reported device performance: Not present. The "SE COMPARISON TABLE" is for Substantial Equivalence comparison of characteristics, not performance criteria.
- Sample size used for the test set and the data provenance: Not applicable. No test set for performance evaluation is described.
- Number of experts used to establish the ground truth...: Not applicable. No ground truth for performance evaluation is described.
- Adjudication method: Not applicable. No performance study requiring adjudication is described.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. No such study is described.
- Standalone performance study: Not applicable. No standalone performance study is described.
- Type of ground truth used: Not applicable. No ground truth for performance evaluation is described.
- Sample size for the training set: Not applicable. There is no mention of a training set as this is not an AI/ML device or a device requiring such data.
- How the ground truth for the training set was established: Not applicable.
The document states that the KURZ Silicone Strips are substantially equivalent in function, performance and material to Silicone Elastomer Sheeting marketed by Specialty Surgical Products, Inc., K974653. This "substantial equivalence" is the primary "proof" for 510(k) clearance, not a performance study against specific acceptance criteria.
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.