(121 days)
The Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus for cytological and histological analyses.
The Cytosponge™ Cell Collection Device is a non-sterile, single-use device. The Cytosponge™ Cell Collection Device consists of a clear, size 00 vegetable-material-derived capsule which holds a 30mm compressed spherical sponge inside of the capsule. The capsule containing the sponge is attached to a silicone-coated braided polyester suture. The suture is attached and secured to a retainer card via an ABS plug. The capsule is swallowed and dissolves in the stomach thereby releasing the self-expanding sponge. The sponge is then retrieved from the stomach using the attached suture. During the retrieval process, the sponge collects cells from the outer layer of esophageal tissue.
This document is a 510(k) Summary for the Cytosponge Cell Collection Device, not a study describing acceptance criteria and device performance. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics cannot be directly extracted from this document.
However, based on the provided text, I can infer the following:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with specific numerical targets. It broadly states that functional testing was performed.
| Acceptance Criteria (Inferred from testing mentioned) | Reported Device Performance (Inferred from "demonstrate performance equivalence") |
|---|---|
| Compression Capability | Met requirements, demonstrating performance equivalence to predicate. |
| Diameter Measurement Uniformity | Met requirements, demonstrating performance equivalence to predicate. |
| Laceration Resistance | Met requirements, demonstrating performance equivalence to predicate. |
| Dissolution Rate (of capsule) | Met requirements, demonstrating performance equivalence to predicate. |
| Tensile Strength (of suture) | Met requirements, demonstrating performance equivalence to predicate. |
| Biocompatibility | Met requirements, demonstrating performance equivalence to predicate. |
| Shelf Life | Met requirements, demonstrating performance equivalence to predicate. |
| User Validation (presumably ease of use/functionality) | Met requirements, demonstrating performance equivalence to predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document, as it describes a device for cell collection, not an AI or diagnostic imaging device that requires expert ground truth for interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided in the document. The document describes a physical medical device (cell collection device), not an algorithm requiring adjudicated interpretations for ground truth.
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
This information is not applicable/provided in the document. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided in the document. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the Cytosponge Cell Collection Device, the "ground truth" would relate to its ability to collect cells for cytological and histological analysis. The document states the device collects cells for these analyses, implying that the ultimate "ground truth" for the collected cells would be established by cytological and histological pathology performed on the collected samples. However, the study described in this document focuses on the performance equivalence of the device itself (e.g., dissolution, tensile strength), rather than a clinical outcome study using pathology as ground truth.
8. The sample size for the training set
This information is not applicable/provided in the document. This is not an AI/machine learning device that uses a training set.
9. How the ground truth for the training set was established
This information is not applicable/provided in the document. This is not an AI/machine learning device.
§ 874.4710 Esophagoscope (flexible or rigid) and accessories.
(a)
Identification. An esophagoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the esophagoscope and is intended to examine or treat esophageal malfunction symptoms, esophageal or mediastinal disease, or to remove foreign bodies from the esophagus. When inserted, the device extends from the area of the hypopharynx to the stomach. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.