(197 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 subject device Cytosponge™ Cell Collection Device is a sterile single-use device. The Cytosponge™ Cell Collection Device consists of a clear, size 00 vegetable-material-derived capsule, which holds a 30mm spherical sponge inside of the capsule. The capsule containing the sponge is attached to silicone-coated braided polyester suture. The suture is attached and secured to a retainer card via an ABS plug. The Cytosponge™ Cell Collection Device consists of a swallowable capsule, which dissolves in the stomach, releasing a self-expandable sponge. The sponge is then retrieved from the esophagus using an attached cord; during the retrieval process, the sponge collects cells from the outer layer of esophageal tissue
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device Name: Cytosponge™ Cell Collection Device
510(k) Number: K152794
This 510(k) submission is for an expanded indication and the addition of clinical information to the labeling, based on a Covidien clinical study. The device itself is technologically identical to the predicate device (K142695). Therefore, the study focuses on the effectiveness of the device in collecting adequate samples for cytological and histological analyses in a specific patient population (individuals with confirmed Barrett's esophagus).
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Adequate sample collection for cytological and histological analyses, defined by the presence of at least one group of columnar cells. (Target performance not explicitly stated as a numerical criterion, but the study aims to demonstrate high adequacy.) | - 64 out of 68 (94.1%) Cytosponge samples were sample adequate after one administration. |
- 66 out of 68 (97%) Cytosponge samples were sample adequate after two administrations. (Two of the four initial inadequate samples achieved adequacy upon repeat administration). |
2. Sample size used for the test set and the data provenance
- Sample Size: 68 subjects met the inclusion criteria for sample adequacy.
- Data Provenance:
- Country of Origin: Not explicitly stated, but the submission is from Covidien LLC, located in Mansfield, MA, USA, and FDA correspondence is to the US.
- Retrospective or Prospective: The text states, "In a Covidien sponsored post-market study," and describes it as an "investigation," implying a prospective study design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The study measures "sample adequacy" based on the presence of columnar cells, but it doesn't specify who made this determination, how many experts were involved, or their qualifications (e.g., pathologists, histotechnologists).
4. Adjudication method for the test set
This information is not provided in the document. Given that the ground truth establishment details are missing, the adjudication method for determining sample adequacy is also not 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
There is no indication that an MRMC comparative effectiveness study was done. This device is a cell collection device, not an AI-assisted diagnostic tool for image interpretation. The study evaluates the device's ability to collect adequate samples for subsequent cytological and histological analyses, which would then be performed by human experts.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No standalone performance study of an algorithm was done. This device is a physical tool for cell collection, not an AI or algorithmic diagnostic system. Its performance is measured by its ability to collect biological samples suitable for human laboratory analysis.
7. The type of ground truth used
The ground truth for the study was based on the presence of columnar cells in the collected samples, as determined through cytological or histological analyses (implied). Specifically, "an adequate sample was one in which at least one group of columnar cell was present. No minimal size was required for a group; a group of columnar cells can consist of two cells that are clearly columnar." This effectively serves as an expert consensus/pathology-derived ground truth for sample adequacy, though the exact process and experts are not detailed.
8. The sample size for the training set
This information is not applicable/not provided. This is a study evaluating the performance of a medical device for sample collection, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/not provided for the same reason as point 8.
§ 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.