(83 days)
The EsoCheck Cell Collection Device is indicated for use in the collection and retrieval of surface cells of the esophagus in the general population of adults and adolescents, 12 years of age and older.
The EsoCheck Cell Collection Device is a sterile single-use disposable non-endoscopic balloon capsule catheter designed to collect and retrieve surface cells of the esophaqus. The balloon capsule is attached to a catheter and swallowed with the balloon deflated and inverted. Once positioned, the balloon is inflated and withdrawn allowing its textured surface to swab the surface of the targeted segment of the esophagus, retrieving cells in the process. The balloon is then deflated, retracting it along with the retrieved cells on its surface into the capsule, where they are protected from dilution or contamination as the capsule is fully withdrawn from the patient. The balloon is cut from the capsule and placed in the desired specimen container. The specimen is then sent for diagnostic processing and analysis.
The provided text describes the EsoCheck Cell Collection Device, but it does not contain specific acceptance criteria or performance metrics in a table format, nor does it detail a study that defines such criteria and measures the device's performance against them.
The "Performance Data" section in the document refers to a GLP animal study that supported the expansion of the device's indications for use to include adolescents. However, this study focused on safety (successful esophageal deployment and no significant injuries) rather than specific performance metrics like sensitivity, specificity, or cell collection efficiency which would typically be associated with acceptance criteria for such a device.
Here's an analysis based on the information provided, and what is missing:
1. A table of acceptance criteria and the reported device performance
- Missing. The document does not provide a table with acceptance criteria or quantitative performance metrics for cell collection, diagnostic accuracy, or similar. The "performance data" discussed is related to safety for expanded use in adolescents.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- The only study mentioned is a GLP animal study in a porcine model.
- Sample size: Not specified.
- Data provenance: Prospective (animal study).
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)
- Not applicable. The animal study was for safety (lack of injury), not for establishing diagnostic ground truth requiring expert interpretation of collected samples.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. The animal study focused on physical outcomes (esophageal deployment, injury assessment), not diagnostic interpretation requiring adjudication methods.
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
- No. This device is a cell collection device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This device does not have an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the animal study related to the expanded indication, the "ground truth" was the absence of significant injuries and successful deployment observed during evaluations after the procedure. This would be based on direct veterinary assessment or pathological examination of the animal tissues.
8. The sample size for the training set
- Not applicable. The device is a physical cell collection device; there is no mention of a training set for an algorithm.
9. How the ground truth for the training set was established
- Not applicable. (No training set for an algorithm).
Summary of what is available regarding performance for the expanded indication:
The document states: "The animal study found that the EsoCheck Cell Collection Devices demonstrated successful esophageal deployment, and evaluations after the EsoCheck procedure found no significant injuries in the test population." This is the reported performance for the specifically mentioned study designed to support the expanded indication for adolescents. It focuses on the safety and mechanical functionality in an adolescent-representative model.
§ 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.