(65 days)
The Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.
The subject device the 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 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 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
The provided text does not contain detailed acceptance criteria or a study that rigorously proves the device meets specific performance criteria in terms of diagnostic accuracy or clinical efficacy. The document is a 510(k) premarket notification for the Cytosponge Cell Collection Device, focusing on demonstrating substantial equivalence to predicate devices rather than clinical performance for diagnostic purposes.
Here's a breakdown of the information that is available and what is missing based on your request:
Missing Information (Crucial for answering most of your questions):
- Acceptance Criteria for Device Performance: The document does not define specific performance metrics like sensitivity, specificity, or accuracy that the device needs to meet for cell collection for diagnostic purposes. It only states the device's function: "collection and retrieval of surface cells in the esophagus."
- Study Proving Device Meets Acceptance Criteria: There is no detailed clinical study presented with a test set, ground truth, expert adjudication, or effectiveness measures for cell collection in a clinical diagnostic context.
- Sample Size for Test Set: Not applicable as no such diagnostic performance study is described.
- Data Provenance (Country, Retrospective/Prospective): Not applicable.
- Number of Experts & Qualifications: Not applicable.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: Not mentioned.
- Standalone Performance (Algorithm only): Not applicable, as this is a physical cell collection device, not an AI algorithm.
- Type of Ground Truth: Not applicable, as no diagnostic performance study is detailed.
- Sample Size for Training Set: Not applicable, as there's no machine learning algorithm being trained.
- How Ground Truth for Training Set was Established: Not applicable.
Information Available from the Text:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: The document implies "conformance to the requirements for its indications for use" and "substantial equivalence" to predicate devices. However, explicit quantitative acceptance criteria for diagnostic performance (e.g., cell yield percentage, detection rate of abnormalities) are not provided.
- Reported Device Performance: The document only mentions "Verification and Validation activity" which included:
- Animal testing to support the indication for use
- Biocompatibility testing
- Sterilization
- Packaging validation
- Shelf life testing
- User validation
- Bench performance testing:
- Suture length testing
- Dissolution testing (of the capsule)
- Sponge diameter testing
- Suture tensile testing
- Laceration testing
Table (Based on the limited information):
Acceptance Criterion (Implied/Tested Aspect) Reported Device Performance (Summary of Testing) Support for Indication for Use Animal testing conducted. Biocompatibility Biocompatibility testing conducted. Sterility Sterilization testing conducted. Packaging Integrity Packaging validation conducted. Shelf Life Shelf life testing conducted. User Acceptability User validation conducted. Suture Length Conformance Bench testing performed. Capsule Dissolution Dissolution testing performed. Sponge Diameter Conformance Sponge diameter testing performed. Suture Tensile Strength Suture tensile testing performed. Device Material Integrity (Laceration) Laceration testing performed. Clinical Diagnostic Performance Not specified in this document.
In summary, this 510(k) submission focuses on the safety and foundational functional aspects of the device and its substantial equivalence to previously approved devices, rather than a detailed clinical performance study for diagnostic accuracy, which would typically involve the criteria you've asked about (test set, ground truth, expert adjudication, etc.). The "animal testing to support the indication for use" is the closest mention to clinical data, but no specifics are provided regarding its design, results, or how it directly ties to acceptance criteria for diagnostic performance.
§ 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.