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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.

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.

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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

• 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.

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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:

1. 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.

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