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This device is used to enter human gastrointestinal tract (stomach or duodenum) via endoscope to collect cells.

The main component of the proposed device is Brush Head, Outer Sheath, Sliding Handle, Thumb ring, Catheter and Steel Wire. The device is expected to use via endoscope to obtain cellular material from the human body. The main operation is move the Finger Ring back and forth to achieve the movement of Brush Head, and then the Brush Head can collect cells from the target site.

The proposed device has twenty-one (21) specifications, the main differences of these specifications are Diameter of Brush Head, Brush Length, Outer Sheath OD and Effective Length.

The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10 ° and placed in a sterility maintenance package to ensure a shelf life of 3 years.

The provided document is a 510(k) premarket notification letter and summary for a medical device called "Single Use Cytology Brush." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new device's safety and effectiveness through extensive clinical trials.

As such, the document does not describe a study proving the device meets acceptance criteria in the manner requested by your prompt (i.e., for an AI/ML-based medical device with performance metrics, ground truth, expert adjudication, etc.). Instead, it focuses on bench testing and an assessment of substantial equivalence.

Therefore, I cannot extract the information to fill your requested categories for acceptance criteria and a study that proves the device meets them in the context of an AI/ML device. However, I can explain what is presented in the document regarding the acceptance of this specific device.

Based on the provided text, here's what can be inferred about the acceptance process for the Single Use Cytology Brush:

The "acceptance criteria" here are fundamentally about demonstrating substantial equivalence to a predicate device (K172663). This is a regulatory pathway, not a performance study of an AI model.

No study proving device meets acceptance criteria in the AI/ML context was performed or described. Instead, the manufacturer performed bench tests to ensure the physical and operational characteristics of the device were comparable to the predicate.

Here's a breakdown of the information from the document related to "acceptance" of this device:

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of quantitative acceptance criteria for device performance with specific numerical targets like sensitivity/specificity for an AI model. Instead, it refers to regulatory and bench testing requirements.

• Appearance
• Dimension
• Operational performance |
  | Substantial Equivalence | Demonstrated to be "Substantially Equivalent (SE)" to the currently cleared predicate device (K172663) based on indications for use, technological characteristics (materials, design, configuration, packaging, fundamental technology, sterilization process), and safety and performance testing. |

2. Sample size used for the test set and the data provenance

The document does not specify sample sizes for the bench tests. It refers to general passing results without providing the number of units tested. This is not a data provenance in the sense of patient data; it's product testing.

• No mention of a "test set" in the context of patient data for an AI model.
• Sample size: Not specified for bench tests.
• Data provenance: Not applicable in the context of clinical data. The tests are performed on the device itself by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a physical medical instrument (cyto brush), not an AI algorithm. Ground truth (e.g., disease presence) is not established by experts for its performance in the way it would be for a diagnostic AI. Its "performance" refers to its physical capabilities and safety.

4. Adjudication method for the test set

Not applicable. There is no "adjudication" necessary for the physical properties and functional tests of a cytology brush.

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

Not applicable. This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for this device's acceptance is its ability to meet engineering specifications, adhere to ISO standards, and be substantially equivalent to a predicate physical device. There are no clinical "ground truth" labels like pathology for its clearance.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model, so there is no training set.

9. How the ground truth for the training set was established

Not applicable. There is no training set or clinical ground truth in the context of this 510(k) submission for a physical device.

Summary relevant to the document:

The provided 510(k) submission for the "Single Use Cytology Brush" demonstrates that the device is substantially equivalent to a predicate device (K172663). This equivalence is based on:

• Similar intended use (collecting cells from the GI tract via endoscope).
• Similar technological characteristics (materials, design, configuration, packaging, sterilization).
• Successful completion of non-clinical bench testing for appearance, dimension, and operational performance, which all yielded "passing" results.
• Compliance with relevant ISO standards for biological evaluation and sterilization.
• Crucially, Section 9 states: "Clinical Test is not applicable for the proposed device. No clinical study is included in this submission." This confirms that no human clinical performance study was conducted or required for this 510(k) clearance, and therefore, no data related to AI/ML performance on patient data, expert ground truth, or MRMC studies would be present.

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The cytology brush has been specifically designed to collect specimens or cells endoscopically for cytologic examination in conjunction with Olympus bronchoscopes with channel φ1.7mm or larger.

The single use cytology brush BC-205D has been designed to collect specimens or cells endoscopically for cytologic examination in conjunction with bronchoscopes. Identical to the predicate device, the subject device is inserted into bronchoscope channel to collect specimens with the brush which is equipped at the distal end of the subject device. Then users withdraw the subject device from bronchoscope channel and collect samples for cytology examination.

The provided document is a 510(k) summary for the Olympus Single Use Cytology Brush BC-205D, demonstrating its substantial equivalence to a predicate device. It focuses on the device's design, materials, and non-clinical performance, rather than a clinical study involving human patients or complex algorithms requiring extensive performance criteria.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone algorithm performance, training set details) are not applicable or cannot be extracted from this type of regulatory submission because the demonstrated substantial equivalence is primarily based on bench testing and material characteristics, not clinical performance against a complex diagnostic ground truth.

Here's a breakdown of what can be extracted and why other parts are not applicable:

1. A table of acceptance criteria and the reported device performance:

The document mentions several tests and standards applied, along with the statement "The technological differences between the predicate device and the subject device have been verified and validated by means of the following tests and standards to endorse the claims of substantial equivalence to the predicate device." However, it does not provide a specific table of quantitative acceptance criteria or detailed numerical results for each test. Instead, it lists the types of tests performed.

1. Brush operation with compatible endoscope
2. Dimension of each part of the brush
3. General durability
4. Joint/tensile strength
5. Package integrity. Implies successful meeting of performance criteria. |

2. Sample size used for the test set and the data provenance:

• Sample Size: The document does not specify the exact sample sizes (number of units) used for each individual bench test (e.g., durability, tensile strength). It only states that tests were performed.
• Data Provenance: The tests are "non-clinical testing" conducted by or for Olympus Medical Systems Corp. and Aomori Olympus Co., Ltd. (Japan). The specific location where the testing was physically conducted (e.g., country of origin of the data/testing) is not explicitly stated beyond the manufacturing location. These are laboratory/bench tests, not patient data.
• Retrospective or Prospective: Not applicable, as these are bench tests, not involving patient data or clinical follow-up.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. Ground truth, in the context of diagnostic device performance based on expert consensus, is not relevant here. The "ground truth" for the engineering and material tests is defined by the physical or chemical properties being measured (e.g., tensile strength, biocompatibility standards, dimensions).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. Adjudication methods are used in clinical studies with human readers/interpreters to establish a consensus ground truth. Here, the "truth" is determined by engineering test methods and established standards.

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:

• Not applicable. This is a physical medical device (cytology brush), not an AI/software algorithm.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a physical medical device; there is no "algorithm only" performance to evaluate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The "ground truth" for this device's performance is established by engineering and material standards, physical measurements, and biological compatibility tests. For example:
  • Dimensions: Met specified dimensions.
  • Strength/Durability: Passed defined stress tests (e.g., joint/tensile strength, general durability).
  • Biocompatibility: Demonstrated non-toxicity, non-irritation, non-hemolysis, etc., as per ISO 10993 series and USP standards.
  • Sterilization: Demonstrated effective sterilization and maintenance of sterility over shelf-life per ISO 11135 and ASTM F1980.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established:

• Not applicable. (See #8)

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