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The MDT Cell Recovery System™ (CRS) is an automated cytology brush for use with a rigid or flexible cystoscope in the collection and retrieval of cells for cytological evaluation.

The MDT Cell Recovery System™ (CRS) is an automated cytology brush for use with a rigid or flexible cystoscope in the collection and retrieval of cells for cytological evaluation. The brush, consisting of nylon bristles secured by twisted stainless steel wires fused and blunted at the tip, is attached to a nickel-titanium shaft and housed in a Teflon sheath. The brush and sheath are designed for single use with cystoscopes having a 6 French working channel. The brush diameter is 10 mm, the brush length is 6.4 mm, and the sheath is 156 cm long. This cytology brush is similar in size, features and components to other commercially available cytology brushes, including the previous CRS version, and has the same intended use. The CRS facilitates brushing of cells by automating the rotation of the cytology brush and aspiration of dislodged cells using a battery operated console coupled to the brush. The console is operated using a foot pedal for hands free operation. The operator can maneuver the brush to the desired location and initiate the brushing procedure as well as the sample retrieval into a 60 cc syringe.

This report, K965037, describes a medical device, the Cell Recovery System™ (CRS), and its substantial equivalence to a previously cleared version. However, it does not contain the kind of detailed information typically found in studies designed to establish acceptance criteria for a diagnostic device or an AI algorithm, nor does it provide performance data in the context of such criteria.

Specifically, the document focuses on the device's mechanical and operational aspects and its similarity to a previous version, rather than its performance in terms of diagnostic accuracy or effectiveness in collecting cells for cytological evaluation with defined performance metrics.

Therefore, for almost all of your requested categories, the information is not available in the provided text. I will indicate "Not applicable" or "Information not provided" for each point.

Acceptance Criteria and Study Information

Reported Device Performance: The document states: "Results from bench-top testing showed the modified CRS is substantially equivalent to the previous version of the CRS device cleared for marketing on March 20, 1996. These studies have demonstrated that the modified CRS features do not pose new safety questions when compared to the currently marketed CRS device." This is a statement of substantial equivalence regarding safety, not a performance metric for cell recovery or diagnostic accuracy. |
| 2. Sample size for the test set and data provenance | Information not provided. The "bench-top testing" mentioned is likely mechanical/functional testing, not clinical performance testing with patient samples. |
| 3. Number of experts and their qualifications | Not applicable, as this is not a study assessing diagnostic performance requiring expert interpretation of results. |
| 4. Adjudication method for the test set | Not applicable. |
| 5. MRMC comparative effectiveness study | Not applicable. This device is a cell collection system, not an AI or diagnostic algorithm that would be used in an MRMC study to compare reader performance with and without AI assistance. |
| 6. Standalone (algorithm only) performance study | Not applicable. This is a physical medical device, not a standalone algorithm. |
| 7. Type of ground truth used | Not applicable, as this is not a diagnostic performance study where ground truth (e.g., pathology, expert consensus) would be established for the interpretation of collected samples. The "ground truth" for the substantial equivalence claim would relate to the mechanical and safety features of the device itself. |
| 8. Sample size for the training set | Not applicable. This document describes a medical device, not a machine learning model, so there is no concept of a "training set" in the conventional sense. |
| 9. How the ground truth for the training set was established | Not applicable. |

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The MDT Cell Recovery System™ (CRS) is an automated cytology brush for use with a rigid or flexible cystoscope in the collection and retrieval cells for cytological evaluation.

The MDT Cell Recovery System™ (CRS) is an automated cytology brush for use with a rigid or flexible cystoscope in the collection and retrieval cells for cytological evaluation. The brush, consisting of nylon bristles secured by twisted stainless steel wires fused and blunted at the tip, is attached to a nickeltitanium shaft and housed in a Teflon sheath. The brush and sheath are designed for single use with cystoscopes having a 6 French working channel. The brush diameter is 10 mm, the brush is 6.4 mm, and the sheath is 156 cm long. This cytology brush is similar in size, features and components to other commercially available cytology brushes and has the same intended use.

The CRS facilitates brushing of cells by automating the rotation of the cytology brush and aspiration of dislodged cells using a battery operated console coupled to the brush. The console is operated using either hand switches or a foot pedal for hands free operation. By pre-selecting the rotation speced between 0-300 rpm the operator can maneuver the brush to the desired location and initiate the brushing procedure as well as the sample retrieval into a syringe using the foot pedal.

The provided text is a 510(k) summary for the Medical Device Technologies, Inc. Cell Recovery System™ (CRS), submitted in 1995. This document focuses on demonstrating substantial equivalence to existing devices and primarily discusses non-clinical studies and a clinical study with a similar prototype. Therefore, it does not contain the detailed information typically found in a clinical study report for specific acceptance criteria, performance metrics, sample sizes, expert qualifications, or comparative effectiveness studies of the final device as requested.

However, based on the information provided, here's what can be extracted and what is missing:

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

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics for the CRS device itself in a table format. The assessment is focused on showing safety and effectiveness by demonstrating substantial equivalence to existing manual cytology brushes and that the automated features do not pose new safety questions.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified for the CRS device. The document mentions "clinical studies with a similar prototype," but no details on sample size, data provenance, or study design are provided for these studies.
• Data Provenance: Not specified.

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 specified. The document refers to "cytological evaluation," which would imply an expert pathologist or cytotechnologist, but no details on their number or qualifications for any study are given.

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

• Not specified.

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, an MRMC comparative effectiveness study was not done. The CRS is a medical device for cell collection, not an AI-assisted diagnostic tool for human readers. The document focuses on the safety and effectiveness of the brushing mechanism itself, not on improving human diagnostic accuracy.

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

• Not applicable. The CRS is a physical device that automates a step in a human procedure (cytology brushing). It is not an algorithm, and its performance is always considered in the context of its use by an operator.

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

• The implicit ground truth for the effectiveness of cell collection would be the quality and diagnostic adequacy of the collected cells as determined by cytological evaluation (pathology). However, the document does not elaborate on how this was assessed or confirmed in any study.

8. The sample size for the training set

• Not applicable. The CRS is a physical device, not a machine learning algorithm that requires a training set. The "studies" mentioned would be engineering tests, biocompatibility tests, and clinical observations, not data used to train a model.

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

• Not applicable, as there is no training set for this type of device.

In summary: The provided 510(k) summary is a regulatory document focused on demonstrating substantial equivalence for a medical device. It attests to the safety and effectiveness based on non-clinical studies and a clinical study with a prototype, but it does not provide the detailed performance data, study methodologies, or expert qualifications that would be expected from a dedicated clinical study report for evaluating acceptance criteria in the manner requested. The device also predates common AI/ML diagnostic tools, so many of the questions related to AI studies are not applicable.

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