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The Diagnostic Catheter System is intended for use as a sampling device by performing mini-bronchoalveolar lavage in adult patients undergoing mechanical ventilation in order to obtain lower respiratory tract samples for laboratory testing and diagnosis.

The Diagnostic Catheter System is a device that consists of an improved nonbronchoscopic Bronchoalveolar Lavage (BAL) catheter to be used for the blind retrieval of lower respiratory tract secretions (also know as mini-BAL).

The provided document is a 510(k) summary for the Cardinal Health Diagnostic Catheter System. It describes the device's intended use and the summary of technological characteristics compared to predicate devices. However, this document does not contain information on acceptance criteria for device performance, nor does it detail a study that proves the device meets specific performance criteria.

The document states:

• "Performance testing demonstrated that the proposed device is substantially equivalent to the currently marketed devices with regard to functional characteristics."
• "All materials used in the fabrication of the Diagnostic Catheter System were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 'Biological Evaluation of Medical Devices'. These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use."

This indicates that testing was performed to demonstrate substantial equivalence and material safety, but it does not provide:

1. A table of explicit acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds).
2. Reported device performance metrics against such criteria.
3. Details of a clinical or analytical study proving the device meets performance criteria beyond substantial equivalence to predicate devices.
4. Sample sizes for test sets or training sets.
5. Data provenance (country, retrospective/prospective).
6. Number or qualifications of experts for ground truth.
7. Adjudication methods.
8. MRMC comparative effectiveness study details.
9. Standalone performance details.
10. Type of ground truth_ used (expert consensus, pathology, outcomes data).
11. How ground truth for training data was established.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy or meeting specific performance criteria through extensive clinical trials as might be required for a PMA (Premarket Approval). The information provided is typical for a 510(k) submission, confirming design similarity, material compatibility, and functional equivalence but not specific performance metrics or detailed study results relevant to the requested questions.

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The COMBICATH Catheter Model 58216.27 is intended for use as a sampling tool by performing mini bronchoalvestar lavage in mechanically ventilated patients to obtain bronchoalveolar samples for laboratory testing and diagnosis.

The COMBICATH Catheter Models 58223.19, 58228.19, and 58229.19 are intended for use as sampling tools to capture protected distal bronchoalveolar samples from mechanically ventilated patients for laboratory testing and diagnosis.

The COMBICATH Catheter, is a radiopaque, double plugged, telescoping catheter designed to capture bronchoalveolar secretion samples in mechanically ventilated patients.

This 510(k) submission (K974642) is for a medical device called the COMBICATH Catheter, which is a physical device for sampling bronchoalveolar secretions, not an AI or software-driven diagnostic tool. Therefore, many of the requested categories related to AI performance metrics, ground truth establishment, expert adjudication, and comparative effectiveness studies are not applicable.

The performance described is purely related to functional and safety testing of a physical device.

Here's the relevant information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a quantitative "sample size" in terms of number of catheters or patients for the functional and safety testing. It mentions "examination of the function of the device under conditions similar to those found in normal usage and testing to ensure conformance to product specifications." The data provenance is not explicitly stated but implies testing conducted by the manufacturer, Plastimed Laboratoire Pharmaceutique, as part of their product development and regulatory submission. It is likely prospective testing related to device validation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This is a physical device. Ground truth as typically understood for diagnostic AI (e.g., presence or absence of a disease) is not relevant here. The "ground truth" during testing would be whether the device physically functioned as intended and met specifications.

4. Adjudication Method for the Test Set

Not applicable. This is a physical device. Adjudication methods are typically used for evaluating human or AI interpretations of data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is focused on the functional and safety performance of a physical sampling catheter, not on the interpretation of medical images or data.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

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

7. The Type of Ground Truth Used

The "ground truth" for this device's testing was its functional performance and adherence to engineering specifications. This includes successful capture of bronchoalveolar secretion samples, material compatibility, and overall device integrity during simulated use, as well as meeting manufacturing and design specifications.

8. The Sample Size for the Training Set

Not applicable. This device does not use a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

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The EMS SwISS LITHOCLAST LITHOTRIPTER is intended for use in fragmenting urinary tract calculi (renal, ureteral, and bladder) through rigid or semirigid endoscopes.

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Here's an analysis of the provided text regarding the acceptance criteria and study for the EMS SWISS LITHOCLAST LITHOTRIPTER, structured to address your specific points:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text for K963285 does not explicitly state numerical acceptance criteria (e.g., minimum success rate, stone-free rate, or complication rate thresholds). Instead, the reported device performance is framed in terms of substantial equivalence to predicate devices. This means the acceptance criteria are implicitly tied to the safety and effectiveness profiles of the cited predicate devices as reported in medical literature.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 83 kidneys
• Data Provenance:
  • Country of Origin: Not explicitly stated. The sponsor is Swiss (Electro Medical Systems SA, Switzerland), and the clinical study was conducted at "two investigational sites," but their locations are not provided.
  • Retrospective/Prospective: Retrospective clinical study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the given text. The study is described as a "clinical study of the results," suggesting that the outcomes were assessed by the clinicians at the investigational sites, but no details on their number or specific qualifications for establishing ground truth are given.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

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 of an MRMC study. This device is a medical instrument (lithotripter), not an AI-powered diagnostic or interpretive tool that would typically involve "human readers" or "AI assistance" in the way an MRMC study evaluates.

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

This refers to a standalone clinical study of the device's performance without the explicit comparison to human interpretation or AI.

• Yes, a standalone clinical study was done. The "retrospective clinical study of the results on 83 kidneys" represents the standalone performance evaluation of the EMS SWISS LITHOCLAST.

7. The Type of Ground Truth Used

The ground truth implicitly relates to the clinical outcomes of stone fragmentation and clearance, as assessed by the clinicians treating the patients. This would fall under outcomes data or clinical assessment of treatment success and safety. The text uses terms like "results," "safety," and "effectiveness," which are direct clinical outcome measures.

8. The Sample Size for the Training Set

This information is not applicable / not provided. This is a medical device, not an AI/machine learning model that typically requires a distinct "training set" in the computational sense. The "clinical study" evaluates the device's performance, not the training of an algorithm.

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. The concept of a "training set" and its "ground truth establishment" is not relevant to the evaluation of this type of medical device in the context described.

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The device is intended to allow blind, non-directed, protected specimen brush sampling of the lower respiratory tract secretions or to perform surveillance cultures or to diagnose pneumonia in patients receiving mechanical ventilation.

The subject device is sterile and consists of a flexible polymeric inner sheath which is contained within an outer sheath. Within the inner sheath is a twisted wire brush. The outer sheath is occluded with a polyethylene glycol wax plug. Upon use, the inner sheath is advanced, the plug expelled and the brush advanced to provide a sterile, non-contaminated specimen brush.

The provided text is a 510(k) summary for a medical device submitted in 1996. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information in a table or answer the specific questions about device performance studies, sample sizes, ground truth establishment, or expert involvement.

The 510(k) summary typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance study results with specific acceptance criteria that would be found in a modern clinical validation study. In 1996, the requirements for 510(k) submissions might have been different, and the information contained in this summary does not include the type of detailed performance data and study design requested in your prompt.

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