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The ADI Sensinel CPM (Cardiopulmonary Management) System is a wireless remote monitoring system intended for use by healthcare professionals for spot checking of physiological data in home and healthcare settings. This can include:

• ECG

• · Heart Auscultation Sounds
• · Skin Temperature
• · Thoracic Impedance (including Changes in Thoracic Impedance)
• · Respiration Rate and relative changes in Tidal Volume
  · Heart Rate
• Diastolic Heart Sounds Strength
• · Body Posture (including Tilt Angle)

Data are transmitted wirelessly from the ADI CPM (Cardiopulmonary Management) Wearable and Base Station for storage and analysis. The device is intended for use on general care adult patients who are 18 years of age or older to provide physiological information. The data from the ADI CPM (Cardiopulmonary Management) System Platform are intended for use by healthcare professional as an aid to diagnosis and treatment.

The ADI CPM System is intended to be used by patients at rest and not performing any activities or movements. This system is for spot checking and does not have continuous monitoring capability. The device does not produce alarms and is not intended for active patient monitoring (real-time).

The ADI CPM System in contraindicated for those patients with life threatening arrhythmias requiring immediate medical intervention.

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The provided FDA 510(k) clearance letter and Indications for Use document for the Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) do not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.

This document primarily states that the device has been found substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements and indications for use. It does not include performance data, study designs, sample sizes, ground truth methodologies, or expert qualifications.

To answer your request, the following information would typically be found in the 510(k) submission's technical documentation (e.g., performance testing details, clinical study reports), which is not included in the provided text.

Therefore, I cannot extract the information required for the detailed answer as it is not present in the given text.

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The Sensititre 20 - 24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System is an in vitro diagnositic product for clinical susceptibility testing of fastidious isolates. This 510(k) is for Ceftolozane-tazobactam in the dilution range of 0.03/4 - 64/4 µg/ml for testing H. influenzae on the Sensitite 20 - 24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System. Ceftolozane-tazobactam has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Haemophilus influenzae

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This FDA 510(k) clearance letter pertains to an in vitro diagnostic (IVD) device, specifically an antimicrobial susceptibility testing system. The questions you've posed (acceptance criteria, study design, ground truth, MRMC, etc.) are highly relevant to the evaluation of AI/ML-driven medical devices, particularly those that interpret images or other complex data to provide a diagnosis or assist in clinical decision-making.

However, the provided text does not contain the detailed study information required to answer your questions. This document is a clearance letter, stating that the Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Ceftolozane-tazobactam has been found substantially equivalent to a predicate device.

Here's why the information is not present in this document:

• Type of Device: This is a microbiology susceptibility testing system, not an AI/ML image interpretation device. While it's an IVD, its function is to determine the minimum inhibitory concentration (MIC) or breakpoint susceptibility of an antibiotic against specific bacteria. This is typically done through a standardized laboratory process (e.g., microdilution) where the growth or inhibition of bacteria is observed, not through complex image analysis or AI algorithms in the way you're inferring.
• 510(k) Process: For traditional IVD devices like this, substantial equivalence is often demonstrated by showing the new device performs comparably to a legally marketed predicate device using established laboratory methods. The detailed performance data, including acceptance criteria and study results, would be submitted in the 510(k) application itself, but not typically summarized in the public clearance letter.
• Lack of AI/ML Component: There is no mention of AI or machine learning in the device description. Therefore, concepts like "human readers," "AI assistance," "effect size," "standalone algorithm," "training set," or "adjudication methods" for image interpretation are not applicable to the Sensititre system as described here.

To answer your questions accurately, one would need access to the actual 510(k) submission (K232310) which is often not publicly available in its entirety, or more specifically, the performance data section of that submission.

For illustrative purposes, if this were an AI/ML imaging device, a typical response addressing your questions would look like this (but again, the provided text does not support this):

Hypothetical Example (if this were an AI/ML imaging device and the information was available):

(Disclaimer: The following is entirely hypothetical and fabricated to demonstrate how your questions would be answered if the provided document were about an AI/ML medical device and contained the necessary study details. This information is NOT present in the provided FDA 510(k) clearance letter.)

The device is an AI-powered system designed to assist radiologists in detecting subtle findings on chest X-rays.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: 5,000 anonymized chest X-ray images (DICOM format).
• Data Provenance: Retrospective study. Data collected from 10 different hospitals across the United States (70%), Canada (15%), and the UK (15%). Images covered a range of scanner types and patient demographics.

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

• Number of Experts: 3 independent expert radiologists.
• Qualifications: All were board-certified radiologists with subspecialty training in thoracic imaging and a minimum of 10 years of post-fellowship clinical experience reading chest X-rays.

4. Adjudication Method for the Test Set

• Adjudication Method: 2+1. Two independent expert radiologists initially reviewed each case. If their initial assessments disagreed, a third, senior expert radiologist reviewed the case to reach a consensus for the final ground truth label.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improving with AI vs. Without AI Assistance

• MRMC Study: Yes, an MRMC study was conducted.
• Effect Size:
  • Sensitivity: Human readers demonstrated a statistically significant increase in sensitivity of 7.2 percentage points (e.g., from 78.0% unaided to 85.2% with AI assistance) for detecting actionable findings.
  • Specificity: No statistically significant change in specificity was observed, indicating the AI assistance did not lead to a significant increase in false positives.
  • Reading Time: Average reading time per case decreased by 15% with AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: Yes, standalone performance was evaluated against the ground truth.
  • Sensitivity: 92.5%
  • Specificity: 83.2%
  • AUC: 0.94 (Receiver Operating Characteristic Area Under the Curve)

7. The Type of Ground Truth Used

• Ground Truth Type: Expert consensus of 3 board-certified thoracic radiologists, further supported by correlation with available clinical outcomes data (e.g., follow-up imaging, pathology reports, surgical findings) where applicable and available in the retrospective dataset.

8. The Sample Size for the Training Set

• Training Set Sample Size: 50,000 anonymized chest X-ray images.

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

• Ground Truth for Training:
  • Initial labeling was performed by a team of trained clinical annotators.
  • A subset of 10% of the training data was reviewed and verified by a single board-certified radiologist to ensure labeling consistency and accuracy.
  • For particularly challenging or ambiguous cases during annotation, an internal consensus review by two radiologists was performed.
  • A semi-supervised learning approach was employed where initial labels were used for training, and the model's performance on a validation set guided further expert review and refinement of labels for challenging cases.

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The Sensis Vibe Hemo (VD15B) and Sensis Vibe Combo (VD15B) recording systems are intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or electrophysiology studies, for cardiac as well as interventional radiology and surgical studies. The system is equipped with modules, enabling various configurations ranging from a standalone acquisition unit with limited administrative functionality to multiunit installations with a common database and satellite workstations accessing the administrative tools.

The device is intended to be used on either or both of the following populations:

1. Adult and pediatric populations requiring electrophysiology examinations, typically when the patient is suffering from cardiac arrhythmias.
2. Adult and pediatric populations requiring hemodynamic examinations, typically when the patient has a heart or vascular disease resulting in insufficient hemodynamic functionality.

SIEMENS Medical Solutions USA. Inc. intends to market the Sensis Vibe Hemo (VD15B) and Sensis Vibe Combo (VD15B), a hemodynamic and electrophysiological recording system. This 510(k) submission describes modifications to the previously cleared Primary Predicate Device the Sensis (K150493). Sensis Vibe Hemo (VD15B) and Sensis Vibe Combo (VD15B) is a multi-channel computer-based stationary system for the measurement, display, and printout of bio-physiological events. There are two configurations for this device: Sensis Vibe-Hemo and Sensis Vibe Combo.

Hemodynamic and electrophysiologic signals such as intracardiac pressure, ECG signals, and intracardiac electrograms (ICEG) are measured and displayed by the system; several hemodynamic calculations are performed based on the measured values of the input signals. These data can be recorded in real-time and stored on removable media or in a digital DICOM archive.

The Sensis Vibe Hemo (VD15B) and Sensis Vibe Combo (VD15B) system is comprised of the following basic hardware components: a small cabinet (video distribution box), front-end electronics, a keyboard with a mouse, and master and slave monitor(s) for real-time presentation of ECG tracings and pressure and ICEG waveforms. The small cabinet (video distribution box) contains power distribution electronics, video drivers, and a separation device for electrical isolation between the small cabinet and the signal input box. The front-end electronics contain modules for the acquisition of invasive blood pressure, ECG, SpO2, CO, and optionally ICEG and NBP, and are normally stalled at the operating table.

The Siemens Medical Solutions USA Inc. Sensis Vibe Hemo (VD15B) and Sensis Vibe Combo (VD15B) are electrophysiological and hemodynamic recording systems. The acceptance criteria and the study proving the device meets these criteria are detailed below. It's important to note that the provided document outlines conformity to standards and non-clinical performance testing for specific modifications to an existing cleared device (Sensis K150493) rather than a comprehensive de novo clinical study for the entire system.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document primarily describes non-clinical bench testing for the modifications made to the device.

• DFR™ Bench Test Study: DFR indices obtained from Sensis Vibe Hemo (VD15B) and Sensis Vibe Combo (VD15B) were compared with DFR indices obtained from a previous bench test study performed and submitted for iLab Polaris-Modality Guidance System (K191008).
• Other Testing: General "verification and validation testing," "non-clinical tests," and "software documentation" were performed. No specific sample sizes for clinical data sets are mentioned, as the focus is on a substantial equivalence claim based on modifications and adherence to standards.
• Data Provenance: The data provenance for the DFR™ comparison is a prior bench test study. For other aspects, it is internal company testing and validation processes. No mention of country of origin for specific test data is provided. Given it's premarket notification, it's likely internal development and testing data.

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

The document does not specify the number or qualifications of experts used to establish ground truth for this submission, as it relies heavily on bench testing and reference to prior clearances. For the DFR™ comparison, the "ground truth" is essentially the established performance of the legally marketed predicate device (iLab Polaris).

4. Adjudication Method for the Test Set:

Given that the testing described is primarily non-clinical bench testing, there is no mention of an adjudication method (e.g., 2+1, 3+1). Such methods are typically used in clinical studies involving interpretation by multiple readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not described in this submission. The device is a "programmable diagnostic computer" intended as a "diagnostic and administrative tool," not an AI-assisted diagnostic aid that directly improves human reader performance in interpreting medical images or signals. Its function is to measure, display, and record bio-physiological events and perform calculations like DFR™.

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

The description of the device and its testing suggests that it functions as a standalone system (algorithm/hardware only) for measuring, displaying, and recording physiological data, and performing calculations like DFR™. The DFR™ bench test compared the device's output numerically to that of a predicate device, indicating a standalone performance evaluation of this specific function.

7. The Type of Ground Truth Used:

For the DFR™ assessment modification, the ground truth relied upon was the numerical output and algorithm of a legally marketed predicate device (iLab Polaris-Modality Guidance System). For other aspects (temperature display, software, etc.), the "ground truth" is adherence to established engineering specifications, safety standards, and performance benchmarks as determined by internal verification and validation processes. There is no mention of pathology or outcomes data as ground truth for this submission.

8. The Sample Size for the Training Set:

The document does not provide information on the sample size for a training set. The submission focuses on modifications to an existing device, which implies that core algorithms have likely been developed and validated previously. The new DFR™ functionality appears to be a direct implementation of an existing, cleared algorithm from a predicate device, rather than a novel AI model requiring a new training set.

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

As no specific training set is mentioned for the modifications, the document does not describe how ground truth for any training set was established.

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The Sensitite 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MC or Breakpoint System is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates.

This 510(k) is for dalbavancin in the dilution range of 0.0005 - 2ug/ml with new FDA breakpoints for testing fastidious Streptococus spp. on the Sensitite 20 - 24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System.

Dalbavancin has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Streptococcus agalactiae Streptococcus pyogenes Streptococcus anginosus group (S. anginosus, S. constellatus and S. intermedius)

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The provided text describes a 510(k) premarket notification for a medical device and includes the Indications for Use, but it does not contain the detailed study information required to answer your specific questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement.

The document is a clearance letter from the FDA, confirming that the device (Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin) is substantially equivalent to a legally marketed predicate device. While this letter refers to the device and its intended use, it does not provide the technical details of the validation studies.

Therefore, I cannot provide the requested information from the given text. To answer your questions, one would need to review the actual 510(k) summary document or the underlying clinical/performance study reports that were submitted to the FDA for review.

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The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious isolates.

This 510(k) is for Sulbactam in the dilution range of 0.015/4-32/4 ug/mL for testing non-fasidious Gram negative organisms on the Sensititre 18 - 24 hour MIC panel.

Sulbactam-durlobactam has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label:

Acinetobacter baumannii-calcoaceticus complex

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This is a 510(k) clearance letter for an antimicrobial susceptibility test (AST) system. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the way typically seen for AI/ML-based medical devices. The document is a regulatory approval for a laboratory diagnostic product, specifically for testing the susceptibility of certain bacteria to a new antibiotic combination (Sulbactam-durlobactam).

The type of "performance" for such a device is related to its accuracy in determining minimum inhibitory concentrations (MICs) or breakpoints, and its ability to correctly classify bacteria as susceptible, intermediate, or resistant to the antibiotic.

Here's how I can address your request based on the provided text, while also noting what is not present:

A. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific acceptance criteria or a detailed performance table for the Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam.

For this type of device (Antimicrobial Susceptibility Test), acceptance criteria typically involve:

• Essential Agreement (EA): The percentage of MIC values that are within ±1 doubling dilution of a reference method.
• Category Agreement (CA): The percentage of isolates that are categorized identically (Susceptible, Intermediate, or Resistant) by the test system and the reference method.
• Major Errors (ME): When the test system reports an isolate as Susceptible when the reference method reports it as Resistant.
• Very Major Errors (VME): When the test system reports an isolate as Resistant when the reference method reports it as Susceptible.

Regulatory guidance for AST devices usually sets specific thresholds for these metrics (e.g., >90% EA, >90% CA, <3% ME, <1.5% VME). However, these specifics are not in the provided document. The document is the FDA's clearance letter, not the detailed submission itself.

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

The provided text does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). For an AST device, this would typically involve a collection of clinical bacterial isolates and challenge isolates tested against a reference method.

C. Number of Experts Used to Establish Ground Truth and Qualifications

The provided text does not mention experts or their qualifications for establishing ground truth. For AST devices, the "ground truth" is typically established by:

• A reference AST method, such as broth microdilution, performed by trained microbiologists.
• Concordance with CDC or CLSI guidelines for interpreting MIC values.

D. Adjudication Method

The provided text does not mention an adjudication method. This is common for AST devices, as the reference method typically provides the definitive result without requiring expert adjudication in the same way as an imaging AI product.

E. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this device. MRMC studies are typically used for imaging AI products to assess how AI assistance impacts human reader performance (e.g., radiologists interpreting images). This device is a diagnostic test kit for antimicrobial susceptibility, not an AI imaging tool. Therefore, there is no discussion of human readers improving with or without AI assistance.

F. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The concept of a "standalone algorithm" is not directly applicable in the same way it would be for an AI/ML device. For an AST system, the "standalone performance" refers to the accuracy of the test panel itself in determining MICs or breakpoints when compared to a gold standard reference method.

The FDA clearance implies that such performance data was submitted and found acceptable, demonstrating the system's ability to accurately determine susceptibility to Sulbactam-durlobactam for the specified organisms. However, the details of this study (e.g., specific metrics like EA, CA, ME, VME) are not included in this clearance letter.

G. Type of Ground Truth Used

The ground truth for this type of device (Antimicrobial Susceptibility Test) would typically be established by a broth microdilution reference method or another CLSI-standardized AST method, along with established clinical breakpoints or interpretive criteria. The FDA drug label for Sulbactam-durlobactam would also provide essential information on activity against specific organisms. The document states: "Sulbactam-durlobactam has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Acinetobacter baumannii-calcoaceticus complex." This implicitly references established in-vitro and clinical data as part of the ground truth.

H. Sample Size for the Training Set

The provided text does not contain information about a "training set" sample size. This term is primarily relevant for AI/ML devices that learn from data. An AST system is a chemical and biological assay, not a machine learning model, so there isn't a "training set" in the AI sense.

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

As there is no "training set" in the AI/ML sense for this type of device, this question is not applicable and therefore, no information is provided on how its ground truth was established.

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The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae MC or Breakpoint System is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates.

This 510(k) is for Imipenem-relebactam in the dilution range of 0.03/4-128/4 ug/ml for testing fastidious Haemophilus influenzae on the Sensitite 20 - 24 hour Haemophilus influenzae/Streptoccus pneumoniae MIC or Breakpoint Susceptibility System.

Imipenem-relebactam has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label:

Haemophilus influenzae

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The provided text describes a 510(k) premarket notification for a medical device called the "Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam". This device is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates, specifically focusing on Imipenem-relebactam for Haemophilus influenzae.

However, the provided document is a regulatory approval letter and indications for use statement. It does not contain any information regarding the acceptance criteria, study details, performance data, sample sizes, ground truth establishment, or expert qualifications that would be required to answer your specific questions about the device's performance and the study that proves it meets acceptance criteria.

To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a detailed test report.

Therefore, I cannot provide the requested table or information regarding the study.

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The Sensititre 20 - 24-hour Haemophilus influenzae Streptococcus pneumoniae MIC or Break is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates. This 510(k) is for Delafloxacin in the dilution range of 0.00025-8 ug/ml for testing fastidious Streptococcus spp., (including S. pneumoniae) and delafloxacin in the dilution range of 0.000125 - 8 ug/mL for testing H. influenzae on the Sensititre 20 - 24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System. Delafloxacin has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: For Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Streptococcus pyogenes Streptococcus agalactiae Streptococcus anginosus grp. For Community Acquired Bacterial Pneumonia (CABP) Streptococcus pneumoniae Haemophilus influenzae

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The provide FDA 510(k) summary does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the requested format.

The document is a clearance letter for a medical device (Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin), indicating it has been deemed substantially equivalent to a predicate device. While it mentions the device's intended use and the specific drug for susceptibility testing, it does not include the specifics of the performance study.

Typically, such information (acceptance criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and training set details) would be explicitly laid out in the 510(k) summary submitted by the manufacturer to the FDA. The provided text is the FDA's response to that submission and does not detail the underlying studies.

Therefore, I cannot provide the answer in the requested format based on the given input.

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The Sensititre YeastOne Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of Candida spp. This 510(k) is for Fluconazole with new FDA breakpoints and indications for testing Candida spp. on the Sensititre YeastOne Susceptibility System. Fluconazole has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Candida albicans Candida glabrata Candida parapsilosis

The Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL

This document is a 510(k) clearance letter for the Sensititre YeastOne Susceptibility System with Fluconazole. It does not contain the detailed study information (acceptance criteria, device performance, sample sizes, expert qualifications, etc.) that you are requesting.

The letter primarily:

• Confirms that the device is substantially equivalent to a legally marketed predicate device.
• States the regulation number, regulation name, and product code.
• Outlines the general controls provisions of the Act that the manufacturer must comply with.
• Specifies the Indications for Use for the device, listing the Candida species against which Fluconazole has shown activity.

To obtain the information regarding acceptance criteria and the study proving the device meets those criteria, one would typically need to refer to the 510(k) summary or the full 510(k) submission for K221198, which are usually more detailed technical documents. These documents are often publicly available via the FDA's 510(k) database if they are submitted as non-confidential information.

Therefore, I cannot fulfill your request with the provided text. The document does not contain the requested information about device performance metrics, study design, or ground truth establishment.

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Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml

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This document is a 510(k) clearance letter from the FDA for a device called "Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol." It is a regulatory clearance for an Antimicrobial Susceptibility Test (AST) and does not pertain to an AI/ML medical device.

Therefore, the requested information regarding acceptance criteria and studies for an AI/ML device, such as:

• A table of acceptance criteria and reported device performance (in the context of AI metrics).
• Sample sizes for test and training sets, data provenance.
• Number and qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Types of ground truth (pathology, outcomes data, etc.).

cannot be extracted from the provided text.

The document primarily focuses on:

• Regulatory clearance: Stating that the device is substantially equivalent to legally marketed predicate devices.
• General controls: Listing the applicable regulations for the device (e.g., annual registration, listing, good manufacturing practice, labeling).
• Contact information: For further inquiries regarding adverse events or regulatory information.
• Indications for Use: (Though the section is blank in the provided snippet, indicating it would be described elsewhere).

In summary, the provided text does not contain the specific details about AI/ML device performance and validation studies that your request asks for.

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I am sorry, but the provided text does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter for a medical device (Sensititre YeastOne Susceptibility System with Voriconazole), but it does not include the specifics of the performance study.

The requested information such as a table of acceptance criteria, reported performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC study details, standalone performance, type of ground truth, and training set details are not present in this document.

While it mentions the device and its intended use, it does not delve into the scientific study details.

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