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Where the clinician decides to monitor cardiac arthythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

The intended use of the ST/AR cardiotach is to monitor a neonatal, pediatic, or adult patient's ECG for heart rate and produce events/alarms for one or two ECG leads. The cardiotach function is capable of monitoring both paced and non-paced patients.

The intended use of the ST/AR arrhythmia analysis algorithm is to monitor a neonatal, pediation of adult patient ECG's for heart rate and ventricular arthythmias, and produce events/alarms for one or two ECG leads. The arrhythmia analysis algorithm is capable of monitoring both paced and non-paced patients.

The intended use of the ST/AR ST analysis algorithm is to monitor an adult patient's ECG for ST segment elevation or depression and produce events/alarms for all possible ECG leads. The ST analysis algorithm is capable of monitoring paced and non-paced adult patients.

Note: The ST algorithm does not analyze ventricularly paced or ventricular ectopic beats.

The intended use of the ST/AR QT/QTc analysis is for use by the physician in the risk assessment process indicated for neonatal, pediatic and adult patients with and without symptoms of arrhythmia. OT measurement is intended to be used by qualified health professionals in hospital or clinical environments. Composite QT (single or multi-lead derived) measures the interval only and is not intended to produce any interpretation or diagnosis of those measurements.

EASI ECG is intended for monitoring multiple leads of ECG of adults, pediatrics and neonates. EASI ECG is indicated for use by health care professionals whenever there is a need to monitor ECG of adult, pediatric, or neonatal patients including arrhythmia monitoring or ST segment changes of adult patients, to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

RLS ECG is intended for monitoring multiple leads of ECG of adults.

RLS ECG is indicated for use by health care professionals whenever there is a need to monitor ECG of adult patients including arrhythmia, ST segment changes, and QT/QTc, to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

The modification is a software-based change that adds the following features:
· Support derived 12-lead ECG (RLS ECG) from a 6-electrode lead set.
· Provide enhanced AF and Irregular HR alarms detection
· Provide enhanced QT and ST analysis and alarms.

The provided text is a 510(k) summary for the Philips ST/AR ST and Arrhythmia Software, Release K.0. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria or a study proving the device meets said criteria in the format requested.

Here's an analysis of what is and is not provided, based on your request:

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

• Not provided. The document states: "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test.results showed substantial equivalence. The results demonstrate that ST/AR Release K.O meets all defined reliability requirements and performance claims."
• This statement indicates that acceptance criteria (pass/fail criteria) were established and met, but it does not specify what those criteria were (e.g., sensitivity, specificity, accuracy targets) nor does it report the device's performance against those criteria with specific metrics.

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

• Not provided. The document mentions "system level tests, performance tests, and safety testing from hazard analysis" but does not detail the sample sizes for these tests or the nature of the data (e.g., patient population, retrospective/prospective).

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 provided. The document does not describe the establishment of a "ground truth" using experts for performance evaluation. The testing described focuses on functional equivalence to predicate devices and adherence to existing specifications.

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

• Not provided. There is no mention of an adjudication process for the test set.

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 provided. This document describes a software update for a physiological monitor with expanded features (e.g., derived 12-lead ECG, enhanced AF/Irregular HR alarms, enhanced QT/ST analysis). It is not focused on an AI-assisted diagnostic tool that would typically involve a multi-reader multi-case study to assess human reader improvement. The focus appears to be on the algorithm's performance itself, rather than its impact on human interpretation.

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

• Implied, but not explicitly detailed. The statement "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate" suggests that the algorithm itself was tested for performance against established specifications. However, specific metrics (like sensitivity, specificity, accuracy) are not provided in this summary. The testing appears to be focused on whether the new features function as intended and meet the specifications set for the predicate device.

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

• Not explicitly stated how ground truth was established, if at all, for performance claims. The document uses the term "specifications cleared for the predicate device" as the basis for pass/fail criteria. This suggests that the ground truth for evaluation would be derived from comparisons to the expected outputs or performance of the cleared predicate devices, rather than an independent clinical ground truth like pathology or expert consensus on new data.

8. The sample size for the training set

• Not provided. Training sets are typically associated with machine learning or AI development. While the device includes "algorithms" (e.g., ST/AR arrhythmia analysis algorithm, ST/AR ST analysis algorithm), this document does not provide details of their development processes that would include training sets. Given the submission date (2010), these algorithms likely rely on more traditional signal processing and rule-based methods rather than large-scale machine learning requiring explicit "training sets" in the modern sense.

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

• Not applicable / Not provided. As no training set information is given, the method for establishing its ground truth is also not mentioned.

In summary, this 510(k) document is a regulatory submission focused on demonstrating substantial equivalence to predicate devices. It confirms that testing was conducted and specifications were met, but it does not provide the detailed performance metrics, study designs, or ground truth establishment methods typically requested for a deeper understanding of a device's clinical performance and validation against specific acceptance criteria. The "study" mentioned is a general "Verification, validation, and testing" activity, not a specific clinical trial with reported outcomes.

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The Cook Vascular VITAL-JECT Power Injectable Safety Infusion Set is intended to be used to administer solutions and medications into vascular implant ports. When used with a power Injectable vascular implant port, the Cook Vascular Safety Infusion Set is indicated for power injection of contract media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s using contrast with a maximum viscosity of 11.8cP.

In addition, to minimize the risk of accidental needle stick after use, the attached safety guard fully encapsulates the needle when manually activated during withdrawal.

The Cook Vascular VITAL-JECT Power Injectable Safety Infusion Set is intended to administer solutions and medications into vascular implant ports. In addition, to minimize the risk of accidental needle stick after use, the attached safety guard fully encapsulates the needle when manually activated during withdrawal.

When used with a power Injectable vascular implant port, the Cook Vascular Safety Infusion Set is indicated for power injection of contract media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s using contrast with a maximum viscosity of 11.8cP.

The device consists of a protector cap, female luer lock, PVC tubing, two each 4 inch tubing length, a pinch clamp, with a needle free y-site, a butterfly wing, a safety needle guard, an AISI 304 (19 ga) stainless steel needle and a needle sheath.

The components and the processes use to manufacture these solution administration sets are the same as the currently legally marketed by Command Medical, K033515 HuberPRO™ Safety Huber Infusion Set.

Cook Vascular, Inc. will label and sterilize the final product. The proposed device is manufactured exactly the same as the currently marketed device. (K033515)

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the Cook Vascular VITAL-JECT™ Power Injectable Safety Infusion Set:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria with specific pass/fail thresholds for each test. Instead, it describes general conclusions about performance. The key performance aspect highlighted is the ability to withstand power injection.

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

• Sample Size for Test Set:
  • For the performance tests (Dynamic Failure Flow, Instantaneous Burst, Static Pressure, Life Cycle Power Injection Tests), a specific sample size is not explicitly stated in the provided summary.
  • For Bioburden testing, nine individual infusion sets were tested.
• Data Provenance: The data appears to be prospective testing conducted by Cook Vascular, Inc. or its contractors. The country of origin is implicitly the USA, where Cook Vascular, Inc. is based and the submission was made to the FDA.

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

• Not applicable for this type of device and study. The testing described involves engineering and microbiological performance metrics, not clinical interpretation by experts to establish a "ground truth." The ground truth is objective performance characteristics measured through laboratory testing.

4. Adjudication Method for the Test Set:

• Not applicable. This study involves objective laboratory tests with measurable outcomes, not subjective assessments requiring adjudication by multiple experts.

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. This document describes a 510(k) submission for a physical medical device (infusion set), not an AI/software-as-a-medical-device. Therefore, no MRMC study or AI-related comparative effectiveness was performed or applicable.

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

• No. As mentioned, this is not an AI/algorithm-based device.

7. The Type of Ground Truth Used:

• The "ground truth" for the performance tests (flow, pressure, burst, life cycle) are engineering specifications and physical measurements designed to assess the device's functional integrity under intended use conditions.
• The "ground truth" for sterilization tests (Bioburden, Endotoxin, EO Residuals, Sterility) are established microbiological and chemical standards for medical device sterilization.

8. The Sample Size for the Training Set:

• Not applicable. There is no "training set" as this is not an AI/machine learning device. The design, components, and manufacturing processes leverage those of a previously cleared predicate device (K033515 HuberPRO™ Safety Huber Infusion Set), which serves as a benchmark for substantial equivalence rather than a training set in the AI sense.

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

• Not applicable. As there is no training set, there's no ground truth established for one. The basis for safety and effectiveness is substantial equivalence to a predicate device, supported by the described physical and microbiological testing.

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