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The Locator™ Steerable Stylet is intended for use when implanting the Pacesetter Tendril® model 1188 T/K pacemaker leads, in 46, 52, and 58 cm lengths in patients requiring long-term lead implantation to provide cardiuc pacing.

The Locator™ steerable stylet consists of a curved wire that fits inside a thin-walled tube. Sliding the tube relative to the wire by manipulating the handle allows different curvatures on the stylet, and thus the lead, to be obtained.

This submission is for a medical device called the "Locator™ Steerable Stylet" (K972814). The provided documents are a 510(k) summary and the FDA's clearance letter.

Based on these documents, the device is an accessory to permanent pacemaker electrodes, specifically intended for use with Pacesetter Tendril® model 1188 T/K pacemaker leads.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific quantifiable acceptance criteria such as performance metrics (e.g., accuracy, sensitivity, specificity, or specific mechanical thresholds) or a table outlining them.

The device's intended use is:

• To facilitate advancement of the lead in the vasculature.
• To allow control of the shape of the lead without removing the stylet from the lead.

The summary states: "Both preclinical and qualification testing of the Locator™ indicate that this device is substantially equivalent with regard to safety and effectiveness to a marketed device." This implies that the device met the safety and effectiveness standards demonstrated by its predicate devices (Pacesetter ball-tipped stylets - straight and j-shaped) through these testing methods.

Without explicit criteria or detailed results of the preclinical and qualification testing, a "table of acceptance criteria and reported device performance" cannot be generated in the traditional sense of a clinical or algorithm performance study. The "performance" being reported is that it met the general requirements for substantial equivalence to its predicate for safety and effectiveness.

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

The 510(k) summary explicitly states: "No clinical testing was performed." This means there was no clinical test set involving human subjects to evaluate the device's performance in its intended use environment.

The testing mentioned ("preclinical and qualification testing") would likely involve bench testing, mechanical testing, and potentially animal studies (though not explicitly stated as such). Details on the sample size for these non-clinical tests are not provided in this summary. The data provenance would be from manufacturing and engineering tests, not patient data, given the absence of clinical testing.

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

Given that no clinical testing was performed, there was no test set requiring human expert-established ground truth related to clinical outcomes or diagnoses. The "ground truth" for preclinical and qualification testing would be established by engineering specifications, material standards, and perhaps expert assessment of mechanical functionality, though specific details or expert numbers are not provided.

4. Adjudication Method for the Test Set

Since no clinical testing was performed and no expert-read test set was described, no adjudication method (e.g., 2+1, 3+1) was used in the context of this 510(k) submission.

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

No MRMC comparative effectiveness study was done. The submission explicitly states "No clinical testing was performed." Therefore, there is no information on how human readers might improve with or without AI assistance, as AI is not mentioned, and human reader performance was not assessed.

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

This device is a physical medical instrument (a steerable stylet), not a software algorithm or an AI-powered device. Therefore, the concept of "standalone (algorithm only)" performance is not applicable.

7. The Type of Ground Truth Used

For the preclinical and qualification testing that was performed, the "ground truth" would be based on:

• Engineering specifications and design requirements: Ensuring the device's physical and mechanical properties meet predefined standards.
• Performance against predicate devices: Demonstrating that the device functions comparably to existing, legally marketed predicate devices without raising new questions of safety or effectiveness. This would involve comparing material properties, dimensions, steerability, and compatibility with the specified leads.

8. The Sample Size for the Training Set

As this is a physical medical device and not an AI or machine learning model, the concept of a "training set" in the context of data-driven algorithm development is not applicable. The device's design, manufacturing, and testing process does not involve a training set for an algorithm.

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

Since there is no training set as defined for algorithms, this question is not applicable. The "ground truth" for the device's design and manufacturing is established through engineering principles, material science, and regulatory requirements.

Summary of the Study:

The "study" that proves the device meets the acceptance criteria is described as "preclinical and qualification testing." This type of testing typically includes:

• Bench Testing: Mechanical stress tests, fatigue tests, material compatibility, dimensional verification, and functional tests (e.g., steerability, ability to fit within pacemaker leads, ease of insertion/removal).
• Biocompatibility Testing: To ensure materials are safe for contact with body tissues.
• Sterilization Validation: To confirm the device can be effectively sterilized.
• Shelf-life Testing: To determine the stability of the device over its intended storage period.

The purpose of this testing, as stated in the 510(k) summary, was to demonstrate substantial equivalence to existing predicate devices (Pacesetter ball-tipped stylets). This means showing that the Locator™ Steerable Stylet is as safe and effective as the predicate devices, without raising new questions of safety or effectiveness, and that it performs its intended function (facilitating lead advancement and control) comparably. The FDA's clearance letter confirms their agreement that the device is substantially equivalent based on the provided non-clinical data.

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The intended use of the Siemens Model 345 Ultra Nebulizer is to nebulize liquid medication for introduction into the patient's airway via an endotracheal tube. It can be used on any patient for whom the use of the Siemens Servo Ventilator 300 is indicated, in any ventilatory mode appropriate for the patient.

The Servo Ultra Nebulizer 345 (SUN 345) is an accessory to the Servo Ventilator 300 that is used to nebulize medication during ventilator treatment. An ultrasonic nebulizer similar to those commonly marketed as a component of home "medication inhaler" devices has been adapted for use in the patient circuit of the Servo Ventilator. The ultrasonic nebulizer does not add any gas volume to the circuit, so that readings and settings on the ventilator are unaffected. The SUN 345 medication cup holds 10 ml of liquid, which is nebulized at a rate of 0.3 ml/min at 0.5 1/min gas flow. The mass median diameter of particles is 4.0 um.

Acceptance Criteria and Device Performance Study for Siemens Servo Ultra Nebulizer 345

This document summarizes the acceptance criteria and the study performed for the Siemens Servo Ultra Nebulizer 345, based on the provided 510(k) summary.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Servo Ultra Nebulizer 345 are implicitly defined by its comparison to predicate devices, focusing on key performance characteristics. The study aimed to demonstrate substantial equivalence by meeting these characteristics or performing within an acceptable range relative to the predicates.

2. Sample Size and Data Provenance

The provided 510(k) summary does not specify the sample size used for the test set in the non-clinical tests. The tests were conducted internally by Siemens-Elema AB in Solna, Sweden. The data provenance is retrospective, as the tests were performed to support the 510(k) submission for an already developed device.

3. Number of Experts and Qualifications for Ground Truth Establishment

The 510(k) summary does not mention the use of experts to establish a "ground truth" for the non-clinical tests. The tests performed (particle size, nebulization rate) are objective measurements based on established scientific methods and instrumentation, rather than subjective interpretation by experts.

4. Adjudication Method for the Test Set

No adjudication method is described, as the tests involved objective measurements rather than subjective assessments requiring expert consensus.

5. Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was conducted or mentioned. The device is a medical accessory, and the study focused on its physical performance characteristics, not on diagnostic accuracy or interpretation requiring human readers.

6. Standalone Performance Study

Yes, a standalone performance study was conducted. The "Nonclinical Tests Used in Determination of Substantial Equivalence" section describes tests to determine particle size and nebulization rate for various medications and ventilator flow rates for the device itself. Additionally, the complete system (SUN 345 and Servo Ventilator 300) was tested for electrical safety and Electromagnetic Compatibility, which are also standalone performance aspects.

7. Type of Ground Truth Used

The ground truth used for the non-clinical tests was based on objective physical measurements using scientific instrumentation and standardized methods for determining:

• Particle size (mass median diameter)
• Nebulization rate
• Electrical safety
• Electromagnetic compatibility

8. Sample Size for the Training Set

The concept of a "training set" is not applicable here as the device is not an AI or machine learning model. The non-clinical tests involved direct performance measurements of the hardware.

9. How Ground Truth for the Training Set Was Established

As there is no training set in the context of an AI/ML model, this question is not applicable. The measurements taken for the non-clinical tests (particle size, nebulization rate, etc.) served as the direct performance data for the device.

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