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The Siesta Medical, Inc. PRELUDE Tongue Suspension System is intended to be used for anterior advancement of the tongue base by means of a bone screw threaded with suture. It is indicated for the treatment of mild or moderate obstructive sleep apnea (OSA) and /or snoring.

The PRELUDE Tongue Suspension System is designed for anterior tongue base suspension by fixation of the soft tissue of the tongue base to the mandible bone using a bone screw and suture. The PRELUDE Tongue Suspension System consists of a pair of suture passers pre-loaded with size 2.0 braided polyester suture, a titanium bone screw that is pre-mounted on an inserter and size 1 monofilament polypropelyne suspension suture.

The Siesta Medical, Inc. PRELUDE Tongue Suspension System is a medical device designed for anterior tongue base suspension to treat mild or moderate obstructive sleep apnea (OSA) and/or snoring. The 510(k) submission (K101060) describes the device and the studies conducted to demonstrate its substantial equivalence to predicate devices, focusing on its performance characteristics.

1. Table of Acceptance Criteria and Reported Device Performance:

The document summarizes the performance tests conducted but does not explicitly define "acceptance criteria" as quantifiable thresholds. Instead, it states that the performance compares favorably to predicate devices. The reported device performance is qualitative, indicating successful completion of the tests.

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

The provided 510(k) summary does not specify the sample sizes used for each of the in vitro mechanical tests. It only states that the tests were "conducted to evaluate the performance characteristics." The data provenance for these in vitro tests would typically be from laboratory testing performed by or for the manufacturer, Siesta Medical, Inc. The document does not specify country of origin for the data, but since the company is based in Los Gatos, CA, it's likely the testing was conducted in the USA or by labs commissioned by them. The study is an in-vitro performance evaluation, not a clinical study, so the terms "retrospective" or "prospective" do not directly apply in the same way they would to human subject research.

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

This information is not applicable as the studies described are in vitro mechanical performance tests. They do not involve human interpretation or subjective assessment that would require expert ground truth establishment in the way an AI diagnostic or image analysis system would. The "ground truth" for these tests is based on objective physical measurements and engineering principles.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3. Adjudication methods like "2+1" or "3+1" are used in clinical studies or expert review processes, typically for establishing consensus ground truth for subjective data (e.g., image interpretation). The mechanical tests performed for this device rely on objective measurements.

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:

This information is not applicable. The PRELUDE Tongue Suspension System is a physical medical device (an implantable system), not an AI or imaging diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI assistance is entirely irrelevant to this device.

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

This information is not applicable. The device is an implantable physical system, not an algorithm or AI system.

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

For the in vitro mechanical tests, the "ground truth" is established through objective physical measurements using calibrated testing equipment and adherence to standard engineering test methodologies (e.g., tensile strength, torque, fixation strength). It is based on the inherent physical properties and performance limits of the materials and design, not on expert consensus, pathology, or clinical outcomes data in the traditional sense.

8. The sample size for the training set:

This information is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. The design and manufacturing processes are informed by engineering principles, material science, and preclinical testing, rather than data-driven machine learning models.

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

This information is not applicable for the same reasons as point 8.

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The Guglielmi Detachable Coil (GDC) is intended for embolizing certain intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be:

a)very high risk for management by traditional operative techniques, or,

b) inoperable,

and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature.

The GDC is also intended for arterial and venous embolizations in the peripheral vasculature.

The indications for use for Stretch Resistant GDC are identical to those for the predicate GDC device cleared under K962503.

The GDC system consists of:

• · GDC power supply
• · GDC occlusion coil attached to a delivery wire
• · set of GDC connecting cables
• patient return electrode
• · two 9-volt batteries

each of which is sold separately.

The occlusion coil is detached by electrolytically dissolving a small portion of the delivery wire upon desired placement of the coil in the anatomy.

GDC occlusion coils are manufactured from platinum wire which is first wound into a primary coil and then formed into a secondary helical shape.

Coils are attached to a delivery wire, which consists of a ground stainlesssteel core wire with a stainless-steel coil welded at the distal end and a Teflon® outer jacket. The delivery wire is the same as that employed for the predicate GDC cleared under K962503.

The GDC Power Supply is a self-contained, battery-operated unit designed to initiate and control detachment of a GDC coil. It has an on/off button, connections for the GDC cables, and the following controls and displays:

• · Current setting switch and display Allows for selection of the different current settings. The selected current (mA) is briefly displayed after which the unit displays the current flowing through the system.
• · Voltage diplay and indicator Displays the DC output voltage.
• · Time display Displays the elapsed time that the current has been flowing through the GDC system.
• Check indicator Flashes on and off at the beginning of a detachment procedure if there is a poor connection to the patient.
• · Detach indicator Flashes on and off when the power supply has detected detachment. Detachment is accompanied by five beeps.
• · Battery indicator Illuminates when the voltage of the internal 9-volt batteries falls below specification.

This document describes the safety and effectiveness of the Guglielmi Detachable Coil (GDC), a Class III artificial embolization device. The information provided focuses on the "Stretch Resistant GDC" and its comparison to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document summarizes a "Verification Test Summary Table: Comparison of Stretch Resistant GDC Devices to the Predicate Device". The acceptance criteria for most tests were established by the predicate device (K962503). For the "Main Coil Stretch Test," acceptance criteria were established for the modified device.

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

The document does not explicitly state the sample sizes used for each specific test mentioned in the "Verification Test Summary Table". It is a descriptive summary of test outcomes rather than a detailed study report with sample sizes.

The data provenance is not specified. However, given that this is a 510(k) submission for a medical device in the US, the testing and data generation would typically follow US regulatory guidelines and standards. It is retrospective in the sense that these tests were conducted to demonstrate substantial equivalence to a previously cleared device.

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

This document is a technical summary for regulatory submission, focusing on material and functional comparisons of a medical device (GDC coils). It does not involve "ground truth" derived from expert consensus on diagnostic interpretations (like for an AI algorithm). Instead, the performance is assessed against established engineering and safety standards, benchmarks set by the predicate device, or specific acceptance criteria defined for the modified device. Therefore, information about the number or qualifications of experts used to establish "ground truth" in this context is not applicable.

4. Adjudication Method for the Test Set:

Not applicable. The tests described are objective engineering and material performance assessments, not subjective diagnostic interpretations requiring adjudication.

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

Not applicable. This document pertains to a physical medical device (embolization coil), not an AI algorithm for diagnostic assistance. Therefore, an MRMC study or the effect size of AI assistance on human readers is not relevant.

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

Not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used:

The "ground truth" in this context refers to established engineering specifications, performance benchmarks derived from the predicate device (K962503), or specific design requirements for the new "Stretch Resistant GDC." For example:

• Friction: Measured against a specific frictional force threshold.
• Tensile Strength, Main Coil Weld: Compared against a minimum tensile strength value.
• Detachment Time: Evaluated against a specified temporal range for detachment.
• Particulate Analysis: Absence of particulate generation.
• Heating Effects (Electrolysis, MRI): No increase beyond acceptable thresholds or predicate device performance.
• Tip Ball Strength: Compared against a minimum strength requirement.
• Main Coil Stretch Test: Evaluated against specific criteria established for the elasticity and resistance of the modified device.

These benchmarks and criteria are based on established medical device safety and efficacy standards and the performance history of the predicate device.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI algorithm that requires a training set.

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

Not applicable.

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