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The Pillar Palatal Implant System is intended for use in stiffening the soft palate tissue which may reduce the severity of snoring in some individuals.

Indications for use of the System include: symptomatic, habitual, and social snoring due to palatal flutter.

The Pillar Palatal Implant System is intended as a treatment option for snoring. The Pillar Palatal Implant System consists of an implant and a delivery tool. The implants are designed to stiffen the tissue of the soft palate reducing the dynamic flutter which causes snoring.

The implant is a cylindrical shaped segment of braided polyester filaments. The delivery tool is comprised of a handle and needle assembly that allows for positioning and placement of the implant submucosally in the soft palate. The implant is designed to be permanent while the delivery tool is disposable.

The provided text is a 510(k) summary for the Medtronic Xomed, Inc. Pillar Palatal Implant System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria in the traditional sense of a clinical trial with quantitative performance metrics.

Therefore, many of the requested items (acceptance criteria table, sample size for test set, number of experts for ground truth, adjudication method, MRMC study, sample size for training set, ground truth for training set) are not applicable or available within this type of regulatory submission.

The essence of this submission is substantial equivalence, meaning the device is considered as safe and effective as a legally marketed predicate device, rather than a de novo demonstration of meeting novel performance criteria through a specific study.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not applicable in the context of this 510(k) submission. The submission does not present specific quantitative acceptance criteria or performance metrics for this device, as it relies on substantial equivalence to a previously cleared device. The "performance" being demonstrated is the identity in intended use, indications for use, design, implant, and target population to the predicate device.

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

Not applicable. This submission is not based on a clinical trial with a "test set" in the context of a new performance study. It's a regulatory filing based on demonstrating equivalence. No specific patient sample size or data provenance for a performance test is provided.

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

Not applicable. See point 2.

4. Adjudication Method for the Test Set:

Not applicable. See point 2.

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:

Not applicable. This device is a physical implant system, not an AI-assisted diagnostic or treatment system involving human readers.

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

Not applicable. This device is a physical implant system.

7. The type of ground truth used:

Not applicable. There is no "ground truth" in the context of a new performance study for this submission. The "truth" being established is the substantial equivalence to a previously cleared device based on a comparison of device characteristics and intended use.

8. The Sample Size for the Training Set:

Not applicable. This submission does not involve machine learning or AI, and therefore no "training set" in that sense.

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

Not applicable. See point 8.

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The Pillar™ Palatal Implant System is intended for the reduction of the incidence of airway obstructions in patients suffering from mild to moderate OSA (Obstructive Sleep Apnea).

The Pillar™ Palatal Implant System (“System”) is intended as a treatment option for snoring and obstructive sleep apnea. The System consists of an implant and a delivery tool. The implants are designed to stiffen the tissue of the soft palate reducing the dynamic flutter which causes snoring. Additionally, the implants reduce the incidence of airway obstruction caused by the soft palate.

The implant is a cylindrical shaped segment of braided polyester filaments. The delivery tool is comprised of a handle and needle assembly that allows for positioning and placement of the implant submucosally in the soft palate. The implant is designed to be permanent while the delivery tool is disposable.

The provided text describes a 510(k) submission for the Pillar™ Palatal Implant System, detailing its intended use, design, and equivalence testing to predicate devices. However, the document does NOT contain information about specific acceptance criteria, a detailed study proving the device meets those criteria, or most of the requested quantitative data regarding sample sizes, expert involvement, or ground truth establishment.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be answered based on the provided document:

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

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

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The text only mentions "clinically evaluated" without further detail.

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)

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

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

• Adjudication Method: Not specified.

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

• MRMC Study: No, this is a physical implant device, not an AI or imaging diagnostic device.
• Effect size of AI assistance: Not applicable.

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

• Standalone Performance: Not applicable as this is a physical medical device.

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

• Type of Ground Truth: The document implies "clinical results" and "performance" related to the treatment of OSA and snoring. This likely refers to patient outcomes or physiological measurements (e.g., AHI reduction, snoring intensity), but the specific metrics used as "ground truth" are not explicitly stated.

8. The sample size for the training set

• Sample Size (Training Set): Not applicable. The device is a physical implant tested in a clinical trial, not an algorithm that undergoes a "training" phase.

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

• Ground Truth Establishment (Training Set): Not applicable.

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