The ALAR™ Nasal Valve Stent is intended for use in supporting the lateral nasal wall during the post-operative healing period following nasal valve surgery. This procedure may be performed independently or in conjunction with other procedures such as septoplasty and turbinoplasty in order to address nasal obstruction.

The ALAR™ Nasal Valve Stent supports and immobilizes intranasal tissues and cartilage during the post-operative healing period following intranasal and nasal valve surgery.

Device Description

The elliptically shaped fluoroplastic stent is approximately 20 mm long and 16 mm wide. Slits symmetrically spaced along the stent's lateral edges allow for left and right nostril usage. The suture and needle attached to the stent provide stent anchoring and hold cartilage plates stable during post-operative healing.

AI/ML Overview

The provided document is a 510(k) premarket notification for the ALAR™ Nasal Valve Stent. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria or details of a study demonstrating the device meets such criteria in terms of performance metrics like sensitivity, specificity, or accuracy.

The "Discussion of the Performance Testing" section (page 4) states: "Testing was completed to ensure the functionality and compatibility with the identified Medtronic Xomed products. Test samples were subjected to simulated real-life use conditions during functional testing. All function testing passed the test specifications and acceptance criteria for the bench top engineering studies. A biocompatibility assessment, sterility adoption, transportation and shelf life/aging testing was also conducted Additional bench, animal or clinical testing was not required to establish substantial equivalence."

This indicates that engineering studies were performed to confirm functionality and compatibility, and these studies had "test specifications and acceptance criteria." However, these specific criteria and the detailed results are not provided in this document. The focus of this 510(k) summary is on demonstrating substantial equivalence to predicate devices, primarily through technological characteristics and existing predicate testing, rather than presenting a performance study with detailed clinical or diagnostic metrics.

Therefore, I cannot populate the requested table and answer many of the questions because the necessary information is not present in the provided text. The device is a physical medical device (stent), not an AI/algorithm-based diagnostic device, so many of the questions pertinent to AI performance metrics (like MRMC studies, standalone algorithm performance, training/test set details, ground truth for AI) are not applicable or detailed in this context.

Here's what can be inferred or stated based on the provided text, and what cannot:

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

Acceptance Criteria	Reported Device Performance
Not specified	"All function testing passed the test specifications and acceptance criteria for the bench top engineering studies."
Biocompatibility	"A biocompatibility assessment... was conducted." (Assumed passed)
Sterility	"sterility adoption... was conducted." (Assumed passed)
Transportation	"transportation... testing was also conducted." (Assumed passed)
Shelf life/aging	"shelf life/aging testing was also conducted." (Assumed passed)
Functionality	"Testing was completed to ensure the functionality and compatibility with the identified Medtronic Xomed products." (Assumed passed)

Missing Information: The document does not provide the specific numerical or qualitative "acceptance criteria" for functionality, biocompatibility, sterility, etc., nor does it provide the detailed "reported device performance" metrics against those criteria. It only states that testing passed the internal specifications.

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

Sample Size: Not specified. The document refers to "test samples" for "bench top engineering studies," but the number of samples is not mentioned.
Data Provenance: Not applicable in the context of clinical/patient data, as these were bench-top engineering studies. The studies were likely conducted internally by Medtronic Xomed Inc.

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 applicable. This device is a physical stent, and the evaluation mentioned consists of engineering studies (biocompatibility, functional testing, etc.), not a diagnostic test with a "ground truth" established by medical experts in the typical sense of evaluating diagnostic accuracy.

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

Not applicable. Adjudication methods are typically used in clinical studies involving interpretation of data by multiple readers. The described tests are bench-top engineering studies.

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 is not an AI/diagnostic device.

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

No. This is not an AI/diagnostic device.

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

Not applicable in the context of clinical "ground truth" for diagnostic performance. Ground truth in the engineering studies would refer to established physical, chemical, or mechanical standards and specifications.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 29, 2015

Medtronic Xomed Inc. Ms. Gabriela Anchondo Regulatory Affairs Manager 6743 Southpoint Drive North Jacksonville, FL 32216

Re: K151758

Trade/Device Name: ALAR™ Nasal Valve Stent Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT, LYA Dated: September 25, 2015 Received: October 1, 2015

Dear Ms. Anchondo:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Eric A. Mann -S

Malvina Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K151758

Device Name ALAR™ Nasal Valve Stent

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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K151758 - 510(k) Summary

I.	Submitter:	Medtronic Xomed, Inc.6743 Southpoint Drive NorthJacksonville, Florida 32216 USA
	Contact:	Gabriela AnchondoRegulatory Affairs ManagerTelephone Number: 904-279-7550Fax Number: 904-296-2386
	Date Summary Prepared:	June 24, 2015
	Trade Name:	ALAR™ Nasal Valve Stent
II.	Common Name:	Surgical Suture with NeedleIntranasal Splint
III.	Classification Name:	Nonabsorbable poly(ethylene terephthalate) surgicalsuture (21 CFR 878.5000)
IV.	Classification:	Class II
V.	Predicate Devices:	K021019 Tevdek® Suture with Needle (GAT)Class I Exempt Medtronic Xomed Internal Nasal Splints(LYA)
VI.	Device Description:	The elliptically shaped fluoroplastic stent is approximately20 mm long and 16 mm wide. Slits symmetrically spacedalong the stent's lateral edges allow for left and right nostrilusage. The suture and needle attached to the stentprovide stent anchoring and hold cartilage plates stableduring post-operative healing.
VII.	Indications for Use:	The ALAR™ Nasal Valve Stent supports and immobilizesintranasal tissues and cartilage during the post-operativehealing period following intranasal and nasal valvesurgery.
VIII.	TechnologicalCharacteristics:	The ALAR™ Nasal Valve Stent system components havesimilar technological characteristics as the MedtronicXomed Internal Nasal Stents and Tevdek® Suture withNeedle including intended use, design, materials,principles or operation and performance.

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IX. Discussion of the Performance Testing

Testing was completed to ensure the functionality and compatibility with the identified Medtronic Xomed products. Test samples were subjected to simulated real-life use conditions during functional testing. All function testing passed the test specifications and acceptance criteria for the bench top engineering studies. A biocompatibility assessment, sterility adoption, transportation and shelf life/aging testing was also conducted Additional bench, animal or clinical testing was not required to establish substantial equivalence.

X. Conclusions

The indications for use, technology and performance characteristics of the ALAR™ Nasal Valve Stent system components are the same as the Medtronic Xomed Internal Nasal Splints and Tevdek® Suture with Needle. Based on this, Medtronic Xomed claims substantial equivalence to the predicate device.

Regulation Number and Section

§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.

(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.