The Patient-Specific Airway Stent is indicated for the treatment of adults ≥22 years of age with symptomatic stenosis of the airway. The silicone stent is intended for implantation into the airway by a physician using the recommended deployment system or an equivalent rigid bronchoscope and stent placement system that accepts the maximum stent diameter being placed. The stent is intended to be in the patient up to 12 months after initial placement.

Device Description

The Patient-Specific Airway Stent is comprised of Web Software and the Patient-Specific Silicone Y-Stent. These two function together as a system to treat symptomatic stenosis of the airway. The Patient-Specific Silicone Stent is designed by a physician using a CT scan as a guide in the Web Software. The Web Software gives the user (physician) the ability to upload a scan, view the airway, and design a stent. The stent, after physician approval, is manufactured via silicone injection into a 3D-printed mold and delivered to the treating physician's medical center nonsterile.

AI/ML Overview

This document (K182743) is a 510(k) Premarket Notification for a Patient-Specific Airway Stent. It primarily focuses on demonstrating substantial equivalence to a predicate device (ENDOXANE, K971509) and the safety/effectiveness of the device.

Based on the provided text, the device in question is a Patient-Specific Airway Stent System, which includes Web Software and the Patient-Specific Silicone Y-Stent. The software allows physicians to design the stent based on a CT scan, and then the stent is manufactured via silicone injection into a 3D-printed mold.

The acceptance criteria and study that proves the device meets them are mostly related to non-clinical performance testing and software verification/validation, rather than a full clinical study with human patients evaluating the AI's diagnostic performance. Therefore, many of the typical acceptance criteria and study elements for an AI-powered diagnostic device are not explicitly detailed in this 510(k) summary.

Here's an attempt to extract the relevant information based on your request, acknowledging the limitations of the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a direct table of acceptance criteria with specific numerical performance metrics for the software's ability to accurately design the stent or for the final stent's intended clinical outcome in terms of patient-specific fit. Instead, it describes various tests performed to ensure the device functions as intended and is substantially equivalent to the predicate.

The closest to "acceptance criteria" are the objectives of the non-clinical performance tests, and "reported device performance" is described qualitatively as "supports the claim" or "confirms."

Please note: The "device performance" here refers to the engineering and functional performance of the stent and software, not clinical outcome metrics (e.g., patient improvement rates).

Acceptance Criteria (Stated Objective of Test)	Reported Device Performance (as described in document)
Sterilization Testing: Ability to be steam sterilized to a SAL of 10-6.	Confirms that the subject device can be steam sterilized to a SAL of 10-6, using a common cycle in medical centers.
Material Equivalence (Tear Strength): Subject device material equivalent to predicate's in tear strength.	Supports the claim that the subject device's material is equivalent to the predicate's material in tear strength.
Fatigue Testing: Device does not fatigue when cyclically compressed over intended life (1 year).	Supports the claim that the subject device does not fatigue when cyclically compressed over the intended life of the implant (1 year).
Stent Deployment Testing: Able to be deployed by common applicator and rigid bronchoscope system.	Supports the claim that the subject device is able to be deployed by a common applicator and rigid bronchoscope system.
Biocompatibility Testing: Acceptable for implant up to one year.	Confirmed that the Patient-Specific Silicone Stent is acceptable for use as a medical device following ISO 10993-1. (Specific tests: Cytotoxicity, Sensitization, Irritation, Toxicity, Pyrogenicity, Subacute/Sub-Chronic Toxicity, Genotoxicity, Chemical Characterization).
Software Verification and Validation: Software functions as designed; risk mitigations are effective.	Supports the claim that the software functions as designed, including any design mitigations.
Human Factors and Usability Testing (Web Software): Software is safe and effective when used by intended users in its intended use-environment.	Supports the claim that the software is as safe and as effective as the predicate device when used by its intended users in its intended use-environment.
Dimensional Testing of Airway Segmentation: Accuracy of segmented airway rendering in proprietary software.	Evaluated the accuracy of segmented airway rendering in proprietary segmentation software. (No specific metric provided, just that it was evaluated).
Airway Segmentation Process Validation: Validation of the process of segmenting an airway from a CT scan in proprietary software.	Validated the process of segmenting an airway from a CT scan in proprietary segmentation software. (No specific metric provided, just that it was validated).

Note on Quantitative Acceptance Criteria: The document explicitly mentions some differences, such as the subject device having lower flat-plate compression strength than the predicate device. However, it states that "Any risks related to these technological differences have been mitigated to an acceptable level," implying that these differences did not prevent meeting overall safety/effectiveness. For the AI component (segmentation and design), specific quantitative acceptance criteria (e.g., Dice score for segmentation accuracy, deviation from ideal stent dimensions) are not provided in this summary document.

2. Sample Size for Test Set and Data Provenance

The document does not specify a sample size for the "test set" in the context of typical AI performance evaluation (e.g., number of CT scans used to validate segmentation or design accuracy).
The closest mentions are "Dimensional Testing of Airway Segmentation" and "Airway Segmentation Process Validation." It's implied that some CT scan data was used for these, but neither the sample size nor the provenance (country, retrospective/prospective) of this data is mentioned.

3. Number of Experts and Qualifications for Ground Truth

The document describes the device as a "Patient-Specific Airway Stent" where creation involves a "physician using a CT scan as a guide in the Web Software" and the stent is manufactured "after physician approval."
The "Web Software" allows "COS technicians to segment the airway and automatically calculate a centerline."
"Ground truth" for the AI component (segmentation, centerline calculation, stent design) is not explicitly defined in terms of expert consensus or pathological verification in this summary. Instead, it appears the software's output is reviewed and approved by a single physician for an individual patient.
Therefore, it's not a panel of experts establishing ground truth for a general test set, but rather an individual physician performing the critical review and approval step for each patient. No specific number of experts used to establish ground truth for a general test set is mentioned, nor are their qualifications.

4. Adjudication Method for the Test Set

Given that the "ground truth" for the AI's output is implied to be physician review and approval for each specific case, there is no multi-reader adjudication method (like 2+1 or 3+1) described for a general test set. The process involves one physician approving the design.

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

No MRMC study comparing human readers with and without AI assistance is mentioned or implied. The product is a custom-designed stent system, not a diagnostic AI intended to assist in interpreting medical images. The AI (software) assists in the design and manufacturing process, which is then approved by a physician.

6. Standalone (Algorithm Only) Performance

No standalone (algorithm only) performance metrics are explicitly provided. The software acts as a design tool that then requires physician approval before manufacturing. The document describes "Software Verification and Validation Testing" and "Dimensional Testing of Airway Segmentation" which implies internal testing of the algorithm, but specific standalone metrics (e.g., segmentation accuracy against ground truth) are not reported in this summary.

7. Type of Ground Truth Used

For the software's AI components (segmentation, centerline calculation), the implicit "ground truth" during real-world use is the physician's subjective review and approval based on the CT scan.
For the non-clinical tests (e.g., tear strength, fatigue), the ground truth relates to engineering specifications and established test methods.
No pathology or outcomes data is mentioned as ground truth for the software's performance, as this is a device design tool, not a diagnostic algorithm.

8. Sample Size for the Training Set

The document does not specify the sample size for the training set used for any AI component (segmentation, centerline calculation). It only refers to a "proprietary software" used by "COS technicians" to segment the airway and calculate the centerline.

9. How Ground Truth for Training Set Was Established

The document does not describe how ground truth for any potential AI training set was established.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 23, 2019

New COS Inc. Keith Grafmeyer Sr. Project Manager 7100 Euclid Ave, Ste 180 Cleveland, Ohio 44103

Re: K182743

Trade/Device Name: Patient-Specific Airway Stent Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal Prosthesis Regulatory Class: Class II Product Code: NWA Dated: October 17, 2019 Received: October 18, 2019

Dear Keith Grafmeyer:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

{1}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

James J. Lee, Ph.D. Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K182743

Device Name Patient-Specific Airway Stent

Indications for Use (Describe)

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
------------------------------------------------	-----------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

510(k) OWNER / MANUFACTURER: New COS, Inc. 7100 Euclid Ave Ste 180 Cleveland OH, 44103

CONTACT PERSON:	Keith GrafmeyerSr. Product ManagerNew COS, Inc.Tel: (216) 800-5905 x 102Email: kgrafmeyer@customorthopaedics.com
-----------------	----------------------------------------------------------------------------------------------------------------------------------

TRADE NAMES: Patient-Specific Airway Stent

October 23, 2019 PREPARATION DATE:

COMMON NAMES: Prosthesis, Tracheal, Preformed/Molded

Product: Patient-Specific	ProductCode	Regulation and ClassificationName	DeviceClass
Patient-Specific Airway Stent System	NWA	21 CFR 878.3720Tracheal Prosthesis	II

PREDICATE DEVICE:

Subject Device: Patient-Specific AirwayStent	Corresponding Predicate Device(s)
Patient-Specific Airway Stent	K971509: ENDOXANE

REFERENCE DEVICES:

Device 510(k) Number	Device Name	Reason for Use
K073468	Mimics	Performancespecification for airwaysegmentation
K894380	Dumon Tracheobronchial Stent	Performancespecification forcompression strength
K121048	Ultraflex Tracheobronchial StentSystem – Sterile Uncovered	Performancespecification forcompression strength

DEVICE DESCRIPTION:

{4}------------------------------------------------

The Patient-Specific Airway Stent includes the following general features:

Deployed through a common applicator system in conjunction with an . appropriate rigid bronchoscope system
Made of biocompatible, implant-grade silicone
Steam sterilizable ●
Anti-Migration studs on anterior surface ●
Single-use only .
Branched (Y-Stent) to prevent migration .
Designed and approved in a proprietary software by a physician for an individual . patient

The Web Software has the following general features:

Gives COS technicians the ability to segment the airway and automatically ● calculate a centerline
Create, edit, and save patient-specific airway stents from segmented airway ●
. Define exact stent diameters at specific locales
Measure stent inner and outer diameters at any point along stent design .
. CT scan as the imaging input modality
Physician able to manage patient's stent designs and CT scans ●
Physician able to approve stent design through software (create 3D prescription) .

INTENDED USE AND INDICATIONS:

BASIS OF SUBSTANTIAL EQUIVALENCE:

The Patient-Specific Airway Stent is substantially equivalent to the ENDOXANE stent (K971509) with regards to intended use and indications for use.

The materials used to design the Patient-Specific stent are substantially equivalent to the materials used to manufacture the Endoxane stents and the performance characteristics of the subject device have been tested to show substantial equivalency to the currently marketed predicate device. Biocompatibility testing has confirmed that the Patient-Specific Silicone Stent is acceptable for use as a medical device following the requirements stated in the FDA's Guidance on the Use of ISO 10993-1.

The primary technological difference between the subject and predicate device is the introduction of software to allow a physician to design a stent for a specific patient. The risks introduced by this difference have been mitigated in the software, rendering the subject device's risk profile substantially equivalent to the predicate. Software verification and validation was performed to confirm that the software fully satisfies all inputs.

{5}------------------------------------------------

TECHNOLOGICAL CHARACTERISTICS SUMMARY:

The Patient-Specific Airway Stent is substantially equivalent to the predicate device in terms of technological characteristics including design, materials, and features.

Identical Characteristics

। Branched (Y) stent configurations (no more than 3 branches).
Method of deployment through a common applicator system in coniunction with । an appropriate rigid bronchoscope system based on the maximum outer diameter being deployed.
Uniform wall thickness option of 1.0mm.
Visually smooth interior and exterior surfaces of device. |
। Removable implant, if necessary (recommended to be replaced after 12 months of implantation).
-Single-use implant only.
Uniform material composed of biocompatible, implant-grade silicone proven | through performance and biocompatibility testing according to ISO 10993-1.
Sterilizable silicone material via common steam cycle from AAMI ST79. -
-Anti-migration studs on anterior surface of main branch of stent.

Technological Differences

(Subject) Stent is designed by a Physician using software for a specific patient vs. (Predicate) Stent is chosen from stock designs out of a catalog for a specific patient.
(Subiect) Ability to vary the inner diameter of the stent at any location along the । stent from 6mm-18mm in 0.1mm increments (patient-specific design with software) vs. (Predicate) Discretely vary the inner diameter from 8-18mm in 1.0mm increments (stock stent design from catalog)
(Subject) Ability to vary the length of the stent up to 145mm according to the । patient's anatomy vs. (Predicate) Ability to vary length up to 110mm based on available stent designs in a catalog
(Subject) 3D-printed molds for silicone injection vs (Predicate) Machined molds । for silicone iniection
(Subject) Secondary branch angle ≤ 100° vs (Predicate) Secondary branch | angle always 75°
Subject device has lower flat-plate compression strength than the predicate | device

Any risks related to these technological differences have been mitigated to an acceptable level, rendering the subject device substantially equivalent to the predicate device. The technological characteristics, including all design mitigations, have been verified and validated.

NON-CLINCICAL PERFORMANCE TESTING

Performance and functional testing were performed to ensure the Patient-Specific Airway Stent functions according to the inputs and demonstrates substantial equivalence to the predicate device.

Sterilization Testing Confirms that the subject device can be steam sterilized to a SAL of 10-6, using a common cycle in medical centers.
Tear Strength Testing - Supports the claim that the subject device's material is equivalent to the predicate's material in tear strength.

{6}------------------------------------------------

Radial Compression Testing Compares the compression strength of the | subject device against the predicate device
-Fatique Testing - Supports the claim that the subject device does not fatigue when cyclically compressed over the intended life of the implant (1 year)
। Stent Deployment Testing – Supports the claim that the subject device is able to be deployed by a common applicator and rigid bronchoscope system
। Biocompatibility Testing - Supports the claim that the subject device is acceptable to implant in terms of biocompatibility for up to one year; identical to the predicate device's permanent implantation duration.
- Cytotoxicity: MEM Elution Test с
- o Sensitization: Guinea Pig Maximization Test
- Irritation: Intracutaneous Reactivity O
- Toxicity: Acute Systemic Toxicity O
- Pyrogenicity: Material-Mediated Pyrogenicity O
- Subacute/Sub-Chronic Toxicity: Sub-Chronic Intramuscular Implantation o in Rabbits for 90days with Histopathology
- O Genotoxicity: Ames Bacterial Reverse Mutation Assay
- Genotoxicity: Mouse Lymphoma Assay o
- Genotoxicity: In Vivo Mouse Micronucleus Mutagenicity Assay O
- Chemical Characterization of Extractables and Leachables o
Software Verification and Validation Testing Supports the claim that the । software functions as designed, including any design mitigations included to reduce risks associated with the addition of software and patient-specific stent creation into the subject device. Per FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, the software was classified as a Major level of concern.
। Human Factors and Usability Testing for Web Software – Supports the claim that the software is as safe and as effective as the predicate device when used by its intended users in its intended use-environment.
-Migration Testing - Bench testing in procedural training model to test migration forces required to dislodge an implanted patient-specific airway stent
Accelerated Aging Testing Testing to evaluate the shelf-life of the patient- specific airway stents
। Dimensional Testing of Airway Segmentation - Evaluated the accuracy of segmented airway rendering in proprietary segmentation software
-Airway Segmentation Process Validation - Validated the process of segmenting an airway from a CT scan in proprietary segmentation software

CONCLUSION

The Patient-Specific Airway Stent is substantially equivalent to the predicate device in intended use, indications for use, principle of operation, and technological characteristics.

Regulation Number and Section

§ 878.3720 Tracheal prosthesis.

(a)
Identification. The tracheal prosthesis is a rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal tracheal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”