StarPore™ implants are intended for the restoration of bony contour in craniofacial defects.
StarPore™ implants are intended for the restoration or augmentation of bony contour in craniofacial defects.

Device Description

StarPore™ (previously cleared as PoreStar™ Patient Specific Implants) is a range of anatomically shaped surgical implants manufactured from porous high-density polyethylene (HDPE). The star ("Star-") shaped particles create an interconnecting porous ("-Pore") architecture resembling trabecular bone. The implants are provided sterile and intended for single-use. StarPore™ is manufactured from medical grade HDPE (an electrically nonconductive and nonmagnetic polymer) and is suitable for use during Magnetic Resonance Imaging (MRI).
The purpose of this Traditional 510(k) submission is to add "off-the-shelt" implant options to the StarPore™ product line. These off-the-shelf implants would provide surgeons the options of various sizes of implants which, unlike the predicate, would not be individually designed from 3D Computed Tomography (CT) scans provided to Anatomics by the referring surgeon. Instead, the subject implants would be offered in various off-the-shelf sizes and shapes which could then be cut by the prescribing surgeon intra-operatively to create an anatomically matched patient specific design.
StarPore™ is intended for single use only and is provided sterile, using ethylene oxide gas.

AI/ML Overview

This document, K200532, is a 510(k) premarket notification for the StarPore™ device. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed performance study with acceptance criteria in the typical sense of diagnostic or AI-driven device evaluation.

The StarPore™ device is a range of anatomically shaped surgical implants made from porous high-density polyethylene (HDPE), intended for restoring or augmenting bony contour in craniofacial defects. The current submission is for "off-the-shelf" implant options, which can be cut by surgeons intra-operatively.

Given the nature of this submission, the provided information does not include a traditional performance study with accuracy metrics, sensitivity, specificity, etc., as would be expected for a diagnostic or AI device. Instead, the submission relies on demonstrating substantial equivalence to a previously cleared predicate device (Anatomics Pty Ltd. PoreStar Patient Specific Implant - K171037) based on intended use, technological characteristics, material, and performance.

Here's an attempt to address your requests based on the provided text, while acknowledging that many points related to AI/diagnostic device performance studies are not applicable:

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

Based on the provided text, specific quantitative acceptance criteria in terms of performance metrics (like accuracy, sensitivity, specificity) for StarPore™ are not explicitly stated or reported in the context of a new performance study. The submission relies on "substantial equivalence" to a predicate device.

The "performance" documented here refers to the equivalence of the characteristics to the predicate.

Characteristic	Acceptance Criteria (Implied by Substantial Equivalence to Predicate K171037)	Reported Device Performance (StarPore™)
Intended Use	Matching the intended use of the predicate device: augmentation or restoration of bony contour in craniofacial defects.	StarPore™ implants are intended for the restoration or augmentation of bony contour in craniofacial defects. (Matches predicate)
Material	Matching the material of the predicate device: Medical grade, HDPE (high density polyethylene).	Medical grade, HDPE (high density polyethylene). (Matches predicate)
Dimensions	The predicate device had patient-specific implants based on CT scans. The new device introduces "off-the-shelf" options. The criterion is that these off-the-shelf sizes are suitable for intra-operative cutting to achieve a fit for craniofacial defects.	Various shapes consisting of lengths 27mm - 80mm, widths 27mm - 110mm, and thicknesses/heights 1mm - 8mm to be further cut by prescribing surgeons intraoperatively to achieve best fit. (Difference from predicate, but deemed safe/effective through risk analysis).
Packaging	Similar packaging to ensure sterility and integrity.	Double steri-pouch and put in shelf box. (Similar to predicate's "Double peel pouched and put in a shelf box").
Sterility	Same sterilization method as the predicate device.	Sterile, by Ethylene Oxide gas. (Matches predicate)
Safety Testing	Previous design validation and verification activities (material properties, sterilization, biocompatibility, shelf-life, stability) for the predicate (PoreStar™) are applicable.	A new risk analysis assessment for StarPore™ showed no new worst case introduced. All previous testing from PoreStar™ (now StarPore™) is applicable. No further performance testing was deemed needed.

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

This information is not applicable as no new performance study with a test set (in the context of AI/diagnostic evaluation) was conducted. The assessment is based on substantial equivalence to a predicate device and a risk analysis.

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)

This information is not applicable as no new performance study with a test set (in the context of AI/diagnostic evaluation) was conducted which would require ground truth established by experts.

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

This information is not applicable as no new performance study with a test set (in the context of AI/diagnostic evaluation) was conducted.

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. StarPore™ is a physical surgical implant, not an AI or diagnostic tool that would involve human readers or comparative effectiveness studies of this nature.

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

This information is not applicable. StarPore™ is a physical surgical implant, not an algorithm.

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

This information is not applicable as no new performance study (in the context of AI/diagnostic evaluation) was conducted. The "ground truth" for this substantial equivalence submission would be the established safety and effectiveness of the predicate device (K171037) through its previous clearance, and the assessment that the new device does not introduce new questions of safety or effectiveness.

8. The sample size for the training set

This information is not applicable as StarPore™ is a physical surgical implant, not an AI or machine learning model that requires a training set.

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

This information is not applicable as StarPore™ is a physical surgical implant, not an AI or machine learning model.

Summary

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June 2, 2020

Anatomics Pty, Ltd. % Christine Scifert Partner MRC Global 9085 East Mineral Circle, Suite 110 Centennial, CO 80112

Re: K200532

Trade/Device Name: StarPore™ Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, Nose, And Throat Synthetic Polymer Material Regulatory Class: Class II Product Code: JOF Dated: March 3, 2020 Received: March 4, 2020

Dear Christine Scifert:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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,

for Michael J. Ryan 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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200532

Device Name StarPore™

Indications for Use (Describe)

StarPore™ implants are intended for the restoration of bony contour in craniofacial defects.

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)

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510(k) Summary StarPore™ June 1, 2020

Company:	Anatomics Pty LtdWarehouse 1, 246 East Boundary Road,Bentleigh East, VIC 3165, AustraliaTelephone: +0011 61 3 9529 8088Fax: +0011 61 3 9529 8099
Primary Contact:	Christine ScifertPhone: (901) 831-8053
Company Contact:	Robert ThompsonVP Product InnovationE-Mail: Robert.thompson@anatomics.com
Trade Name:	StarPore™
Common Name:	Polymer, Ent Synthetic, Porous PolyethylenePlate, Cranioplasty, Preformed, Alterable
Classification:	Class II
Regulation Number:	21 CFR 874.3620 (Ear, Nose, and Throat Synthetic Polymer Material)
Panel:	Ear, Nose, and Throat
Product Code:	JOF

Predicate Device:

. Anatomics Pty Ltd. PoreStar Patient Specific Implant - K171037

Reference Devices:

Porex MEDPOR Surg Implant Material: Prefor Cran/Fac Impla - K922489
Porex MEDPOR Plus Surgical Biomaterial - K012350
Porex MEDPOR Pterional Surgical Implant - K002586

K922489 and K012350 provide reference devices that have previously been cleared with preformed shapes for craniofacial defects. The geometries of the subject implants are similar to the reference devices previously cleared under K922489 and K002586 for craniofacial defects.

Device Description:

The purpose of this Traditional 510(k) submission is to add "off-the-shelt" implant options to the StarPore™ product line. These off-the-shelf implants would provide surgeons the options of various sizes of implants which, unlike the predicate, would not be individually designed from 3D Computed

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Tomography (CT) scans provided to Anatomics by the referring surgeon. Instead, the subject implants would be offered in various off-the-shelf sizes and shapes which could then be cut by the prescribing surgeon intra-operatively to create an anatomically matched patient specific design.

StarPore™ is intended for single use only and is provided sterile, using ethylene oxide gas.

Indications for Use:

StarPore™ implants are intended for the restoration or augmentation of bony contour in craniofacial defects.

Technological Characteristics Summary:

The subject device is substantially equivalent to the following predicate:

Anatomics Pty Ltd. PoreStar Patient Specific Implant - K171037 (S.E. 12/27/2017)

The subject and predicate devices are similar in Intended Use, Technological Characteristics, Performance Specifications, and Material. See the table below for details on comparison between the subject and predicate devices:

Characteristic	StarPore™ (New Device)	PoreStar Patient Specific Implant (K171037)
Intended Use	StarPore™ implants are intended for therestoration or augmentation of bonycontour in craniofacial defects.	The PoreStar Patient Specific Implant isintended for the augmentation or restoration ofbony contour in craniofacial defects.
Material	Medical grade, HDPE (high densitypolyethylene)	Medical grade, HDPE (high densitypolyethylene)
Dimensions	Various shapes consisting of lengths27mm - 80mm, widths 27mm - 110mm,and thicknesses/heights 1mm - 8mm to befurther cut by prescribing surgeonsintraoperatively to achieve best fit.	Patient specific implants created based onpatient CT scans and approved by prescribingphysician
Packaging	Double steri-pouch and put in shelf box	Double peel pouched and put in a shelf box
Sterility	Sterile, by Ethylene Oxide gas	Sterile, by Ethylene Oxide gas

Performance Testing Summary:

Previous design validation and verification activities were performed for the PoreStar™ (renamed StarPore™) implants. A new risk analysis assessment for the subject products and design specifications has been performed and show no new worst case has been introduced. Therefore, all previous testing including validation of specifications related to material properties, sterilization, biocompatibility, shelflife, stability, and material properties are applicable to the subject device. Thus, it has been determined that no further performance testing is needed.

Substantial Equivalence Conclusions:

In conclusion, the subject StarPore™ device is similar to the predicate device in intended use, technological characteristics, material, and performance. No new questions of safety and effectiveness have been raised. Therefore, the subject device can be considered substantially equivalent.

Regulation Number and Section

§ 874.3620 Ear, nose, and throat synthetic polymer material.

(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.