The PoreStar Patient Specific Implants are a range of anatomically shaped, patient specific surgical implants manufactured from high density polyethylene (HDPE) to the reconstructive boundaries indicated by the surgeon. The interconnecting porous ("Pore-") architecture created from a star ("-Star”) shaped particle resembles trabecular bone and permits tissue ingrowth into the implant. PoreStar Patient Specific Implants are individually designed from 3D Computed Tomography (CT) scans provided to Anatomics by the referring surgeon. The PoreStar Patient Specific Implants are provided sterile and intended for single-use.

AI/ML Overview

The PoreStar Patient Specific Implant is intended for the augmentation or restoration of bony contour in craniofacial defects. The submission demonstrates substantial equivalence to a predicate device, the MEDPOR Customized Surgical Implant (K083621).

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly present a stand-alone "acceptance criteria" table with corresponding "reported device performance" in the typical sense for clinical performance. Instead, it focuses on non-clinical testing to demonstrate equivalence to a predicate device. The acceptance criteria are implicitly met if the results of all non-clinical tests are successful and demonstrate substantial equivalence.

Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Material Safety (Biocompatibility)	Compliance with ISO 10993-1, 10993-11, 10993-3, 10993-5, 10993-6, 10993-10 for various tests (Systemic toxicity, Genotoxicity, Cytotoxicity, Implantation, Intracutaneous reactivity, Skin sensitization).	Biocompatibility testing of material in accordance with ISO 10993-1 (Systemic toxicity, Genotoxicity, Cytotoxicity, Implantation, Intracutaneous reactivity, Skin sensitization) was performed. The presence of additives in the material's formulation has no impact on the safety or efficacy of the device and its biocompatibility has been fully assessed according to ISO 10993-1 requirements.
Mechanical Integrity	Tensile testing according to ASTM D638, Flexural testing according to ASTM D790.	Tensile testing according to ASTM D638 and Flexural testing according to ASTM D790 were performed. Mechanical characteristics have been assessed to be equivalent to the predicate.
Compatibility	Screw pull-out testing according to ASTM F543. Verification of mechanical compatibility with screws or other fixation methods.	Screw Pull-out testing in accordance to ASTM F543 and Verification testing of PoreStar's mechanical compatibility with screws or other fixation methods were performed.
Sterilization	Sterilization validations in accordance with ISO 11135-1 and 11737-1. EO residuals testing per ISO 10993-7.	Sterilization validations were performed in accordance with ISO 11135-1 and 11737-1. EO residuals testing per ISO 10993-7 was performed. The sterilization method (EO Gas) is the same as the predicate.
Shelf-life (Packaging & Implant)	Packaging shelf-life testing on accelerated aged samples as per ASTM F1980-07, including Peel testing to ASTM F88-09, Dye-testing to ASTM F1929-98 and ASTM1929-12. Mechanical characterization of aged implants including Tensile testing according to ASTM D638, Flexural testing according to ASTM D790, Screw Pull-out testing according to ASTM F543. Packaging dye testing according to ASTM F1929-15, Bubble emission testing according to ASTM F2096-11. Transport simulation test stipulated in ISTA 2A.	Packaging shelf-life testing on accelerated aged samples as per ASTM F1980-07 consisting of Peel testing to ASTM F88-09 and Dye-testing to ASTM F1929-98 and ASTM1929-12 was performed. Mechanical characterization of aged implants consisting of Tensile testing according to ASTM D638, Flexural testing according to ASTM D790, Screw Pull-out testing according to ASTM F543 was performed. Packaging Dye testing according to ASTM F1929-15, Bubble emission testing according to ASTM F2096-11, and Transport simulation test stipulated in ISTA 2A (Compression, Vibration, Shock) were performed. A validated shelf-life of 2 years for the proposed device (compared to 10 years for predicate) is deemed equivalent as there is no safety or efficacy impact, and this mode of use is stipulated in the product labeling.
Porous, High Density Polyethylene	Device is manufactured from high density porous polyethylene.	Both devices are manufactured from high density porous polyethylene.
Patient Specific Design Method	Implants are manufactured to specifications set by the surgeon via CT scan submission.	Both devices have the same design method whereby the implants are manufactured to the specifications set by the surgeon via submission of CT scan.
Fixation Method	Utilizes plates and screws for fixation.	Both devices utilize plates and screws as the method of fixation.
Sterilization Method	EO Gas sterilization.	Both devices have the same sterilization method (EO Gas).

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

This submission relies on non-clinical bench testing to demonstrate substantial equivalence, rather than clinical data or a "test set" of patient cases, as would be typical for an AI/ML device. Therefore, a sample size for a test set of patient data, data provenance, retrospective/prospective nature, number of experts, or adjudication methods are not applicable to this type of submission.

The "samples" used were for the various material and mechanical tests (e.g., test specimens for tensile, flexural, and pull-out tests, packaging samples for integrity and shelf-life tests). The specific number of samples for each test is not detailed in the provided summary but would be standard for compliance with the cited ASTM and ISO standards. The provenance of these test samples (e.g., where the HDPE material was manufactured) is not given.

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, as this is a non-clinical bench testing submission for a physical implant.

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

Not applicable, as this is a non-clinical bench testing submission for a physical implant.

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

Not applicable. This device is a passive implant, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This device is a passive implant, not an algorithm.

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

For the non-clinical tests, the "ground truth" is defined by the standards and specifications outlined in the ASTM and ISO documents. For example:

Material Safety: Compliance with biocompatibility limits defined by ISO 10993 standards.
Mechanical Integrity: Measured mechanical properties (e.g., tensile strength, flexural strength) meeting established material specifications or being equivalent to the predicate device’s properties.
Sterilization: Sterility assurance levels (SAL) and residual limits defined by ISO 11135-1, 11737-1, and 10993-7.
Shelf-life: Packaging integrity and mechanical properties after accelerated aging meeting predefined acceptance criteria referenced in ASTM F1980-07, ASTM F88-09, ASTM F1929-98, ASTM F1929-12, ASTM F1929-15, ASTM F2096-11, ISTA 2A.

8. The sample size for the training set

Not applicable. This device is a passive implant and does not involve AI/ML requiring a training set.

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

Not applicable. This device is a passive implant and does not involve AI/ML requiring a training set or its associated ground truth establishment.

Summary

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December 27, 2017

Anatomics Pty Ltd % Nicholas Connell. Consultant Brandwood Biomedical Level 8, 1 Chandos St St Leonards, NSW 2065 Australia

Re: K171037

Trade/Device Name: PoreStar Patient Specific Implant Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, Nose, And Throat Synthetic Polymer Material Regulatory Class: Class II Product Code: JOF, GWO Dated: November 28, 2017 Received: December 1, 2017

Dear Nicholas Connell:

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.

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

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(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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.

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Srinivas Nandkumar -S

for 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) K171037

Device Name PoreStar Patient Specific Implant

Indications for Use (Describe)

The PoreStar Patient Specific Implant is intended for the augmentation of bony contour in craniofacial defects.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

Date Prepared:	25 December 2017
510(k) Owner:	Anatomics Pty23-27 Wellington Street,St Kilda, VIC 3182AustraliaTel: +61 (0) 3 9529 8088
Application Contact	Nicholas ConnellLevel 8, 1 Chandos StSt Leonards NSW 2065AustraliaTel: +61(0) 299062984Fax: +61(0) 285804613
Trade Name:	PoreStar Patient Specific Implant
Common Name:	Porous Polyethylene Implants
Classification Name:	21 CFR 874.3620
Product Code:	JOF, GWO
Predicate Device:	MEDPOR Customized Surgical Implant (K083621)
Indications for Use:	The PoreStar Patient Specific Implant is intended for theaugmentation or restoration of bony contour in craniofacial defects.
Device Description:	The PoreStar Patient Specific Implants are a range of anatomicallyshaped, patient specific surgical implants manufactured from highdensity polyethylene (HDPE) to the reconstructive boundariesindicated by the surgeon. The interconnecting porous ("Pore-")architecture created from a star ("-Star”) shaped particle resemblestrabecular bone and permits tissue ingrowth into the implant.PoreStar Patient Specific Implants are individually designed from 3DComputed Tomography (CT) scans provided to Anatomics by thereferring surgeon. The PoreStar Patient Specific Implants areprovided sterile and intended for single-use.
Non-Clinical Testing: All non-clinical testing relating to the PoreStar Patient SpecificImplant device is summarised in the table below
Characteristic	Testing
Material Safety	Biocompatibility testing of material in accordance with ISO 10993-1 Systemic toxicity testing according to ISO 10993-11 Genotoxicity testing according to ISO 10993-3 Cytotoxicity testing according to ISO 10993-5 Implantation testing according to ISO 10993-6 Intracutaneous reactivity testing according to BS EN ISO 10993-10 Skin sensitization testing according to ISO 10993-10
Mechanical Integrity	Tensile testing according to ASTM D638Flexural testing according to ASTM D790
Compatibility	Screw Pull-out testing in accordance to ASTM F543Verification testing of PoreStar's mechanical compatibility with screws orother fixation methods
Sterilization	Sterilization validations were performed in accordance with ISO 11135-1and 11737-1
EO residuals testing per ISO 10993-7
Shelf-life	Packaging shelf-life testing on accelerated aged samples as per ASTM F1980-07 consisting of:
	Peel testing to ASTM F88-09 Dye-testing to ASTM F1929-98 and ASTM1929-12
	Mechanical characterization of aged implants consisting of:
	Tensile testing according to ASTM D638 Flexural testing according to ASTM D790 Screw Pull-out testing according to ASTM F543
	Packaging
Dye testing according to ASTM F1929-15
Bubble emission testing according to ASTM F2096-11
Transport simulation test stipulated in ISTA 2A. Includes:
Compression Vibration (fixed and random displacement) Shock

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Summary of Equivalence:

Characteristic	MEDPOR Customized	PoreStar Patient	Comment
	Surgical Implant	Specific Implant
Intended Use	The MEDPORCustomized SurgicalImplant is intended forthe augmentation orrestoration of bonycontour in craniofacialdefects.	The PoreStar PatientSpecific Implant isintended for theaugmentation orrestoration of bonycontour in craniofacialdefects.	Same
Prescription/ОТС	Prescription - sale by oron the order of aphysician	Prescription - sale by oron the order of aphysician	Same
Materials	Porous, high densitypolyethylene	Porous, high densitypolyethylene withstabilizing additives	Equivalent - the presence ofadditives in the material'sformulation has no impact onthe safety or efficacy of thedevice. The biocompatibility ofthe PoreStar Patient SpecificImplant has been fullyassessed according to therequirements of ISO 10993-1(Section 16) and its mechanicalcharacteristics have beenassessed to be equivalent tothe predicate (Section 19).
Size Range/Specifications	Patient specific implantscreated based on patientCT scans and approvedby prescribing physician	Patient specific implantscreated based on patientCT scans and approvedby prescribing physician	Same
Packaging	Double-peel pouchedand put in a clamshell orshelf box	Double peel pouched andput in a shelf box	Same
Sterile/Non-Sterile	Sterile	Sterile	Same
SterilizationMethod	EO Gas	EO Gas	Same

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Shelf-Life	10 Years	2 Years	Equivalent - no safety or efficacy impact as this mode of use is stipulated in the product labeling
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Conclusion: The predicate and proposed devices share the same indications for use, usage environments and general principle of operation. Both devices are single patient, single-use devices which are supplied sterile. The technical characteristics are equivalent between the Anatomics PoreStar Patient Specific Implants and the Predicate device and include:

Both devices are manufactured from high density porous polyethylene ●
Both devices have the same design method whereby the implants are ● manufactured to the specifications set by the surgeon via submission of CT scan
Both devices utilise plates and screws as the method of fixation
Both devices have the same sterilization method ●

The primary differences between the devices are:

. The addition of small quantities of proprietary additives in the formulation of the PoreStar Patient Specific Implant's HDPE
. A validated shelf-life of 2 vears for the proposed device, compared with 10 years for the predicate device.

These differences raise no issues regarding the safety or effectiveness of the proposed device and have been documented and validated in this submission.

On the basis of these similarities in design and performance, it can be established the proposed device is substantially equivalent to the predicate.

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.