The Ascential IBD PEEKc Spacers are indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from the C2-C3 disc to the C7-T1 disc. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Ascential IBD PEEKc Spacers are to be used with autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and are to be implanted via an open, anterior approach.

The Ascential IBD PEEKc Spacer is intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

Device Description

The Ascential IBD PEEKC Spacer is a hollow, ring-shaped PEEK Optima® LT1 implant with three Tantalum marker pins. The spacers are offered in a variety of lengths, heights, and lordotic angles to adapt to varying patient anatomies. The hollow, ring-shaped implants have serrations on the top and bottom surfaces of the spacer. The hollow space of the implant is intended to hold bone graft material. The IBD PEEKC spacer is to be used as an interbody fusion device (IBD) for the cervical spine (from C2-C3 to C7-T1).

The Ascential IBD PEEKC Spacers to be used for cervical IBD applications are available in a variety of sizes, from 4 mm to 12 mm in height (in 1 mm increments), two depths: 12 mm and 14 mm and two widths: 14 mm and 16 mm. There are also 0° and 4° wedge shaped options that allow the surgeon to choose the size better suited to the patient's anatomy and pathology.

Class I instruments are provided for successfully performing anterior cervical interbody fusion procedures.

The Ascential IBD PEEKC Spacer is a sterile version (gamma sterilized) of the AVS® AS PEEK Spacer

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the Ascential IBD PEEK(c) Spacer, an intervertebral body fusion device. The document primarily focuses on establishing substantial equivalence to a predicate device, the AVS® AS PEEK Spacer (K142251), particularly regarding the impact of terminal sterilization (gamma sterilization) on the device's material properties and performance.

The "study" or justification provided in this document is a comparison of material properties after sterilization and reliance on previous testing of the predicate device. It is not a clinical study or a comparative effectiveness study involving human readers or AI.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance (Table)

This document does not specify quantitative acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or clinical outcomes that would typically be associated with AI or diagnostic device studies. Instead, the acceptance criteria are implicitly related to maintaining the mechanical properties and sterility of the device after gamma sterilization, and being "substantially equivalent" to an existing predicate device.

Acceptance Criterion (Implicit)	Reported Device Performance
Mechanical properties of sterilized material equivalent to non-sterilized material.	The sterilized material of IBD PEEK(c) has mechanically equivalent material properties to the non-sterile AVS AS implants. Supporting documentation from Invibio shows that gamma sterilization (up to 75 kGy) of PEEK-OPTIMA® material does not impact mechanical performance.
Pyrogenicity within limits.	Bacterial endotoxin testing (BET) as specified in ANSI/AAMI ST72:2011 is used for pyrogenicity testing to achieve the Endotoxin limit of < 20EU/Device. (Assumed met, as no failure is reported).
Sterility maintained for recommended shelf-life.	Accelerated aging data demonstrated that the sterilization process and sterile barrier packaging system are effective in maintaining sterility for the recommended 5-year shelf-life.
Maintaining same technological characteristics, design, materials, and intended use as predicate.	The subject sterile packed implants have the same technological characteristics as the non-sterile packed predicate devices. These characteristics include same design, technical requirements, materials of construction, and indications/intended use.
Substantially equivalent to predicate device.	The subject implants that are intended to be sterile packed are substantially equivalent to the predicate non-sterile devices. The subject implants retain the same intended and indications for use, technological characteristics, and mode of operation as the predicate non-sterile implants.

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

This document describes engineering and material testing, not a clinical study with a "test set" of patient data in the context of AI or diagnostic devices.
The "test set" for material properties would be samples of the PEEK-OPTIMA® material that underwent gamma sterilization and subsequent mechanical testing. The specific number of samples for these tests is not mentioned in the provided text.
Data provenance: The "supporting documentation from Invibio" refers to the PEEK material manufacturer. The location of this testing is not specified, nor whether it was retrospective or prospective in relation to this specific device submission.

2. 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 question is not applicable to the type of data presented in this submission. There is no "ground truth" established by human experts in the context of image interpretation or clinical diagnosis. The "ground truth" here is the result of laboratory mechanical and sterility testing.

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

This question is not applicable. No adjudication method for expert review of a test set is mentioned.

4. 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 MRMC comparative effectiveness study was done. This document is for a physical intervertebral body fusion device, not an AI or diagnostic imaging device.

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

Not applicable, as this is not an AI algorithm.

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

The "ground truth" for this submission revolves around:
- Mechanical properties: Measured directly through laboratory testing (e.g., tensile strength, compressive strength, flexural modulus, etc. - though specific tests are not detailed beyond "mechanical performance").
- Sterility: Demonstrated through bacterial endotoxin testing (BET) and sterility assurance level (SAL) studies (implied by "sterilization process and sterile barrier packaging system are effective").
- Substantial Equivalence: Based on comparison of design, materials, technological characteristics, and intended use to a legally marketed predicate device, supported by the material property testing.

7. The sample size for the training set

Not applicable, as this is not an AI algorithm requiring a training set.

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

Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked one behind the other.

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

July 15, 2016

Stryker Spine Ms. Tina Mornak Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401

Re: K161407

Trade/Device Name: Ascential IBD PEEK Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: June 23, 2016 Received: June 24, 2016

Dear Ms. Mornak:

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 (21 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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" (21CFR 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,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K161407

Device Name Ascential IBD PEEKc Spacer

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)

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Special 510(k) Premarket Notification

510(k) Summary: Ascential IBD PEEKC Spacer
Submitter:	Stryker Spine2 Pearl CourtAllendale, New Jersey 07401
Contact Person	Tina MornakRegulatory Affairs SpecialistPhone: 201-760-8193Fax: 201-962-4070Email: tina.mornak@stryker.com
Date Prepared	May 11, 2016
Trade Name	Ascential IBD PEEKC Spacer
Common Name	Cervical Interbody Device
Proposed Class	Class II
Classification Nameand Number	Intervertebral body fixation device21 CFR §888.3080
Product Code	ODP
Predicate Devices	Primary Predicate:AVS® AS PEEK Spacer (K142251)
Device Description	The Ascential IBD PEEKC Spacer is a hollow, ring-shaped PEEK Optima® LT1implant with three Tantalum marker pins. The spacers are offered in a varietyof lengths, heights, and lordotic angles to adapt to varying patient anatomies.The hollow, ring-shaped implants have serrations on the top and bottomsurfaces of the spacer. The hollow space of the implant is intended to holdbone graft material. The IBD PEEKC spacer is to be used as an interbodyfusion device (IBD) for the cervical spine (from C2-C3 to C7-T1).The Ascential IBD PEEKC Spacers to be used for cervical IBD applications areavailable in a variety of sizes, from 4 mm to 12 mm in height (in 1 mmincrements), two depths: 12 mm and 14 mm and two widths: 14 mm and 16mm. There are also 0° and 4° wedge shaped options that allow the surgeon tochoose the size better suited to the patient's anatomy and pathology.Class I instruments are provided for successfully performing anterior cervicalinterbody fusion procedures.The Ascential IBD PEEKC Spacer is a sterile version (gamma sterilized) of theAVS® AS PEEK Spacer
Intended Use	The Ascential IBD PEEKC spacers are indicated for use in cervical interbodyfusion procedures in skeletally mature patients with degenerative disc disease(DDD) at one level from the C2-C3 disc to the C7-T1 disc. DDD is defined asback pain of discogenic origin with degeneration of the disc confirmed byhistory and radiographic studies.The Ascential IBD PEEKC spacers are to be used with autogenous bone graftand/or allogenic bone graft comprised of cancellous and/or corticocancellousbone graft, and are to be implanted via an open, anterior approach.The Ascential IBD PEEKC spacers are intended to be used with supplementalfixation systems that have been cleared for use in the cervical spine. Thiscervical device is to be used in patients who have had six weeks of non-operative treatment.
510(k) Summary: Ascential IBD PEEKc Spacer
Summary of theTechnologicalCharacteristics	The subject sterile packed implants have the same technologicalcharacteristics as the non-sterile packed predicate devices. Thesecharacteristics include same design, technical requirements, materials ofconstruction, and indications/ intended use. Design modifications were notincorporated to facilitate sterile packaging of the implants.
Summary of thePerformance Data	The sterilized material of IBD PEEKc has mechanically equivalent materialproperties to the non-sterile AVS AS implants. Therefore, verification testingconducted for AVS AS is appropriate for the IBD PEEKc implants as they aredimensionally identical. Supporting documentation from Invibio shows of theeffects of up to 75kGY gamma sterilization of PEEK-OPTIMA® material,gamma sterilization does not impact mechanical performance of the material.Bacterial endotoxin testing (BET) as specified in ANSI/AAMI ST72:2011 isused for pyrogenicity testing to achieve the Endotoxin limit of < 20EU/Device.
Conclusions	The subject implants that are intended to be sterile packed are substantiallyequivalent to the predicate non-sterile devices. The subject implants retain thesame intended and indications for use, technological characteristics, and modeof operation as the predicate non-sterile implants. The accelerated aging datademonstrated that the sterilization process and sterile barrier packagingsystem are effective in maintaining sterility for the recommended 5 year shelf-life.

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Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.