· Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
· Opening wedge of Medial Cuneiform of Cotton osteotomies
· Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy) Midfoot Wedges
· Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
· Nonunion of arthrodesis of the Midfoot including Metatarsal/Cunciform arthrodesis (TMT os Lapidus)

The device is intended for use with ancillary fixation The Tyber Medical Wedge System is not intended for use in the spine

TyPEEK System Indications

The Tyber Medical Wedge System is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot such as:

Cotton and Evans Wedges

· Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
· Opening wedge of Medial Cuneiform of Cotton osteotomies
· Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy) Midfoot Wedges
· Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
· Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform arthrodesis (TMT of Lapidus)

The device is intended for use with ancillary fixation The Tyber Medical Wedge System is not intended for use in the spine

Device Description

This submission is to add additional footprints to the system.

The Tyber Medical Wedge System, manufactured from PEEK-Optima®, consist of implants available in various foot prints, heights and indication configurations with an open architecture to accept packing of bone graft materials. The exterior of the device has "teeth" or other generally sharp engagement members on the superior and inferior surfaces. The device comes in a PEEK or PEEK with a plasma-sprayed commercially pure titanium coating on the superior and inferior surfaces.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Tyber Medical Wedge System," specifically for adding new footprints (configurations) to an already cleared system. This type of submission relies on demonstrating "substantial equivalence" to a predicate device, rather than proving efficacy or performance through extensive clinical trials as would be the case for a novel device.

Therefore, the typical metrics and study designs used for evaluating AI/ML-based medical devices (like MRMC studies, sensitivity/specificity, AUC, etc.) are not applicable to this document. The document explicitly states:

"Performance Data (Clinical) Clinical data and conclusions were not needed for this device" (Page 5)
"The worst-case device has not changed from the prior submission and so no new testing has been completed." (Page 5)

The acceptance criteria here concern demonstrating the device functions comparably to a predicate device, without introducing new safety or effectiveness concerns, particularly for the new configurations.

Here's an interpretation based on the provided document, addressing the prompt's questions where applicable, and noting where the information is not present or relevant due to the nature of a 510(k) for an updated existing device:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence for a 510(k) Modification)

Acceptance Criteria (for 510(k) Substantial Equivalence of a Modified Device)	Reported Device Performance / Justification
1. Maintain Identical Intended Use	The "Indications for Use" for the Tyber Medical Wedge System (both PEEK and TyPEEK) remain unchanged from the predicate device. They are intended for internal bone fixation for bone fractures or osteotomies in the ankle and foot, specifically for Cotton and Evans Wedges (opening wedge osteotomies of the bones of the foot including for Hallux Valgus, opening wedge of Medial Cuneiform of Cotton osteotomies, Lateral Column Lengthening) and Midfoot Wedges (opening wedge osteotomies, nonunion of arthrodesis including Metatarsal/Cuneiform arthrodesis). Not for use in the spine.
2. Maintain Similar Technological Characteristics	The device is still manufactured from PEEK-Optima®, with an option for plasma-sprayed commercially pure titanium coating. It has "teeth" or sharp engagement members on superior and inferior surfaces. The submission extends the available "footprints, heights and indication configurations" but explicitly states the "material, tooth profile, heights, lengths and graft volume are unchanged" from the predicate. The "worst-case device has not changed."
3. No New Safety or Effectiveness Concerns Introduced	"The addition of the new configurations does not add a new worst case device. Given that no new worst case is introduced, the new configurations to the Tyber Medical Wedge System do not raise any additional risk to safety and effectiveness." (Page 5)
4. Performance Data (Non-Clinical)	"The worst-case device has not changed from the prior submission and so no new testing has been completed." (Page 5). Pyrogenicity testing was performed per ST72:2011, indicating biocompatibility.
5. Performance Data (Clinical)	"Clinical data and conclusions were not needed for this device." (Page 5) This means the FDA agreed that the changes were minor enough not to warrant new human clinical studies.

Detailed Answers to Specific Questions (as per this 510(k) document):

A table of acceptance criteria and the reported device performance:
- See table above. The acceptance criteria for this 510(k) are based on demonstrating substantial equivalence, meaning the device's modifications do not introduce new safety or effectiveness concerns compared to the predicate. The performance is assessed by confirming the new configurations do not alter the existing, accepted performance envelope.
Sample sizes used for the test set and the data provenance:
- N/A. This document is for a 510(k) submission adding new configurations to an existing device. It explicitly states, "The worst-case device has not changed from the prior submission and so no new testing has been completed." (Page 5) and "Clinical data and conclusions were not needed for this device" (Page 5). Therefore, there is no "test set" in the context of clinical or performance data for new configurations, nor is there provenance data in the sense of patient-based studies. Pyrogenicity testing was mentioned, but no sample sizes for that are provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. As no clinical "test set" was generated, no experts were used in this context. The "ground truth" for a 510(k) is typically established by the predicate device's existing clearance and the established safety and performance of its design and materials.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No clinical test set.
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:
- N/A. This device is a physical implant (a bone wedge/fastener), not an AI/ML diagnostic or assistive software. Therefore, MRMC studies and AI assistance are irrelevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a physical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this 510(k) and its claims of substantial equivalence, the "ground truth" rests on the established safety and effectiveness profile of the predicate device (Tyber Medical Wedge System (K150394)) and the demonstration that the new configurations do not introduce new safety or performance risks. This often involves engineering analysis, material properties, and comparison to existing biomechanical data of the cleared predicate.
The sample size for the training set:
- N/A. There is no "training set" in the context of AI/ML or a traditional clinical study for this device type.
How the ground truth for the training set was established:
- N/A. No training set exists.

In summary: This FDA document is a 510(k) clearance based on "substantial equivalence" of a modified device (adding new sizes/footprints). It is not a document describing the rigorous clinical testing typically associated with demonstrating efficacy or diagnostic performance for novel or high-risk devices, nor is it related to AI/ML software validation. The "acceptance criteria" revolve around demonstrating that the modified device remains as safe and effective as its predicate.

Summary

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Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the first profile being the most prominent.

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

Tyber Medical LLC Mark F. Schenk Vice President of Regulatory and Ouality 83 S Commerce Way. Suite 310 Bethlehem. Pennsylvania 18017

May 16, 2017

Re: K171327

Trade/Device Name: Tyber Medical Wedge System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: PLF, HRS, HWC Dated: May 5, 2017 Received: May 5, 2017

Dear Mr. Schenk:

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 Part 801); medical device reporting of medical device

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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.

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,

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) K171327

Device Name Tyber Medical Wedge System

Indications for Use (Describe)

PEEK System Indications

The Tyber Medical Wedge System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot such as:

Cotton and Evans Wedges

· Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
· Opening wedge of Medial Cuneiform of Cotton osteotomies
· Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy) Midfoot Wedges
· Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
· Nonunion of arthrodesis of the Midfoot including Metatarsal/Cunciform arthrodesis (TMT os Lapidus)

The device is intended for use with ancillary fixation The Tyber Medical Wedge System is not intended for use in the spine

TyPEEK System Indications

The Tyber Medical Wedge System is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot such as:

Cotton and Evans Wedges

· Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
· Opening wedge of Medial Cuneiform of Cotton osteotomies
· Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy) Midfoot Wedges
· Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
· Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform arthrodesis (TMT of Lapidus)

The device is intended for use with ancillary fixation The Tyber Medical Wedge System is not intended for use in the spine

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.

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510(k) Summary of Safety and Effectiveness:

TYBER MEDICAL Wedge System

Submitter by:	Tyber Medical LLC83 South Commerce WaySuite 310Bethlehem, PA 18017
Contact Person	Mark F. SchenkVice President of Regulatory and QualityPhone: (610) 849-0645 Fax: (866) 889-9914Email: mschenk@tybermed.com
Date Prepared	May 12, 2017
Common Names	Bone WedgeOsteotomy Bone Wedge
Trade Name	Tyber Medical Wedge System
Classification Nameand Number	Single/multiple component metallic bone fixation appliances and accessories(21 CFR 888.3030)Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040)
Product Code	PLF, HRS and HWC
Predicate Device	Tyber Medical Wedge System (K150394)
Device Description	This submission is to add additional footprints to the system.The Tyber Medical Wedge System, manufactured from PEEK-Optima®, consistof implants available in various foot prints, heights and indicationconfigurations with an open architecture to accept packing of bone graftmaterials. The exterior of the device has "teeth" or other generally sharpengagement members on the superior and inferior surfaces. The devicecomes in a PEEK or PEEK with a plasma-sprayed commercially pure titaniumcoating on the superior and inferior surfaces.

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Intended Use/ Indications for use

PEEK System Indications

The Tyber Medical Wedge System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot such as:

Cotton and Evans Wedges
- Opening wedge osteotomies of the bones of the foot O including osteotomies for Hallux Valgus
- Opening wedge of Medial Cuneiform of Cotton osteotomies о
- Lateral Column Lengthening (Evans Lengthening Osteotomy o or Calcaneal Z Osteotomy)
Midfoot Wedges
- O Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
- Nonunion of arthrodesis of the Midfoot including o Metatarsal/Cuneiform arthrodesis (TMT or Lapidus)

The device is intended for use with ancillary fixation The Tyber Medical Wedge System is not intended for use in the spine

TyPEEK System Indications

The Tyber Medical Wedge System is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot such as:

Cotton and Evans Wedges
- Opening wedge osteotomies of the bones of the foot o including osteotomies for Hallux Valgus
- Opening wedge of Medial Cuneiform of Cotton osteotomies O
- Lateral Column Lengthening (Evans Lengthening Osteotomy o or Calcaneal Z Osteotomy)
Midfoot Wedges ●
- Opening wedge osteotomies of the bones of the foot o including osteotomies for Hallux Valgus
- Nonunion of arthrodesis of the Midfoot including o Metatarsal/Cuneiform arthrodesis (TMT or Lapidus)

The device is intended for use with ancillary fixation The Tyber Medical Wedge System is not intended for use in the spine

Performance Data(Non-Clinical)	• The worst-case device has not changed from the prior submission and scno new testing has been completed.
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· Pyrogenicity testing was performed per ST72:2011.

Performance Data(Clinical)	Clinical data and conclusions were not needed for this device
--------------------------------	---------------------------------------------------------------

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Statement of	Tyber Medical Wedge System and its predicate device have the same
Technological	indications for use, materials, technology and similar design, principles of
Comparison	operation and test results.
Conclusion	The new Tyber Medical Wedge System is substantially equivalent to thepredicate device because the material, tooth profile, heights, lengths andgraft volume are unchanged. The addition of the new configurations does notadd a new worst case device. Given that no new worst case is introduced, thenew configurations to the Tyber Medical Wedge System do not raise anyadditional risk to safety and effectiveness.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.