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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

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.

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)

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

1. 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.

2. 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.

3. 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.

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

   • N/A. No clinical test set.

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:

   • 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.

6. 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.

7. 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.

8. 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.

9. 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.

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