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PEEK System Indications
The Tyber Medical PEEK 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 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 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 TyPEEK 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 or Lapidus)
  The device is intended for use with ancillary fixation The Tyber Medical Wedge System is not intended for use in the spine

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 come in a PEEK or PEEK with a plasma-sprayed commercially pure titanium coating on the superior and inferior surfaces.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Tyber Medical Wedge System (K150394), presented in the requested format.

Based on the provided FDA 510(k) summary, the Tyber Medical Wedge System is a Class II medical device, and the submission does not involve clinical data for performance assessment. Instead, its substantial equivalence to predicate devices is established through non-clinical mechanical testing. Therefore, many of the typical acceptance criteria and study details for AI/software devices (like expert adjudication, MRMC studies, or training set details) are not applicable here.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Test Set: Not applicable in the context of clinical studies with human participants.
• Data Provenance: The "test set" here refers to the physical devices and materials used in non-clinical mechanical testing. The provenance relates to the manufacturing process of the Tyber Medical Wedge System and the specific tests conducted. The document does not specify the exact number of samples or iterations performed for each mechanical test, nor does it detail the specific lab or location where the tests were performed beyond stating "non-clinical mechanical testing was performed."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable. This device's performance was evaluated through non-clinical mechanical testing, not through expert human assessment of clinical data or images. The "ground truth" is defined by the objective standards of the ASTM specifications for mechanical strength and material properties.

4. Adjudication Method for the Test Set

• Not applicable. There was no expert adjudication involved as the performance was determined by
  non-clinical mechanical testing to objective standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is not an AI-assisted device. The evaluation method was non-clinical mechanical testing to establish substantial equivalence.

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

• Not applicable. This is not an AI/algorithm device. The evaluation was a standalone device performance (mechanical testing) without human-in-the-loop for its primary function.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is established by engineering standards and specifications, specifically the ASTM standards referenced (ASTM F2077, ASTM F1044, ASTM F1147, ASTM F1978), which define the acceptable mechanical properties and coating characteristics for similar bone fixation devices. The actual results of the tests (e.g., load to failure, shear strength) are compared against the performance of predicate devices, which implicitly adhere to similar standards.

8. The Sample Size for the Training Set

• Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. There is no training set for this device.

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