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The Intramedullary Fixation System is indicated for the fixation of extra-articular fractures of the long bones of the hand including the metacarpals and the proximal and middle phalanges. The optional locking device may be used to minimize axial and rotational motion of the implantable nail during healing.

The Intramedullary Fixation System for the Hand is a sterile, single use, disposable device that is delivered non-toxic. The Intramedullary Fixation System for the Hand consists of the Slotted Awl Assembly, the Implantable Nail Handle Assembly, and Exchange Guide and Bend Tube. Prior to use the implantable nail assembly is nested in the slotted awl assembly. The slotted awl assembly has a trocar point. The implantable nail has a blunt point that is positioned just behind the trocar point of the slotted awl. The sharp point of the slotted awl assembly is passed through a small incision. A hole is drilled into the metacarpal bone by twisting the assembled handles back and forth. After gaining access to the intramedullary space, the slotted awl handle is held stationary while the implantable nail is then advanced distally from the base of the metacarpal bone. The awl handle is then withdrawn and removed for advancement of the implantable nail. The implantable nail is then cut adjacent to the nail handle. Using the bending tube end of the exchange guide and bend tube the implantable nail is bent to 90° with the apex of the bend at the implantable nail insertion site. The nail is trimmed so that the end is below the skin. The small piece remaining will facilitate removal of the implantable nail subsequent to healing. The implantable nail will remain implanted for approximately six weeks. Upon healing of the fracture, the implantable nail is percutaneously removed. In the event that it is desired to reform the implantable nail or implant a smaller nail, this may be accomplished without loosing access to the medullary canal. The exchange guide is advanced along the implantable nail into the medullar space. Once the medullar space is accessed, the nail is removed. Another nail may be placed into the medulla by inserting it into the groove of the exchange guide. After the nail has been inserted into the medullar space, remove the exchange guide. An optional locking device may be used to minimize rotation of the implantable nail. The device consists of a pointed stainless steel cannula mounted to a polymeric handle. After the implantable nail is bent to a 90-degree angle, the locking sleeve is positioned over the end of the implantable nail and manually advanced downward through the cortical perforation and into the metaphysis. The locking device is then advanced until tactile feedback confirms ratchet engagement. The locking device may be further advance to the desired depth. When resistance is felt, the locking nail is impacted into its final position with a few sharp taps. The nail and locking sleeve are simultaneously trimmed.

Here's a breakdown of the acceptance criteria and study information for the Intramedullary Fixation System for the Hand, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated as a numerical sample size for a clinical test set. The submission focuses on bench testing and material standards compliance.
• Data Provenance: The 'data' primarily comes from:
  • Bench tests: Conducted to establish safety and efficacy.
  • Material standards compliance: Based on the properties of the materials used in the device.
  • Comparison to a predicate device: The K-wire manufactured by MicroAire Surgical Equipment.
• Retrospective or Prospective: Not applicable as a clinical study with retrospective/prospective patient data is not described. The studies were laboratory-based (bench testing) and materials analysis.

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

• Number of Experts: Not applicable. Ground truth, in this context, refers to established engineering standards, material properties, and comparative performance against a predicate device.
• Qualifications of Experts: Not applicable for establishing ground truth in this type of submission. The 'expertise' lies in the established ASTM standards and the technical assessment by the manufacturers and presumably, the FDA reviewers.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There was no human interpretation or adjudication described for the bench test results or material compliance. The results would be objectively measured against predefined criteria or the predicate device's performance.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done.
• Effect Size of AI: Not applicable, as this device submission predates widespread AI integration in medical devices of this type and does not involve AI.

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

• Standalone Performance: No, a standalone algorithm performance study was not done. This device is a mechanical implant, not an AI or software algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth:
  • Engineering Standards: Adherence to recognized ASTM standards for materials and fixation pins/wires.
  • Predicate Device Performance: Performance data from the legally marketed predicate device (K-wire by MicroAire Surgical Equipment) served as a benchmark for equivalence in bench testing (stiffness/yield, cutting geometry, drilling).
  • Biocompatibility Data: Established history of biocompatibility for the materials used.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a physical implant, not an AI or machine learning model that requires a "training set." The design and manufacturing processes are iterative, but there is no specific "training set" in the computational sense.

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

• Ground Truth Establishment for Training Set: Not applicable. As there is no training set, there is no ground truth established for one. The design and validation relied on established engineering principles, material science, and comparison to existing, proven devices.

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