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The PIP Fix is indicated for the treatment of unstable dorsal fracture dislocations of the proximal interphalangeal (PIP) joint of the fingers in which external skeletal fixation as provided by the PIP Fix alone is sufficient to obtain and maintain concentric reduction of the fracture dislocation during bone and soft tissue healing.

The PIP Fix is an external skeletal fixator designed to obtain and maintain concentric reduction of an unstable dorsal fracture dislocation of the proximal interphalangeal (PIP) joint. This device is capable of exerting both palmar translation and distal length restoration forces on the middle phalanx while simultaneously lifting the distal end of the proximal phalanx to restore joint alignment. With the dorsal dislocation of the middle phalanx reduced, the fractured fragments of the joint surface are reopposed. The effect of the PIP Fix is present throughout the complete range of finger motion allowing full active flexion and extension during healing of the bone and soft tissues.

The PIP Fix is installed by a surgeon in a healthcare facility / hospital environment. Included with the gamma irradiated, sterile PIP Fix is a Pin Placement Guide that allows for a Transverse Bone Pin to be accurately placed through the axis of PIP joint rotation. A Dorsal Bone Pin is inserted vertically into the middle phalanx. The device is installed on the Dorsal Bone Pin and is linked to the Transverse Bone Pin with Elastic Bands. These bands provide the translating forces that hold the joint concentrically reduced. The device enables the surgeon to determine the distribution of the direction of the forces between palmar translation and distal length restoration. This is accomplished by rotating the Elastic Band posts about an arc concentric with the PIP joint axis such that the force vector resolution may be purely in a palmar translation direction or a combination of palmar translation and length restoration. An Angle Lock Screw locks the device in the chosen position to maintain the force distribution. A Tension Adjust Screw on the PIP Fix allows the surgeon to adjust the amount of tension in the Elastic Bands so they exert the least amount of tension necessary to maintain joint alignment.

The PIP Fix is manufactured using metal and Ultem plastic. The Bone Pins are fabricated from 316L stainless steel per ASTM F138. Both latex and non-latex elastic bands are supplied with the device. All components are designed for single use only. The device is typically worn for 6 to 8 weeks depending on the rate of healing and the surgeon's assessment of the same. During this time, the Bone Pins are the only portion of the device contacting or penetrating the skin in a non-transient manner.

The provided text is a 510(k) summary for the PIP Fix device. It outlines the device's indications for use, its comparison to a predicate device, and performance data. However, it does not include a table of acceptance criteria and reported device performance with numerical values, nor does it describe a study that explicitly tested the device against such criteria in the way typically found for AI/ML device submissions.

The information provided focuses on demonstrating substantial equivalence to a predicate device for a mechanical external fixation device, not an AI/ML algorithm. Therefore, many of the requested items related to AI/ML specific studies (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable or not present in this document.

Here's a breakdown of the available information based on your request, with an emphasis on what is not present given the nature of the document:

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the document in the format of specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) and corresponding numerical performance results. The document instead discusses computational analyses comparing force generation and stress on components with a predicate device.

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

Not applicable/Not provided. This document describes a physical medical device (external fixator) and its mechanical properties, not a software algorithm that would typically have a "test set" in the context of AI/ML. The "performance data" refers to computational analysis of force and stress.

3. 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):

Not applicable/Not provided. This information is relevant for AI/ML diagnostic or prognostic devices where expert consensus is used to establish a "ground truth" for evaluating algorithm performance. This document does not describe such a study.

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

Not applicable/Not provided. Similar to point 3, this is relevant for expert ground truth establishment in AI/ML studies.

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:

No. This document does not mention an MRMC study or any study involving human readers with or without AI assistance. The device is a physical external fixator operated by a surgeon.

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

Not applicable. The device is a mechanical external fixator; there is no standalone algorithm performance to evaluate.

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

Not applicable. For the "performance data" presented (computational analysis), the "ground truth" is based on engineering principles and material properties, rather than clinical outcomes or pathological diagnoses. The assessment relies on computational models and material specifications to determine if the device components can withstand the forces generated.

8. The sample size for the training set:

Not applicable/Not provided. As there is no AI/ML algorithm, there is no training set mentioned.

9. How the ground truth for the training set was established:

Not applicable/Not provided.

Summary of available information relevant to "proving the device meets acceptance criteria" (within the context of a 510(k) for a mechanical device):

The "acceptance criteria" for this device, while not explicitly stated in a table with numerical thresholds, appear to be implicitly linked to demonstrating substantial equivalence to the predicate device and showing the device performs safely and effectively for its intended use. This is achieved through:

• Computational Analyses:
  • Force Performance: The PIP Fix's force performance is comparable to the predicate device when in palmar translation only positions.
  • Increased Length Restoration Force: The PIP Fix applies 5 times greater length restoration force than the predicate device in "translation & length restoration force" positions. This is a design enhancement over the predicate, addressing an unmet need.
  • Dorsal Pin Stress Analysis: A computational analysis was performed on the dorsal pin due to the increased length restoration force. This showed a 5x increase in bending stress.
    • Proof it meets acceptance implicitly: The reported bending stress remains significantly below the pin material yield strength. This implies the material and design are robust enough for the increased forces, thus meeting an implicit "acceptance criterion" of structural integrity.
• Bacterial Endotoxin Testing (BET):
  • Result: Detected endotoxin levels were less than the FDA guidance recommended limit of 20.0 EU/device.
  • Proof it meets acceptance: This directly demonstrates the device meets a specific biological safety "acceptance criterion" related to sterility.

Study/Evidence that proves the device meets the implicit acceptance criteria:

The "study" referenced for performance is primarily computational analysis and a Bacterial Endotoxin Test. These are not clinical studies, but engineering and laboratory tests.

• Computational Analyses: These involved modeling the forces and stresses on the device components (specifically, the dorsal pin) under the conditions of use, especially considering the increased length restoration force compared to the predicate.
• Bacterial Endotoxin Testing: This was a laboratory test performed on the implantable components of the device to quantify endotoxin levels.

In conclusion, for this specific mechanical device, the "acceptance criteria" and "proof" are demonstrated through engineering analyses and specific lab tests to ensure mechanical integrity and biological safety, aligned with the requirements for substantial equivalence to a predicate device, rather than through large-scale clinical trials or AI/ML specific performance studies.

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