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Intended for the treatment of fracture fixation, osteotomies (ex. Akin, Chevron, Scarf, Weil), reconstruction, revision surgery and arthrodesis of small bones in the upper and lower extremities.

The Pinit™ Small Bone Fusion System consists of 2-hole bone plates made available in three length options and two thickness options, and 2.0 mm and 2.7 mm diameter bone screws having lengths varying from 8 mm to 24 mm. The bone plate is pre-assembled with a suture loop intended to provide a traction force required to achieve compression between bone seaments. The bone screws have a snap-off feature designed to work with the plates and/or as standalone bone fixation fasteners. The bone plates and screws are manufactured from implant grade stainless steel.

The only modification made in this submission was the addition of bone plates having the same design profile with a different thickness. Also, the Trade/Proprietary Name was changed from CheckMate™ to Pinit™.

The provided text describes a 510(k) submission for a medical device called the "Pinit™ Small Bone Fusion System." This submission is a "Special 510(k): Device Modification," meaning the device is largely the same as a previously cleared device, with minor modifications.

The evaluation for this submission primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness criteria through extensive clinical studies. Therefore, the details requested in your prompt (like specific acceptance criteria tables, sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone performance, and large training sets with detailed ground truth methods) are not typically present or required in this type of 510(k) submission for a device modification.

The provided document does not contain information regarding specific quantitative acceptance criteria for device performance, a study proving the device meets these criteria in the way you've outlined, or detailed clinical study results involving human readers or large datasets.

However, based on the information provided, I can infer and summarize what was done to demonstrate substantial equivalence:

Summary of Acceptance Criteria and the Study Demonstrating Conformance for the Pinit™ Small Bone Fusion System (K140617)

The Pinit™ Small Bone Fusion System is a modification of a previously cleared device (CheckMate™ Small Bone Fusion System, K122334). The primary modification was the addition of bone plates with the same design profile but a different thickness and a change in the trade/proprietary name.

The "acceptance criteria" in this context are not quantitative performance metrics in a clinical trial, but rather a demonstration that the modified device remains substantially equivalent to its predicate device(s) in terms of safety and effectiveness, despite the changes. This is achieved by showing that the fundamental scientific technology, indications for use, operating principles, design profile, materials, shelf life, packaging, and sterilization processes are either unchanged or the changes do not raise new questions of safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

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

• No "test set" in the traditional sense of a clinical or imaging study was used. The evaluation was based on non-clinical bench testing and engineering analyses.
• The data provenance for bench testing would be from laboratory testing performed by or for Arthrosurface, Inc., on samples of the modified device. This is a controlled, prospective testing environment, not dependent on country of origin of patient data.

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

• No external experts (e.g., radiologists) were used to establish ground truth for this type of non-clinical evaluation. The "ground truth" for mechanical properties is established by the engineering specifications and validated testing methods (e.g., ASTM standards for mechanical testing). The interpretation and validation of these results would be done by qualified engineers and regulatory specialists within the company and at the FDA.

4. Adjudication Method for the Test Set

• Not applicable. There was no human "test set" requiring adjudication. Mechanical testing results are objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic imaging devices or algorithms that interpret images, and is not applicable to an orthopedic implant like the Pinit™ Small Bone Fusion System, especially for a device modification submission focused on substantial equivalence.

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

• Not applicable. This device is a mechanical implant; it does not involve algorithms or AI.

7. The Type of Ground Truth Used

• The "ground truth" for this submission was based on engineering and mechanical specifications, validated material properties, and established test methods for orthopedic implants. The performance targets are derived from the predicate devices and general standards for such implants.

8. The Sample Size for the Training Set

• Not applicable. There was no "training set" in the context of an AI/algorithm. For the physical device, manufacturing and process controls ensure consistency across production runs, but this isn't a "training set" in the data science sense.

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

• Not applicable. As no training set was used, no ground truth needed to be established for one. The "truth" for this device revolves around its physical and mechanical properties meeting established engineering principles and performance comparable to its predicate through bench testing.

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