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The Ensplint™ Bone Screws are intended to treat fractures of various small and long bones. The Ensplint™ Bone Screws can also be used with the EnsplintRx Distal Radius System.

HA Cortical Self-Tapping Bone Screws in diameters of 1.5mm to 5.0mm and lengths of 4mm to 90mm.

This 510(k) summary describes a medical device, the Ensplint™ Bone Screw, that is seeking clearance as substantially equivalent to a predicate device. The primary method for demonstrating substantial equivalence is through comparison to existing, legally marketed devices and adherence to relevant standards, rather than extensive new performance studies.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Study that Proves Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a comparison to a predicate device and adherence to an industry standard, rather than a clinical trial or a performance study generating new data. The rationale for substantial equivalence explicitly states:

"The Ensplint™ Bone Screw utilizes the same material and technology characteristics as the Syntec Scientific Corp. Bone Screws and conforms to the ASTM F543-2 Standard Specification for HA Bone Screws. The diameters and lengths are within the diameters and lengths of the predicate Syntec Scientific Corp bone screws. Therefore testing is not needed to demonstrate that the subject devices are substantially equivalent to other legally marketed bone screws."

This indicates that the "study" is a benchmarking and documentation exercise showing direct equivalence or adherence to established standards and the predicate.

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

• Sample Size: Not applicable in the context of a traditional performance "test set." The basis for clearance is comparison to a predicate device and adherence to a standard, not empirical testing of a "test set" of devices from this specific manufacturer. The "device performance" in the table above refers to descriptive characteristics matching the predicate/standard, not measured performance data from a specific test sample.
• Data Provenance: Not applicable for new data generation. The provenance stems from the characteristics of the predicate device (Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, K983495) and the published ASTM F543-2 standard. This is not prospective or retrospective patient data but rather existing device specifications and industry standards.

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

• Not applicable. There's no "ground truth" established by experts for a test set in the traditional sense of a clinical or diagnostic study. The "ground truth" for the equivalence claim is implicitly the established safety and effectiveness profile of the predicate device and the criteria defined in the ASTM standard.

4. Adjudication Method for the Test Set

• Not applicable. No "test set" requiring adjudication in the context of this 510(k) submission.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

• No. This is not a diagnostic imaging device or an AI-assisted tool where human reader performance would be a relevant metric.

6. Standalone Performance Study

• No, a standalone (algorithm only without human-in-the-loop performance) study was not done. The submission explicitly states "testing is not needed" due to direct equivalence to a predicate and conformance to a standard. This is a characteristic-based comparison.

7. Type of Ground Truth Used

• The "ground truth" in this context is based on:
  • Predicate Device Characteristics: The established design, material, and technological specifications of the legally marketed predicate device (Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, K983495).
  • Industry Standard: The requirements and specifications outlined in the ASTM F543-2 Standard Specification for HA Bone Screws.

8. Sample Size for the Training Set

• Not applicable. This is not an AI/ML device that requires a training set. The device design is based on established engineering principles and comparison to an existing device, not on learning from a data set.

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

• Not applicable, as there is no training set for this type of device submission.

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