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Electro-Spec Steri-Caps are indicated for use in protection of protruding ends of wires. Examples of procedures that may leave protruding wires include:

• Osteotomies or arthrodesis of fractures management in the foot or hand
• Fixation of small bone fragments, in long bones or small bones fractures

The Electro-Spec Steri-Caps are indicated for use in protection of protruding ends of wires. Examples of procedures that may leave protruding wires include:

• Osteotomies or arthrodesis of fractures management in the foot or hand
• Fixation of small bone fragments, in long bones or small bones fractures- Fixation of small bone fragments, in long bones or small bones fractures

Steri-Caps are comprised of a pin ball intended to be placed on the end of a wire or pin protruding from bone, secured with a setscrew, and used to protect the user and wire.

The pin balls are offered in diameters of 8.95mm and 12.13mm, and designed to accommodate K-wires or pins less than 1.65mm in diameter. The set screws are offered in lengths of 3.30mm. The longer of the set screws is referred to as the Long Set Screw. Each set screw is threaded with an M4 x 0.7 outer thread, and has a 2.50mm diameter hexagonal cannulation for use with the 2.5mm driver. The 2.5mm driver is used to set the set screw once the pin or wire has been placed through the pin ball. Each pin ball and set screw is offerent materials, namely 6A4V ELI Titanium per ASTM F136, 304 SST, or 17-4 SST, Heat Treat to condition H900. The component is then treated with an ES (Electro-Spec) Surface Treatment, intended to add hardness, scratch resistance, hydrophobicity, and wear resistance. The ES Surface Treatment is a 4-to-15-micron thick, electroplated alloy that can be plated on numerous types of surfaces providing better scratch-resistance, corrosion, and tarnish properties than conventional surfaces can provide due to its hardness and hydrophobic properties. A satin finish is provided on all components.

All components and the instrument are offered non-sterilization before use

The provided text is a 510(k) summary for a medical device called "Electro-Spec Steri-Caps." It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a study with detailed performance metrics.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in the provided document. The document explicitly states:

• "No non-clinical testing was performed."
• "No clinical testing was performed."

This implicitly means there was no study conducted in the typical sense to establish performance against acceptance criteria for this specific 510(k) submission. The device is being cleared based on substantial equivalence to existing devices, relying on the safety and effectiveness established for the predicate devices.

However, I can extract the available information and highlight what is missing.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The above "Acceptance Criteria" are implied by the device's function and comparison to predicate devices, and the "Reported Device Performance" is derived from the device description and material claims. There are no specific numerical acceptance criteria or test results presented in this summary, as no non-clinical or clinical testing was performed for this 510(k) submission. The FDA cleared it based on substantial equivalence.

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable, as no dedicated test set or study was performed for this 510(k) submission.
• Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable, as no dedicated test set or study requiring expert ground truth establishment was performed.

4. Adjudication method for the test set

• Not applicable.

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

• Not applicable. This device is a mechanical component, not an AI-assisted diagnostic tool.

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

• Not applicable. This is not an algorithm or AI device.

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

• Not applicable.

8. The sample size for the training set

• Not applicable, as no algorithm or AI was developed or studied.

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

• Not applicable.

Summary of what the document does provide regarding device evaluation:

The 510(k) submission for Electro-Spec Steri-Caps relies on substantial equivalence to legally marketed predicate devices (K203698 and K192768).

The comparison focuses on:

• Indications for Use: Stated to be the same as the primary predicate device (K203698).
• Technological Characteristics: The subject device has the same intended use and characteristics such as inserting a pin/K-wire through the device with a locking mechanism. Any differences (shape, materials) are stated not to "result in new questions of safety or effectiveness." Specifically, the materials of the subject device are asserted to meet the requirements of ISO 10993-1.

The crucial information about formal acceptance criteria and the study proving adherence to them is absent because the regulatory pathway chosen (510(k) substantial equivalence) for this type of device (a metallic bone fixation fastener component) typically does not require new non-clinical or clinical studies if substantial equivalence to a predicate can be demonstrated through design, material, and intended use comparisons.

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