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The Jet-X HA Coated Half Pin is intended to be used with an external fixation system for fracture fixation (open and closed); pseudoarthrosis or nonunion of long bones; limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformity; correction of segmental bony or soft tissue defects; and joint arthrodesis.

The Jet-X Half Pin is a modification of the Jet-X Half Pin that was cleared for market under K023921. This submission describes measures taken to implement an alternate supplier for application of the hydroxyapatite (HA) coating.

This 510(k) submission (K033289) for the Jet-X® Half Pins describes a modification to an already cleared device (K023921), specifically related to an alternate supplier for the hydroxyapatite (HA) coating. This type of submission generally relies on demonstrating substantial equivalence to a predicate device rather than conducting new clinical trials for performance acceptance criteria. Therefore, the information typically found in a study proving acceptance criteria for new device performance (like accuracy, sensitivity, specificity, etc.) is not present in this document.

The document emphasizes that the modified device has identical technological characteristics, design, material type, principle of operation, indications for use, and intended use to the predicate device, with the only change being the HA coating supplier. The new HA coating is stated to be equivalent to the coating used on the predicate.

Given this context, I will address the requested points based on what is available in the provided text, and explicitly state when information is not present due to the nature of this type of 510(k) submission.

Acceptance Criteria and Device Performance Study (Missing/Not Applicable for this Submission Type)

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: This 510(k) is for a modification (change in HA coating supplier) to an already cleared device, not a new device. The acceptance criteria for the original device would have been established and met in K023921. For this submission, the "acceptance criteria" is primarily the demonstration of substantial equivalence to the predicate device, particularly regarding the alternate HA coating's equivalence. The document doesn't detail performance metrics or specific test results for the modified device, but rather asserts its equivalence to the predicate.

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

• Sample Size for Test Set: Not applicable / Not specified. No new clinical or performance testing on a "test set" is detailed in this 510(k) summary for the modified device. The submission relies on affirming equivalence.
• Data Provenance: Not applicable. No new data from a test set is provided.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable / Not specified. This type of submission, focusing on material/supplier change for an orthopedic implant, does not involve clinical "ground truth" establishment by medical experts in the way an AI diagnostic device would.

4. Adjudication Method for the Test Set

• Not applicable. No test set requiring adjudication is described.

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

• Not applicable. This is an orthopedic implant with a HA coating, not an AI-assisted diagnostic tool. Therefore, an MRMC study is irrelevant to this submission.

6. Standalone (Algorithm Only) Performance Study

• Not applicable. This is an orthopedic implant, not an algorithm.

7. Type of Ground Truth Used

• Not applicable. For this type of submission, "ground truth" in the diagnostic sense is not relevant. The substantial equivalence argument relies on comparing the modified device's characteristics (materials, design, function, HA coating properties) to the predicate device, not on diagnostic accuracy against a clinical reference standard.

8. Sample Size for the Training Set

• Not applicable. This is an orthopedic implant, not a machine learning model.

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

• Not applicable.

Summary of the Study (as described in the 510(k) document):

The "study" presented in this 510(k) is not a clinical trial or performance study in the traditional sense. It's a comparative analysis demonstrating substantial equivalence to a predicate device.

• Objective: To demonstrate that the Jet-X Half Pin with an alternate hydroxyapatite (HA) coating supplier is substantially equivalent to the currently marketed Jet-X Half Pin (cleared under K023921).
• Methodology: The submission asserts that:
  • The dimensional characteristics, design, material type, principle of operation, indications for use, and intended use of the subject Jet-X Half Pin are identical to the predicate device (K023921).
  • The hydroxyapatite (HA) coating applied to the subject device is equivalent to the HA coating currently used on Smith & Nephew's Jet-X Half Pin (K023921).
• "Results" / Conclusion: The FDA reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. This indicates that the claim of equivalence, including the HA coating, was accepted by the FDA based on the provided documentation (which is not fully contained in this summary).

Key Takeaway: This 510(k) focuses on demonstrating that a manufacturing change (alternate HA coating supplier) does not alter the fundamental safety and effectiveness profile such that the device is no longer substantially equivalent to its predicate. It does not involve de novo clinical performance testing with human experts or AI algorithms.

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The Jet-X HA Coated Half Pin is intended to be used with an external fixation system for fracture fixation (open and closed); pseudoarthrosis or nonunion of long bones; limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformity; correction of segmental bony or soft tissue defects; and joint arthrodesis.

The Jet-X Half Pin is a modification of the Jet-X TiN Coated Half Pin that was cleared for market under K023134. This submission design modifications to the threads and provides for a hydroxylapatite (HA) coated stainless steel half pin.

The provided text describes a 510(k) submission for the "Jet-X HA Coated Half Pins," which is a rigid implant and does not involve AI or algorithms, nor does it present any studies involving device performance data against acceptance criteria in the manner typically seen for diagnostic or AI-driven medical devices.

Therefore, I cannot extract the requested information as it is not present in the provided document. The document focuses on establishing substantial equivalence to predicate devices based on design, materials, and intended use for regulatory clearance, rather than presenting a performance study with acceptance criteria.

Response:

The provided document describes a 510(k) submission for the "Jet-X HA Coated Half Pins," which is a medical device for bone fixation. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with specific acceptance criteria and reported device performance in the context of an AI or diagnostic device.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, as typically found in studies for AI-driven or diagnostic devices, is not available in the provided text.

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