Search Results

The TIMESH® Titanium Mini-Softplate/Screw and Micro-Softplate/Screw System is intended for use in any oral-maxilio-cranio-facial surgical procedure, either orthognathic or trauma, wherein rigid or semi-rigid internal fixation is utilized as a means of holding bone fragments together.

The TIMESH® Titanium Mini-Softplate/Screw and Micro-Softplate/Screw System consists of a system of small plate and screws of various sizes and shapes. The implant components are fabricated from Ti-6Al-4V titanium alloy as described by ASTM F-136 or its ISO equivalent. Alternatively, the entire system or parts of it may be made out of commercially pure titanium. The TIMESH® Titanium Mini-Softplate/Screw and Micro-Softplate/Screw System may be supplied either sterile or non-sterile.

This 510(k) premarket notification for the TIMESH® Titanium Mini-Softplate/Screw and Micro-Softplate/Screw System does not contain acceptance criteria for device performance or a study demonstrating the device meets those criteria from an AI/algorithm perspective.

This submission is for a medical device (bone plates and screws) and the assessment of "substantial equivalence" is based on:

• Material composition: Ti-6Al-4V titanium alloy (ASTM F-136 or ISO equivalent) or commercially pure titanium.
• Intended Use: Oral-maxillio-cranio-facial surgical procedures (orthognathic or trauma) for rigid or semi-rigid internal fixation of bone fragments.
• Mechanical Test Data: Literature concerning commercially available predicate devices was supplied, and the submission mentions "Mechanical test data were provided in support of this notification."

Therefore, for the information requested, I can only provide details based on what is available in the provided text.

Analysis based on the provided FDA 510(k) Summary:

1. A table of acceptance criteria and the reported device performance

   • Acceptance Criteria (Implicit - Substantial Equivalence): The device's materials, intended use, and mechanical properties should be substantially equivalent to predicates legally marketed prior to May 28, 1976. Specific quantitative mechanical performance criteria are not detailed in this summary but are referred to as "Mechanical test data."
   • Reported Device Performance: The summary states "Mechanical test data were provided in support of this notification." However, the specific results or how they compare to acceptance criteria for mechanical tests are not included in the provided text. The FDA's letter states that they "determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976." This implies the mechanical data met the necessary comparison to predicate devices, but the criteria themselves are not explicit.

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 in the provided text. This information would typically come from the detailed mechanical test reports, which are not included. The concept of a "test set" in this context refers to the physical samples of the device undergoing mechanical testing, not a dataset for an algorithm.

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 in the provided text. This device is a surgical implant. "Ground truth" for its performance is established through engineering and biological testing (e.g., biocompatibility) and comparison to established medical device standards or predicate device performance, not expert consensus on medical images or diagnoses.

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

   • Not Applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., radiologists reviewing images) to resolve discrepancies. This device's evaluation relies on objective mechanical and material properties.

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 is a hardware implant, not an AI or diagnostic algorithm. MRMC studies are irrelevant for this type of device.

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

   • No. This is a physical medical device (bone plate and screws), not an algorithm.

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

   • Regulatory Substantial Equivalence / Engineering Standards / Predicate Device Performance. The "ground truth" for this type of device's regulatory clearance is its conformity to material specifications (ASTM F-136, ISO equivalent), its mechanical performance in tests (e.g., fatigue, static strength) being equivalent to or better than a predicate device, and demonstration of biocompatibility. Specific quantitative details are not in the summary.

8. The sample size for the training set

   • Not Applicable. This is not an AI/ML device, so there is no "training set."

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

   • Not Applicable. This is not an AI/ML device.

Summary of what can be extracted from the document regarding the "study":

The "study" refers to the mechanical testing conducted, as mentioned: "Mechanical test data were provided in support of this notification." This testing would have compared the performance of the TIMESH® Titanium Mini-Softplate/Screw and Micro-Softplate/Screw System to that of legally marketed predicate devices, or against established engineering standards for such implants. The FDA's determination of "substantial equivalence" indicates that these mechanical tests demonstrated acceptable performance relative to existing devices. However, the exact methodology, sample sizes of the test articles, or specific results of these mechanical tests are not detailed within the provided 510(k) summary.

Ask a specific question about this device