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The Tandry CMF System is a Maxillofacial plate and screw system intended for osteotomy, stabilization and rigid fixation of maxillofacial/midface fractures and reconstruction including infraorbital area and maxillofacial, and mandibular and maxillary correction surgery.

Each plate is indicated to be used in the following anatomic regions:

• · 1.2mm upper-face plates Orbital floor region, zygomatic region, and dento-alveolar region
• · 1.5mm mid-face plates Zygomatic region, orbital floor region, and maxilla
• · 2.0 mm mini plates Orthognathics midface/mandible
• · 2.0/2.3mm mandible plates Mandibular

The Tandry CMF Plate System consists of various sized plates and screws. The plates and screws are fabricated from pure titanium and Ti-6Al-4V. The plates are designed to distribute for respective anatomical and indicated areas, besides, they can be used with self-tapping, self-drilling, emergency self-tapping and locking screws.

This document is a 510(k) Premarket Notification from Microware Precision Co., Ltd. for their Tandry CMF Plate System. It describes the device, its intended use, and compares it to predicate devices to demonstrate substantial equivalence.

Based on the provided text, here's an analysis of the acceptance criteria and study information:

Key Takeaway: The submission explicitly states that clinical studies were NOT required to support substantial equivalence for this device. Therefore, information related to clinical performance, human reader studies, and specific AI acceptance criteria (which would typically be evaluated in such studies) is not present in this document. The "study" here refers to non-clinical tests.

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

The document does not present a formal table of acceptance criteria in the sense of a numerical performance target (e.g., sensitivity, specificity, accuracy) combined with reported device performance from a clinical study. This is because, as stated, clinical studies were not required.

Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to predicate devices through non-clinical testing (biomechanical tests, biocompatibility, reprocessing, and sterilization).

Here's a breakdown of the non-clinical test results:

• The results support substantial equivalence to predicate devices. |
  | Biocompatibility | - Sample preparation per ISO 10993-12.
• Biological Safety Assessment guided by ISO 10993-1.
• Cytotoxicity testing per ISO 10993-5.
• The previous testing results for the predicate device (Tandry Locking Plate System K171904) are utilized, asserting the proposed device meets validation requirements. |
  | Reprocessing and Sterilization | - Previous testing results for the predicate device (Tandry Locking Plate System K171904) are utilized, as the material, manufacturing process, geometry, physico-chemical, body/fluid contact, and sterilization process are the same.
• Validated steam sterilization instructions to a sterility assurance level (SAL) of 10-6 using the biological indicator overkill method (in accordance with ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO 14937). |
  | Design Characteristics | - Dimensions, shape, and sizes are similar to predicate devices (as detailed in the comparative table on page 6). |
  | Material Composition | - Fabricated from pure titanium (ASTM F67) and Ti-6Al-4V (ASTM F136), which are standard materials used in predicate devices. |

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not applicable as no clinical test set or human data was used for a performance study. The "test set" for this submission consists of device samples evaluated in non-clinical lab settings (biomechanical and biocompatibility tests). No specific sample sizes for these lab tests are provided in the summary, other than "representative samples."

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)

This information is not applicable as no clinical study with expert interpretation was conducted.

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

This information is not applicable as no clinical study with human readers requiring adjudication was conducted.

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 MRMC comparative effectiveness study was done or required. The device is a traditional medical implant (plate and screw system), not an AI-powered diagnostic or assistive technology.

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

This information is not applicable as the device is not an algorithm or AI system.

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

For the non-clinical tests, the "ground truth" is defined by established engineering standards and biological safety guidelines (e.g., ASTM standards for biomechanics, ISO series for biocompatibility and sterilization). There is no clinical "ground truth" (like pathology or outcomes data) established or reported because no clinical study was performed.

8. The sample size for the training set

This information is not applicable as the device is not an AI/ML algorithm that requires a training set.

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

This information is not applicable as the device is not an AI/ML algorithm that requires a training set.

In summary, the document details a 510(k) submission for a traditional mechanical medical device, where substantial equivalence is demonstrated through non-clinical bench testing and comparison to predicate devices, rather than through clinical trials or AI performance evaluations.

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