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The intended use of the Normed Transport Distraction Device is described and is identical to the 510 (k) number K990140 in which, the Normed Transport Distraction Device is designed for use in totally or partially edentulous mandibles or maxillae to increase bone height and mass by means of distraction osteogenesis. As clinically defined the gradual step lengthening of a callus for distraction osteogenesis can be achieved with the transitory use of the Normed Transport Distraction Device. This Normed transitory monofocal or bifocal distraction device is indicated for use in maxillofacial alveolar and small craniofacial skeletal bones. Clinical indications are as follows: - Tumor Resections - Severe trauma which make continuous bone segments no longer possible . - Bone grafting defects . - Sever open mandibular fractures . - Facial deformity corrections

External Mandibular Fixator and/or Distractor

This FDA 510(k) summary does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.

The document is a notification for an additional distributor (Osteomedics® Inc.) for a device (Normed Bone Transport Distraction Device) that was previously cleared under 510(k) number K990140. It explicitly states that "The manufacturer, product design, product material, manufacturing process, device description, product intend use, labeling', quality assurance procedures, sterilization, substantial equivalency information and operational principal is identical to the information available in the 510 (k) number K990140."

Therefore, none of the requested information can be extracted from the provided text. To obtain this information, one would need to refer to the original 510(k) submission (K990140) for the Normed Bone Transport Distraction Device.

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The ACE/Normed Transport Distraction Device is designed for use in totally or partially edentulous mandibles or maxillae to increase bone height and mass by means of distraction osteogenesis. As clinically defined the gradual step lengthening of a callus for distraction osteogenesis can be achieved with the transitory use of the ACE/Normed Transport Distraction Device. This ACE/Normed transitory monofocal or bifocal distraction device is indicated for use in maxillofacial alveolar and small craniofacial skeletal bones.

Clinical Indications are as follows:

• · Tumor Resections
• Severe trauma which make continuous bone segments no longer possible
• · Bone grafting defects
• · Severe open mandibular fractures
• · Facial deformity corrections

The ACE/Normed Transport Distraction Device is designed for use in totally or partially edentulous mandibles or maxillae to increase bone height and mass by means of distraction osteogenesis. As clinically defined the gradual step lengthening of a callus for distraction osteogenesis can be achieved with the transitory use of the ACE/Normed Transport Distraction Device. This ACE/Normed transitory monofocal or bifocal distraction device is indicated for use in maxillofacial alveolar and small craniofacial skeletal bones.

This document is a 510(k) clearance letter from the FDA for a medical device called the "Normed Bone Transport" (also referred to as the ACE/Normed Transport Distraction Device). This type of document does not contain the detailed study information, acceptance criteria, or performance data that your request asks for.

The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, rather than proving device performance against specific, pre-defined acceptance criteria in the way a clinical trial for a new drug or a novel high-risk device might.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: Not present. The clearance is based on substantial equivalence, not a performance study as described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not present.
4. Adjudication method for the test set: Not applicable/not present.
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: This device is a mechanical distraction device, not an AI-powered diagnostic or assistive technology. Therefore, this type of study is not relevant and not present.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/not present for the clearance determination.
8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of what the document does provide:

• Device Name: Normed Bone Transport / ACE/Normed Transport Distraction Device
• Regulatory Class: II
• Product Code: JEY
• Indications for Use: Designed for use in totally or partially edentulous mandibles or maxillae to increase bone height and mass by means of distraction osteogenesis. Specifically, it's indicated for maxillofacial alveolar and small craniofacial skeletal bones, with clinical indications including tumor resections, severe trauma, bone grafting defects, severe open mandibular fractures, and facial deformity corrections.
• Contraindications: Insufficient available bone, poor bone quality, generalized diseases, allergies, or habits that may contribute to poor healing or osteogenesis (e.g., uncontrolled diabetes, blood dyscrasias, hyperthyroidism, AIDS, alcohol addiction, psychiatric disorders, oral infections, malignancies, myocardial infarction within the last 12 months, heavy smoking, use of chewing tobacco, poor oral hygiene). Requires good medical health status and history, plus a radiographic evaluation of anatomical conditions.

To find the kind of detailed study information you're asking for, you would typically need to consult a 510(k) summary (if available publicly in more detail than this letter), a premarket approval (PMA) application, clinical study reports, or peer-reviewed publications associated with the device if such studies were conducted and published. The provided letter is merely the FDA's decision regarding substantial equivalence.

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