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The Rod-5 Distraction device is intended for use in patients with bone loss due to periodontal disease, trauma or post tumor resection, Ankylosed teeth, or Atrophic boney areas inadequate for implant placements or restorative procedures which need to increase in bone mass and height by means of distraction osteogenesis.

The device consists of two bondable attachments and a horizontal rod that spans the distraction site. the rod is supported by these attachments which are bonded to the teeth and has holes for engagement of distraction wire. The spring washers and detents allow for activation of the device during distraction and provide a self-locking mechanism to prevent deactivation of the device. The device is activated by a screwdriver, which is inserted in to the screwdriver slot, pushed against the washer to disengage the detent, and then rotated. The device is predominately - tooth bone, with only a fixation wire attached to the bone; no screws are required. Removal of the device requires only cutting the fixation wire. The wire can then be pulled through the bone and soft tissue without the need for an incision.

The provided document is a 510(k) summary for a medical device (Oral Osteodistraction Distraction Rod Appliance (ROD 5)) and does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria related to a performance study with a test set, expert ground truth, or an AI algorithm.

The document discusses substantial equivalence to a predicate device (KLS-Martin Track Distractor K002152) and uses a comparison chart to highlight similarities in material, distraction rate, distraction mechanism, activation, site of distraction, target use, latency period, distraction period, retention period, intended use, and surgical technique. This type of comparison is standard for 510(k) submissions to demonstrate that a new device is as safe and effective as a legally marketed predicate, rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with the elements you've listed.

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The Rod-4 Distraction device is utilized for the purpose of maxillary and midface Osteodistraction in the reconstruction of patients with congenital and acquired craniofacial anomalies, narrow and underdeveloped maxilla.

The device consists of two to four preformed stainless steel crowns, which are cemented over maxillary first permanent molars and first permanent bicuspids. Stainless steel crowns have male and female precision attachments welded to them prior to cementation. Three Leone hyraax screws are also welded to the above-described attachments (two on the buccal and one on the palatal surfaces). The device is activated by a screwdriver, which is inserted in to the screwdriver slot of the hyraax screw and then rotated. The device is predominately - tooth bone, with KILS bone plates attached to the bone. Surgical mini screws are required to secure bone plates to the bone. Removal of the device requires removal of mini screws and removal of the crows.

This document describes a 510(k) premarket notification for a medical device, the "Oral Osteodistraction Distraction Rod Appliance (Rod 4)." This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving safety and effectiveness through clinical trials with specific acceptance criteria and performance metrics typically associated with AI/software devices.

Therefore, many of the requested elements (acceptance criteria, specific study details like sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment) are not applicable to this type of device and submission. The FDA 510(k) process for traditional devices like this focuses on material, design, and functional equivalence to a legally marketed predicate.

Here's what can be extracted and what cannot:

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

• Not applicable in the typical sense for a 510(k) of a mechanical device. This submission focuses on demonstrating substantial equivalence to a predicate device based on its materials, intended use, and design principles, rather than performance against pre-defined acceptance criteria from a clinical trial. The "performance" is implicitly deemed equivalent to the predicate.

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

• Not applicable. There is no "test set" in the context of clinical data for this type of 510(k) submission.

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. There is no "ground truth" establishment in the context of clinical data for this type of 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) 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 is a mechanical distraction device, not an AI or software device.

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

• Not applicable.

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.

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

• Not applicable.

Summary of Device and Equivalence Information (as provided in the document):

The submission for the Oral Osteodistraction Distraction Rod Appliance (Rod 4) is a 510(k) premarket notification. The purpose of this submission is to demonstrate that the Rod 4 device is substantially equivalent to legally marketed predicate devices, meaning it is as safe and effective as those devices.

Predicate Devices:

• KLS Martin Rigid External Distractor K972047
• Oral Osteodistraction Rod Appliances (Rod 1, 2, 3) K014001

Intended Use of Rod 4:
The Rod-4 Distraction device is utilized for the purpose of maxillary and midface Osteodistraction in the reconstruction of patients with congenital and acquired craniofacial anomalies, narrow and underdeveloped maxilla.

Basis for Substantial Equivalence (derived from the "Comparison Chart"):
The document compares Rod 4 to its predicates based on several key characteristics. The "performance" is implicitly demonstrated through the similarities to the predicate devices, which are already legally marketed.

Key Finding from the 510(k) process:
The FDA determined that the device is substantially equivalent to the predicate devices for its stated indications for use. This means the FDA believes it is as safe and effective as the existing devices on the market. The primary difference noted (and justified for equivalence) is the shift in intended use for the "Rod" type device from mandibular to maxillary distraction, aligning its intended use with the KLS Martin predicate. The physical and operational characteristics are largely similar to or variations of the Rod 1, 2, 3 series.

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The Oral Osteodistraction Distraction Rod Appliances is intended to be used in the mandible for conditions such as mandibular deficiency or post-traumatic effects of the mandible, where gradual bone distraction is required.

Distraction Osteogenesis Rod Appliances are used for mandibular bone distraction.

The major components include:

• 1. KLS Martin bone plates and screws.
• Ormco Stainless steel crowns, Herbst Rods. 2.
• 3. Leone expansion screws.

This is a 510(k) premarket notification for a medical device called "Oral Osteodistraction Distraction Rod Appliances." It's important to note that a 510(k) submission generally does not require the robust clinical studies with acceptance criteria and performance data that you would expect for new, high-risk devices or software. Instead, it demonstrates "substantial equivalence" to a predicate device already on the market.

Therefore, the information you're asking for, such as detailed acceptance criteria, a specific study proving it meets those criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies, is typically not present in a 510(k) submission for a device of this type (a physical implantable device, not an AI/software device).

The document you provided focuses on:

• Device Description and Intended Use: What the device is and what it's for.
• Predicate Devices: Identifying similar devices already legally marketed.
• Comparison Chart: Demonstrating that the new device is substantially equivalent to the predicate devices based on materials, distraction rate, fixation methods, activation, placement, and intended use. This comparison is the "study" for substantial equivalence.

Here's how I can address your points based on the provided text, while also explaining why some information is absent:

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

Acceptance Criteria & Device Performance (Based on Substantial Equivalence):

Explanation: The "acceptance criteria" here are implicitly the characteristics of the legally marketed predicate devices. The "reported device performance" is the description of the Oral Osteodistraction device. The comparison aims to show that the new device is sufficiently similar to the predicates, or where it differs, the differences do not raise new questions of safety or effectiveness. For instance, the material difference (Stainless Steel 304 vs. Titanium Alloy/Surgical Stainless Steel) or the slight variation in initial distraction rate (.5mm/day first 2 days, then 1mm/day vs. 1mm/day) would have been evaluated by the FDA to determine if they affect substantial equivalence.

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

• Sample Size: Not applicable. This 510(k) submission does not present a clinical study with a "test set" as one would for a diagnostic or AI device. The "test" is the comparison against predicate devices' specifications and intended use.
• Data Provenance: Not applicable. No clinical data is presented for this substantial equivalence submission.

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. There was no "test set" and no ground truth established by experts in a clinical study for this 510(k). The "ground truth" for substantial equivalence is the established performance and safety profile of the predicate devices, as understood by the FDA and the medical community.

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

• Not applicable. No clinical test set or adjudication method outlined.

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 physical intraoral distractor, not an AI or software device, and therefore MRMC studies are irrelevant in this context.

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

• Not applicable. This device is a physical intraoral distractor, not an algorithm.

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

• For demonstrating substantial equivalence: The "ground truth" is the regulatory acceptance and established safety and effectiveness of the legally marketed predicate devices (KLS-Martin Intraoral Distractor K973275 and Synthes Mandibular Distractor K962272). This relies on prior FDA clearances and generally accepted medical and engineering principles for such devices.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

In summary, the provided document is a 510(k) premarket notification that demonstrates substantial equivalence to predicate devices, rather than a clinical trial report with specific acceptance criteria and detailed performance studies for a novel device or AI.

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