(427 days)
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:
-
- KLS Martin bone plates and screws.
- Ormco Stainless steel crowns, Herbst Rods. 2.
-
- 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):
| Feature | Acceptance Criteria (Predicate Devices - KLS-Martin & Synthes) | Reported Device Performance (Oral Osteodistraction) |
|---|---|---|
| Material | TI - 6AL4V Titanium Alloy / Surgical Stainless Steel | Stainless Steel 304 |
| Facial Skeleton/Pins | TI - 6AL4V Titanium Alloy / Surgical Stainless Steel | Stainless Steel 301 |
| Distraction Rate | 1mm/day | .5mm/day first 2 days, then 1mm/day after that |
| Fixed to Patient Bone | Screws | Screws |
| Completed Distraction | Geared Rod | Geared Rod |
| Distraction Activation | Hex Key / Screwdriver External | Hex Key |
| Facial Bone Distractor | Intraoral / Internal | Intraoral |
| Intended Use | Mandible Distraction | Mandible Distraction |
| Device Placement | Subcutaneous | Subcutaneous |
| User | Craniofacial Surgeon | Craniofacial Surgeon |
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.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.