OSTEOMED INTRAORAL DISTRACTION SYSTEM

• K Number: K990944
• Device Name: OSTEOMED INTRAORAL DISTRACTION SYSTEM
• Manufacturer: OSTEOMED CORP.
• Date Cleared: 1999-06-16 ( 86 days)
• Product Code: MQN , MON
• Regulation Number: 872.4760
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: K964649 , K972166

Intended Use

Indicated for use as a mandibular bone lengthener for patients diagnosed with conditions where treatment includes mandibular distraction osteogenesis. These conditions mav include diagnoses such as mandibular micrognathia or hemifacial microsomia.

Device Description

The OsteoMed Intraoral Distraction System is a subcutaneous bone distractor. It features various curved and straight bars activated with a threaded wire that has screw holes that are fixed to bone via 1.6mm bone screws. The distractor is available in right and left versions: The threaded wire is activated by a hex driver and is capable of distraction lengths of up to 25mm.

AI/ML Overview

This document is a 510(k) Summary for the OsteoMed Intraoral Distraction System, and as such, it focuses on demonstrating substantial equivalence to previously approved devices rather than presenting a performance study with detailed acceptance criteria and reported device performance.

Therefore, the information you've requested about acceptance criteria, specific device performance, sample sizes, expert involvement, and ground truth for a study proving the device meets acceptance criteria is not present in this 510(k) submission.

Here's why and what information is available:

• 510(k) Submissions and Substantial Equivalence: A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. This is primarily done through showing similarities in intended use, technological characteristics, and often by comparing performance to the predicate device if there are differences that raise new questions of safety or effectiveness. For devices like this one, based on mature technology, the primary evidence often revolves around material and design similarity, and existing clinical history of predicate devices.

• Absence of a Performance Study: The submission explicitly states: "Due to the similarity of materials and design to both pre-enactment and postenactment devices, OsteoMed believes that the OsteoMed Intraoral Distraction System does not raise any new safety or effectiveness issues." This statement indicates that a new, extensive performance study with pre-defined acceptance criteria, as one might see for a novel diagnostic algorithm or a drug, was not deemed necessary for this submission. The demonstration of equivalence relies on the established safety and effectiveness of the predicate devices.

Based on the provided text, I can answer your questions as follows:

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

   • Not Applicable. The document does not provide a table of acceptance criteria or specific reported device performance data from a new study designed to prove the device meets such criteria. The submission relies on substantial equivalence to predicate devices (Leibinger Vazquez-Diner Intraoral Distraction Device (K964649) and Howmedica Guerrero-Bell Distractor (K972166)).

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. No new test set or data provenance is mentioned as part of a performance study for this 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. No experts were used for a new ground truth establishment related to a performance study for this device's submission.

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

   • Not Applicable. No test set or adjudication method is mentioned.

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 mechanical surgical distractor, not an AI or imaging diagnostic tool. Therefore, an MRMC study or AI assistance is irrelevant to its approval.

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

   • Not Applicable. This is a mechanical surgical device, not an algorithm.

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

   • Not Applicable. No new ground truth data was generated for a performance study. The "ground truth" for the submission's approval is essentially the FDA's acceptance of the safety and effectiveness of the predicate devices based on their prior approvals and established clinical use.

8. The sample size for the training set:

   • Not Applicable. This is a mechanical device, not an algorithm requiring a training set.

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

   • Not Applicable. No training set was used.

Regulation Number and Section

§ 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.