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Intended as a bone stabilizer and lengthening (and/or transport) device when correction of congenital deficiencies or post traumatic defects of the mandible (including ramus, body, symphisis), require gradual distraction. This system is intended for use in pediatric population for children under 4 years of age including infants and neonates. The OsteoMed Pediatric Intraoral Mandibular Distraction System, Extended is intended for single patient use only.

This submission describes the OsteoMed Pediatric Intraoral Mandibular Distraction System, Extended indicated for use as a bone stabilizer and lengthening (and/or transport) device when correction of congenital deficiencies or post traumatic defects of the mandible (including ramus, body, symphisis) require gradual distraction. This system is intended for use in pediatric population for children under 4 years of age including infants and neonates. The OsteoMed Pediatric Intraoral Mandibular Distraction System, Extended is intended for single patient use only. The OsteoMed Pediatric Intraoral Mandibular Distraction System, Extended is a subcutaneous bone distractor. It features various curved and straight bars, activated with a threaded wire, that have plates that are fixed to bone via 1.2mm 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 45mm.

The provided text is a 510(k) summary for the OsteoMed Pediatric Intraoral Mandibular Distraction System, Extended. It describes a medical device for bone stabilization and lengthening in the mandible for pediatric patients under 4 years of age.

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

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

The document does not explicitly state specific acceptance criteria or report device performance in a quantitative manner. This 510(k) relies on "substantial equivalence" to predicate devices. The primary assertion is that due to similarities in materials and design, the device "does not raise any new safety or effectiveness issues."

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

The document does not describe a test set, sample size, or data provenance for evaluating the performance of the OsteoMed Pediatric Intraoral Mandibular Distraction System, Extended. The submission is based on a determination of substantial equivalence to previously cleared devices rather than a new performance study.

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 and not provided. The submission does not describe a study involving expert-established ground truth for a test set.

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

This information is not applicable and not provided. No ground truth adjudication method is mentioned as there is no described test set or study.

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 information is not applicable and not provided. The device is a physical surgical implant, not an AI or digital diagnostic tool, thus an MRMC study is irrelevant.

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

This information is not applicable and not provided. The device is a surgical implant, not an algorithm.

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

This information is not applicable and not provided. No ground truth is mentioned as there is no described performance study for this device.

8. The sample size for the training set

This information is not applicable and not provided. The device is a physical medical implant, and the submission is based on substantial equivalence, not a machine learning model that would require a training set.

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

This information is not applicable and not provided. As there is no training set, there is no ground truth establishment method described.

Summary of the study and acceptance process based on the provided document:

The document describes a medical device, the OsteoMed Pediatric Intraoral Mandibular Distraction System, Extended, which is an intraoral distractor intended for bone stabilization and lengthening in the mandible of pediatric patients under 4 years of age.

Acceptance Criteria and Study:

The acceptance of this device by the FDA is based on a 510(k) premarket notification which asserts "substantial equivalence" to legally marketed predicate devices. This means that the device is considered safe and effective because it shares similar intended use, materials, design, and operational principles with devices already cleared by the FDA.

• Predicate Devices:
  • OsteoMed Pediatric Intraoral Mandibular Distraction System (K043434)
  • KLS-Martin LP, MOD Line of Molina Distractors 51-600 Series (K994154)

The submission explicitly states: "Due to the similarity of materials and design to both pre-enactment and post-enactment devices, OsteoMed believes that the OsteoMed Pediatric Intraoral Mandibular Distraction System, Extended does not raise any new safety or effectiveness issues."

Therefore, there was no new, independent clinical or performance study described in this 510(k) summary with specific acceptance criteria beyond demonstrating substantial equivalence to the identified predicate devices. The FDA's letter confirms their finding of "substantial equivalence" as the basis for allowing the device to be marketed.

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Intended as a bone stabilizer and lengthening (and/or transport) device when correction of congenital deficiencies or post traumatic defects of the mandible (including ramus, body, symphisis), require gradual distraction. This system is intended for use in pediatric population for children under 4 years of age including infants and neonates. The OsteoMed Pediatric Intraoral Mandibular Distraction System is intended for single patient use only.

The OsteoMed Pediatric Intraoral Mandibular Distraction System is a subcutaneous bone distractor. It features various curved and straight bars. activated with a threaded wire, that have plates that are fixed to bone via 1.2mm 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 35mm.

The provided text describes the OsteoMed Pediatric Intraoral Mandibular Distraction System (K043434), a medical device. However, it does not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert involvement for a study proving the device meets acceptance criteria.

The document is a 510(k) summary for a medical device submitted to the FDA. Such summaries primarily focus on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed study results against specific acceptance criteria.

Therefore, I cannot fulfill your request for the detailed table and study information because the provided input lacks the necessary data.

To answer your request, the input document would need to include sections detailing:

1. Specific performance metrics the device was designed to achieve (acceptance criteria).
2. A study design that evaluated these metrics.
3. Results from that study, comparing them to the acceptance criteria.
4. Information on the data used (sample size, provenance), ground truth establishment (experts, adjudication), and training set details (if applicable for an AI device, which this is not).

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Indicated for use as a mandibular bone lengthener for patients diagnosed with conditions where treatment includes mandibular distraction osteogenesis. These conditions may include diagnoses such as mandibular micrognathia or hemifacial microsomia. The OsteoMed Intraoral Mandibular Distraction System is intended for single patient use only.

The OsteoMed Intraoral Mandibular 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/2.0mm bone screws. The distractor is available in two sizes and in right and left versions. The threaded wire is activated by a hex driver and is capable of distraction lengths of up to 35mm.

I'm sorry, but the provided text does not contain the information required to describe acceptance criteria or a study proving device performance. The document is a 510(k) summary and FDA clearance letter for the OsteoMed Intraoral Mandibular Distraction System. It details the device's intended use, description, and claims of substantial equivalence to predicate devices, but it does not include:

• A table of acceptance criteria and reported device performance.
• Details about a study with sample sizes, data provenance, ground truth establishment, or expert involvement.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.

The document states that "Due to the similarity of materials and design to both pre-enactment and postenactment devices, OsteoMed believes that the OsteoMed Intraoral Mandibular Distraction System does not raise any new safety or effectiveness issues." This suggests that the clearance was based on equivalence rather than new performance studies demonstrating against specific acceptance criteria.

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