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510(k) Data Aggregation
(53 days)
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:
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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(60 days)
The KLS-Martin 3DX External Distraction System is a bone stabilizer and lengthening device when congenital deficiencies, mandibular hypoplasia or post traumatic defects of the mandible require gradual bone lengthening, including bone transport.
The device is comprised of two (2) interchangeable distraction arms, a central body which allows angular adjustment of the arms and pin clamps. The pin clamps will accept 2.0mm and 2.7mm Molina (K994154) pins. Bone stabilization can be achieved with carbon rods after distraction.
The provided document is a 510(k) summary for the KLS Martin 3DX External Distraction System. This type of document is a premarket notification for a medical device seeking to demonstrate substantial equivalence to a legally marketed predicate device.
Crucially, this document does NOT contain information about acceptance criteria or a study proving the device meets those criteria, as it is a summary of the notification process, not a performance study report.
510(k) submissions typically rely on comparisons to existing devices (predicate devices) and may include bench testing or non-clinical performance data to demonstrate that the new device performs as intended and is as safe and effective as the predicate. However, detailed acceptance criteria and a structured study demonstrating primary endpoint achievement against these criteria are not typically a required component of the 510(k) summary itself, nor are they usually presented in the format requested.
Therefore, I cannot provide the requested information based on the text provided. The document states that "Substantial equivalence is based on comparison of performance, method of distraction, bone stabilization and clinical literature assessment." This suggests that the "study" demonstrating performance was a comparison to predicate devices, rather than a standalone clinical trial with specific acceptance criteria.
To address the prompt directly based on the provided document, the response would be:
1. A table of acceptance criteria and the reported device performance:
* Acceptance Criteria: Not specified in the provided document.
* Reported Device Performance: The document states that "Substantial equivalence is based on comparison of performance, method of distraction, bone stabilization and clinical literature assessment" against predicate devices. The exact performance metrics or quantitative results are not detailed.
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/Not provided. The document does not describe a "test set" in the context of human clinical data or a specific performance study. The comparison is against predicate devices and clinical literature.
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/Not provided. No "test set" or ground truth establishment by experts is described for this device in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not applicable/Not provided.
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/Not provided. This device is an external distraction system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable/Not provided. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* Not applicable/Not provided in the context of a performance study. The "ground truth" for substantial equivalence is implicitly the performance and safety established by the predicate devices through their own regulatory pathways and clinical use.
8. The sample size for the training set:
* Not applicable/Not provided. The device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
* Not applicable/Not provided.
In summary, the provided 510(k) document is a regulatory notification focusing on substantial equivalence to predicate devices, rather than a detailed report of a performance study with explicit acceptance criteria and corresponding results for the KLS Martin 3DX External Distraction System.
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