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Internal Distraction - Sterile includes devices intended as bone stabilizers and lengthening (and or transport) devices for correction of congenital deficiencies or post traumatic defects of the cranial bones that require gradual distraction.

Internal Distraction - Sterile consists of sterile internal distraction devices intended for the correction of cranial bones that are comprised of several different designs and components intended for bone stabilization and elongation through distraction osteogenesis. It is composed of multiple sizes and shapes of distractor footplates and either fixed or detachable activator arms. The devices are positioned internally with a connected activation arm extending through the soft tissue for external activation. Some devices, due to their anatomical positioning, are directly activated using a patient activation driver, eliminating the need for attaching an activation arm to the device. The distractor footplates are fixated to the bone on either side of the osteotomy using previously cleared bone screws (K943347, K944561, K944565, K971297, K060177). Distraction is achieved by rotating the distractor threaded drive screws with the patient driver, often with an activation arm, which causes a separation of the distractor footplates and induces the body to grow bone and expand soft tissue as a response. Various lengths of distractor drive screws are available to achieve the desired distraction length. Upon completion of distraction and consolidation of the bone, the screws are removed from the footplates and the distractor is explanted.

This document is a 510(k) premarket notification for the "Internal Distraction - Sterile" device. The acceptance criteria and supporting studies are based on demonstrating substantial equivalence to a predicate device, the "Zurich Distraction System (K010139)".

Here's a breakdown of the requested information:

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

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

The document primarily relies on non-clinical performance data (bench testing) and comparison to the predicate device.

• Biocompatibility: No new testing was performed; it relied on the predicate device's clearance.
• Pyrogenicity: The sample size for Bacterial Endotoxins testing is not specified.
• Mechanical Performance: The sample size for axial load, bending torsion, axial-torsion, and transverse shear testing is not specified. This was bench testing, not clinical data, so provenance like "country of origin" or "retrospective/prospective" is not applicable in the typical sense for patient data.

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. The study is a 510(k) submission based on non-clinical bench testing and demonstration of substantial equivalence to a predicate device. There was no test set requiring expert ground truth for clinical cases.

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

Not applicable. No clinical test set or adjudication for diagnostic ground truth was performed or required.

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 medical implant (internal distraction system), not an AI-assisted diagnostic or therapeutic tool. No MRMC study was conducted.

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

Not applicable. This is a medical device, not an algorithm, so the concept of standalone performance does not apply.

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

Not applicable in the context of clinical ground truth for diagnostic accuracy. The "ground truth" for this submission is based on:

• Predicate Device Equivalence: The safety and effectiveness profile of the legally marketed predicate device (Zurich Distraction System, K010139).
• Engineering Standards: Compliance with recognized standards for biocompatibility (ISO 10993-1), pyrogenicity (ANSI/AAMI ST72:2011, USP , EP 2.6.14), and mechanical performance through bench testing against design requirements.

8. The sample size for the training set

Not applicable. This is a medical device clearance, not an AI model. There is no concept of a "training set" for the device itself.

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

Not applicable. See point 8.

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Internal Distraction - Sterile includes devices intended as bone stabilizers and lengthening (and or transport) devices for correction of congenital deficiencies or post traumatic defects of the mandible (including ramus, body, alveolar ridge, palate, symphysis) and mid-face bones that require gradual distraction.

Internal Distraction - Sterile consists of sterile internal distraction devices intended for the correction of the mandible and mid-face bones that are comprised of several different designs and components intended for bone stabilization and elongation through distraction osteogenesis. It is composed of multiple sizes and shapes of distractor footplates and either fixed or detachable activator arms. The devices are positioned internally with a connected activation arm extending through the soft tissue for external activation. Some devices, due to their anatomical positioning, are directly activated using a patient activation driver, eliminating the need for attaching an activation arm to the device. The distractor footplates are fixated to the bone on either side of the osteotomy using previously cleared bone screws (K943347, K944561, K944565, K971297, K060177). Distraction is achieved by rotating the distractor threaded drive screws with the patient driver, often with an activation arm, which causes a separation of the distractor footplates and induces the body to grow bone and expand soft tissue as a response. Various lengths of distractor drive screws are available to achieve the desired distraction length. Upon completion of distraction and consolidation of the bone, the screws are removed from the footplates and the distractor is explanted.

This document describes a 510(k) premarket notification for the "Internal Distraction - Sterile" device. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily by indicating that the new device is a sterile version of existing non-sterile devices.

Based on the provided document, here's a breakdown of the requested information:

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

The document does not explicitly state "acceptance criteria" in a quantitative, measurable sense for a clinical study. Instead, it describes general design requirements and performance evaluations for mechanical properties and biocompatibility. The "reported device performance" indicates that these requirements were met.

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 for the test set: Not applicable (N/A). This submission did not involve a clinical study with a "test set" of patients. The performance data presented is from non-clinical bench testing and biocompatibility assessments of the device materials.
• Data provenance: N/A. The data provenance described is related to bench testing, not patient data.

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)

• Number of experts: N/A. No clinical test set with ground truth established by experts was used.

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

• Adjudication method: N/A. No clinical test set to adjudicate was utilized.

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

• MRMC study done: No. This is a medical device (bone plate/distractor) submission, not an AI/software as a medical device (SaMD) submission. An MRMC study would not be relevant in this context.
• Effect size: N/A.

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

• Standalone done: No. This submission is for a physical medical device.

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

• Type of ground truth: N/A. For the mechanical and biocompatibility testing, the "ground truth" is defined by established engineering and biological standards and specifications (e.g., design requirements, ANSI/AAMI ST72:2011, USP , EP 2.6.14 for endotoxins). No clinical ground truth (like expert consensus or pathology) was used as there was no clinical study.

8. The sample size for the training set

• Sample size for the training set: N/A. There was no "training set" in the context of an algorithm or AI. The design and manufacturing processes for the device are well-established based on existing predicate devices.

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

• How ground truth was established for the training set: N/A. This concept is not applicable to the type of device and submission described.

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