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AutoStrut G2 is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which growth plates have fused and will not be crossed with hardware:

• fracture fixation (open and closed)
• pseudoarthrosis of long bones
• limb lengthening (epiphyseal or metaphyseal distraction)
• joint arthrodesis
• infected fractures or nonunions
• correction of bony or soft tissue deformities ●
• correction of segmental defects. ●

The AutoStrut G2 is comprised of control system, software, and six length-adjustable struts powered by a motor. The devices are used in conjunction with the DePuy Synthes MAXFRAME multi axial correction system (K161417), including all its parts and software, except that the MAXFRAME struts are substituted with the AutoStrut G2 motorized struts.

The MAXFRAME was cleared with software that generates a treatment plan for the patient, detailing how much each strut should be extended after a given amount of time. The output of this software is downloaded to the AutoStrut G2 control box which will then automatically extend the motorized struts the predetermined amount at the prespecified times. The AutoStrut G2 struts are provided in three (3) sizes, Large, Medium and Small corresponding to the MAXFRAM and should be steam sterilized by the user prior to use.

The provided text describes a medical device called AutoStrut G2 and its substantial equivalence to a predicate device, AutoStrut (K191241). However, the document does not contain information about acceptance criteria, reported device performance in those terms, or a study specifically designed to prove the device meets acceptance criteria related to clinical or diagnostic accuracy.

The "Performance Data" section lists various engineering and electrical safety tests, and mentions "Software characterization and validation," "Speed and accuracy evaluation," "Reliability, force and accuracy test," but does not explicitly state acceptance criteria or the results of these tests in a way that matches the requested output format.

Therefore, I cannot fully complete the table or the requested detailed information about a study proving the device meets acceptance criteria in the manner requested. The document focuses on demonstrating substantial equivalence through technological characteristics and bench testing, rather than a clinical performance study with defined acceptance criteria for diagnostic or treatment effectiveness.

I will fill in what information is available and indicate when requested information is not present in the provided text.

Acceptance Criteria and Device Performance

No specific acceptance criteria for clinical or diagnostic performance are provided in the document. The performance data section lists various engineering and safety tests, but does not detail numerical acceptance criteria or reported performance results in a table format for the device's functional or clinical effectiveness.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (AutoStrut K191241) through technological characteristics and bench testing. The "Performance Data" section lists several types of tests conducted:

Study Details

The provided document describes bench testing to demonstrate performance and substantial equivalence, not a clinical study to establish acceptance criteria for efficacy or diagnostic performance.

1. Sample size used for the test set and the data provenance: Not applicable, as this refers to bench testing rather than a clinical test set. The document does not specify sample sizes for the materials/devices tested in the listed engineering tests. Data provenance (e.g., country of origin, retrospective/prospective) is also not applicable.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The tests performed are engineering and electrical safety tests, not requiring expert ground truth for clinical interpretation.
3. Adjudication method for the test set: Not applicable.
4. 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: No, an MRMC study was not described. The device is an external fixation system with automated struts, not an AI-assisted diagnostic or interpretation tool for human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document mentions "Software characterization and validation" and "Speed and accuracy evaluation" for the device, which operates automatically. This implicitly confirms standalone algorithm (control system) performance testing was done, but details of this testing (acceptance criteria, results) are not provided. The device's function is to automatically extend motorized struts based on a pre-determined treatment plan (generated by separate software, mentioned as MAXFRAME software, and downloaded to the AutoStrut G2 control box).
6. The type of ground truth used: For the engineering and electrical tests, the "ground truth" would be the specifications and requirements of the ASTM, IEC, and ISO standards referenced. For the "Speed and accuracy evaluation" and "Reliability, force and accuracy test," the ground truth would be the expected or target speed, accuracy, and force output of the struts.
7. The sample size for the training set: Not applicable. The document refers to bench testing and substantial equivalence, not a machine learning model requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

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AutoStrut is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which growth plates have fused and will not be crossed with hardware:

• · fracture fixation (open and closed)
• · pseudoarthrosis of long bones
• · limb lengthening (epiphyseal or metaphyseal distraction)
• · joint arthrodesis
• · infected fractures or nonunions
• · correction of bony or soft tissue deformities
• · correction of segmental defects.

AutoStrut is comprised of six length-adiustable struts powered by a motor, a control system and software. The device is used in conjunction with the predicate DePuy Synthes MAXFRAME multi axial correction system (K161417), including all its parts and software but the MAXFRAME struts are substituted with the AutoStrut motorized struts.

The provided text is a 510(k) summary for the OrthoSpin AutoStrut device. It describes the device, its intended use, and its technological characteristics. Crucially, this document is a regulatory submission focused on demonstrating substantial equivalence to a predicate device, not on presenting a clinical study or detailed performance acceptance criteria in the manner typically seen for diagnostic AI/ML devices.

Therefore, many of the requested categories (such as sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not available in this document, as the submission does not describe a study involving human or image-based diagnostic performance.

Here's a breakdown of the available information:

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

Since this is a mechanical device rather than a diagnostic AI, the acceptance criteria relate to mechanical and electrical performance, biocompatibility, and sterilization, not diagnostic accuracy. The document mentions performance testing, but it does not provide specific acceptance criteria (e.g., "tensile strength must be >X Newtons") or detailed reported performance values in a tabular format. Instead, it makes general comparative statements.

2. Sample size used for the test set and the data provenance

Not applicable. This is not a study involving a test set of data (e.g., medical images, patient records). The performance data relates to mechanical and electrical testing of the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No ground truth based on expert consensus for a diagnostic output is involved.

4. Adjudication method for the test set

Not applicable. No diagnostic test set or adjudication process is described.

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 an external fixation system, not a diagnostic AI tool, and thus no MRMC study was conducted or is relevant.

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

Not applicable. This device is not an algorithm for diagnosis. Its "standalone" performance refers to its mechanical and electrical function. The document states that the AutoStrut's motorized adjustment "simply carries out the treatment plan generated by the same software as the predicate device," implying it functions as an automated executor of a plan, rather than a standalone diagnostic tool.

7. The type of ground truth used

For the mechanical and electrical tests conducted (e.g., static compression), the "ground truth" would be established by the physical properties and performance metrics defined in the ASTM and ISO standards themselves. It's objective, quantitative measurement, not expert consensus, pathology, or outcomes data in the clinical diagnostic sense.

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI/ML algorithm requiring a training set for model development.

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

Not applicable. There is no AI/ML training set.

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