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The ActivaScrew™ Products are indicated for fixation of bone fractures, osteotomies, arthrodeses, bone grafts and osteochondral fractures of upper extremity, ankle and foot in the presence of appropriate immobilization.

The ActivaScrew™ Products are indicated for fixation of bone fractures, osteotomies, arthrodeses, bone grafts and osteochondral fractures of upper extremity, ankle and foot in the presence of appropriate immobilization. Screws are available as non-cannulated and cannulated, fully and partially threaded, in several different sizes, including diameters of 2.0 – 4.5 mm and lengths of 10 - 90 mm. The ActivaScrew™ Products are made of the completely bioabsorbable poly(L-lactide-coglycolide) (PLGA) material, and they degrade in vivo by hydrolysis into alpha-hydroxy acids that are metabolized by the body. As the operated bone fracture or osteotomy gains strength during healing, the ActivaScrew™ gradually loses its strength, however, maintaining its function at least 8 weeks. Bioabsorption takes place within approximately two years thus eliminating the need for implant removal surgery.

The provided text describes a special 510(k) summary for a modification to the Bioretec ActivaScrew™ and its equivalence to marketed products. It focuses on the device's characteristics and its substantial similarity to predicate devices through in vitro and mechanical bench testing. However, it does not contain any information about acceptance criteria, clinical study design, sample sizes for test or training sets, ground truth establishment, expert qualifications, or multi-reader multi-case studies.

Therefore, I cannot fulfill your request for that specific information based on the provided text. The document primarily addresses regulatory aspects of a device modification and its equivalence based on bench testing, not clinical performance.

Here's what I can extract from the provided text regarding the closest relevant points, acknowledging the missing information:

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

No acceptance criteria or reported device performance for clinical outcomes are mentioned. The document states:
"In vitro and mechanical bench testing determined that the ActivaScrew™ has substantially similar performance as compared to its predicate devices."
This indicates that the "acceptance criteria" were related to achieving "substantially similar performance" in these bench tests, but the specific metrics 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. The study mentioned is "in vitro and mechanical bench testing," not a clinical study with human data. Therefore, there's no mention of a test set sample size, data provenance, or whether it was retrospective or prospective.

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, as there is no mention of a clinical test set requiring expert ground truth. The "study" was bench testing.

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

Not applicable. No clinical 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

No. A multi-reader multi-case study is not mentioned. The document focuses on bench testing for a bioabsorbable screw.

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

This question is not applicable to the device described. The ActivaScrew™ is a physical surgical implant, not an AI algorithm.

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

For the "in vitro and mechanical bench testing," the ground truth would be established by engineering standards, physical measurements, and material properties. The document does not specify the exact ground truth used for these tests, only that the performance was "substantially similar" to predicate devices.

8. The sample size for the training set

Not applicable. The described testing is not related to training an AI algorithm.

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

Not applicable. No AI algorithm training set is mentioned.

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