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The ActivaScrew™ Interference is indicated for fixation of tissue, including ligament or tendon to bone, or a bone-tendon to bone in the presence of appropriate immobilization / controlled mobilization. Interference fixation is intended for surgeries of knee, shoulder, elbow, ankle, foot and hand/wrist.

The product family consists of fully threaded ActivaScrew™ Interference, diameters 4 - 10 mm and lengths 10 - 33 mm. The ActivaScrew™ Interference is constructed of bioabsorbable poly(L-lactide-co-glycolide) (PLGA).

Here's an analysis of the provided text regarding the Bioretec ActivaScrew™ Interference, focusing on the acceptance criteria and the study that proves the device meets them:

Disclaimer: The provided text is a 510(k) summary for a medical device. 510(k) submissions primarily demonstrate substantial equivalence to existing legally marketed devices, rather than establishing de novo safety and effectiveness through extensive clinical trials as would be required for a PMA. Therefore, the "acceptance criteria" discussed here relate to demonstrating equivalence rather than clinical performance targets. Similarly, the "study" refers to non-clinical testing for equivalence.

Acceptance Criteria and Reported Device Performance

The Bioretec ActivaScrew™ Interference sought clearance by demonstrating substantial equivalence to predicate devices. The acceptance criteria were implicitly met by showing that the new device performs "substantially similar" to the predicates in specific mechanical tests.

The study (non-clinical testing) did not raise "any new questions of safety or effectiveness of the ActivaScrew™ Interference and demonstrates that the ActivaScrew™ Interference performs mechanically in a manner substantially similar to the tested predicate device."

Study Details

Given this is a 510(k) submission focusing on substantial equivalence, the "study" described is a series of non-clinical, in vitro tests comparing the new device to predicate devices. It is not a clinical study with human patients, nor a study involving AI.

1. 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 specify the exact sample sizes (number of screws or test repetitions) for each non-clinical test (pull-out, shear strength, inherent viscosity, dimensional stability).
   • The data provenance is not explicitly stated beyond being "non-clinical tests and in vitro testing." Given the manufacturer (Bioretec Ltd.) is based in Finland, the testing likely occurred in Finland or by a contract lab; however, this is not confirmed in the text. These are prospective tests conducted specifically for this submission.

2. 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 question is not applicable to this submission. "Ground truth" in the context of clinical disease detection or diagnosis, and the involvement of experts for adjudication, are concepts relevant to diagnostic device performance studies (e.g., for AI/ML devices). This submission is for a physical orthopedic implant and relies on engineering and material science standards and comparative mechanical testing, not expert interpretation of clinical data for a "ground truth" diagnosis.

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

   • This is not applicable. See point 2.

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:

   • This is not applicable. This is not an AI/ML device, nor a diagnostic device requiring human reader interpretation. No MRMC study was conducted.

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

   • This is not applicable. This is not an algorithm or AI device.

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

   • This is not applicable in the traditional sense for diagnostic performance. For this device, the "ground truth" for demonstrating equivalence largely relies on established engineering principles, material science properties, and direct mechanical comparison to physically identical predicate devices against specified performance metrics (e.g., force to failure, material degradation rate). The "truth" is the measured physical property.

7. The sample size for the training set:

   • This is not applicable. There is no "training set" as this is not an AI/ML device.

8. How the ground truth for the training set was established:

   • This is not applicable. There is no "training set" or "ground truth" for one in this context.

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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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The ActivaScrew™ is 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™ is 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 fully and partially threaded in several different sizes, including diameters of 2.0 – 4.5 mm and lengths of 10 – 90 mm. The ActivaScrew™ is made of the completely bioabsorbable poly(L-lactide-co-glycolide) (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 approximately within two years thus eliminating the need for implant removal surgery.

The Bioretec ActivaScrew™ received 510(k) clearance based on substantial equivalence to predicate devices, namely the Inion OTPS™ Biodegradable Fixation System (K030900) and the Bioretec ActivaPin™ (K061164). The clearance did not provide acceptance criteria and directly reported device performance metrics in the same way clinical studies do for novel devices. Instead, the focus was on demonstrating that the ActivaScrew™ has substantially similar performance to its predicates through non-clinical and in-vitro testing.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state specific acceptance criteria in terms of numerical thresholds for device performance. Instead, the acceptance was based on demonstrating "substantial equivalence" to predicate devices. This typically means the device performs within the expected range for its class and intended use, and any differences do not raise new questions of safety or effectiveness.

Therefore, a direct table of acceptance criteria vs. statistical device performance is not available in this 510(k) summary. The summary states:

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "non-clinical tests and in vitro -testing."

• Sample Size: The specific sample sizes for these tests are not provided in the 510(k) summary.
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given it's non-clinical/in-vitro testing, it would generally be considered laboratory-based performance rather than human data.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable to this 510(k) summary. The substantial equivalence determination for this device relies on non-clinical and in-vitro testing, not on clinical data requiring expert consensus or ground truth derived from expert review.

4. Adjudication Method:

This information is not applicable as the clearance was based on non-clinical and in-vitro testing, not on clinical studies requiring adjudication of outcomes or diagnoses.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was mentioned or performed as part of this 510(k) submission. No effect size of human reader improvement with/without AI assistance is provided. This type of study is not typically required for a Class II device like a bone fixation screw based on substantial equivalence to existing predicates.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):

This information is not applicable. The Bioretec ActivaScrew™ is a physical medical device (a bone fixation screw), not an algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm or "human-in-the-loop performance" does not apply.

7. Type of Ground Truth Used:

For the non-clinical and in-vitro testing, the "ground truth" would likely be derived from:

• Material specifications and established testing standards: Performance metrics (e.g., tensile strength, bending strength, degradation rate) would be compared against expected values or regulatory standards for similar implant materials and designs.
• Performance of predicate devices: The "ground truth" for comparison would be the known mechanical and degradation characteristics of the predicate devices.

8. Sample Size for the Training Set:

This information is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI algorithms. The design and manufacturing process would involve material characterization and engineering validation, not data training.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as there is no training set for this type of device.

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