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The devices of Bloretec ActivaPin™ Product Group including ActivaPin™ Fusion, ActivaNail™ Conical, ActivaNail™ Flat and ActivaPin™ HT are indicated for fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures in the presence of appropriate immobilization.

The modified ActivaPin™ Product Group is identical to the currently cleared device expect for the modification. The modification of the initial ActivaPin™ Product group 510(k) (K080879) adds one trade name; Biorelec ActivaPin™ HT in the AclivaPin™ Product Group. That device has a small modification to ActivaPin™ Fusion; the instrument accepting hole is made on the both ends instead of one end of the device to enable insertions. The labeling will be revised accordingly.

Bioretec ActivaPin™ Product Group covers Bioretec's bioabsorbable devices AclivaPin™, ActivaPin™ Fusion, ActivaPin™ HT, ActivaNail™ Conical and ActivaNail™ Flat.

The Bioretec ActivaPin™ products do not differ significantly or at all in purpose, design, materials, function or any other feature related to safety and effectiveness. ActivaPin™ HT is almost identical with a predicate device and the other devices of Bioretec's ActivaPin™ Product Group. ActivaPin141 HT is the same kind of device as ActivaPin™ Fusion, but it's both ends have an instrument accepting hole. The diameter of ActivaPin™ HT is 1,5 mm and the lengths are 20 - 70 mm.

The devices of Bioretec ActivaPin™ Product Group are indicated for fixation of bone fractures, osteotomies, arthrodeses and osleochondral fractures in the presence of appropriate immobilization.

The Bioretec ActivaPin™ Product Group devices are made of completely bioabsorbable poly(L-lactide-co-glycolide) (PLGA), and they degrade in vivo by hydrolysis into alphahydroxy acids that are metabolized by the body. As the operated bone fracture or osteotomy gains strength during healing, the Bioretec ActivaPin™ products gradually loses their strength, however, maintaining their function at least 8 weeks. Bioabsorption lakes place within approximately two years thus eliminating the need for implant removal surgery.

This document is a 510(k) summary for a Special 510(k) submission, focusing on a modification to an already cleared medical device, the Bioretec ActivaPin™ Product Group. As such, the purpose of this submission is to demonstrate substantial equivalence to previously cleared devices, rather than to present a de novo study with acceptance criteria and a detailed study report for new device performance.

Therefore, many of the requested items (e.g., specific acceptance criteria, detailed study results proving the device meets those criteria, expert ground truth establishment, MRMC studies, standalone performance, training set details) are not applicable or not present in the provided document. The submission relies on the prior clearance of the predicate devices for performance, safety, and effectiveness.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. This is a Special 510(k) for a modification (adding a new trade name and a minor design change) to an already cleared device. The "acceptance criteria" here implicitly refer to demonstrating substantial equivalence to the predicate devices, not to a new performance study against specific metrics. The document states: "The modified ActivaPin™ Product Group is identical to the currently cleared device expect for the modification. ... The Bioretec ActivaPin™ products do not differ significantly or at all in purpose, design, materials, function or any other feature related to safety and effectiveness."

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

Not applicable. No new clinical or performance test set data is presented for this Special 510(k) in the provided summary. The substantial equivalence argument relies on the existing clearances and the minimal nature of the modification.

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 establishment for a test set is discussed in this Special 510(k) summary.

4. Adjudication method for the test set

Not applicable. No test set or adjudication method is discussed.

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 bioabsorbable fixation pin, not an AI-powered diagnostic or assistive tool.

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

Not applicable. This device is a physical fixation pin, not an algorithm.

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

Not applicable. No new ground truth is established for this Special 510(k) submission. The safety and effectiveness are supported by the substantial equivalence to predicate devices, which would have had their performance and safety established through prior studies (not detailed in this document). The device itself (a bioabsorbable pin) is evaluated based on its mechanical properties, biocompatibility, and degradation characteristics, often through bench testing and sometimes animal or clinical studies for initial clearance.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.

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

Not applicable. This is a physical medical device.

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The devices of Bioretec ActivaPin™ Product Group including ActivaPin™, ActivaPin™ Fusion, ActivaNail™ Conical and ActivaNail™ Flat are indicated for fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures in the presence of appropriate immobilization.

Bioretec ActivaPin™ Product Group covers Bioretec's bioabsorbable devices ActivaPin™ ActivaPin™ Fusion, ActivaNail™ Conical and ActivaNail™ Flat. The Bioretec ActivaPin™ products do not differ significantly or at all in purpose, design, materials, function or any other feature related to safety and effectiveness. ActivaPin" is identical with a predicate device and the other devices of Bioretec's ActivaPin™ Product Group are its modifications. ActivaPin™ Fusion is the same as ActivaPin™, but its both ends are tapered. ActivaNail™ Conical and ActivaNail™ Flat are also ActivaPin™'s modifications with conical and flat heads. All pins of Bioretec ActivaPin™ Product Group are available in several different dimensions, including diameters of 1.5 - 3.2 mm and lengths of 5 - 70 mm. The devices of Bioretec ActivaPin" Product Group are made of completely bioabsorbable poly(L-lactide-co-glycolide) (PLGA), and they degrade in vivo by hydrolysis into alphahydroxy acids that are metabolized by the body. As the operated bone fracture or osteotomy gains strength during healing, the Bioretec ActivaPin™ products gradually loses their strength, however, maintaining their function at least 8 weeks. Bioabsorption takes place within approximately two years thus eliminating the need for implant removal surgery.

I am sorry, but the provided text describes a 510(k) submission for a medical device (Bioretec ActivaPin™ Product Group) and determines its substantial equivalence to a predicate device.

It does not contain information about acceptance criteria, device performance metrics, clinical study design, sample sizes, expert involvement, or ground truth establishment. The document is a regulatory filing, not a clinical study report.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

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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 ActivaPin™ is indicated for fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures in the presence of appropriate immobilization.

The modified ActivaPin™ is identical to the currently cleared device except for the modification. The only modification to the initial 510(k) K061164 to be cleared is adding a Disposable Pin Applicator with K-wire for installation of ActivaPin™ and revising labeling accordingly. The change does not affect the intended use or alter the fundamental scientific technology of the device.

The ActivaPin" is indicated for fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures in the presence of appropriate immobilization. Pins are available in several different dimensions, including diameters of 1.5 - 3.2 mm and lengths of 20 - 70 mm.

ActivaPin™ is made of completely bioabsorbable poly(L-lactide-co-glycolide) (PLGA), and they decrade in vivo by hvdrolysis into alpha-hydroxy acids that are metabolized by the body. As the operated bone fracture or osteotomy gains strength during healing, the ActivaPin"1" gradually loses its strength, however, maintaining its function at least 8 weeks. Bioabsorption takes place within two years thus eliminating the need for implant removal surgery.

The provided text describes a Special 510(k) submission for a modification to an existing device, the Bioretec ActivaPin™. The modification involves adding a Disposable Pin Applicator with a K-wire. This submission focuses on demonstrating substantial equivalence to the predicate device, not on proving general effectiveness through clinical studies with acceptance criteria in the way a novel device might.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, ground truth establishment, expert involvement, and MRMC studies is not applicable or available within this document.

Here's why and what information is provided:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not applicable / Not provided. The document states: "Microbiological testing determined that the ActivaPin™ and the ActivaPin™ Disposable Pin Applicator with K-wire instrument set has substantially similar performance as compared to its predicate devices." This is a qualitative statement of equivalence, not a report against specific, quantified acceptance criteria for performance. The modification is primarily about adding an accessory, and the core device performance (e.g., strength, bioabsorption) is assumed to be unchanged from the predicate.

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

• Not applicable / Not provided. No "test set" in the context of image analysis or algorithm performance is mentioned. The assessment is based on demonstrating equivalence for the new applicator and confirming the overall device's safety and effectiveness remain unchanged.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

• Not applicable / Not provided. No "ground truth" establishment in a clinical or imaging context is described.

4. Adjudication Method for the Test Set:

• Not applicable / Not provided. No adjudication needed for this type of submission.

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 a medical implant, not an AI-powered diagnostic or assistive tool for human readers.

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

• Not applicable / Not provided. This device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used:

• Not applicable / Not provided. No "ground truth" in the context of medical imaging or clinical outcome data is used in this submission. The "ground truth" for a device like this would be its physical/material properties and performance in vivo, which are implicitly covered by its predicate status.

8. The Sample Size for the Training Set:

• Not applicable / Not provided. No machine learning "training set" is involved.

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

• Not applicable / Not provided. No machine learning "training set" is involved.

Summary of what the document does state about the device and its assessment:

• Device: Bioretec ActivaPin™ (a bioabsorbable pin for bone fixation)
• Modification: Addition of a Disposable Pin Applicator with K-wire for installation.
• Purpose of Submission: To demonstrate that this modification does not affect the intended use, alter the fundamental scientific technology, or raise new questions of safety and effectiveness compared to the predicate device (the original ActivaPin™ K061164).
• Evidence for Equivalence:
  • The modified device is "identical to the currently cleared device except for the modification."
  • The change "does not affect the intended use or alter the fundamental scientific technology of the device."
  • "Microbiological testing determined that the ActivaPin™ and the ActivaPin™ Disposable Pin Applicator with K-wire instrument set has substantially similar performance as compared to its predicate devices." (This is the closest the document comes to a "study," albeit briefly mentioned and without details.)
• Conclusion: The FDA reviewed the 510(k) and determined the device (with the modification) is substantially equivalent to the legally marketed predicate device.

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The ActivaPin™ is indicated for fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures in the presence of appropriate immobilization.

The ActivaPin™ is made of completely bioabsorbable poly(L-lactide-co-glycolide) (PLGA), 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 ActivaPin™ gradually loses its strength, however, maintaining its function at least 8 weeks. Bioabsorption takes place within two years thus eliminating the need for implant removal surgery.

The provided document is a 510(k) summary for the Bioretec ActivaPin™. It describes the device, its intended use, and its equivalence to predicate devices. However, the document does not contain any information about acceptance criteria or specific studies proving the device meets those criteria, as typically found in clinical trials or performance testing reports.

Instead, the submission focuses on demonstrating substantial equivalence to already marketed devices (Inion OTPSTM Biodegradable Pin and Bionx Implants Inc., SmartPin™ PDX, PLGA Pin) through non-clinical tests and in vitro-testing. This type of submission relies on comparing the new device's characteristics and performance to those of legally marketed predicate devices, rather than conducting new clinical studies or setting explicit acceptance criteria for novel performance claims.

Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported device performance, nor can I answer questions about sample sizes, ground truth establishment, expert adjudication, or MRMC studies, as these details are not present in the provided 510(k) summary.

The document states: "Non-clinical tests and In vitro-testing determined that the ActivaPin™ has substantially similar performance as compared to its predicate devices." This is the core of the proof of meeting acceptance criteria, which in this context means "being substantially equivalent to predicate devices."

In summary, based only on the provided text:

• Acceptance Criteria and Reported Device Performance: Not explicitly stated as numerical criteria or specific performance values. The acceptance criterion is "substantial equivalence" to predicate devices, which was determined through non-clinical and in vitro testing.
• Sample size for the test set and data provenance: No information provided. The testing was non-clinical and in vitro, not on human subjects.
• Number of experts used to establish the ground truth for the test set and qualifications: Not applicable, as there was no human-based ground truth establishment described for a test set.
• Adjudication method for the test set: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned or conducted.
• Standalone (algorithm only without human-in-the-loop performance) study: Not applicable, as this is a physical medical device, not an algorithm.
• Type of ground truth used: Not applicable in the traditional sense of clinical studies. The "ground truth" for the equivalence assessment was the performance of the predicate devices.
• Sample size for the training set: Not applicable, as this is not a machine learning algorithm; it's a physical device.
• How the ground truth for the training set was established: Not applicable.

The 510(k) process for this device relies on demonstrating that it is as safe and effective as a legally marketed device through comparison, rather than establishing de novo performance metrics with new clinical data.

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