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The Inion FreedomScrew™M products are intended for maintenance of alignment and fixation of bone fractures, comminuted fractures, osteotomies, arthrodeses or bone grafts (i.e., autografts or allografts) in the presence of appropriate additional immobilization (e.g., rigid fixation implants, cast or brace).

In addition, the Inion FreedomScrew™ Ø3.5/4.0/4.5 mm products are specifically intended for use in following indications:

A. General indications: maintenance of reduction and fixation of cancellous bone fractures, osteotomies or arthrodeses of the upper extremity, ankle and foot in the presence of appropriate brace and/or immobilization.

B. Specific indications: fractures and osteotomies of the malleoli, and ankle fractures.

Inion FreedomScrew™ implants are internal fracture fixation devices made of degradable co-polymer composed of 100 % poly(L-lactide-co-D,L-lactide). Based on in vitro testing, the implants retain their initial strength up to 12 weeks after implantation, and gradually lose their strength thereafter. Bioresorption takes place within two to four years.

Inion FreedomScrews™ are in the range of diameter: 2.0 - 4.5 mm and length: 10 - 90 mm. The designs include fully and partially threaded screws, as well as solid and cannulated screws. Inion FreedomScrew™ implants are used together with the previously cleared Inion OTPS™ plating systems, as well as alone according to their indications for use. The Inion FreedomScrew™ products provide fixation and are not intended to replace healthy bone or withstand the stress of full load bearing.

Inion FreedomScrews™ are provided sterile to the user and are non-collagenous. The shelf life of the device is 3 years and they are intended for single use only.

The Inion FreedomScrews™ are primarily designed to be used with customized Inion instrumentation, such as drill bits, bone taps, holding sleeves, screwdriver shafts, countersinks, depth gauges, K-wires and cutting instruments, as well as with ISO 5835/ISO 9714 compatible instrumentation.

Here's a breakdown of the acceptance criteria and the study information for the Inion FreedomScrew™ based on the provided text:

Acceptance Criteria and Device Performance

The provided text focuses on demonstrating substantial equivalence to predicate devices through various performance tests rather than setting explicit numerical acceptance criteria in the way one might see for an AI algorithm's diagnostic accuracy. The key acceptance criteria here are successful comparison to predicate devices across different mechanical and functional properties.

• Gradually lose strength thereafter.
• Bioresorption within two to four years.
• Sufficient mechanical stability over the healing period as the polymer degrades.
• Ensure degradation of the Inion FreedomScrews™. | - "Bioreabsorption takes place within two to four years."
• "Based on in vitro testing, the implants retain their initial strength up to 12 weeks after implantation, and gradually lose their strength thereafter."
• "In vitro degradation testing was carried out to determine the degradation profile (i.e., change in material and mechanical properties) and verify the sufficiency of the mechanical stability over healing period as the polymer degrades and to ensure the degradation of the Inion FreedomScrews™." (Implies successful verification) |
  | Mechanical Strength | - Comparable shear properties to predicate devices.
• Comparable torsion properties to predicate devices.
• Comparable pull-out properties to predicate devices.
• Comparable fixation properties with Inion FreedomPlate™ to predicate devices. | - "Mechanical shear, torsion and pull-out tests were performed to verify the strength properties of Inion FreedomScrew™ implants and to compare them to the predicate devices." (Implies successful comparison/verification)
• "Mechanical fixation test was performed to verify the properties of Inion FreedomScrew™ with the Inion FreedomPlate™ and to compare them to the fixation properties of the predicate devices." (Implies successful comparison/verification) |
  | Functional & Handling | - Implants, accessory instruments, packaging, and instructions for use function together as intended.
• Conform to defined user needs and intended uses.
• Favorable comparison to predicate devices in functionality and handling. | - "Functional and handling test and simulated clinical use test were performed to verify that the implants, accessory instruments, packaging and instructions for use are functioning together as intended, and conform to the defined user needs and intended uses."
• "The tests were done also in comparison to the predicate devices."
• "The devices have passed the tests for functionality and handling in simulated clinical use settings and compare favourably to the predicate devices." |
  | Substantial Equivalence | - The intended use, material composition, scientific technology, degradation profile, and mechanical properties of Inion FreedomScrew™ are substantially equivalent to the predicate devices (Inion OTPS™ Mesh System K031961, Inion OTPS™ Mini Screws K043142, and Inion OTPS™ Fixation System K030900). | - "The data demonstrates that the intended use, material composition and scientific technology, degradation profile and mechanical properties of Inion FreedomScrew™ are substantially equivalent with the predicate devices Inion OTPS™ Mesh System (K031961), Inion OTPS™ Mini Screws (K043142) and Inion OTPS™ Fixation System (K030900)." |

Study Information

The provided document describes physical and mechanical testing of a medical device (bone screw), not an AI-powered diagnostic device. Therefore, many of the requested fields are not applicable in this context.

1. Sample size used for the test set and the data provenance:

   • Sample size: Not explicitly stated as a number of cases or patients. The testing involved "Inion FreedomScrew™ implants" and comparisons to predicate devices. The specific number of screws or test specimens used for each mechanical and degradation test is not provided.
   • Data provenance: The tests were "in vitro," implying laboratory-based testing rather than studies on human or animal subjects. No country of origin for the data is specified, but the manufacturer is based in Finland (Inion Oy, Tampere, Finland).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These were engineering/mechanical performance tests, not clinical studies requiring expert ground truth for interpretation.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This was mechanical and material performance testing, not a clinical study with image or data interpretation.

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: Not applicable. This device is a physical bone screw, not an AI system for human reader assistance.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical implant.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this type of device is established by engineering and material science principles, measured physical properties (e.g., strength, degradation rate), and comparison against established predicate device performance and regulatory standards for biocompatibility and mechanical integrity.

7. The sample size for the training set: Not applicable. This document describes testing of a physical device, not a machine learning model that requires a training set.

8. How the ground truth for the training set was established: Not applicable.

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