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Inion CPS™ 1.5 Baby Bioabsorbable Fixation System implants are intended for use in trauma and reconstructive procedures in the craniofacial skeleton (e.g., infant craniofacial surgery, craniosynostosis, congenital malformations, craniotomy flap fixation), mid-face and maxilla.

The Inion CPS™ 1.5/2.0/2.5 Bioabsorbable Fixation System implants are intended for use in trauma and reconstructive procedures and to maintain the relative position of bone grafts or bone graft substitutes in the cranium, including craniotomy flap fixation.

Inion CPS™ and Inion CPS™ Baby implants are bioabsorbable plates, screws and mesh plates made of bioabsorbable co-polymers. Inion CPS™ 1.5/2.0/2.5 System implants are composed of L-lactic acid, D-lactic acid and Trimethylenecarbonate. Inion CPS™ 1.5 Baby System implants are composed of L-lactic acid, D-lactic acid and Poly-Glygolic acid. These polymers have a long history of safe medical use and they degrade in vivo by hydrolysis into alpha-hydroxy acids that are metabolised by the body. The implants retain sufficient strength to fulfil their intended function during the healing period of the fracture or osteotomy, and degrade gradually thereafter. Bioresorption of Inion CPS™ implants takes place within 2-4 years, and Inion CPS™ Baby implants within 2-3 years.

The systems consist of fixation plates, meshes and screws offered in different sizes and designed to be used with the Inion CPS™ bone drill bits, bone taps, self-drilling bone taps, countersinks, screw drivers, plate bending pliers and heating device. The instruments are nonsterile and reusable. They are intended to be cleaned and sterilized before initial use and after each use.

The implants are provided sterile by gamma irradiation. They are intended for single use and shall not be re-sterilized or re-used. Implants are non-pyrogenic and fully synthetic.

This FDA 510(k) clearance letter is for bioabsorbable fixation systems, not an AI/ML powered medical device. Therefore, many of the requested fields are not applicable. I will provide information from the document as it relates to the general acceptance criteria and the study that proves the device meets them, while noting when a specific AI/ML related field is not relevant to this type of device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Description: Not directly applicable as this is not an AI/ML device with a specific "test set" in the context of algorithm validation. The "testing" refers to various evaluations:
  • Biocompatibility/Non-pyrogenicity Testing: Representative samples of the subject devices were selected for rabbit pyrogen tests. The exact number of samples or rabbits is not specified but it generally follows standard laboratory protocols. The provenance is likely from laboratory testing.
  • Clinical Evaluation: The clinical evaluation relied on published clinical studies.
    • Inion CPS™ Baby 1.5 Bioabsorbable Fixation System: 11 publications including 240 patients.
    • Inion CPS™ 1.5/2.0/2.5 System: 39 publications including 1755 patients.
  • Data Provenance for Clinical Studies: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective, beyond being "published clinical studies."

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. This device is a physical implant, not an AI/ML diagnostic tool that requires experts to establish ground truth for image interpretation or similar tasks. The "ground truth" for its performance is assessed through physical testing (material properties, pyrogenicity) and clinical outcomes reported in published literature.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in AI/ML performance studies, where multiple human experts independently review cases and then resolve disagreements. This concept does not apply to the evaluation of a physical bioabsorbable fixation system.

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. MRMC studies are specific to evaluating human reader performance with and without AI assistance for tasks like medical image interpretation. This device is a physical surgical implant and does not involve "human readers" in this context.

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

Not applicable. This device does not have an algorithm for standalone performance.

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

The "ground truth" (or basis for acceptance) for this device is established through:

• Physical Properties: Material composition, degradation profile, and strength retention are measured against pre-defined specifications.
• Biocompatibility and Non-pyrogenicity: Demonstrated through laboratory testing (e.g., rabbit pyrogen tests) against established biological safety standards (ISO 10993-1, USP chapters).
• Clinical Outcomes Data: Safe and effective use, performance rates, and complication rates are evidenced by published clinical literature and post-market follow-up data.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model that requires a training set.

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

Not applicable. This device is not an AI/ML model that requires a training set with established ground truth.

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

In addition, the Inion CompressOn™ Ø 3.5/4.0/4.5/5.0/6.0 mm products are specifically intended for use in following indications:

A. General indication: maintenance of reduction 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 CompressOn™ Screws are cannulated headless compression screws made of degradable co-polymers composed of L-lactic acid and D-lactic acid. These polymers have a long history of safe medical use and they degrade in vivo by hydrolysis into alpha-hydroxy acids that are metabolised by the body. The implants retain sufficient strength to fulfil their intended function during the healing period of the fracture or osteotomy, and degrade gradually thereafter. Bioresorption takes place within two to four years. The implants are provided sterile to the user and are not to be re-used or re-sterilized.

Inion CompressOn™ Screws have nominal dimensions ranging from 2.7-6.0 mm in diameter and 12-90 mm in length. They are designed to be inserted using Inion® instrumentation: drill bits, bone taps, drill taps, screwdriver shafts, drill sleeves, K-wires and depth gauges. The screws can be inserted over a guide wire.

Inion CompressOn™ Screws provide fixation and are not intended to replace healthy bone or withstand the stress of full load bearing.

This is a 510(k) premarket notification for the Inion CompressOn™ Screw, a medical device for bone fixation. The document focuses on demonstrating substantial equivalence to a predicate device (Inion FreedomScrew™). As such, it does not describe an AI/ML device or a study proving its performance against acceptance criteria in the way typically expected for such products.

The primary method for demonstrating substantial equivalence here is through mechanical performance testing and in vitro degradation testing, comparing the new device to a predicate device. There is no mention of an algorithm or AI model.

Therefore, many of the requested sections regarding AI/ML device performance (like sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance) are not applicable to this document.

However, I can extract information related to the performance testing conducted for this traditional medical device.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a non-AI/ML device, the acceptance criteria are not typically expressed as performance metrics like sensitivity/specificity. Instead, they relate to meeting specified mechanical and degradation properties, and being substantially equivalent to the predicate device.

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

This information is not provided in the document. The document refers to standard ASTM and ISO tests but does not specify the number of screws or test specimens used for each mechanical and degradation test. Data provenance is not relevant in the context of mechanical property testing of a fabricated device.

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

Not applicable, as this is a non-AI/ML device and ground truth is not established by expert review in this context. The "ground truth" for mechanical testing is derived from the physical properties and performance metrics defined in consensus standards.

4. Adjudication Method for the Test Set

Not applicable, as this is a non-AI/ML device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

Not applicable, as this is a non-AI/ML device.

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

Not applicable, as this is a non-AI/ML device. The "standalone" performance here refers to the device's inherent mechanical and degradation properties.

7. The Type of Ground Truth Used

For mechanical and degradation testing, the "ground truth" is defined by adherence to established consensus standards (ASTM F2502-11, ISO 13781:2017, ASTM F1635-16, ASTM F1839-08). The testing seeks to demonstrate that the device's physical properties meet these standards or are substantially equivalent to a predicate device that meets these standards.

8. The Sample Size for the Training Set

Not applicable, as this is a non-AI/ML device. There is no concept of a "training set" for mechanical performance testing.

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

Not applicable, as this is a non-AI/ML device.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets its "acceptance criteria" (i.e., demonstrating substantial equivalence and sufficient mechanical/degradation properties) consists of the following pre-clinical bench testing:

• Mechanical Torsion Testing: Conducted to determine and verify sufficient mechanical properties for insertion.
• Mechanical Pull-out Test: Conducted to verify that the pull-out properties are substantially equivalent to the predicate device (Inion FreedomScrew™).
• In vitro Degradation Test: Conducted in accordance with ISO 13781:2017 and ASTM F1635-16 to verify that the degradation rate and pull-out properties are substantially equivalent to the predicate device, both initially and over the specified healing period.
• Functional and Handling Test: Performed to verify that the implants, accessory instruments, packaging, and instructions for use function together as intended and conform to user needs.
• Simulated Clinical Use Test: Performed for the same purpose as the functional and handling test, in a simulated environment.

These tests were conducted according to FDA recognized consensus standards, indicating a standardized and accepted methodology for evaluating such devices. The conclusion states that "The data demonstrates that the intended use, material composition and scientific technology, degradation profile and mechanical properties of Inion CompressOn™ Screws are substantially equivalent with the predicate device Inion FreedomScrew™ (K123672). The devices have passed the tests for functionality and handling in simulated clinical use settings."

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These INION BIORESTORE™ implants are bone graft substitutes indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. INION BIORESTORE™ is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Inion BioRestore™ is a biodegradable bone graft substitute made of bioactive, biodegradable glass. Inion BioRestore™ system consists of different size cylinders, blocks and morsels made of degradable bioactive glass. When implanted, a kinetic modification of the surface occurs, resulting in the formation of a calcium phosphate layer that is essentially similar in composition and structure to the hydroxyapatite found in bone mineral. This apatite layer provides scaffolding onto which the patient's new bone will grow allowing complete repair of the defect. Based on pre-clinical testing, most of the material degrades in vivo in six months. The material is radiopaque. Inion BioRestore™ implants are intended for single use and are provided sterile to the user. They are completely synthetic and non-pyrogenic.

With this modification, additional packaging sizes and packaging configurations are introduced for the Inion BioRestore™ morsels.

This document is a 510(k) premarket notification for the Inion BioRestore device. The information provided primarily focuses on the regulatory aspects, device description, and verification testing related to packaging modifications for an existing bone graft substitute. As such, the document does not contain the typical acceptance criteria and a study design for a software or AI-based medical device.

Therefore, many of the requested details, such as those related to AI algorithm performance, human reader studies, or training/test set ground truth establishment for an AI device, are not applicable to this submission.

However, I can extract the information that is present concerning the physical device's verification testing and acceptance criteria related to its packaging and shelf-life.

Here's the information based on the provided text, aligning with the closest relevant aspects of your request:

Acceptance Criteria and Device Performance for Inion BioRestore (Packaging Modification)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for each specific test (biological safety, sterilization, shelf life, transportation). The document mentions "evaluation was conducted," "validation was conducted," "studies were performed," and "a test was performed," implying a sample was used for each.
• Data Provenance: Not explicitly stated regarding country of origin or specific patient data as this relates to a physical device's integrity and sterility, not clinical data from patients. The testing appears to be laboratory-based and engineering-based (e.g., sterilization validation, physical handling tests). The submission itself originates from Tampere, Finland (Manufacturer: Inion Oy).

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

• Not Applicable in the context of an AI device's ground truth. For this physical device's packaging verification, the "ground truth" would be established by validated scientific and engineering methods, adhering to relevant standards (e.g., ISO, ASTM for sterilization, shelf-life, and transportation testing). These tests are typically performed by qualified laboratory personnel and engineers, but specific numbers and qualifications are not provided in this regulatory summary.

4. Adjudication Method for the Test Set

• Not Applicable in the context of an AI device's ground truth adjudication. For physical device testing, results are adjudicated against pre-defined engineering and performance specifications, not through consensus of expert readers.

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

• No, not done. This type of study is relevant for AI-assisted diagnostic devices, not for the physical device (bone graft substitute) described here, nor its packaging modifications.

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

• No, not applicable. This refers to AI algorithm performance, which is not the subject of this 510(k) submission.

7. Type of Ground Truth Used

• For the physical device's performance related to packaging and shelf-life, the "ground truth" is based on:
  • Validated laboratory measurements (e.g., sterility testing, material degradation analysis).
  • Engineering specifications and standards (e.g., for packaging integrity, transport resilience).
  • Biological safety assessments based on established toxicology and biocompatibility standards.

8. Sample Size for the Training Set

• Not Applicable. This refers to an AI training set, which is not relevant to this submission.

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

• Not Applicable. This refers to an AI training set's ground truth, which is not relevant to this submission.

Summary regarding the device (Inion BioRestore) as a whole (not just AI/Software):

The Inion BioRestore is described as a resorbable bone void filler device made of bioactive, biodegradable glass. The 510(k) submission (K191764) is specifically for a modification to the device, introducing "additional packaging sizes and packaging configurations" for existing morsels. The document emphasizes that "There are no changes to the implant, i.e. Inion BioRestore morsels are the same." Therefore, the submission primarily focuses on ensuring that the new packaging does not negatively impact the safety, sterility, or efficacy of the device, and that it maintains its shelf life and integrity during transport.

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The Inion spinal graft containment plate system, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load bearing indications.

INION S-2™ Biodegradable Anterior Thoraco-Lumbar Fusion System plates are bioresorbable anterior thoraco-lumbar fusion devices for graft containment (screws and plates). The plates are made of degradable poly(L-lactide-co-D,L-lactide 80:20). Based on in vitro data: the implants retain most of their initial strength 16 weeks and gradually lose their strength thereafter. Bioresorption takes place within two to four years. The implants are provided sterile to the user and are non-collagenous. The shelf life of the device is 3 years.

INION S-2™ Biodegradable Anterior Thoraco-Lumbar Fusion System devices provide fixation and are not intended to replace healthy tissues or withstand the stress of full load bearing.

The purpose of this submission is a line extension for new sizes.

The user is asking for information about the acceptance criteria and study proving the device meets those criteria, based on the provided FDA 510(k) document for the "Inion Spinal Graft Containment System".

Here's the breakdown of the information requested, based on the provided document:

Acceptance Criteria and Device Performance

Study Details

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

   • Test Set Sample Size: The document does not explicitly state numerical sample sizes for the mechanical tests (e.g., number of plates tested for push-off, torsion, etc.). It refers to "mechanical testing" and "functional and handling test and simulated clinical use test" that were performed.
   • Data Provenance: The document does not specify the country of origin for the data or whether the tests were retrospective or prospective. Given the nature of mechanical testing for a medical device regulatory submission, it is almost certainly prospective laboratory testing conducted by the manufacturer (Inion Oy, Finland).

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

   • Not applicable. This device is a passive mechanical implant (surgical plate) and does not involve AI, image interpretation, or diagnostic analysis where experts establish ground truth. The "ground truth" here is the physical performance of the device against established engineering and material science standards, and comparison to a predicate device.

3. Adjudication method for the test set:

   • Not applicable. As the "ground truth" is based on objective mechanical measurements and performance against specifications, there is no need for expert adjudication in the context of diagnostic 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:

   • No. This is a physical medical implant, not an AI or diagnostic imaging device. Therefore, no MRMC study, human reader improvement with AI, or AI assistance is relevant or discussed.

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

   • No. This is a physical medical implant, not an AI algorithm.

6. The type of ground truth used:

   • The "ground truth" for this device's performance is based on mechanical test results (e.g., strength, torsion, compression values) and functional verification against established engineering principles and performance of the legally marketed predicate device. The goal was to demonstrate "substantial equivalence" to the predicate in terms of mechanical properties and function.

7. The sample size for the training set:

   • Not applicable. This is a physical medical implant, not an AI algorithm that requires a training set.

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

   • Not applicable. This is a physical medical implant, not an AI algorithm.

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The INION FreedomPin™ products are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).

The Inion FreedomPin™ products are intended to maintain accurate alignment of fragments of fractured bone in the presence of appropriate immobilization. The INION FreedomPin™ products are made of degradable co-polymers composed of L-lactic acid and D-lactic acid. These polymers have a long history of safe medical use and they degrade in vivo by hydrolysis into alpha-hydroxy acids that are metabolised by the body. The pins are dyed green for better visualization during the surgical procedure by a minimal amount of Drug and Cosmetic (D&C) Green No. 6, which is used in several biodegradable sutures and implants. Inion FreedomPins have nominal dimensions ranging from 1.5 - 3.2 mm in diameter and 30 - 70 mm in length. In addition, sterile Pin Kits are offered which contain 2-3 pins and the required sterile, single use instruments needed for the insertion. The implants retain sufficient strength to fulfil their intended function during the healing period of the fracture or osteotomy, and degrade gradually thereafter. Bioresorption takes place within two to four years. The implants are provided sterile to the user and are not to be resterilized. Inion FreedomPins provide fixation and are not intended to replace healthy bone or withstand the stress of full load bearing. Inion FreedomPins are designed to be used with customized instrumentation consisting of drill bits. K-wires, applicators. and arthroscopic pistons and tips.

The provided text describes a 510(k) summary for the Inion FreedomPin™. It details the device, its intended use, and the performance testing conducted to demonstrate substantial equivalence to a predicate device. However, it does not contain the level of detail typically found in a clinical study report or a statistical analysis plan for an AI/ML device.

Therefore, many of the requested categories cannot be fully addressed. The information below reflects what is available in the provided text.

Acceptance Criteria and Study Details for Inion FreedomPin™

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary for the Inion FreedomPin™ does not explicitly state numerical acceptance criteria in the format typically seen for AI/ML performance metrics (e.g., sensitivity, specificity thresholds). Instead, the performance testing aimed to demonstrate "substantial equivalence" to a predicate device in terms of mechanical properties and degradation profile.

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

The provided text describes mechanical and in vitro degradation testing, as well as functional and handling tests and simulated clinical use tests. These are not clinical studies with "test sets" in the context of an AI/ML device's performance evaluation on patient data.

• Sample Size for Testing: Not specified in terms of number of pins, but implied to be sufficient for mechanical and degradation tests. It does not refer to patient samples.
• Data Provenance: The tests are described as in vitro and simulated clinical use, meaning they were conducted in a laboratory setting. There is no mention of patient data, geographical origin, or retrospective/prospective nature as this is a physical medical device.

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

This information is not applicable. The device is a physical bone fixation pin, not an AI/ML diagnostic or predictive system that requires expert-established ground truth from medical images or patient records. The "ground truth" for this device would be its physical properties and degradation characteristics, measured through established engineering and chemical testing methods.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation of data for "adjudication" in the context of the described physical and mechanical tests.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, this was not done. An MRMC study is relevant for AI-powered diagnostic or screening tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. The Inion FreedomPin™ is a physical implant, not a diagnostic or image-analysis device.

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

Not applicable. The Inion FreedomPin™ is a physical medical device that is implanted surgically and supports bone healing. It does not involve an algorithm that operates "standalone" in the typical sense of AI/ML performance evaluation. Its "performance" is its mechanical integrity and biodegradation profile.

7. The Type of Ground Truth Used

For the Inion FreedomPin™, the "ground truth" for the performance testing refers to:

• Standardized Mechanical Test Results: Measurements of shear strength, bending strength, pull-out strength, and torsion using established engineering test methods.
• In Vitro Degradation Data: Measurements of material and mechanical property changes over time in a controlled laboratory environment mimicking physiological conditions.
• Predicate Device Performance: The primary "ground truth" for substantial equivalence was the known and accepted performance of the predicate device (Inion OTPS Biodegradable Pin K050275), against which the new device's performance was compared.

8. The Sample Size for the Training Set

Not applicable. The Inion FreedomPin™ is a physical device, and its development and testing did not involve a "training set" in the context of AI/ML model development.

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

Not applicable, for the same reasons as point 8.

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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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Inion CPS Orbital Plates are intended for use in trauma and reconstructive procedures of the orbital cavity as part of the Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System.

The Inion CPS® Orbital Plate fixation plates made of resorbable polylactic acid/trimethylcarbonate copolymer: This copolymer degrades in vivo by hydrolysis into L-lactic, D-lactic and TMC monomers which are then metabolised by the body.

Inion CPS® Orbital Plates are of dimensions: length: 25-40 mm, width: 24-40 mm, thickness: 0.5 mm. The fixation of the plates with Inion CPS® ø1.5 mm screws. The implants retain sufficient strength to fulfil their intended function during the healing period of the fracture or osteotomy, and degrade gradually thereafter. Bioresorption takes place within two to four years. The implants are provided sterile to the user and are not to be resterilized.

The Inion CPS® Orbital Plates provide fixation and are not intended to replace healthy bone or withstand the stress of full load bearing.

The Inion CPS® Orbital Plates are designed to be used with customized instrumentation consisting of template, drill bits, bone taps, screw driver, plate benders and a heating device.

The provided text describes a 510(k) summary for the Inion CPS® Orbital Plate, focusing on the device description, indications for use, and performance testing for substantial equivalence. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically seen in discussions of AI/ML device performance.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, AI performance, ground truth, or study details.

The document primarily discusses:

• Device Description: Resorbable polylactic acid/trimethylcarbonate copolymer plates for orbital cavity trauma.
• Indications for Use: Trauma and reconstructive procedures of the orbital cavity as part of the Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System.
• Performance Testing: Mechanical shear test, biomechanical fixation test, in vitro degradation testing, functional and handling test, and simulated clinical use test were performed to demonstrate substantial equivalence to a predicate device (Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System K010352). These tests verified strength, fixation, degradation profile, and functionality.

No information regarding the performance of an AI/ML device, its acceptance criteria, or a study to demonstrate its performance against such criteria is present in the provided text.

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The Inion BioRestore™ implants are bone graft substitutes indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Inion BioRestore™ is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Inion. BioRestore™ is an osteoconductive and osteostimulative bioactive bone graft device. In vivo tests have demonstrated more bone formation at each post-implantation timepoint and more total bone formation compared to other osteoconductive devices such as hydroxyapatite. In vitro cell culture tests with human adipose mesenchymal stem cells have demonstrated an osteostimulative effect, defined as the active stimulation of osteoblast proliferation and differentiation as evidenced by alkaline phosphatase activity. This stimulation has been attributed as being the result of the interaction between osteoblasts and the ionic dissolution products released from Inion BioRestore™ during its absorption. Clinical data on humans on rate and extent of bone formation observed in cell culture and animal models has not been established. Bioactive materials are those materials that elicit a specific biological response at the interface of the material that results in the formation of a bond between the tissues and the material. Osteostimulation is a "... property of some bioactive materials to enhance, actively stimulate both the proliferation and differentiation of progenitor cells (e.g. mesenchymal stem cells) ... "1 The Inion BioRestore™ system consists of different size cylinders, blocks and morsels made of degradable bioactive glass. When implanted, a kinetic modification of the surface occurs, resulting in the formation of a calcium phosphate layer that is essentially similar in composition and structure to the hydroxyapatite found in bone mineral. This apatite laver provides scaffolding onto which the patient's new bone will grow allowing complete repair of the defect. Based on pre-clinical testing, most of the material degrades in vivo in six months. The material is radiopaque. Inion BioRestore™ implants are intended for single use and are provided sterile to the user. They are completely synthetic and noncollagenous.

The provided text does not contain information about acceptance criteria or a study proving that the Inion BioRestore™ device meets specific acceptance criteria.

The document is a 510(k) summary for the Inion BioRestore™ device, primarily focusing on establishing substantial equivalence to a predicate device (Inion BioRestore™ K070998). It describes the device, its principles of operation, indications for use, and confirms that it is substantially equivalent to the predicate. The FDA letter confirms the substantial equivalence determination.

Therefore, I cannot fulfill your request for the tables and details about acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

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The INION BIORESTORE™ implants are bone graft substitutes indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. INION BIORESTORE™ is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Inion BioRestore™ is an osteoconductive and osteostimulative bioactive bone graft device. In vivo tests have demonstrated more bone formation at each post-implantation timepoint and more total bone formation compared to other osteoconductive devices such as hydroxyapatite. In vitro cell culture tests with human adipose mesenchymal stem cells have demonstrated an osteostimulative effect, defined as the active stimulation of osteoblast proliferation and differentiation as evidenced by alkaline phosphatase activity. This stimulation has been attributed as being the result of the interaction between osteoblasts and the ionic dissolution products released from Inion BioRestore™ during its absorption. Clinical data on humans on rate and extent of bone formation observed in cell culture and animal models has not been established.

Bioactive materials are those materials that elicit a specific biological response at the interface of the material that results in the formation of a bond between the tissues and the material. Osteostimulation is a "... property of some bioactive materials to enhance, actively stimulate both the proliferation and differentiation of progenitor cells (e.g. mesenchymal stem cells) ... "1.2

Inion BioRestore™ system consists of different size cylinders, blocks and morsels made of degradable bioactive glass. When implanted, a kinetic modification of the surface occurs, resulting in the formation of a calcium phosphate layer that is essentially similar in composition and structure to the hydroxyapatite found in bone mineral. This apatite layer provides scaffolding onto which the patient's new bone will grow allowing complete repair of the defect. Based on pre-clinical testing, most of the material degrades in vivo in six months. The material is radiopaque. Inion BioRestore™ implants are intended for single use and are provided sterile to the user. They are completely synthetic and noncollagenous.

This 510(k) summary for Inion BioRestore™ describes a medical device clearance based on substantial equivalence to predicate devices, rather than a study against a pre-defined set of acceptance criteria with detailed performance metrics. Therefore, several requested categories of information directly related to performance studies with acceptance criteria, ground truth, and expert evaluation are not applicable or not provided in this document.

Here's a breakdown of the requested information based on the provided text:

Table of Acceptance Criteria and Reported Device Performance

Study Information

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

   • Test set and data provenance specific to a performance study: Not explicitly stated. The document refers to "in vivo tests" and "in vitro cell culture tests," but does not provide details on sample sizes or data provenance (e.g., country of origin, retrospective/prospective nature) for these tests in the context of a "test set" for regulatory evaluation against acceptance criteria.
   • The "performance data and specifications" mentioned in the substantial equivalence statement are used to compare the device to predicates, not against a standalone test set for specific acceptance criteria.

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

   • Not applicable as no specific "test set" requiring expert ground truth establishment for regulatory acceptance is detailed in this 510(k) summary. The evaluation relies on comparison to predicate devices and general pre-clinical testing results.

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

   • Not applicable as no specific "test set" with a need for expert adjudication is detailed.

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 bone graft substitute, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant and not mentioned.

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

   • Not applicable. This device is a physical bone graft substitute, not an algorithm.

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

   • For the "in vivo tests" demonstrating bone formation: The "ground truth" would likely be based on histological analysis, imaging (e.g., radiography, micro-CT) for assessing bone growth, and potentially gross examination by animal pathologists or histology experts. However, specific details are not provided.
   • For the "in vitro cell culture tests": The "ground truth" for osteostimulation is evidenced by "alkaline phosphatase activity," which is a biochemical marker for osteoblast differentiation.

7. The sample size for the training set:

   • Not applicable. This device is a physical bone graft substitute, not an AI model that requires a "training set."

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

   • Not applicable, as there is no "training set" for this type of device.

In summary, this 510(k) clearance is based on demonstrating "substantial equivalence" to existing predicate devices, leveraging pre-clinical (in vivo and in vitro) data for general characterization rather than a specific performance study against defined acceptance criteria with a detailed clinical test set and expert evaluation. The document confirms that there are "no applicable mandatory performance standards" for this device.

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The Inion Hexalon™ Biodegradable ACL/PCL Screw is intended for soft tissue (including ligament, tendon, and bone-tendon-bone graft) fixation to bone in surgeries of the knee, shoulder, elbow, ankle, foot, hand and wrist where the offered screw sizes are patient appropriate.

Inion Hexalon™ Biodegradable ACL/PCL Screw is made of resorbable polylactic acid / trimethylenecarbonate copolymer. The Inion Hexalon™ Biodegradable Screws are coloured green for better visualization during surgical operation.

Inion Hexalon™ Biodegradable ACL/PCL Screws gradually lose their strength during 18-36 weeks. Bioresorption takes place within two to four years. Inion Hexalon™ Biodegradable ACL/PCL Screw is sterile and non-collagenous. The shelf life of the product is three years.

This document is a 510(k) summary for the Inion Hexalon™ Biodegradable ACL/PCL Screw, a medical device for orthopedic fixation. It does not contain information about acceptance criteria or a study proving the device meets them in the way a diagnostic AI would.

This 510(k) summary focuses on demonstrating substantial equivalence to predicate devices already on the market, rather than proving the performance of a novel diagnostic algorithm against specific acceptance criteria. This process is common for medical devices.

Therefore, many of the requested categories for a diagnostic AI study on acceptance criteria and performance cannot be directly extracted from this document, as they are not applicable to the type of regulatory submission presented.

Here's a breakdown of what can be derived from the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not applicable / Not provided in this format. This document does not present acceptance criteria or reported performance as it would for a diagnostic AI. The goal of a 510(k) is to show substantial equivalence to existing devices. The "performance" is implicitly deemed equivalent to the predicate devices.
• The closest "performance" related information is that the device "gradually lose their strength during 18-36 weeks" and "Bioresorption takes place within two to four years." These are characteristics, not performance metrics against acceptance criteria.

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

• Not applicable. This is a medical implant, not a diagnostic AI that uses a test set of data. The "study" mentioned here is the comparison to predicate devices and the characterization of the material properties described above.

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

• Not applicable. Again, this is not a diagnostic AI performance study.

4. Adjudication Method for the Test Set:

• Not applicable.

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 is not a diagnostic AI and therefore no MRMC study would be conducted in this context.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

• Not applicable in the context of an AI ground truth. For this device, the "ground truth" for substantial equivalence relies on:
  • Material composition: Polylactic acid / trimethylenecarbonate copolymer.
  • Scientific technology: Biodegradable screw for fixation.
  • Degradation profile: 18-36 weeks for strength loss, 2-4 years for bioresorption.
  • Mechanical properties: Implied to be similar to predicate devices.
  • Predicate devices: Arthrex Interference Screw, Arthrex Tenodesis Screw Family, Biomet Bio-Core Interference Screw, Biomet Resorbable Interference Screw. The "ground truth" for their safety and effectiveness is their prior FDA clearance and market history.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable.

Summary of what can be extracted concerning "acceptance criteria" and "study" for this type of device:

The "study" presented in this 510(k) is primarily a comparative study for substantial equivalence to previously cleared predicate devices.

Acceptance Criteria for Substantial Equivalence (Implicit from the document):

The device is considered to have met "acceptance criteria" for marketing if it is demonstrated to be substantially equivalent to predicate devices, meaning:

• Same intended use: Soft tissue (ligament, tendon, bone-tendon-bone graft) fixation to bone in surgeries of the knee, shoulder, elbow, ankle, foot, hand, and wrist.
• Similar technological characteristics: Material composition (resorbable polylactic acid/trimethylenecarbonate copolymer), degradation profile, and mechanical properties are comparable to predicate devices.
• No new questions of safety and effectiveness: The differences between the Inion Hexalon™ screw and the predicate devices do not raise new concerns.

The "Study" that Proves the Device Meets these Criteria:

• The "study" is a technical and scientific comparison to predicate devices, backed by information on the device's material properties and degradation profile.
• The document states: "The evidence demonstrates that the intended use, material composition and scientific technology, degradation profile and mechanical properties of Inion Hexalon™ Biodegradable ACL/PCL Screw are substantially equivalent with the predicate devices."
• Data Provenance: This would typically involve laboratory testing of the Inion Hexalon™ screw's material and mechanical properties (e.g., strength testing, degradation studies) and a review of the predicate devices' characteristics. The document does not specify where these tests were conducted or the specific experimental design, but it implies such data was submitted to the FDA to support the substantial equivalence claim.
• No specific sample sizes for "test sets" or "training sets" are provided because this is not a diagnostic AI or a clinical trial in the conventional sense of proving efficacy or safety from scratch. Instead, it relies on the established safety and efficacy of the predicate devices.

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