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Locking Screw,CoCrMo is indicated for the fixation of clavicle, scapula, pelvis, humerus, ulna, radius, femur, tibia, fibula, metacarpals, metatarsals and phalanges fractures.

Locking Screw, CoCrMo is used to fasten plates onto bones, or, as lag screws, to hold bone fragments together. The screws are differentiated by the manner in which they are inserted into bone, their function, their size, and the type of bone they are intended for. Locking Screw, CoCrMo consists of a series of screws with different sizes and structures, which is designed according to the anatomical characteristics of human bones. In clinical practice, the bone screw shall be used in combination with the bone plate, which acts as a temporary internal support, provides a stable local environment for the fractured end, and creates conditions for the healing of the fractured end. Locking Screw,CoCrMo is made of CoCrMo following ASTM F1537. Locking Screw,CoCrMo is provided as sterile and non-sterile. The implants are intended for single-use only.

This submission describes a medical device, the "Locking Screw, CoCrMo," and its substantial equivalence to predicate devices, not an AI/ML powered device. Therefore, the information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, are not applicable here.

The document provides details for a traditional medical device submission, focusing on material, design, and mechanical performance. Here's a breakdown of the relevant information provided:

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

The document does not provide a table with explicit acceptance criteria and reported device performance in the manner expected for an AI/ML device. Instead, it states that the device was tested to demonstrate substantial equivalence to the predicate device based on specific mechanical tests. The acceptance is implied by the FDA's substantial equivalence determination.

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

The document mentions "non-clinical performance data" and mechanical tests (Torsion, Insertion/removal, Pullout). It does not specify the sample sizes used for these tests. Data provenance (country of origin, retrospective/prospective) is not applicable as these are laboratory mechanical tests, not clinical studies with patient data.

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)

This is not applicable as this is a submission for a physical medical device (locking screw), not an AI/ML diagnostic or predictive tool. Ground truth in this context typically refers to objective measurements and compliance with established ASTM standards for mechanical properties and biocompatibility, not expert consensus on interpretations of medical data.

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

Not applicable. This is not an AI/ML device undergoing a diagnostic performance study requiring adjudication of expert interpretations.

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 an AI/ML device. No MRMC study was performed. The product is a physical implant, not a software tool assisting human readers.

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

Not applicable. This is not an AI/ML algorithm.

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

For this type of device, the "ground truth" for non-clinical testing refers to:

• Established ASTM Standards: The mechanical tests (Torsion, Insertion/removal, Pullout) are performed according to ASTM F543-17. The acceptance criteria for these tests are derived from these industry standards, often with comparative data to the predicate device to show equivalence.
• Biocompatibility Standards: The biocompatibility evaluation follows ISO 10993-1, with acceptance based on meeting the requirements of this international standard.
• Material Specifications: The material (CoCrMo) must conform to ASTM F1537.

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable. This is not an AI/ML device.

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The Posterior Cervical Spine System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T2:

(1)Traumatic spinal fractures and/or traumatic dislocations.

(2)Instability or deformity.

(3)Failed previous fusions (e.g. pseudarthrosis).

(4)Tumors involving the cervical spine.

(5)Degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The Posterior Cervical Spine System consists of pedicle screws, nut, rods, connectors, hook, transconnectors, laminar hooks, occipital plates and occipital screw.

The implants in Posterior Spine Cervical System is made from Ti-6A1-4V ELI following ASTM F136 or Ti-6Al-4V following ASTM F1472.

The implants are provided as sterile or non-sterile, while the instruments are provided as non-sterile.

The implants are intended for single-use only, while the instruments are reusable.

The provided text is a 510(k) summary for a medical device (Posterior Cervical Spine System) and does not describe acceptance criteria, device performance, or details of a study involving AI or human readers. The document explicitly states:

"No clinical performance data was provided to demonstrate substantial equivalence."

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample size for testing/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the given input.

The document focuses on demonstrating substantial equivalence through:

• Comparison of Technological Characteristics: Stating similarity in regulatory classification, indications for use, materials, and design features to predicate devices.
• Non-Clinical Performance Data: Referring to biocompatibility testing (in accordance with FDA Guidance "Use of International Standard ISO 10993-1") and mechanical testing (per ASTM F2706-08, ASTM F543-17, and ASTM F1798-13) to ensure the device's physical properties are safe and effective.

No AI-related information or clinical study details are present in this document.

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Cervical Plate System is intended for anterior interbody screw fixation from C2 to T1 and is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); 2)trauma (including fractures); 3)tumors: 4)deformity(defined as kyphosis, lordosis,or scoliosis); 5)pseudoarthrosis; 6)failed previous fusions

Cervical Plate System consist of anterior cervical spine plate II, anterior cervical spine plate IV and screws. The anterior cervical spine plate is fixed to the front of the cervical vertebrae by screws to play an auxiliary role in maintaining the stability of the surgical segment and preventing the fusion implant from coming out. Screws are available for fixed angle or variable angle implantation.

Bone plates in Cervical Plate System are made of unalloyed titanium following ASTM F67 and titanium alloy following ASTM F1472 as well as ASTM F1295, and bone screws in Cervical Plate System are made of titanium alloy following ASTM F136.

Cervical Plate System is provided as non-sterile. The implants are intended for single-use only, while the instruments are reusable.

This document, K223753, is a 510(k) premarket notification for a Cervical Plate System. It seeks to demonstrate substantial equivalence to a legally marketed predicate device (K141632 ZEVO™ Anterior Cervical Plate System).

The request asks for acceptance criteria and a study that proves the device meets these criteria. However, the provided text does not contain information about an AI/ML-based medical device, nor does it describe a study involving human-in-the-loop performance, expert consensus on images, or training/test sets for an algorithm.

Instead, this submission details the regulatory approval process for a physical orthopedic implant used in spinal surgery. The "acceptance criteria" discussed are primarily related to biocompatibility and mechanical testing of the physical device to ensure its safety and efficacy, not performance metrics of an AI algorithm.

Therefore, I cannot provide the requested information. The document explicitly states:

• "No clinical performance data was provided to demonstrate substantially equivalence." (Section 5.8)
• The non-clinical performance data focuses on biocompatibility testing (ISO 10993-1) and mechanical testing (ASTM F1717) for the physical implant (Static compression bending test, Static torsion test, Dynamic compression bending test).

To explicitly answer your questions based only on the provided text, and acknowledging the mismatch with your request for AI/ML study details:

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

   • Acceptance Criteria (Implied from tests performed): The Cervical Plate System must demonstrate biocompatibility and mechanical performance (static compression bending, static torsion, dynamic compression bending) that is substantially equivalent to the predicate device, as per ASTM F1717 and ISO 10993-1.
   • Reported Device Performance: The document states these tests were "performed... to demonstrate substantially equivalent of safety and efficacy with the predicate device," but it does not provide numerical results or specific performance metrics from these tests. It only states that the information provided "demonstrates that proposed device is determined to be substantially equivalent (SE) to the predicate device." This implies the acceptance criteria were met, but the specific data is not in this summary.

2. Sample sizes used for the test set and the data provenance: This is not applicable to this document as it does not describe an AI/ML study with test sets of data. The "test set" here refers to physical samples of the cervical plate subjected to mechanical and biocompatibility tests. No information on the number of physical samples tested is provided, nor is the "provenance" of such samples described in terms of geographical origin or retrospective/prospective collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable. Ground truth, in the context of an AI/ML study, would involve expert labeling of medical images or data. No such process is described for this physical device. The "ground truth" for a physical device is its material properties and mechanical behavior under stress.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: This is not applicable as there is no data labeling or consensus-building process for an AI/ML 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: This is not applicable to this submission. The device is a physical implant, not an AI assistance tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not applicable. There is no algorithm described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a physical device, "ground truth" refers to established material properties and biomechanical standards. The document refers to ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model) and ISO 10993-1 (Biological evaluation of medical devices). These standards serve as the "ground truth" for evaluating the physical and biological characteristics of the device.

8. The sample size for the training set: This is not applicable as there is no AI/ML model or training set.

9. How the ground truth for the training set was established: This is not applicable as there is no AI/ML model or training set.

In summary, the provided document is a 510(k) summary for a physical medical device (Cervical Plate System) and does not involve AI/ML technology or studies with expert reading of medical images.

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The Advanced Bone Plate (AIMIMINI VARIABLE ANGLE LOCKING PLATES SYSTEM, ITVAL Foot & Ankle VAL System, and Distal Fibular VAL Plate) is internal fixation. Specific indications for the plates included in the system as follows:

The AIMIMINI VARIABLE ANGLE LOCKING PLATES SYSTEM is inticated for the internal fixation (fractures, osteotomies, arthrodesis, replantations and reconstructions) of the hand (metacarpals and phalanges) and wrist of adults and adolescents (age 12-21 years) in which growth plates have fused or will not be crossed by fixation.

The ITVAL Foot & Ankle VAL System is internal fixation (fractures, osteotomies, fusions, nonunions, malunions, small fragment replantations) of the foot and ankle in adults and adolescents (age 12-21 years) possessing normal or osteopenic bone where growth plates have fused or will not be crossed by fixation.

The Distal Fibular VAL Plate is indicated for internal fractures, osteotomies, nonunions, malunions, small fragment replantations) of the distal fibula of adults and adolescents (age 12-21 years) where growth plates have fused or will not be crossed by fixation.

Advanced Bone Plate is mainly used for internal fixation of hand, wrist, foot, ankle and distal fibular fractures. According to the anatomical characteristics of human bones, locking plates of different shapes and locking screws of different diameters are designed. In clinical practice, locking bone plate and locking bone screw are used in combination to play the role of temporary internal stent, providing a stable local environment for fracture ends and creating conditions for the healing of fracture ends.

Bone plates in Advanced Bone Plate are made of titanium alloy following ASTM F1472, and bone screws in Advanced Bone Plate are made of titanium alloy following ASTM F136. Advanced Bone Plate is provided as non-sterile. The implants are intended for single-use only, while the instruments are reusable.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:

Disclaimer: This document is a 510(k) summary for a medical device (Advanced Bone Plate) and primarily focuses on demonstrating "substantial equivalence" to predicate devices, rather than establishing de novo efficacy or setting new acceptance criteria. Therefore, the information provided will reflect this context.

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

The provided 510(k) summary does not explicitly define quantitative "acceptance criteria" in the traditional sense of a performance study with numerical targets. Instead, it aims to demonstrate "substantial equivalence" in terms of characteristics and performance to legally marketed predicate devices. The "reported device performance" is described through the successful completion of various non-clinical tests that show the device functions similarly to the predicate devices.

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

• Sample Size for Test Set: The document does not specify exact sample sizes for each mechanical test (e.g., number of plates or screws tested). It refers to standard ASTM methods (F382-17, F543-17) which would prescribe sample sizes.
• Data Provenance: The tests are non-clinical, conducted in a laboratory setting by the manufacturer (Double Medical Technology Inc.) or a contracted lab. The data is thus prospective experimental data generated for the purpose of this submission.
  • Country of Origin: Likely China, given the submitter's address.

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

This section is not applicable in the context of this 510(k) submission. The "ground truth" for non-clinical mechanical testing is established by the specifications in the relevant ASTM standards (e.g., ASTM F382-17, ASTM F543-17) and successful execution according to those methods, rather than expert consensus on medical images or patient outcomes.

4. Adjudication method for the test set

This section is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human readers where there's a need to resolve discrepancies in expert interpretations of data (e.g., imaging scans). For mechanical testing, the results are quantitative and objective, based on physical measurements and adherence to standard protocols.

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 (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or AI-assisted diagnostic tools, not for a passive internal fixation device like a bone plate. The document explicitly states: "No clinical performance data was provided to demonstrate substantially equivalence."

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

No, a standalone performance study in the context of an algorithm or AI device was not done. This device is a physical implant, not a software algorithm.

7. The type of ground truth used

The "ground truth" for this device, within the scope of this 510(k), is established by:

• Accepted Industry Standards: Primarily ASTM F382-17 and ASTM F543-17 for mechanical properties, and ISO 10993-1, ISO 17665-1:2006, and AAMI TIR30:2003 for biocompatibility, sterilization, and reprocessing. These standards define the acceptable methods and performance benchmarks for such devices.
• Comparison to Predicate Devices: The core of a 510(k) relies on demonstrating that the new device performs as safely and effectively as a legally marketed predicate device. The "ground truth" for substantial equivalence is met if the new device's characteristics and performance fall within the established safety and efficacy profile of the predicates.

8. The sample size for the training set

This section is not applicable. This device is a physical bone plate, not an AI/ML algorithm that requires a "training set."

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

This section is not applicable for the same reason as point 8.

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The Anatomic Bone Plates are intended for the internal fixation of fractures (VAL Distal Clavicle, VAL Proximal Humeral, VAL Distal Humeral, Distal Ulnar Locking, Distal Radial Locking, VAL Proximal Tibia, VAL Distal Tibia, VAL Distal Lateral Fibular, VAL Distal Femoral, Pelvic Bone Plate), fracture dislocations (VAL Proximal Humeral), osteotomies, and mal/non-unions (VAL Distal Clavicle, VAL Proximal Humeral, VAL Distal Humeral) of the clavicle, pelvis, and the upper (i.e., humerus, ulna and radius) and lower (i.e., femur, tibia, and fibula) extremities. Additional plates included in the system with specific indications as follows:

• A VAL (Variable Angle Locking) Distal Clavicle Plate is indicated for fractures of the shaft and lateral clavicle, malunions and non-unions ;

• VAL Distal Humeral Plate is indicated for fractures (including supracondylar), and nonunions :

• A VAL Distal Femoral Plate is indicated for distal femoral fractures (diaphyseal, supracondylar, and intra-articular);

• Pelvic Bone Plate is indicated for pelvic fractures (e.g., acetabular , iliac wing, and symphysis pubis).

Anatomic Bone Plate is mainly used for internal fixation of fracture. According to the anatomical characteristics of human bones, locking plates of different shapes and locking screws of different diameters are designed. In clinical practice, locking bone plate and locking bone screw are used in combination to play the role of temporary internal stent, providing a stable local environment for fracture ends and creating conditions for the healing of fracture ends. Anatomic Bone Plate is provided as non-sterile. The implants are intended for single-use only, while the instruments are reusable.

Anatomic Bone Plate are made of titanium alloy following ASTM F1472 or unalloyed titanium following ASTM F67.

This document is a 510(k) premarket notification for a medical device called "Anatomic Bone Plate." It does not include information about acceptance criteria or a study proving that an AI/software device meets those criteria. The submission is for a traditional medical device (an orthopedic implant), not a software device, and therefore the types of studies and acceptance criteria you are asking for (related to AI performance, ground truth, expert consensus, MRMC studies, etc.) are not applicable here.

The document discusses:

• Device Description: Anatomic Bone Plate, made of titanium alloy, for internal fixation of fractures.
• Indications for Use: Internal fixation of fractures, fracture dislocations, osteotomies, and mal/non-unions in various bones (clavicle, pelvis, upper and lower extremities).
• Comparison to Predicate Device: States substantial equivalence in regulatory classification, indications for use, materials, and design features to a predicate device (K130108).
• Non-Clinical Performance Data:
  • Biocompatibility testing: Performed according to FDA Guidance "Use of International Standard ISO 10993-1".
  • Mechanical testing: Performed per ASTM F382-17 (Standard Specification and Test Methods for Metallic bone plate) and a three-point bending test method to determine bending stiffness, strength, and structural stiffness. This is to demonstrate substantial equivalence in safety and efficacy.
• Clinical Data: States that "Clinical literature was provided to demonstrate substantially equivalence."

Therefore, I cannot provide the requested information for acceptance criteria and a study proving an AI/software device meets acceptance criteria, as this document pertains to a physical orthopedic implant and not a software device.

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Metal Cannulated Screw is indicated for internal fixation of fracture, fusion and correction of limb bone and metaphysis, hand and foot:
1)The 2.3mm No Profile Cannulated Screw is indicated for the fixing the elective osteotomies of the mid foot bones and the metatarsal and phalanges of the foot only.
2)The 3.0mm No Profile Cannulated Screw is indicated for internal fixation of bone fractures of ulna, and small bones (metacarpals, metatarsals, and phalanges).
3)The 4.0mm No Profile Cannulated Screw and 4.0mm No Profile Cannulated Screw, Oblique are indicated for fixation of fractures, fusions, osteotomies, non-unions of small bones and small bone fragments.
4)The 5.0mm No Profile Cannulated Screw and 5.0mm No Profile Cannulated Screw, Oblique are indicated for fixation of fractures, fusions, osteotomies, non-unions of long bones and long bone fragments, and the bones of the hand and foot.
5)The 7.0mm No Profile Cannulated Screw and 7.0mm No Profile Cannulated Screw, Oblique are indicated for fixation of fractures, fusions, osteotomies, non-unions of long bones and long bone fragments, pelvis, sacrum, and the bones of the foot. These screws are also indicated for femoral neck fractures, slipped capiplysis, an adjunct to DHS (Dynamic Hip System) in basilar neck fractures, ankle arthrodesis, intercondylar femur fractures, SI joint disruptions and subtalar arthrodesis.
6)The Headless Cannulated Screw (2.5-4.5mm)/Headless Compression Screw (2.5-4.5mm) are indicated for fixation of fractures in large bones of humerus, ulna, radius, tibia and fibula, and small bones of the foot. These screws are also indicated for intra-articular fractures of knee and ankle joint.
7)The Headless Cannulated Screw (5.0-7.0mm)/ Headless Compression Screw (5.2-7.0mm) are indicated for fixation of fractures of femur, tibia and calcaneus, and intra-articular fractures of knee joint.
8)The 3.5mm/4.0mm Headless Compression Screw, Oblique are indicated for fixation of bone fractures or for bone reconstruction of the foot and hand, including calcaneus, talar, navicular, metacarpals, metatarsals and phalanges.
9)The 6.5mm Cannulated Screw are intended for fixation of fractures, non-unions, and malunions of long bones and long bone fragments, pelvis, sacrum, and the bones of the foot. These screws are also indicated for femoral neck fractures, slipped capital femoral epiphysis, an adjunct to DHS (Dynamic Hip System) in basilar neck fractures, tibial plateau fractures, ankle arthrodesis, intercondylar femur fractures, SI joint disruptions and subtalar arthrodesis.
10)The 7.3mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions of long bones and long bone fragments, pelvis, sacrum and the bones of the foot. These screws are also indicated for slipped capital femoral epiphysis, ankle arthrodesis and subtalar arthrodesis.

Metal Cannulated Screw consists of a series of screws with different sizes and structures, which is designed according to the anatomical characteristics of human bones. In clinical practice, Metal Cannulated Screw is used alone, which acts as a temporary internal support, provides a stable local environment for the fractured end, and creates conditions for the healing of the fractured end. Metal Cannulated Screw are made of Ti-6Al-4V ELI following ASTM F 136. Metal Cannulated Screw is provided as non-sterile. The implants are intended for single-use only, while the instruments are reusable.

The provided text (K221090) describes a premarket notification for a medical device called "Metal Cannulated Screw." It details the device's indications for use, comparison to predicate devices, and non-clinical performance data.

However, the provided document does not contain any information about an AI/ML-based medical device, nor does it mention any studies involving acceptance criteria, device performance metrics (such as sensitivity, specificity, accuracy), sample sizes for test or training sets, ground truth establishment by experts, adjudication methods, multi-reader multi-case (MRMC) studies, or standalone algorithm performance.

The document states: "No clinical performance data was provided to demonstrate substantially equivalence." This further indicates that the submission relies on non-clinical (mechanical and biocompatibility) testing to demonstrate equivalence to a traditional medical device (bone screws), not a software-based AI device requiring performance metrics.

Therefore, I cannot answer your request based on the provided text, as it does not contain the necessary information regarding acceptance criteria and a study proving an AI device meets these criteria.

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Advanced Intramedullary Nail System is intended to be implanted into the medullary canal of limbs for alignment. stabilization, fixation of fractures caused by trauma or diseases.

Indications:

1. Ulna Nail: Indicated for the fixation of fractures and osteotomies of the ulna.

2.Fibular Nail: Indicated for fixation of fractures and osteotomies of the fibula.

3. Ankle Fusion Nail: Indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot: tibiocalcaneal arthrodesis; combined arthrodesis of the ankle and subtalar joints; avascular necrosis of the ankle and subtalar joints; failed total ankle replacement with subtalar intrusion;failed ankle arthrodesis with insufficient talar body; rheumatoid arthritis; severe deformity secondary to untreated talipes equinovarus or neuromuscular disease; and severe pilon fractures with trauma to the subtalar joints.

The method of intramedullary nail fixation is symmetrical central splint fixation; central fixati on is theoretically superior to cortical external fixation, which can reduce the moment arm, re duce the incidence of varus and valgus angulation and internal fixation failure. Intramedullary nail fixation of fractures is stress-distributed fixation rather than stress-shielded fixation, whi ch is beneficial to the plasticity of callus. Advanced Intramedullary Nail System are made of Ti-6Al-4V ELI following ASTM F136. Advanced Intramedullary Nail System is provided as non-sterile. The implants are intended for single-use only, while the instruments are reusable.

This document is a 510(k) Pre-market Notification for a medical device called "Advanced Intramedullary Nail System." It is a submission to the FDA seeking clearance to market the device based on its substantial equivalence to previously cleared predicate devices.

Based on the provided text, there is no study conducted to prove the device meets specific acceptance criteria in the context of an AI/algorithm-based medical device performance study.

The document describes a medical implant device, not an AI or software algorithm. The "Advanced Intramedullary Nail System" is a physical device used for fixation of fractures. The information provided is typical for a 510(k) submission for a physical medical device, focusing on material equivalence, design features, biocompatibility, and mechanical testing.

Therefore, many of the questions asked cannot be answered because they pertain to performance studies of AI/algorithmic devices, which are not relevant to this submission.

Let's break down why and what information is available:

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

• Not applicable in the context of an AI/algorithmic device. The document discusses the device's physical properties and its equivalence to predicate devices.
• The "acceptance criteria" here would be related to the mechanical performance standards (e.g., specific loads the nails can withstand, or how well the screws perform under torsion), which are tested against ASTM standards (F543-17 and F1264-16). However, specific numerical acceptance criteria and reported performance values are not explicitly stated in a table format in this summary. The summary only lists the types of tests performed.

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 in the context of an AI/algorithmic device. For mechanical testing, the "sample size" would refer to the number of physical nails and screws tested. This information is not provided in the summary.
• There's no data provenance in the sense of patient data because this is a physical device, not an AI output.

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. There is no "ground truth" in the diagnostic or clinical sense for this physical device as it's not an AI evaluating patient data.

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

• Not applicable. There is no clinical "test set" requiring adjudication for a physical device like an intramedullary nail.

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 study design is relevant for AI image analysis or diagnostic support systems, not for a physical orthopedic implant.

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

• Not applicable. This refers to AI algorithm performance.

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

• Not applicable. The "ground truth" for this device's safety and effectiveness relies on its mechanical properties (meeting ASTM standards) and biocompatibility with human tissue, demonstrating equivalence to already cleared devices.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable.

Summary of relevant information from the document related to "acceptance criteria" (understood as compliance with standards) and "study" (understood as non-clinical testing):

Acceptance Criteria (Implicit via Standards Compliance):

• Biocompatibility: The device should be biocompatible according to the FDA Guidance "Use of International Standard ISO 10993-1." Specific pass/fail criteria are not detailed in this summary but are inherent in the standard.
• Mechanical Performance: The device materials and mechanical properties should meet the requirements of:
  • ASTM F543-17 (Standard Specification and Test Methods for Metallic Medical Bone Screws) for the locking screws.
  • ASTM F1264-16 (Standard Specification and Test Methods for Intramedullary Fixation Devices) for the intramedullary nail.
  • Specific acceptance values (e.g., minimum torque, maximum deflection) are not listed in this summary but would have been presented in the full 510(k) submission.

The Study that Proves the Device Meets the Acceptance Criteria:

The document refers to "Non-Clinical Performance Data" as the study justifying the device's safety and effectiveness and its substantial equivalence.

• Biocompatibility Testing: Conducted in accordance with FDA Guidance and ISO 10993-1. (No further details on methods or results are provided in this summary).
• Mechanical Testing: Performed on the Advanced Intramedullary Nail System.
  • Locking Screw Tests: Torsion Test, Insertion/Removal Test, Self-tapping Test, Pullout Test, Bending Test. (These tests implicitly compare the device's performance to the predicate device and relevant ASTM standards).
  • Intramedullary Nail Tests: Four-Point Bend Test, Static Torsion Test. (These tests implicitly compare the device's performance to the predicate device and relevant ASTM standards).

Conclusion: The supplied document is a 510(k) summary for a physical medical implant. It does not contain information about acceptance criteria or studies related to AI/algorithmic performance. The "studies" conducted are non-clinical (biocompatibility and mechanical testing) to demonstrate substantial equivalence to predicate devices by meeting recognized industry standards.

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Metal Bone Screw is indicated for the fixation of clavicle, scapula, pelvis, humerus, ulna, radius, femur, tibia, fibula, metacarpals, metatarsals and phalanges fractures.

Metal Bone Screw are used to fasten plates onto bones, or, as lag screws, to hold bone fragments together. The screws are differentiated by the manner in which they are inserted into bone, their function, their size, and the type of bone they are intended for. Metal Bone Screw consists of a series of screws with different sizes and structures, which is designed according to the anatomical characteristics of human bones. In clinical practice, the bone screw can be used alone or in combination with the bone plate, which acts as a temporary internal support, provides a stable local environment for the fractured end, and creates conditions for the healing of the fractured end. Metal Bone Screw are made of Ti-6A1-4V ELI following ASTM F136. Metal Bone Screw is provided as non-sterile. The implants are intended for single-use only, while the instruments are reusable.

This document is a 510(k) premarket notification for a medical device called "Metal Bone Screw." It is a regulatory filing with the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not a study evaluating AI or software performance. Therefore, most of the requested information regarding acceptance criteria, AI study design, human-in-the-loop performance, and training/test set details is not applicable to this document.

However, I can extract the relevant information from this document:

Device Description and Purpose:

The "Metal Bone Screw" is a medical device used for the fixation of various bone fractures. It is made of Ti-6A1-4V ELI (a titanium alloy).

Acceptance Criteria and Device Performance (Based on this document, these refer to mechanical and biocompatibility testing for a hardware device, not AI performance):

This document describes the regulatory process for a physical medical device (Metal Bone Screw), not a software or AI-driven device. Therefore, the "acceptance criteria" and "device performance" are established through non-clinical performance data (mechanical testing and biocompatibility testing) to demonstrate substantial equivalence to a legally marketed predicate device.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document for a medical hardware device):

• Insertion/removal Test (per ASTM F543-17)
• Pullout Test (per ASTM F543-17) | Tests performed "to demonstrate substantially equivalent of safety and efficacy with the predicate device". (Implied successful performance to meet substantial equivalence, specific numerical results are not detailed here). |

Details Not Applicable to This Document (as it's a hardware device 510(k) not an AI study):

• Sample size used for the test set and the data provenance: Not applicable. This refers to mechanical and biocompatibility testing of the physical device, not an AI test set.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not describe a study involving expert-established ground truth for a test set in the context of an AI device.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 for AI-assisted diagnostic devices.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI algorithm performance.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of an AI test set. For this hardware device, the "ground truth" for demonstrating substantial equivalence is established through adherence to recognized standards (ASTM) and a comparison of performance characteristics to a predicate device.
• The sample size for the training set: Not applicable, as this is a hardware device, not an AI model.
• How the ground truth for the training set was established: Not applicable.

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Double Medical Femoral Nail System is intended for femoral fracture fixation and promoting femoral fracture healing.

Indications for use of the Proximal Femoral Nail, Anti-rotation, short; and Anatomical Proximal Femoral Nail (APFN ), short (Length 170 mm - 240 mm) include:

• Pertrochanteric fractures (31-A1 and 31-A2);
• Intertrochanteric fractures (31-A3);
• High subtrochanteric fractures (32-A1).

Indications for use of the Proximal Femoral Nail. Anti-rotation. long (Length 300 mm - 420 mm), Anatomical Proximal Femoral Nail (APFN ), long (Length 300 mm - 480 mm) include:

• Low and extended subtrochanteric fractures;
• Ipsilateral trochanteric fractures;
• Combination fractures (in the proximal femur);
• Pathological fractures.

Indications for use of the Universal Femoral Nail, Cannulated (UFN I) include:

• Femoral shaft fractures.

Indications for use of the Universal Femeral Nail II, Cannulated (UFN II) include:

• Standard Locking UFN II: femoral shaft fractures;
• Reconstruction Locking UFN II : femoral shaft combined with femoral neck fractures, subtrochanteric fractures.

Double Medical Femoral Nail System consists of a series of nails, spiral blades, locking screws, end caps and related instrument. The implants are provided in a variety of lengths and anatomical designs to accommodate the medullary canal of femur. All of the implants in the Double Medical Femoral Nail System are made of made of Ti-6AI-4V following ISO 5832-3 or Ti-6Al-4V ELI following ASTM F 136, which are widely used for surgical implants with well-known biocompatibility. Double Medical Femoral Nail System is provided as non-sterile.

The provided text is a 510(k) summary for the Double Medical Femoral Nail System, which is a medical device for femoral fracture fixation. The document details the device's indications for use, comparison with predicate devices, and non-clinical performance data. It explicitly states, "No clinical performance data is included in this submission."

Therefore, based on the provided text, there is no study described that proves the device meets specific acceptance criteria related to a clinical study with algorithms, human readers, or ground truth. The device's clearance is based on substantial equivalence to predicate devices, supported by non-clinical bench testing.

Here's a breakdown of the information available based on your request, highlighting where data is not present:

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

Since no clinical study evaluating algorithmic or human reader performance is mentioned, there are no acceptance criteria or reported device performance for such a study. The document focuses on performance relative to engineering standards.

Non-Clinical Performance Data is reported as:
"The test results demonstrated that the proposed device conforms to ASTM F1264-16e1 Standard Specification and Test Methods for Intramedullary Fixation Devices, ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws, ASTM F384-17 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices, including:

• Static Four-point Bending Test of Nail
• Dynamic Four-point Bending Test of Nail
• Static Torsion Test of Nail
• Static Three-point Bending Test of Locking Screw
• Dynamic Three-point Bending Test of Locking Screw
• Insertion/removal Test of Locking Screw
• Pullout Test of Locking Screw
• Torsion Test of Locking Screw.
• Cantilever Bending Test
• Insertion/removal test, static torsion and axial pullout test of Lag Screw
• Cut-out Test"

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, as no clinical or algorithmic test set is described. The non-clinical tests would have involved specific numbers of physical device samples for mechanical testing, but these details (sample size, provenance) are not provided in the summary.

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 no clinical or algorithmic test set requiring expert-established ground truth is described.

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

Not applicable, as no clinical or algorithmic test set requiring adjudication is described.

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 MRMC comparative effectiveness study was done or mentioned. The submission explicitly states, "No clinical performance data is included in this submission."

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

No standalone algorithmic performance study was done or mentioned. The submission explicitly states, "No clinical performance data is included in this submission."

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

Not applicable, as no clinical or algorithmic performance data requiring ground truth is described.

8. The sample size for the training set

Not applicable, as no algorithm or training set is mentioned.

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

Not applicable, as no algorithm or training set is mentioned.

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Double Medical Cage System is indicated for use in patients with degenerative disc disease (DDD) at one or two levels from L2 to L5 whose condition requires the use of interbody fusion combined with supplemental fixation. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Cage should be packed with autogenous bone graft (i.e. autograft).

Double Medical Cage System consists of cages of various lengths and heights, which can be inserted between two vertebral bodies to give support during interbody fusion surgeries. The cages consist of main bodies and marker pins. The main bodies are made of PEEK, which meets the requirements of ASTM F 2026-02 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications. Marker pins are made of Ti-6Al-4V following ASTM F 1472-14 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Allov for Surgical Implant Applications.

The provided document is a 510(k) premarket notification for a medical device called the "Double Medical Cage System," an intervertebral body fusion device.

Crucially, this document explicitly states: "No clinical performance data is included in this submission."

Therefore, I cannot provide information regarding acceptance criteria or a study proving the device meets those criteria, as no such study or data is presented in this submission.

The 510(k) submission primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance data and material comparisons.

Here's what I can extract based on your request, as much as possible given the lack of clinical data:

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

Since no clinical studies or clinical performance data were provided, there are no predefined clinical acceptance criteria or reported clinical device performance to list.

The non-clinical performance data section mentions that the device met design specifications and conformed to specific ASTM standards:

• ASTM F2077 Test Methods For Intervertebral Body Fusion Devices
• ASTM F2267 Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression

The tests conducted under these standards include:

• Static axial compression test
• Static compression shear test
• Dynamic axial compression test
• Dynamic compression shear test
• Subsidence Test

However, the document does not specify the acceptance criteria (e.g., minimum load, maximum deformation) for these non-clinical tests nor the exact reported performance values of the Double Medical Cage System against those criteria. It only states that the device "met all design specifications" and "conforms" to these standards.

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, as no clinical test set data is provided. For the non-clinical tests, the report does not specify the number of units tested. The data would be from laboratory testing, presumably performed in China, given the submitter's location.

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 no clinical test set data is provided.

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

Not applicable, as no clinical test set data is provided.

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 physical intervertebral body fusion system, not an AI or imaging device that would involve human readers or MRMC studies.

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

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

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

Not applicable, as no clinical studies were performed or reported in this submission. For the non-clinical tests, the "ground truth" would be the expected mechanical properties and performance defined by the ASTM standards and the device's design specifications.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is a physical device, not a machine learning model.

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

Not applicable. There is no mention of a training set.

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