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The SMV Scientific 2.4mm and 3.0mm Cannulated Screws are intended for fixation of fractures and non-unions of small bones and small bone arthrodesis. Examples include, but are not limited to scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies. The SMV Scientific 3.5mm Cannulated Screws are intended for fixation of small bones and small bone fragments, such as fractures of the metatarsals, arthrodeses of the carpals and phalanges, steochondritis dissecans, and ligament fixation. The SMV Scientific 4.5mm Cannulated Screws is intended for fracture fixation of long bones and long bone fragments. The SMV Scientific 6.5mm and 7.3mm Cannulated Screws are intended for fracture fixation of large bones and large bone fragments, femoral neck fractures, slipped capital femoral epiphyses, as an adjunct to DHS in basilar neck fractures, tibial plateau fractures, ankle arthrodesis, pediatric femoral neck fractures, intercondylar femur fractures, and subtalar arthrodesis.

The SMV Scientific Cannulated Bone Screws consist of cannulated screws in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The screws are provided non-sterile. Screws are manufactured from Stainless Steel per ASTM F138 or Titanium per ASTM F136 or F1295.

I am sorry, but based on the provided document, there is no information available regarding the acceptance criteria or any study that proves the device meets those criteria. The document is a 510(k) premarket notification letter from the FDA, a summary of the device, and a comparison to predicate devices, focusing on substantial equivalence for a medical device (SMV Scientific Cannulated Screws).

The information you are requesting, such as performance metrics, sample sizes, data provenance, expert qualifications, ground truth establishment, or any details about a multi-reader multi-case (MRMC) study or standalone algorithm performance, is not present in this document.

The document primarily states that the SMV Scientific Cannulated Screws are substantially equivalent to legally marketed predicate devices based on:

• Identical indications for use
• Identical materials of manufacture
• Identical principles of operation
• Engineering analysis and dimensional comparison
• Mechanical performance data (though no specific data or acceptance criteria are detailed).

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The 4.0 SMV Scientific Cancellous Bone Screw and Washer is intended for fixation of fractures with medium fragments, e.g .: - tarsal and metatarsal fractures and fixation in metatarsal and phalangeal osteotomies - tarsometatarsal and metatarsophalangeal arthrodeses - ligament fixations - hallux valgus corrections. Additionally, the 4.0 SMV Scientific Cancellous Screw and Washer is intended for arthrodesis and osteotomies of small joints, including scaphoid and other carpal bones, metacarpals, tarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.

The 6.5 SMV Scientific Cancellous Bone Screw and Washer is intended for fixation of fractures with large fragments, e.g.: - femoral neck fractures - intercondylar femoral fractures epiphyseolysis of the femoral head - ankle arthrodeses. Additionally, the 6.5 SMV Scientific Cancellous Screw and Washer is intended for reconstruction, osteotomy, and arthrodesis of various bones and bone fragments appropriate for the size of the device including joint fusions (arthrodesis) in the foot and ankle.

The SMV Scientific 4.0 and 6.5 Cancellous Bone Screw and Washer are manufactured from medical grade stainless steel. The SMV Scientific 4.0 and 6.5 Cancellous Bone Screw and Washer are offered in various diameters and lengths. The SMV Scientific 4.0 and 6.5 Cancellous Bone Screw and Washer are intended to provide fracture fixation. Implants are provided nonsterile with instructions for sterilization.

This document is a 510(k) summary for a medical device (SMV Scientific 4.0 and 6.5 Cancellous Bone Screw and Washer). This type of regulatory submission is focused on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a large clinical study.

Therefore, the information typically requested in your query (e.g., sample size for test/training sets, number of experts, MRMC studies, ground truth types) is primarily relevant for AI/ML-based diagnostic or prognostic devices, not for a bone fixation fastener that is evaluated based on mechanical performance.

Here's an attempt to answer your questions based on the provided text, while acknowledging its limitations for an AI/ML context:

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

The document does not explicitly state "acceptance criteria" in a quantitative manner for specific performance metrics; rather, it indicates that the device's strength is "sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

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 testing" and specific ASTM standards (F543) for evaluating mechanical properties. It does not specify the sample size for these tests, nor the data provenance (country of origin, retrospective/prospective). Such details would typically be in the full test reports, not a 510(k) 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)

This is not applicable as the evaluation is based on mechanical testing of a physical device, not on expert interpretation of data or images.

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

Not applicable for mechanical testing of a physical device.

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 a medical device (bone screw) and not an AI/ML diagnostic or prognostic tool that would involve human readers.

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)

For mechanical testing, the "ground truth" is defined by the objective measurements obtained from standardized tests (e.g., torque values, pullout strength) against predefined specifications or comparison to predicate devices, rather than expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set

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

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

Not applicable. This is a physical medical device, not an AI/ML model.

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The SMV Scientific Schanz Screws are intended for use as external fixation for fracture fixation (open and closed); pseudoarthrosis or non-union of long bones; limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformity; correction of segmental bony or soft tissue defects; and joint arthrodesis.

SMV Scientific Schanz Screws are manufactured from medical grade stainless steel. SMV Scientific Schanz Screws are offered in various diameters and lengths. SMV Scientific Schanz Screws are intended to provide fracture fixation.

This document is a 510(k) premarket notification for the "SMV Scientific Schanz Screws." It primarily focuses on demonstrating substantial equivalence to a predicate device based on mechanical performance rather than AI/algorithm performance. Therefore, many of the requested elements for an AI device study are not applicable or cannot be found in this document.

However, I can extract the information relevant to the device's performance testing and acceptance criteria as presented.

Here's an attempt to answer your request based only on the provided text, acknowledging that much of the information you asked for is not present for this type of device submission:

1. Table of Acceptance Criteria and the Reported Device Performance

For this specific device (Schanz Screws), the "acceptance criteria" and "reported device performance" are based on mechanical testing and comparison to a predicate device rather than diagnostic accuracy or AI model metrics.

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

This document describes non-clinical mechanical testing of physical devices. It does not involve a "test set" of patient data or clinical samples in the way an AI diagnostic device would. Therefore:

• Sample Size: Not specified for testing individual screws, but implied to be sufficient for ASTM F1541-02 standards.
• Data Provenance: Not applicable in the context of patient data; the data comes from mechanical testing performed on manufactured Schanz screws.

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. Ground truth, in the AI context, refers to a verified diagnosis or condition. For this mechanical device, "ground truth" relates to physical properties, established through standardized testing (ASTM F1541-02), not by expert human interpretation.

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

Not applicable. This concept pertains to resolving discrepancies in expert interpretations for establishing ground truth in clinical/diagnostic studies, which is not relevant for mechanical device testing.

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 bone fixation fastener, not an AI-assisted diagnostic tool. No human reader studies are mentioned or relevant to its 510(k) submission for mechanical equivalence.

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

Not applicable. There is no algorithm or AI component in the SMV Scientific Schanz Screws as described in this document. The "standalone performance" refers to the mechanical properties of the screws themselves.

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

The "ground truth" for this device's performance is established via standardized mechanical testing results (Static Four-point Bending and Static Torsion per ASTM F1541-02). The "ground truth" for equivalence is a comparison to the mechanical performance characteristics of the predicate device (Synthes Self-Drilling Schanz Screws, K040701).

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI, so there is no training set.

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

Not applicable. As there is no training set for an AI model, this question is not relevant.

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The SMV Bone Plate and Screw System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, including, periarticular and intraarticular fractures.

The SMV Bone Plate and Screw System consists of implants and instruments designed for fixation to treat fractures, deformations, revisions and replantations of bones and bone fragments. The system features nineteen (19) types of plates, bone screws for fixation, and a set of instruments to facilitate installation and removal of the implants. The plates have screw holes, which allow for attachment to the bones or bone fragments. The plates are fabricated from medical grade stainless steel (ASTM F138), and offered in various widths and lengths. Plates and screws are provided non-sterile. The implants in this submission can be used with the screws cleared in K150981 and K150188.

This is a premarket notification (510(k)) for a medical device, the SMV Bone Plate and Screw System. It does not describe a clinical study or acceptance criteria for an AI/CADe device. Instead, it demonstrates substantial equivalence to predicate devices through technological characteristics and non-clinical performance testing. Therefore, most of the requested information regarding acceptance criteria and study details for AI performance cannot be extracted from this document.

Here's what can be extracted based on the provided text, and where gaps exist:

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

The document does not specify "acceptance criteria" in the sense of a numerical threshold for clinical performance (e.g., sensitivity, specificity) that an AI device would need to meet. Instead, it describes a non-clinical testing approach to demonstrate substantial equivalence.

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. This document refers to mechanical/non-clinical testing, not a clinical test set 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)

Not applicable. Ground truth for clinical data is not relevant for this type of non-clinical device testing.

4. Adjudication method (e.g. 2+1, 3+1, none) 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 an AI/CADe device.

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

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

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

For the mechanical testing, the "ground truth" is implied by the ASTM F382 standards and the performance of the predicate devices. The study aims to show that the new device's mechanical properties are comparable.

8. The sample size for the training set

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

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

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

Summary of the study:

The study described is a non-clinical performance testing to demonstrate the mechanical strength and substantial equivalence of the SMV Bone Plate and Screw System to legally marketed predicate devices.

• Test Methods:
  • Static Four-point Bending per ASTM F382
  • Dynamic Four-point Bending per ASTM F382
• Outcome: The results showed that "the strength of the Bone Plate and Screw System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."
• Purpose: To support the 510(k) premarket notification for the SMV Bone Plate and Screw System by showing its mechanical characteristics are comparable to existing, legally marketed devices.

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The SMV Scientific 2.0mm and 2.4mm Bone Screws are intended for use in trauma procedures, reconstructive procedures, and general surgery of the hand, wrist, and other small bones and bone fragments in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The SMV Scientific 2.7mm Bone Screw is intended for fractures and osteotomies of small bones and bone fragments, including the foot, ankle, and hand in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The SMV Scientific 3.5mm and 4.0mm Bone Screws are intended for fixation of fractures, osteotomies and non-unions of the clavicle. scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneus, femur and fibula in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The SMV Scientific 4.5mm Bone Screw is intended for fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of non-unions or malunions in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The SMV Scientific Bone Screws consist of cortical screws in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The screws are provided both sterile and non-sterile. Screws are manufactured from stainless steel.

The provided document describes the SMV Scientific Bone Screws and their substantial equivalence to a predicate device, focusing on mechanical performance rather than clinical efficacy studies involving human readers or AI. Therefore, most of the requested information regarding acceptance criteria for AI models, human reader performance, expert ground truth, and training/test set details cannot be extracted from this document, as it pertains to a mechanical device and not an AI/software product.

Here's what can be extracted and inferred:

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

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

• Sample size: Not explicitly stated. The document refers to "testing" but does not give specific numbers of screws or test runs.
• Data provenance: Not applicable in the context of this device. The testing is described as "non-clinical testing," implying laboratory-based mechanical tests rather than patient data.

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

• Not applicable as this is a mechanical device, not an AI/software product requiring expert ground truth in a clinical context.

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

• Not applicable for the type of mechanical testing 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, a multi-reader multi-case study was not done. This is a medical device (bone screw), not an AI-assisted diagnostic tool.

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):

• For mechanical tests, "ground truth" would be established by the physical properties and performance metrics defined by standards like ASTM F543. The document states the device was tested "per ASTM F543," indicating conformance to these standardized testing procedures and corresponding acceptance criteria.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

• Not applicable.

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