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The Tandry Q-Locking Plate System is intended to provide fixation during fractures, fusions, and osteotomies. The Tandry Q-Locking Plate System is indicated for the clavicle, pelvis, scapula and calcaneus, small bones including the metacarpals, wrist, metatarsals, tarsals and phalanges, and long bones including the radius, ulna, humerus, olecranon, fibula, femur, and tibia.

Each plate is indicated for the following anatomic regions:

• 1.5mm and 2.0mm Q-locking plates: Metacarpals, metatarsals, tarsals, and phalanges
• 2.4mm Q-locking plates: Radius, wrist, and ulna
• 3.5 mm Q-locking plates: Clavicle, scapula, humerus, olecranon, pelvis, fibula, calcaneus, and tibia
• 5.0 mm Q-locking plates: Femur and tibia

The Tandry Q-Locking Plate System consists of various sized plates, screws and instruments. The plates are designed to distribute for local anatomies and can accept, cortex, shaft and cancellous, locking (variable angle) screws. The screws are designed with self-tapping to promote the operation efficiency to insert the bones. Both plate and screw feature variable angle locking design.

The provided document is a 510(k) premarket notification for the Tandry Q-Locking Plate System, a medical device used for bone fixation. It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML (Artificial Intelligence/Machine Learning) device.

The document discusses the device's indications for use, technological comparison to predicate devices, and non-clinical/clinical tests performed (biomechanical tests according to ASTM F543-17) to demonstrate substantial equivalence. These tests focus on mechanical performance, not on AI/ML performance metrics such as sensitivity, specificity, or reader improvement.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device from the given text. The text does not describe an AI/ML device or its associated performance studies.

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NCB® Polyaxial Locking Plate System:
The NCB Polyaxial Locking Plate System is indicated for temporary internal fixation and stabilization of distal femoral (NCB DF), proximal humeral (NCB PH), and proximal tibial (NCB PT) fractures and osteotomies.

NCB® Periprosthetic Femur Plate System:
The NCB Periprosthetic Femur Plate System is indicated for temporary internal fixation and stabilization of femoral fractures and osteotomies, including periprosthetic fractures.

If combined with the NCB Periprosthetic Trochanter Plate and Connection Screw, the NCB Periprosthetic Proximal Femur Plate is additionally indicated for temporary internal fixation and stabilization of greater trochanter fractures and osteotomies including re-attachment of the greater trochanter following fracture and osteotomy in total hip arthroplasty.

The NCB Periprosthetic Trochanter Plate and Connection Screw can only be used in combination with the NCB Periprosthetic Proximal Femur Plate.

NCB® Cable Button:
The NCB Cable Button for the NCB Polyaxial Locking Plate System in combination with the Zimmer Biomet NCB Polyaxial Locking Plate System and Cable-Ready System Cerclage Cables is indicated for temporary internal fixation of fractures and osteotomies.

NCB® Straight Narrow Shaft Plate
The NCB Straight Narrow Shaft Plate is indicated for temporary internal fixation and stabilization of humeral and tibial shaft fractures and osteotomies, including periprosthetic fractures.

NCB® Polyaxial Locking Plate System
The NCB (Non-Contact-Bridging) Polyaxial Locking Plate System is a plate solution intended for the treatures and osteotomies of the distal femur (NCB DF), proximal humerus (NCB PH) and proximal tibia (NCB PT). NCB plate holes allow for polyaxial screw placement (30° cone) with subsequent screw locking, the screws can act as lag screws and be used for fracture reduction. In the locked mode, the plates act as an internal fixator without contact between the plate and the risk of periosteal blood supply impairment.

An additional extension tuberculum minus plate can be assembled to the humeral plate with cerclage wire technique for fixation of anteroposterior (AP) tuberculum minus fractures. NCB femoral, humeral and tibial plates, cortical, cancellous and cannulated screws, locking cap, blind screw inserts and spacers are made from titanium alloy Protasul®-64 (Ti-6Al-4V - ISO 5832-3/ASTM F136). The tuberculum minus plate is made from cpTi (ISO 5832-2/ASTM F67), cortical screws from titanium alloy Protasul-100 (Ti-6Al-7Nb ISO 5832-11/ASTM F1295) and the cerclage wire from 1.4441 stainless steel Protasul-S (ISO 5832-1/ASTM F138-F139).

NCB® Periprosthetic Femur Plate System
The NCB (Non-Contact-Bridging) Periprosthetic Femur Plate System is a line of polyaxial locking plates for the treatment of femoral fractures, particularly of periprosthetic femoral fractures. The system consists of Proximal Femur Plates, Curved Shaft Plates, Trochanter Plates and a Connection Screw. The NCB System technology allows for polyaxial screw placement (30° cone) with screw locking achieved with the use of locking caps that are threaded into the locked mode the NCB Periprosthetic Plate acts as an internal fixator without contact between the bone suface, reducing the risk of periosteal blood supply impairment. This Non-Contact Bridging concept can be specifically controlled through the use of 1, 2, or 3 mm spacers, which are threaded into the plate holes prior to plate insertion.

Additionally, within this system, the NCB Periprosthetic Trochanter Plates used in combination with the NCB Periprosthetic Proximal Femur Plates for the treatment of proximal femoral fractures, which includes greater trochanter fractures and osteotomies. The Connection Screw for NCB Periprosthetic Trochanter Plate is used to attach the Proximal Femur Plate. The NCB Periprosthetic Trochanter Plates contain threaded conical holes which allow for monoaxial screw placement using locking screws with threaded heads. Non-locking cortical screws can also be used.

The NCB Periprosthetic Proximal Femur Plates are available in five lengths (Length=245mm, 324mm, 363mm, 401mm) which can be used either as standalone implants or in combination with the NCB Periprosthetic Trochanter Plates. The NCB Periprosthetic Proximal Femur Plate short (Length=115 mm) is used only in combination with the NCB Periprosthetic Trochanter Plates. The NCB Curved Shaft Plates are also included in the NCB Periprosthetic Femur Plate System and are specifically designed for the femur. The Proximal Femur Plates, Distal Femur Plates, Trochanter Plates and Connection Screw are made of a titanium alloy (Ti-6Al-4V (Protasul®-64WF) ISO 5832-3).

NCB Cable Button for NCB Polyaxial Locking Plate
The NCB (Non-Contact-Bridging) Cable Button for NCB Polyaxial Locking Plate is a temporary internal fixation component used in conjunction with Zimmer Biomet NCB Polyaxial Locking Plate System Cerclage Cables. The Cable Button is threaded into a vacant screw hole of the Zimmer Biomet NCB Polyaxial Locking Plate System and provides a positioning point for a Cerclage Cable.

The Cable Button is made of titanium alloy (Ti-6Al-4V (Protasul®-64WF) ISO 5832-3) and has a color anodization (Type III).

NCB Straight Narrow Shaft Plate
The NCB (Non-Contact-Bridging) Straight Narrow Shaft Plate is a line of polyaxial locking plates for the treatment of humeral and tibial shaft fractures, including periprosthetic fractures. The NCB System technology allows for polyaxial screw placement (30° cone) with screw locking achieved with the use of locking caps that are threaded into the locked mode the NCB Straight Narrow Shaft Plate acts as an internal fixator without contact between the plate and the risk of periosteal blood supply impairment. This Non-Contact-Bridging concept can be specifically controlled through the use of 1, 2, or 3 mm spacers, which are threaded into the plate holes prior to plate insertion.

The NCB Straight Narrow Shaft Plate is made of Titanium alloy [Ti6Al4V (Protasul®-64WF) ISO 5832-3].

Here's an analysis of the provided text regarding the acceptance criteria and study for the NCB® Polyaxial Locking Plate System and related devices.

Based on the provided FDA 510(k) summary, this submission is for a medical device (bone fixation plates), not an AI/software device. Therefore, many of the requested categories related to AI/software performance metrics, ground truth, expert adjudication, and MRMC studies are not applicable.

This document describes a substantial equivalence submission for metal bone fixation implants. The "acceptance criteria" and "device performance" in this context refer to mechanical, material, and biocompatibility testing results, not AI model performance metrics like sensitivity, specificity, or F1-score.

The document states that "Clinical data and conclusions were not needed for this device," and the substantial equivalence determination relies on comparisons to legally marketed predicate devices, along with non-clinical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a mechanical medical device, the "acceptance criteria" are typically defined by recognized standards for mechanical properties, biocompatibility, and sterilization. The "reported device performance" would be the results of testing against those standards.

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

This is not applicable as this is a medical device (bone plate) and not an AI/software device with a "test set" in the computational sense. The "testing" refers to non-clinical mechanical and material tests. No patient data or clinical studies are mentioned.

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

Not applicable. "Ground truth" in the context of AI models does not apply to this type of device.

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 device is not an AI product.

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

Not applicable. This device is a passive mechanical implant, not an algorithm.

7. The Type of Ground Truth Used

Not applicable. For a mechanical device, performance is evaluated against engineering specifications and industry standards, not "ground truth" derived from expert consensus, pathology, or outcomes data in the way an AI system is evaluated.

8. The Sample Size for the Training Set

Not applicable. This device does not use a training set as it is not an AI/machine learning product.

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

Not applicable.

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The Tandry Locking Plate System is intended to provide fixation during fractures, fusions, and osteotomies. The Tandry Locking Plate System is indicated for the clavicle, pelvis, scapula and calcaneus, small bones including the metacarpals, wrist, metatarsals, tarsals and phalanges, and long bones including the radius, ulna, humerus, olecranon, fibula, femur, and tibia.

In addition, the Tandry Locking Hip Plate System is indicated for fixation of fractures to the proximal femur. The plates are indicated for use in trochanteric, intertrochanteric, and basilar neck fracture.

Each plate is indicated for the following anatomic regions:

• 1.5mm and 2.0mm locking plates Metacarpals, metatarsals, tarsals, and phalanges
• 2.4mm locking plates Radius, wrist, and ulna
• 3.5 mm locking plates Clavicle, scapula, humerus, olecranon, pelvis, fibula, calcaneal, and tibia
• 5.0 mm locking plates Femur and tibia

The Tandry Locking Plate System consists of various sized plates, screws and instruments. The plates are designed to distribute for local anatomies and can accept locking, cortex, shaft and cancellous screws. The screws are designed with self-tapping to promote the operation efficiency to insert the bones. The instruments are used for completing the surgery.

This document describes the Tandry Locking Plate System, a medical device for bone fixation. However, it does not include information about acceptance criteria and a study that proves the device meets those criteria in the way typically expected for an AI/ML powered device. This submission is for a traditional medical device (bone plates and screws), and its clearance is based on substantial equivalence to a predicate device, rather than a performance study against specific acceptance criteria for diagnostic or prognostic accuracy.

Therefore, many of the requested fields cannot be extracted or are not applicable.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance

The document does not specify quantitative acceptance criteria for device performance in terms of diagnostic accuracy, sensitivity, specificity, or similar metrics typically found for AI/ML devices. Instead, the "acceptance criteria" for clearance appear to revolve around demonstrating substantial equivalence to a predicate device through non-clinical testing (biomechanical, biocompatibility, reprocessing, and sterilization).

Since this is not a diagnostic device, there are no metrics like sensitivity or specificity.

Study Details

1. Sample size used for the test set and the data provenance: Not applicable. There is no "test set" in the context of diagnostic performance evaluation. The device undergone non-clinical testing.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic performance is not relevant for this type of device.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 is not an AI-assisted diagnostic device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the conventional sense. "Ground truth" for this device would refer to the successful demonstration of mechanical properties, biocompatibility, and sterilization effectiveness through standardized tests.
7. The sample size for the training set: Not applicable. This is not a machine learning device.
8. How the ground truth for the training set was established: Not applicable.

Summary from Document:

This device, the Tandry Locking Plate System, received FDA clearance (K230690) based on substantial equivalence to a predicate device (Tandry Locking Plate System, K171904). The evaluation focused on non-clinical tests including biomechanical, biocompatibility, and reprocessing/sterilization studies. The document explicitly states: "Clinical studies are not required to support substantially equivalent." The biomechanical and reprocessing/sterilization performance of the proposed device are deemed equivalent to the predicate device, thus utilizing the predicate's testing results. Biocompatibility testing was performed on representative samples according to ISO standards. The modifications to the device (material, anodization, and some length specifications) were deemed not to change its intended use, fundamental scientific technology, or biocompatibility requirements.

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The OIC Variable Angle Small Fragment Locking Plate System is indicated for the fixation of fractures, mal-unions, nonunions or osteotomies for the clavicle, humerus, radius, ulna, metacarpal, tibia, fibula, malleolus and metatarsal.

The OIC Variable Angle Small Fragment Locking Plate System consists of titanium plates for the Distal Radius, Clavicle, Proximal Humerus, Tibia, Distal Fibula, a Low Profile 1/3 Tubular and Hook plate, bone screws and instruments for implantation. The plates come in a variety of sizes and accept 2.5mm, 3.5mm and 4.0mm bone screws. The bone screws are available in two diameters of cortex screws (2.5mm and a 4.0mm cancellous screw. They range in length from 6mm to 130mm. The cortex screws are available with both threaded (locking) and non-threaded (non-locking) heads. The OIC Variable Angle Small Fragment Locking Plate System is made of titanium alloy in compliance with ASTM F136, ASTM F1472 or ASTM F67. The OIC Variable Angle Small Fragment Locking Plate System is provided non-sterile and is steam-sterilized by the medical facility prior to implantation.

This document describes the OIC Variable Angle Small Fragment Locking Plate System and its 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the manner of an AI/ML device.

Therefore, the requested information elements related to AI/ML device studies (such as sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not applicable to this submission.

The acceptance criteria here refer to the mechanical properties required for a bone plate system to be considered safe and effective, and the "study" is the performance testing conducted to confirm those properties.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable in the context of an AI/ML device study. For mechanical testing, samples were likely taken to represent each type of plate and screw for destructive testing. The data provenance is from in vitro mechanical testing performed by the manufacturer, not from patient data.

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

Not applicable. "Ground truth" for mechanical testing is established by the physical properties measured against industry standards (ASTM). No human experts are involved in establishing this type of ground truth beyond standard laboratory practices.

4. Adjudication Method for the Test Set

Not applicable. Mechanical testing results are objective measurements.

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 plate system), not an AI/ML diagnostic or assistive tool.

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

Not applicable. This is a physical implantable device.

7. The Type of Ground Truth Used

Mechanical Property Standards: The ground truth for this device's performance is adherence to established ASTM (American Society for Testing and Materials) standards for metallic bone plates (ASTM F382) and metallic medical bone screws (ASTM F543-07), and material composition (ASTM F136, ASTM F1472, ASTM F67). These standards define the acceptable range of mechanical properties for such devices to ensure safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of mechanical medical device testing.

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

Not applicable. There is no "training set" for this type of medical device submission.

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Comus Locking Plate systems can be used for adult patients with age above 21 as indicated for fixation of Bone fracture in ulna, radius, humerus, femur and tibia.

The proposed device Comus Locking Plate systems are a combination of plates and screws, which can be used for adult patients with age above 21 as indicated for fixation of fractures. The plate is made of Titanium, which meet ASTM F67, and the screw is made of titanium allov (Ti-6A-14V ELI) which conforms to ASTM F136, which both are widely used for surgical implants with well-known biocompatibility and mechanical properties.

The provided text describes a 510(k) premarket notification for the "Comus Locking Plate systems." This is a medical device for bone fixation, and the documentation focuses on demonstrating its substantial equivalence to previously cleared predicate devices, not on proving effectiveness through clinical trials with specified acceptance criteria as one might expect for a novel AI/software medical device.

Therefore, many of the requested elements for acceptance criteria and study details (like sample size for test sets, expert qualifications, MRMC studies, training set details) are not applicable or not present in this type of submission.

Here's a breakdown based on the provided information:

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

The acceptance criteria are implicitly defined by the chosen ASTM standards and the demonstration of "substantial equivalence" to predicate devices. The reported performance is that the subject device's mechanical testing results were "comparable" to the predicate device.

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

The document does not specify the exact sample sizes for the mechanical tests (e.g., how many plates/screws were tested for each criterion). The data provenance is from non-clinical comparative performance tests conducted by or for the manufacturer, Jiangsu Trauhui Medical Instrument Co., Ltd. The specifics of where the testing was physically conducted (e.g., in China) are not detailed but can be inferred to be related to the manufacturer's location. This is retrospective in the sense that it's comparing a new device to existing predicate devices based on established standards.

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, expert consensus, or clinical experts are not used for this type of mechanical and material comparative study. The "truth" is established by adherence to recognized ASTM standards and direct comparison of physical properties.

4. Adjudication method for the test set

This is not applicable. There is no adjudication in the context of mechanical performance testing. The results are quantitative measurements against predefined standards.

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. This submission is for a physical medical device (locking plates and screws), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are irrelevant.

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

This is not applicable. This is not an algorithm or software device.

7. The type of ground truth used

The "ground truth" for this submission is based on:

• Mechanical Testing Standards: Adherence to ASTM F382-14 and ASTM F543-17.
• Material Standards: Adherence to ASTM F67 and ASTM F136 for biocompatibility and material properties.
• Comparison to Predicate Devices: Demonstrating that the subject device's performance, materials, and design are substantially equivalent (comparable) to legally marketed predicate devices.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of mechanical device testing.

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

This is not applicable.

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The NCB Polyaxial Locking Plate System is indicated for temporary internal fixation of fractures and osteotomies of long bones.

The NCB Polyaxial Locking Plate System is an extramedullary internal fixation plate system to be used for proximal humeral fractures. It is intended to be implanted either percutaneously or by a traditional open method. The Tivanium 3.5 mm locking screws are used to engage the proximal locking screw holes within the NCB Polyaxial Locking Plate System, Proximal Humeral Plates.

I am sorry, but the provided text is a 510(k) summary for a medical device (NCB Polyaxial Locking Plate System). It describes the device, its intended use, comparison to predicate devices, and regulatory information.

However, it does not contain the specific information required to answer your request about acceptance criteria for a study and its proving evidence.

The "Performance Data (Nonclinical and/or Clinical)" section explicitly states: "Clinical data and conclusions were not needed for this device." This indicates that a clinical study with acceptance criteria for device performance, as you've requested, was not performed or at least not submitted as part of this 510(k). Instead, the performance data cited is: "Class II: Amendment of Design Controls with verification of mechanical integrity and resistance." This likely refers to non-clinical, benchtop testing to ensure the device meets engineering specifications, not a clinical study on patient outcomes or human reader performance.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size for test set or data provenance.
3. Number of experts or their qualifications for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results or effect size.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This 510(k) summary is for a bone fixation system, not an AI/software device that would typically involve the type of performance evaluation you are asking about (e.g., assessing accuracy, sensitivity, specificity, and human reader improvement with AI).

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Tandry Locking Plate System is intended to provide fixation during fractures, fusions, and osteotomies for bones including the clavicle, pelvis, scapula and calcaneal, small bones including the metatarsals, tarsals and phalanges; long bones including the radius, ulna, humerus, olecranon, fibula, femur, and tibia.

In addition, Tandry Locking Hip Plate System is in fixation of fractures to the proximal femur. The plates are indicated for use in trochanteric, pertrochanteric, and basilar neck fracture.

Each plate is indicated to be used in the following anatomic regions:

• 1.5mm and 2.0mm locking plates Metacarpals, metatarsals, tarsals, and phalanges
• 2.4mm locking plates Radius, wrist, and ulna
• 3.5 mm locking plates Clavicle, scapula, humerus, olecranon, pelvis, fibula, calcaneal, and tibia
• 5.0 mm locking plates Femur and tibia

The Tandry Locking Plate System consists of various sized plates, screws and instruments. The plates are designed to distribute for local anatomies and can accept locking, cortex, shaft and cancellous screws. The screws are designed with self-tapping to promote the operation efficiency to insert the bones. The instruments are used for completing the surgery.

Based on the provided text, the device in question, the "Tandry Locking Plate System," is a bone fixation device seeking 510(k) clearance, which means it is determined to be substantially equivalent to legally marketed predicate devices. This type of device, being a physical implant, does not involve AI or algorithms, and therefore, the acceptance criteria and study data provided in the document are not related to AI/algorithm performance.

The document describes non-clinical (biomechanical) testing to demonstrate substantial equivalence, rather than studies typically performed for AI-driven medical devices.

Therefore, I cannot provide information for the following points as they are not applicable to this type of device and the information provided:

• A table of acceptance criteria and the reported device performance (in the context of AI/algorithms)
• Sample sizes used for the test set and data provenance (for AI/algorithms)
• Number of experts used to establish ground truth and qualifications (for AI/algorithms)
• Adjudication method (for AI/algorithms)
• MRMC comparative effectiveness study (for AI/algorithms)
• Standalone performance (for AI/algorithms)
• Type of ground truth used (for AI/algorithms)
• Sample size for the training set (for AI/algorithms)
• How ground truth for the training set was established (for AI/algorithms)

Instead, here is a summary of the acceptance criteria and study information provided in the document for the physical medical device:

The "Tandry Locking Plate System" is a bone fixation device, not an AI/algorithm-driven device. Its approval is based on demonstrating substantial equivalence to existing predicate devices through non-clinical testing, primarily biomechanical tests, rather than clinical studies or performance against AI-specific metrics.

Acceptance Criteria & Device Performance (Physical Device Context):

The acceptance criteria for this type of device are centered around demonstrating that its mechanical performance (strength, integrity) is comparable to that of legally marketed predicate devices.

Study Details (for Physical Device):

• Sample sizes used for the test set and the data provenance: Not specified in terms of number of test articles beyond "biomechanical tests ASTM F543 and F382 were performed." The "data provenance" would be from laboratory biomechanical testing.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For biomechanical testing, the "ground truth" is the established mechanical properties and performance data from predicate devices and the physical test results.
• Adjudication method: Not applicable. Biomechanical tests follow standardized protocols.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is for diagnostic or AI-assisted devices where human readers interpret cases.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This is a physical device, not an algorithm.
• The type of ground truth used: For biomechanical testing, the ground truth is derived from the established mechanical properties and performance of predicate devices as measured through standardized laboratory tests.
• The sample size for the training set: Not applicable. There is no "training set" for a physical medical device.
• How the ground truth for the training set was established: Not applicable.

In summary, the provided document pertains to a traditional medical device (bone plate system) cleared via the 510(k) pathway, which primarily relies on demonstrating substantial equivalence through non-clinical (biomechanical) testing rather than AI-specific performance metrics or clinical studies involving human readers and AI assistance.

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Locking Plate System can be used for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur, tibia and fibula.

The proposed product, Locking Plate System, contains (1) Locking Plates, (2) Locking screws and (3) various specific instruments. The raw material of the plate, titanium, conforms to ASTM F67-13, Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNSR50550, UNS R50700). The bone screws are made of titanium alloy (TI-6AL-4V ELI), which complies with ASTM F136-13, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The devices are provided un-sterilized, but shall be sterilized via autoclave method to achieve Sterility Assurance Level of 10-6 by hospital prior to use.

The provided text describes a 510(k) submission for a Locking Plate System. This is a medical device for bone fixation, and the documentation focuses on demonstrating its substantial equivalence to previously cleared devices through non-clinical testing. No acceptance criteria for device performance in the context of diagnostic accuracy, image quality, or clinical effectiveness (as would be applicable to AI/ML software or imaging devices) are provided.

Instead, the "acceptance criteria" here refer to the device's ability to meet established ASTM standards for metallic bone plates and screws, as well as material specifications. The "study that proves the device meets the acceptance criteria" refers to non-clinical bench testing performed according to these ASTM standards.

Here's the information extracted from the document, framed in the context of device performance in a non-clinical setting:

1. A table of acceptance criteria and the 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)

• The document does not explicitly state the sample sizes (e.g., number of plates or screws tested) for the non-clinical bench tests.
• The data provenance is from non-clinical (bench) testing performed by the manufacturer, Beijing Keyi Medical Device Technology Co., Ltd., based in China.

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 to this type of submission. Performance is judged against engineering standards, not expert interpretation of clinical data.

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

• This is not applicable as there is no human interpretation or adjudication involved for the non-clinical bench tests against specified engineering standards.

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 or studies involving human readers or AI assistance were performed. This device is a passive metallic implant, not an AI/ML diagnostic or imaging device.

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)

• The "ground truth" for the non-clinical tests is defined by the specifications and methodologies outlined in the referenced ASTM international standards. These standards set physical and mechanical requirements (e.g., strength, torque, pull-out force) that the device must meet.

8. The sample size for the training set

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

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

• Not applicable as there is no training set.

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The osteo-WEDGE II ® Open Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations.

The osteo-WEDGE II® Open Wedge Bone Locking Plate System consists of plates and screws and incorporates a screw-to-plate locking mechanism. The plate is attached to a prepared surface of the involved bone(s) of the foot using six (6) screws for fixation. The fully threaded screws are available in 2 diameters, with numerous lengths and previously cleared under K111326.

The provided text describes the 510(k) premarket notification for the "OsteoWedge II Open Wedge Bone Locking Plate System." This document primarily focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance testing. It does not describe an AI/ML-based medical device. Therefore, many of the requested categories related to AI/ML device evaluation (like sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this submission.

Here's a summary of the information that is available in the provided text, structured to address the relevant points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This submission details non-clinical, mechanical testing of a medical implant, not an AI/ML device that uses patient data as a test set. The testing involved mechanical components (plates and screws).

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

• Not Applicable. Ground truth, in the context of expert review, is not relevant for the mechanical performance testing described.

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

• Not Applicable. Adjudication is not relevant for the mechanical performance 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. This is not an AI/ML device; therefore, no MRMC study was conducted.

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

• No. This is not an AI/ML device.

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

• Not Applicable. The "ground truth" for this device's performance would be the physical properties and mechanical behavior of the materials and design, evaluated against engineering standards (like ASTM F382-99(2008)), rather than clinical outcomes or expert labels.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device; there is no "training set."

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

• Not Applicable. This is not an AI/ML device; there is no "training set."

Study that proves the device meets the acceptance criteria:

The study that proves the device meets the acceptance criteria is termed "Non-Clinical Performance Testing" in the document.

• Description: "Non-clinical testing was performed to demonstrate the change of the plate geometry is substantially equivalent to other predicate devices."
• Specific Tests Performed: "Static and dynamic four-point bending testing per ASTM F382-99(2008)."
• Conclusion: Based on this testing, the "OsteoWedge II Open Wedge Bone Locking Plate System is shown to be substantially equivalent to legally marketed predicate devices."

The provided text is a 510(k) clearance letter and an associated summary for a Class II metallic bone fixation appliance. It explicitly details that the submission is based on demonstrating "substantial equivalence" through non-clinical, mechanical performance testing to legally marketed predicate devices, not through clinical trials or AI/ML algorithm evaluation.

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MEDICREA INTERNATIONAL S.A. Anterior Cervical Locking Plate System is intended for anterior interbody screw/ plate fixation of the cervical spine until the bone fusion occurs.

The MEDICREA INTERNATIONAL S.A. Anterior Cervical Locking Plate System is indicated for use in the temporary stabilization of the anterior cervical (C2 to T1) spine during development of a solid fusion in patients with the following conditions:

· degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),

• · spondylolisthesis,
• · trauma (i.e., fracture or dislocation),
• · spinal stenosis,
• · deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
• · tumor,
• · pseudoarthrosis,
• · and failed previous fusion

This implant has to be used with an appropriate bone graft.

Patients should have been unresponsive for a minimum six (6) weeks to conservative treatment before the surgery.

MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System is an anterior system, which consists of a variety of cervical plate lengths and a variety of cervical bone screws.

The implants are manufactured in titanium alloy Ti-6Al-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications.

This document, a 510(k) Premarket Notification from the FDA, focuses on the substantial equivalence of a medical device (MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System) to existing predicate devices. It does not present acceptance criteria or a study proving the device meets specific acceptance criteria in the way a performance study for a diagnostic AI device would.

Instead, the document primarily demonstrates that the device is substantially equivalent to legally marketed predicate devices in terms of intended use, materials, mechanical safety, and performance. This is a regulatory pathway that relies on comparison to existing devices rather than new clinical outcome studies for performance.

Therefore, many of the requested sections about acceptance criteria, study design, expert ground truth, and AI performance metrics are not applicable to this type of regulatory submission.

Here's an analysis based on the information provided, highlighting what is present and what is absent:

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

• Not Applicable in the traditional sense of a performance study for a diagnostic device.
• The document implies "acceptance criteria" through demonstrating substantial equivalence to predicate devices. This means the device is considered acceptable if its features, materials, and mechanical performance are comparable to devices already on the market.
• Reported device performance: The "performance" reported here is mechanical testing results, comparing the device to industry standards (ASTM F1717-15) and implicitly to the predicate devices. The document states: "The components of MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System were mechanically evaluated in static and dynamic compression and static torsion tests following the ASTM F1717-15." The results are not explicitly detailed in a table beyond the statement that these tests were conducted.

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

• Not Applicable. This is a mechanical device, not a diagnostic AI device. The testing involves physical prototypes of the device, not a "test set" of patient data.
• The mechanical tests (static and dynamic compression, static torsion) would have been performed on a sample of the manufactured device components. The specific number of test articles is not detailed.
• "Data provenance" related to patient data is not relevant here.

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 context of expert consensus, is not relevant for the mechanical testing of this type of device. Mechanical testing results are based on objective physical measurements and engineering standards.

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

• Not Applicable. Adjudication methods are used to establish ground truth in studies involving subjective interpretation (like AI diagnostics). Mechanical tests do not require this.

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. An MRMC study is relevant for evaluating the impact of AI on human diagnostic performance. This device is a surgical implant, not an AI diagnostic tool.

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

• Not Applicable. This device is a physical surgical implant, not an algorithm or AI system.

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

• For mechanical testing: The "ground truth" is defined by established engineering principles and the limits specified by the ASTM F1717-15 standard, as well as comparison to the known performance of predicate devices. There's no "expert consensus" on mechanical measurements in the way there is for medical diagnoses.
• For demonstrating substantial equivalence: The ground truth is the performance and safety profiles of the legally marketed predicate devices.

8. The sample size for the training set

• Not Applicable. This device is not an AI algorithm, 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 algorithm, this question is not relevant.

In summary, this FDA 510(k) submission primarily relies on demonstrating substantial equivalence through a comparison of design, materials, intended use, and mechanical testing to predicate devices already on the market. It does not involve a performance study against specific acceptance criteria for a diagnostic AI system, and therefore, many of the requested elements are not present in this document.

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