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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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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 Tandry CMF System is a Maxillofacial plate and screw system intended for osteotomy, stabilization and rigid fixation of maxillofacial/midface fractures and reconstruction including infraorbital area and maxillofacial, and mandibular and maxillary correction surgery.

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

• · 1.2mm upper-face plates Orbital floor region, zygomatic region, and dento-alveolar region
• · 1.5mm mid-face plates Zygomatic region, orbital floor region, and maxilla
• · 2.0 mm mini plates Orthognathics midface/mandible
• · 2.0/2.3mm mandible plates Mandibular

The Tandry CMF Plate System consists of various sized plates and screws. The plates and screws are fabricated from pure titanium and Ti-6Al-4V. The plates are designed to distribute for respective anatomical and indicated areas, besides, they can be used with self-tapping, self-drilling, emergency self-tapping and locking screws.

This document is a 510(k) Premarket Notification from Microware Precision Co., Ltd. for their Tandry CMF Plate System. It describes the device, its intended use, and compares it to predicate devices to demonstrate substantial equivalence.

Based on the provided text, here's an analysis of the acceptance criteria and study information:

Key Takeaway: The submission explicitly states that clinical studies were NOT required to support substantial equivalence for this device. Therefore, information related to clinical performance, human reader studies, and specific AI acceptance criteria (which would typically be evaluated in such studies) is not present in this document. The "study" here refers to non-clinical tests.

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

The document does not present a formal table of acceptance criteria in the sense of a numerical performance target (e.g., sensitivity, specificity, accuracy) combined with reported device performance from a clinical study. This is because, as stated, clinical studies were not required.

Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to predicate devices through non-clinical testing (biomechanical tests, biocompatibility, reprocessing, and sterilization).

Here's a breakdown of the non-clinical test results:

• The results support substantial equivalence to predicate devices. |
  | Biocompatibility | - Sample preparation per ISO 10993-12.
• Biological Safety Assessment guided by ISO 10993-1.
• Cytotoxicity testing per ISO 10993-5.
• The previous testing results for the predicate device (Tandry Locking Plate System K171904) are utilized, asserting the proposed device meets validation requirements. |
  | Reprocessing and Sterilization | - Previous testing results for the predicate device (Tandry Locking Plate System K171904) are utilized, as the material, manufacturing process, geometry, physico-chemical, body/fluid contact, and sterilization process are the same.
• Validated steam sterilization instructions to a sterility assurance level (SAL) of 10-6 using the biological indicator overkill method (in accordance with ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO 14937). |
  | Design Characteristics | - Dimensions, shape, and sizes are similar to predicate devices (as detailed in the comparative table on page 6). |
  | Material Composition | - Fabricated from pure titanium (ASTM F67) and Ti-6Al-4V (ASTM F136), which are standard materials used in predicate devices. |

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

This information is not applicable as no clinical test set or human data was used for a performance study. The "test set" for this submission consists of device samples evaluated in non-clinical lab settings (biomechanical and biocompatibility tests). No specific sample sizes for these lab tests are provided in the summary, other than "representative samples."

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 information is not applicable as no clinical study with expert interpretation was conducted.

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

This information is not applicable as no clinical study with human readers requiring adjudication was conducted.

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 required. The device is a traditional medical implant (plate and screw system), not an AI-powered diagnostic or assistive technology.

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

This information is not applicable as the device is not an algorithm or AI system.

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

For the non-clinical tests, the "ground truth" is defined by established engineering standards and biological safety guidelines (e.g., ASTM standards for biomechanics, ISO series for biocompatibility and sterilization). There is no clinical "ground truth" (like pathology or outcomes data) established or reported because no clinical study was performed.

8. The sample size for the training set

This information is not applicable as the device is not an AI/ML algorithm that requires a training set.

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

This information is not applicable as the device is not an AI/ML algorithm that requires a training set.

In summary, the document details a 510(k) submission for a traditional mechanical medical device, where substantial equivalence is demonstrated through non-clinical bench testing and comparison to predicate devices, rather than through clinical trials or AI performance evaluations.

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Tandry Compression Screw System is intended for the treatment of fractures, and fusions of bone with the appropriate screw size.

Tandry Compression Screw System consists of 2.8mm, 4.1mm, 4.7mm, 5.5, and 7.5mm cannulated compression screw, 2.0mm compressions screw and 2.0mm compression pin. The 2.0mm compression pin features a beak-off groove between a shaft and compression screw body, the shaft can be separated from the compression screw body by bending it back and forth. The screw system has multiple lengths depending on the diameter of the screws and pins are fabricated from Ti-6Al-4V and anodized.

The provided FDA 510(k) K220359 summary for the Tandry Compression Screw System does not describe an AI/ML medical device. It pertains to a physical medical device (bone fixation screws). Therefore, many of the requested elements for describing the acceptance criteria and study of an AI/ML device are not applicable or cannot be extracted from this document.

However, I can extract information related to the non-clinical performance testing of the physical device, including the acceptance criteria and the study that demonstrated compliance.

Here's the breakdown of the information that can be extracted, and where the requested AI/ML specific information is not available:

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)

• Test Set Sample Size: Not explicitly stated in this summary. Biomechanical testing would typically involve a specific number of screws for each test (e.g., 5-10 samples per test arm).
• Data Provenance: Not explicitly stated. Non-clinical (bench) testing is typically conducted in controlled laboratory environments, possibly by the manufacturer or a contract testing organization.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. This is a physical device, and its performance is evaluated through objective biomechanical and material testing, not through expert reading of images or data. Ground truth here refers to actual physical properties and performance metrics.

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

• Not Applicable. Adjudication methods are relevant for subjective evaluations, typically in clinical studies or expert review of images/data. Biomechanical testing relies on measurable physical parameters.

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 physical device, not an AI/ML system that would assist human readers.

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

• Not Applicable. This is a physical device, not a software algorithm.

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

• For biomechanical performance: Direct measurement of physical properties and mechanical performance (e.g., torsion, bending, fatigue) against established engineering standards (ASTM F-543-17) and FDA guidance documents.
• For biocompatibility: Laboratory testing results according to ISO 10993-1.
• For reprocessing/sterilization: Laboratory testing results, leveraging prior data from a substantially equivalent predicate device (K171904).

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

Additional Study Information Extracted:

• Study Type: Non-clinical (bench) testing, including biomechanical tests, biocompatibility assessments, and reprocessing/sterilization validation.
• Standards Utilized:
  • ASTM F-543-17: Standard Specification and Test Methods for Metallic Medical Bone Screws
  • Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway (FDA guidance)
  • ANSI/AAMI/ISO 10993-1: 2018: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.
  • AAMI TIR30: 2011(R2016): A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices.
  • ANSI/AAMI/ISO 17665-1: 2006/(R)2013: Sterilization of health care products – Moist heat – Part1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.
  • ANSI/AAMI/ISO 14937: 2009(R)2013: Sterilization of healthcare products – General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices.

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The BIO-RAY A-1 Anchor Screw System is intended to provide fixed anchorage for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It's used temporarily and intended after orthodontic treatment has been completed. The screw is intended for single use only.

The BIO-RAY A-1 Anchor Screw System is made of stainless steel 316L (ASTM F138) and titanium alloy Ti-6Al-4V (ASTM F136). Electrolytic polishing is for surface treatment of stainless steel screws and anodizing is for surface treatment of Ti-6Al-4V screws. There is a self-drilling and self-tapping feature in the screw tip for insertion and removal . The screw head designs include a mushroom, hook, or none head feature for attachment to orthodontic appliances. The screws are available in various configurations, shapes and sizes.

The provided document describes the BIO-RAY A-1 Anchor Screw System, an orthodontic mini-screw, and its substantial equivalence to predicate devices. The document explicitly states that clinical studies were determined to be not required to support substantial equivalence. Therefore, the information regarding acceptance criteria and study design elements related to clinical performance (such as sample size for test set, data provenance, expert ground truth, adjudication methods, MRMC studies, effect size, and standalone algorithm performance) is not available or applicable in this context.

The acceptance criteria and the study that proves the device meets them are based on non-clinical performance (bench testing, biocompatibility, and sterilization validation).

Here's the breakdown of the available information:

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

2. Sample size used for the test set and the data provenance:
Not applicable as no clinical test set was used. The non-clinical tests were conducted on device samples. The provenance of these samples is the manufacturer, Microware Precision Co., Ltd. in Taiwan. The tests are prospective in nature, as they are conducted for regulatory clearance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable as no clinical test set requiring expert ground truth was used. Ground truth for non-clinical tests is established by adhering to the standards (e.g., ASTM, ISO, USP) and the results obtained from standardized testing methods.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable as no clinical test set requiring adjudication was used.

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 medical implant, not an AI-assisted diagnostic or imaging system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable as this is a medical implant, not an AI algorithm.

7. The type of ground truth used:
For non-clinical performance, the "ground truth" is defined by the established industry standards (e.g., ASTM F543 for mechanical properties, ISO 10993 series for biocompatibility, ISO 17665-1 for sterilization) and the expected performance thresholds specified within those standards or internal specifications derived from predicate device performance.

8. The sample size for the training set:
Not applicable as this is a physical device, not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established:
Not applicable as this is a physical device, not an AI algorithm that requires a training set.

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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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Microware Bone Plates and Bone Screws are provided non-sterile. Microware Bone Plates and Bone Screws are intended to treat fractures of various bones, including the clavicle, pelvis, scapula, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals and phalanges).

Microware Bone Plates and Bone Screws Accessories:

1. The round washer is used to increase bone contact area for distributing the forces/load and prevent the screw head from sinking into the bone.
2. The spherical washer is used to increase bone contact area for distributing the forces/load and prevent the screw head from sinking into the bone. In addition, it can be applicable on the insertion at acute angles.
3. The spiked washer is used for ligament reattachment or fixation.
4. The support screw is anchored in cancellous bone by its thread. It supports the countersink head of a cannulated screw in cancellous bone.

The added devices do not change the original intended use, material, label, and package. The added devices with changes are described as follows:

1. Added cortex, cancellous, and shaft screws are designed with self-tapping flutes and are easier to insert into the bone than non-self-tapping screws.
2. Added cortex screws 1.5 and 2.0mm are designed with a cruciform recess and can be applied with a cruciform tool.
3. Added screws of all sizes are designed with a hexalobular socket and they can improve torque transmission to facilitate easy insertion and removal.
4. Added cannulaed screws extend diameter specification with 6.5, 4.5, 4.0, 3.0 and 2.4mm.
5. Added implants include the round washer, spherical washer, spiked washer, and support screw which can be used with or without other implants.
6. Added screws extend length specifications.

The provided document is a 510(k) summary for PREDICATE DEVICES, not a study that proves a device meets specific acceptance criteria. This submission is to establish substantial equivalence for Microware Bone Plates and Bone Screws to existing predicate devices. Therefore, a detailed study with acceptance criteria, sample sizes, expert ground truth, MRMC studies, or standalone performance metrics as specified in your request are not included.

However, I can extract the information related to the performance testing demonstrating substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Instead of formal acceptance criteria and quantitative performance metrics as might be found in a clinical study for an AI/diagnostic device, this 510(k) submission relies on performance testing to demonstrate substantial equivalence to predicate devices. The acceptance criterion is implicitly that the new device's performance in these tests is comparable to or better than the predicate devices, thereby ensuring it is as safe and effective.

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

Not applicable. This is a 510(k) submission for orthopedic implants, not a clinical study involving a test set of data. The "test set" here refers to the physical devices undergoing mechanical performance testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This is for mechanical device performance, not for establishing ground truth on medical diagnoses.

4. Adjudication Method

Not applicable.

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

Not applicable. This type of study is typically done for diagnostic devices, particularly those involving human interpretation, to compare human performance with and without AI assistance. This document is for orthopedic implants.

6. Standalone Performance Study

Yes, in a sense. The performance testing (axial pullout, self-tapping performance, driving torque, torsional properties) characterizes the standalone physical and mechanical properties of the device itself. This is done without human-in-the-loop for the test execution.

7. Type of Ground Truth Used

The "ground truth" for the mechanical performance testing would be established by standardized testing methods and material science principles, comparing the new device's properties against established benchmarks and the predicate devices' known characteristics. It's not "expert consensus, pathology, or outcomes data" in a clinical sense.

8. Sample Size for the Training Set

Not applicable. There is no AI algorithm being developed or "trained" in this context. The "training set" would implicitly refer to the design, manufacturing, and quality control processes that lead to the final device.

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

Not applicable, as there is no "training set" for an AI algorithm. The device's design and manufacturing rely on engineering specifications, material standards (e.g., stainless steel and titanium alloy), and adherence to good manufacturing practices, all aimed at producing a safe and effective implant.

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Microware Bone Plates and Bone Screws are provided non-sterile. Microware Bone Plates and Bone Screws are intended to treat fractures of various bones, including the clavicle, pelvis, scapula, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals and phalanges).

Microware DHS/DCS Plate System is provided non-sterile. Microware DHS/DCS Plate System is intended for use in fixation of fractures to the proximal femur. The system is indicated for use in trochanteric, pertrochanteric, intertrochanteric, and basilar neck fracture.

The Bone Plates and Bone Screws system & DHS/DCS Plate System consist of non-sterile bone plate and bone screw implants. The plates are devices, which are fastened to bone for purpose of providing fixation. They are principally differentiated by their function. Thus there are five kinds of styles: dynamic compression plate (DCP), tubular, special, mini and dynamic hip screw/dynamic condylar screw (DHS/DCS). The shape of the plate is an adaptation of the plate to the local anatomy and doesn't denote any function. Thus the name depends on the biomechanical function the plate is performing. Every plate is divided various types as following:

The series in size of Microware bone screws and bone plates except DHS/DCS are divided into mini, small and large. The range of plates in thickness are from 1.0 to 6.0 mm, width from 3.8 to 17 mm, length from 17 to 359 mm, and hole number from 2 to 22 holes.

On the other hand, the screws used either to fasten plates or similar devices onto bone, or, as lag screws, to hold together fragments of bone. 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. Thus there are four kinds of style: cortex, cancellous, malleolar, and cannulated. All screws have a hexagonal recess; this feature has proven itself to be of great advantage at the time of the screw removal and insertion. The range of screws in thread is diameter from 1.5 to 7.3 mm, total length from 6 to 150 mm.

The DHS/DCS Plate System consists of DHS/DCS plate, DHS/DCS Screw, DHS/DCS Compression Screw, and 4.5mm Cortex Screw (self-tapping). The DHS Plates are available with short and standard barrel which length is 25mm and 38mm respectively. And the barrel angles are available in 95', 135 , 140', 145', and 150'. The self-tapping 4.5mm Cortex Serew can be used to fix the DHS/DCS Plate to the femoral shaft.

The DHS/DCS Screw is available in total length from 50 to 145mm, thread length 22mm, shaft diameter 7.9mm, and outer diameter 12.5 to 14mm. The thread of DHS/DCS screw has a buttress type.

The DHS/DCS Compression Screw can be used to achieve fracture compression. Its dimension is available with thread length 26mm and outer diameter 4.0mm.

The provided text describes a 510(k) submission for bone plates and bone screws. A 510(k) submission is a premarket notification for demonstrating substantial equivalence to a legally marketed predicate device, not typically a study that proves a device meets specific performance acceptance criteria in the way a clinical trial or a novel technology validation would.

Therefore, the requested information elements (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) are not applicable in the context of this 510(k) submission for bone plates and bone screws.

Here's why and how the document addresses substantial equivalence:

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

• Not Applicable. This submission is not about performance against specific acceptance criteria for a new or novel device's function (e.g., diagnostic accuracy, treatment efficacy). Instead, it's about demonstrating that the proposed device is "substantially equivalent" to predicate devices already on the market.
• The document states: "A comparison between the proposed device and the predicate device has shown that three devices are very similar or identical in terms of indication for use, material, followed performance and standard and sterilization, and no significant difference between the proposed and predicate devices has been found." This statement is the "reported device performance" in the context of a 510(k) – it performs similarly to the predicate.

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. No test set or human/animal data is mentioned for performance evaluation. The substantial equivalence is based on comparison of specifications and materials.

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. No ground truth establishment for a test set is part of this type of submission.

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

• Not Applicable. No adjudication method is relevant here.

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 submission for medical implants (bone plates and screws), not an AI/software device. MRMC studies are not relevant.

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

• Not Applicable. Not an algorithm/AI device.

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

• Not Applicable. No ground truth for an evaluation dataset is created. The "truth" in a 510(k) is the established safety and efficacy of the predicate device, to which the new device is compared.

8. The sample size for the training set:

• Not Applicable. No training set for an algorithm is involved.

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

• Not Applicable. No training set or ground truth establishment is involved.

Summary of the 510(k) Submission's Approach:

The Microware Bone Plates and Bone Screws & Microware DHS/DCS Plate System received 510(k) clearance based on demonstrating substantial equivalence to existing predicate devices:

• Syntec-Taichung Non-sterile Bone Plate and Screw Implants (K983495)
• Syntec-Taichung Non-sterile DHS/DCS Plate System (K983873)
• INTAI Bone Plate and Bone Screw System & INTAI DHS/DCS Plate System (K063020)

The key findings for substantial equivalence were:

• Indication for use: "very similar or identical"
• Material: "very similar or identical" (316L stainless steel meeting ASTM F138 and ASTM F139, and titanium alloy (Ti-6Al-4V) meeting ASTM F136).
• Performance and standard: "followed performance and standard" – implying compliance with relevant engineering standards applicable to such implants.
• Sterilization: "very similar or identical" (provided non-sterile).

The essence of a 510(k) is not to prove that a device meets independently defined acceptance criteria through a specific study, but rather to show that it is as safe and effective as a legally marketed device and does not raise new questions of safety and effectiveness. This is done through direct comparison of indications for use, technological characteristics (materials, design, function), and any relevant performance testing (often mechanical, biocompatibility, etc.) that demonstrates equivalence to the predicate. The document implies such testing was done ("followed performance and standard") but does not detail it with acceptance criteria tables or study specifics in this summary.

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