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The TDM Plate and Screw Systems are indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of bones appropriate for the size of the device.

Mini and Mid Locking Plate and Screw System:
The Mini and Mid Locking Plate and Screw System is intended to be used in the hands, wrist, and small bones in the foot.

Small Locking Plate and Screw System:
The Small Locking Plate and Screw System is indicated for the clavicle, scapula, olecranon, humerus, radius, ulna, tibia, and fibula.

The TDM Screws (1.5mm and larger, Solid and Cannulated) are intended to be used with the plate for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, and fibula.

The TDM Plate and Screw system consists of a family of flat and contoured plates and screws that make up the Mini and Mid Locking Plate and Screw System and the Small Locking Plate and Screw System. The Plates are constructed from Titanium alloy (Ti-6AL-4V) or pure Titanium (Ti) and come in a variety of configurations. The Plates are intended to be used with locking and non-locking screws and non-locking low profile Screws. The Screw are constructed from Titanium alloy (Ti-6AL-4V) and are available as threaded locking screws, cortical or cancellous, cannulated screws from 1.5mm to 4.0 in diameter and range from 6mm to 100 in length.

The provided text is a 510(k) premarket notification for a medical device (TDM Plate and Screw System). It describes the device, its indications for use, and a summary of performance testing to demonstrate substantial equivalence to predicate devices. However, it does NOT include acceptance criteria for a quantitative performance metric, nor does it describe a study that uses a test set against ground truth with experts and specific adjudication methods.

Instead, the performance data section mentions nonclinical tests and engineering analysis conducted in accordance with ASTM standards (F543-17 and F1264-16) to establish substantial equivalence. These standards are typically for mechanical properties and material compatibility, not for diagnostic or clinical performance against ground truth as would be evaluated for AI/ML-driven devices.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance with the specific details requested (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, and ground truth establishment for training set). This type of information is generally found in submissions for devices that rely on algorithmic performance, often involving image analysis or diagnostic support, which is not the case for this bone fixation system.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

• Cannot provide. The document does not describe specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or reported device performance in a clinical or diagnostic context. The "Performance Data" section refers to mechanical tests.

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

• Cannot provide. The document describes mechanical tests, not a study involving a test set of data (e.g., images, patient records).

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

• Not applicable. There is no "ground truth" in the clinical or diagnostic sense for this type of mechanical device evaluation. The "ground truth" for mechanical testing would be the physical properties measured in a lab.

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

• Not applicable. No such adjudication method is described as there isn't a test set with expert interpretation.

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, an MRMC study was NOT done. This type of study is relevant for AI/ML diagnostic tools, not for a bone plate and screw system.

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

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

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

• Not applicable. The "ground truth" for mechanical testing would be direct measurements of physical properties (e.g., ultimate tensile strength, fatigue life), not expert consensus or pathology in a clinical context.

8. The sample size for the training set:

• Not applicable. There is no mention of a "training set" for this device, as it is not an AI/ML-driven product.

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

• Not applicable. As there is no training set, this question is not relevant.

Summary of available "Performance Data" from the document:

The "Performance Data" section states:
"The following testing was performed in accordance with the ASTM F543-17 and ASTM F1264-16:

• Static 4-Point Bending
• Axial Pullout
• Torsional
  The nonclinical tests and engineering analysis demonstrate that the TDM Plate and Screw Systems is as safe, as effective, and is substantially equivalent to the legally marketed predicate device."

This indicates that mechanical and material performance was evaluated, likely against the thresholds or expectations set by the referenced ASTM standards, which are considered the "acceptance criteria" for this type of device in terms of its physical integrity and performance. The study demonstrating this is the suite of nonclinical tests and engineering analysis performed according to those standards.

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(1) Femur Reconstruction Interlocking Nail System
The Femur Reconstruction Interlocking Nail System is intended to stabilize femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions.

(2) Femur Retrograde Interlocking Nail System
The Femur Retrograde Interlocking Nail System is indicated for simple long bone fractures: severely comminuted, spiral, large oblique and segmental fractures; nonunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grating; supracondylar fractures; bone lengthening and shortening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of long bones being treated.

(3) Humerus Interlocking Nail System
The Humerus Interlocking Nail System indicated for fractures of the proximal humerus, including 2-part surgical neck fractures, 3-part fractures, and 4-part fractures with diaphyseal extension, diaphyseal extension, diaphyseal fractures of the humeral shaft, and impending pathologic humeral fractures.

(4) Tibia Interlocking Nail System
The Tibia Interlocking Nail System is intended to stabilize fractures of the proximal and distal thatt; open and closed tibial shaft fractures; certain pre- and post-isthmic fractures; and tibial malunions and non- unions.

(5) Compression Hip Nail System
The Compression Hip Nail System is intended to treat stable proximal femoral fracture including Pertrochanteric fractures, Intertrochanteric fractures and High sub trochanteric fractures and combination of these fractures.

This intramedullary fixation rod is used for stabilization of shaft fracture in humeral bone, femoral bone and tibial bone. It is implanted into medullary cavity inside of the long bone (humeral bone, femoral bone and tibial bone) with a fracture and the fractured long bone (humeral bone, femoral bone and tibial bone) is fixed to the nail by using the locking screw at the upper and lower parts of the fractured part.
The nailing system consists of the Femur Reconstruction Interlock Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, and Compression Hip Nailing System.

The provided document is a 510(k) premarket notification FDA clearance letter for an intramedullary fixation rod system. It does not contain any information about acceptance criteria, device performance, study design, or ground truth establishment.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. The document is concerned with demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of technical characteristics, rather than reporting on a clinical or performance study with defined acceptance criteria.

The relevant sections explicitly state:

• "Clinical Test Conclusion: Clinical testing was not required for this submission."
• "Non-clinical Test Conclusion: The following properties were tested based on the referenced standards. All the test results support substantial equivalence to the predicate devices." (lists biological and mechanical standards).

To answer your questions, I would need a different document, such as a summary of safety and effectiveness data or a clinical study report.

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The TDM Anterior Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to C7). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment ve 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.

The TDM Anterior Cervical Plate System consists of cervical plates, screws and the instruments necessary to implant this specific system. All implant components are made from a titanium alloy (Ti-6AL-4V). The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping and self-drilling bone screws using an anterior approach. Cervical Plate System is provided as non-sterile. The implants are intended for single-use only, while the instruments are reusable.

I am sorry, but the provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria.

The document is a 510(k) premarket notification clearance letter from the FDA for the "TDM Anterior Cervical Plate System." It confirms that the device is substantially equivalent to a legally marketed predicate device.

The section titled "Performance Data" mentions:

• Non-clinical testing: static compression, dynamic compression, and static torsion.
• Standard: ASTM F1717.
• Purpose: to demonstrate substantial equivalence to the predicate device.

However, it does not provide specific acceptance criteria values for these tests, nor does it list detailed results or a study report with sample sizes, data provenance, ground truth establishment, or any of the other specific information requested in your prompt regarding acceptance criteria and a study proving their fulfillment. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study with explicit acceptance criteria.

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The TopFix System is indicated for the fixation of fractures and ostectomies of the distal femur and proximal tibia related to the treatment of bone and joint deformities and / or malalignment caused by injury or disease (e.g., osteoarthritis).

The Trifix Large System is indicated for the fixation of fractures (including periprosthetic), non-unions of the femur and tibia in adult patients with normal or osteopenic bone.

The Newnecks System is indicated for the fixation of fractures of the femoral trochanteric region (e.g., simple intertrochanteric, reverse oblique trochanteric, complex multi-fragmentary, and fractures with associated medial cortex instability).

The TDM Large Bone Plate and Screw System contains the TopFix System, Trifix Large System, and the Newnecks System, which comprise a family of flat and contoured plates and screws. The plates are constructed from Titanium alloy (Ti-6AL-4V) and come in a variety of configurations. The plates are intended to be used with solid locking and non-locking screws and non-locking low profile screws. The screws are constructed from Titanium alloy (Ti-6AL-4V) and are available as threaded locking screws, cortical or cancellous, cannulated screws from 4.0mm to 6.5mm in diameter and range from 12mm to 100mm in length.

This FDA 510(k) premarket notification summary describes a orthopedic device, not an AI/ML device, therefore the requested information for acceptance criteria and study details for an AI/ML device are not applicable.

The document discusses the substantial equivalence of the TDM Large Bone Plate and Screw System to previously cleared predicate devices. The "acceptance criteria" discussed are primarily related to mechanical performance testing against established ASTM standards and biocompatibility.

Here's a breakdown based on the provided text, noting where the requested AI/ML specific information is not relevant:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set: Not explicitly stated as a "test set" in the context of an AI/ML device. The testing involved bench testing of the physical device components (plates and screws).
• Sample Size:
  • For mechanical testing, the number of samples tested per configuration is not detailed in this summary but would be specified in the full test reports.
  • Biocompatibility likely involved material testing and review, not a "sample size" in the traditional sense of patient data.
• Data Provenance: Not applicable as this is a physical device, not a data-driven AI/ML model. The "data" comes from engineered bench tests.

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

• Ground Truth Establishment: Not applicable. The "ground truth" for mechanical performance is defined by engineering standards (ASTM F382-17, ASTM F543-17) and FDA guidance documents related to orthopedic fracture fixation plates/screws. There are no clinical experts establishing "ground truth" for the mechanical properties of a bone plate.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. Bench tests are assessed against objective, predefined engineering performance criteria, not requiring expert adjudication.

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

• MRMC Study: No. This is a physical orthopedic implant, not an AI/ML device.

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

• Standalone Performance: Not applicable. This is a physical orthopedic implant, not an AI/ML device.

7. The type of ground truth used

• Ground Truth: Engineering specifications, material standards (ASTM F136, ASTM F67), and mechanical testing standards (ASTM F382-17, ASTM F543-17), along with relevant FDA guidance documents ("Orthopedic Fracture Fixation Plates – Performance Criteria for Safety and Performance Based Pathway" and "Orthopedic Non-Spinal Metallic Bone Screws and Washers -Performance Criteria for Safety and Performance Based Pathway").

8. The sample size for the training set

• Training Set: Not applicable. This is a physical orthopedic implant.

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

• Ground Truth for Training Set: Not applicable. This is a physical orthopedic implant.

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The TDM Screw Systems are indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of bones appropriate for the size of the device.
Cannulated Screw System:
The Cannulated Screw System is intended to be used for fracture of the hand or foot or small and large bones.
Headless Compression Cannulated Screw System:
The Headless Compression Cannulated Screw System is intended to be used for a wide range of different indications in the hand, wrist and joint fusion (arthrodeses) in the foot and fixation of intra-articular fractures of the humerus, femur and tibia.
Limited Sliding Screw System:
The Limited Sliding Screw System is intended to be used for fracture fixation of the proximal femur.

The TDM Screw Systems consist of a family of devices intended for internal bone fixation of fractures, fusions, osteotomies, non unions, and malunions. The subject devices are constructed from Titanium alloy (ASTM F136) and are comprised of cannulated screws, headless compression cannulated screws, limited sliding screws, compression screws, and washers. The subject devices are available in diameters ranging from 2.5mm to 7.5mm and lengths ranging from 10mm to 125mm. The Washer is available in 5.5mm to 13mm. The Screws are intended for standalone use.

The provided text is related to an FDA 510(k) clearance for a medical device called the "TDM Screw System". It describes the device, its indications for use, and a summary of performance data. However, the document primarily focuses on regulatory approval based on substantial equivalence to a predicate device, rather than a clinical study evaluating the device's performance against specific acceptance criteria for an AI/algorithm-driven system.

Therefore, the information requested in your prompt regarding acceptance criteria, study design for AI/algorithm performance (e.g., test/training sets, expert ground truth, MRMC studies, standalone performance), and similar details are NOT present in the provided FDA 510(k) clearance document.

This document is for a physical medical device (metallic bone fixation fasteners), not an artificial intelligence or algorithmic diagnostic/decision-support system. The "Performance Data" section specifically mentions "The following testing was performed in accordance with the ASTM F543-17 and ASTM F1264-16: - Torsional - Pullout - 3-Point Bending". These are mechanical engineering tests for the physical properties of the screws, entirely unrelated to AI or software performance.

Therefore, I cannot populate the requested tables and information as the provided text does not contain the type of study data you are asking about for an AI/algorithm-driven device.

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TDM Lumbar Interbody Fusion Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1, who have had six months of non-operative treatment. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). This device is to be used with autogenous bone graft. TDM Lumbar Interbody Fusion Cage System is to be used with supplemental fixation.

The TDM Lumbar Interbody Fusion Cage System (EVERGREEN PEEK PLIF Cage, LIME PEEK TLIF Cage, and PORTIA HYBRID TLIF cage) consists of intervertebral body fixation devices intended for use as an aid in spinal fixation. This system is fabricated and manufactured from PEEK as described by ASTM F2026. The Tantalum and Titanium marker used for this product is made to the voluntary standard of ASTM F560 and ASTM F136. The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates. The EVERGREEN PEEK PLIF Cages are to be implanted via posterior approach. Two PLIF PEEK cages are placed on each side of the interbody space (right and left). The LIME PEEK TLIF Cages and PORTIA HYBRID TLIF cages are dedicated to transforaminal approach. TLIF technique involves placing only one bone graft spacer in the middle of the interbody space, without retraction of the spinal nerves.

The provided document is a 510(k) summary for the TDM Lumbar Interbody Fusion Cage System, a medical device used in spinal fusion procedures. It outlines the device's intended use, technological characteristics, and a comparison to predicate devices, focusing on non-clinical performance testing.

Crucially, this document does not contain information about a study proving that an AI/software device meets acceptance criteria for diagnostic performance metrics (e.g., sensitivity, specificity, AUC). The performance data section explicitly states: "Non-clinical testing was performed to demonstrate that the subject TDM Lumbar Interbody Fusion Cage System is substantially equivalent to the predicate device. The following testing was performed in accordance with the ASTM F2077, and ASTM F2267: - Static Axial Compression - Dynamic Axial Compression - Static Torsion - Static Shear - Dynamic Shear - Subsidence."

These are mechanical and biocompatibility tests for a physical implantable device, not performance studies for an AI/software as a medical device (SaMD) that would have diagnostic accuracy metrics.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets those criteria for an AI/software device based on the provided text. The document is for a physical orthopedic implant.

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PINE Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute or chronic spinal instabilities or deformities in the thoracic, lumbar, and sacral spine:

• Degenerative disc disease (DDD) as defined by back pain of discogenc origin with degeneration of the disc confirmed by patient 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
• Failed previous fusion

The PINE Pedicle Screw System is a top-loading multiple component, posterior spinal fixation system which consist of pedicle screws, rods, set screws, connectors, and transverse (cross) linking mechanisms. The implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6Al-4V ELI) as specified in ASTM F136. Various sizes of these implants are available.

The provided text is a 510(k) summary for the "PINE Pedicle Screw System," a medical device. It does not describe acceptance criteria for an AI/ML device or a study involving such a device. Instead, it details the regulatory process for a spinal implant system.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance for an AI/ML device based on this input. The document focuses on mechanical testing for a physical implant, not on the performance of a software algorithm.

Here's why the provided text isn't suitable for your request:

• Device Type: The device described is the "PINE Pedicle Screw System," which is a "top-loading multiple component, posterior spinal fixation system" made of "pedicle screws, rods, set screws, connectors, and transverse (cross) linking mechanisms." This is a physical, mechanical implant, not an AI/ML device.
• Performance Data: The "Performance Data" section explicitly states: "Non-clinical testing was performed to demonstrate that the subject PINE Pedicle Screw System is substantially equivalent to the predicate device. The following testing was performed in accordance with the ASTM F1717: - Static compression - Dynamic compression - Static Torsion." These are mechanical tests for structural integrity, not performance metrics like sensitivity, specificity, or AUC typically used for AI/ML algorithms.

To answer your request, I would need a document related to an AI or Machine Learning device.

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Park's Pectus System is intended for use in surgical procedures to repair Pectus Excavatum and other anterior chest wall deformities

Park's Pectus System is used in a minimally invasive surgical procedure to correct pectus excavatum, a type of deformity of the thoracic wall, characterized by a concave shaped chest. This device consists of pectus bar and stabilizer to lift the sternum upwards to lessen the severity of the deformity.

Park's Pectus System includes appliance accessories used in surgical procedures to insert a fixation bar into the thoracic cavity and get it fixed to the coastal ribs for repairing pectus excavatum, a type of deformity of the thoracic wall.

The provided text does not contain information about an AI device or a study proving its performance against acceptance criteria. It discusses the "Park's Pectus System," which is a medical device for correcting pectus excavatum, comprising pectus bars and stabilizers. The document is an FDA 510(k) premarket notification and focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance study against acceptance criteria typically associated with AI/software devices.

Therefore, many of the requested details, such as sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set information, and ground truth establishment for an AI device, are not applicable to this document.

However, I can extract the acceptance criteria and performance information as presented for the Park's Pectus System in relation to its predicate device. This will be based on the substantial equivalence discussion.

Here's a summary of the information available in the document, framed as acceptance criteria and reported performance in the context of substantial equivalence to a predicate device:

Acceptance Criteria and Reported Device Performance (Park's Pectus System vs. Predicate Device)

The "acceptance criteria" for the Park's Pectus System, as presented in this 510(k) summary, are its features and performance demonstrating substantial equivalence to the predicate device, Lorenz Pectus Support Bar System (K061384), and reference devices (TDM Plate and Screw System K171808/K190391).

Study Information (Non-AI device context):

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

   • Test set: The document refers to "worst case scenario" samples for mechanical testing: a pectus bar with dimensions of 431.8 mm (17 inch) long x 12.7mm width x 2.8 mm thick. Both stainless and titanium pectus bars were tested, as were pectus bars with rounded and serrated ends.
   • Data provenance: Not explicitly stated, but these were non-clinical, in-vitro tests conducted by the manufacturer (TDM Co. Ltd.) to compare its device against the predicate.

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

   • Not applicable. This device is not an AI/diagnostic software. The "ground truth" for non-clinical performance refers to established engineering standards (e.g., ASTM F382-14) and direct comparison to the predicate device under specific test conditions.

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

   • Not applicable. This is not a clinical study involving human readers or interpretation.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This is not an AI device.

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

   • Not applicable. This is not an AI device.

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

   • For material properties and biocompatibility: Compliance with ISO10993 requirements, use of well-established medical-grade materials (ASTM F136, ASTM F138 & F139), and equivalence to previously cleared devices (K171808/K190391).
   • For mechanical performance: Comparison to a legally marketed predicate device (Lorenz Pectus Support Bar System, K061384) under specific ASTM-standardized mechanical tests (ASTM F382-14 for metallic bone plates). The "ground truth" is that the new device performs comparably to the predicate under these conditions.

7. The sample size for the training set:

   • Not applicable. This is not an AI device, so there is no training set in the AI sense.

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

   • Not applicable.

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Mini and Mid Locking Plate and Screw System: The Mini and Mid Locking Plate and Screw System is intended to be used in the hands, wrist, and small bones in the foot. Small Locking Plate and Screw System: The Small Locking Plate and Screw System is indicated for the clavicle, scapula, olecranon, humerus, radius, ulna, tibia, and fibula. The TDM Screws (1.5mm and larger, solid) are intended to be used with the plate for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, and fibula.

The TDM Plates and Screw System consists of a family of flat and contoured plates and screws that make up the Mini and Mid Locking Plate and Screw System and the Small Locking Plate and Screw System. The Plates are constructed from Titanium alloy (Ti-6AL-4V) or pure Titanium (Ti) and come in a variety of configurations. The Plates are intended to be used with solid locking and non-locking screws and non-locking low profile Screws. The Screws are constructed from titanium alloy (Ti-6AL-4V) and are available as threaded locking screws, cortical or cancellous, from 1.5mm to 4.0mm in diameter and range from 6mm to 100mm in lenath.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies related to its AI performance. The document is a 510(k) premarket notification for a medical device called "TDM Plate and Screw Systems," which are metallic bone fixation appliances.

The document discusses:

• The device's trade name, regulation, and product codes.
• Its intended use (internal bone fixation for fractures, fusions, osteotomies, and non-unions in various parts of the body).
• The materials it is constructed from (Titanium alloy or pure Titanium).
• A comparison to predicate devices for substantial equivalence.
• Performance testing according to ASTM standards for metallic bone plates and screws.

However, it explicitly states: "Clinical data was not needed for this device." This indicates that no clinical studies, and therefore no studies evaluating AI performance or human reader improvement with AI, were conducted or presented in this 510(k) submission.

Therefore, I cannot provide answers to your specific questions regarding acceptance criteria, reported device performance (in the context of AI), sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details because this information is not present in the provided text.

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The TDM Screw Systems are indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of bones appropriate for the size of the device.

Cannulated Screw System:
The Cannulated Screw System is intended to be used for fracture of the hand or foot (2.5mm) or small and large bones (4.0mm larger).

Headless Compression Cannulated Screw System:
The Headless Compression Cannulated Screw System is intended to be used for a wide range of different indications in the hand, wrist and joint fusion (arthrodeses) in the foot (2.3mm & 4.0mm) and fixation of intraarticular fractures of the humerus. femur and tibia (3.5mm & 5.0mm).

Limited Sliding Screw System:
The Limited Sliding Screw System is intended to be used for fracture fixation of the proximal femur, large bones and large bone fragments.

The TDM Screw Systems consist of a family of devices intended for internal bone fixation of fractures, fusions, osteotomies, non-unions, and malunions. The subject devices are constructed from Titanium alloy (ASTM F136) and are comprised of cannulated screws, headless compression cannulated screws, limited sliding screws, compression screws, and washers. The subject devices are available in diameters ranging from 2.5mm to 7.5mm and lengths ranging from 10mm to 120mm. The Washer is available in 5.5mm to 13mm. The Screws are intended for standalone use.

The provided text is a 510(k) summary for the TDM Screw Systems, a medical device for bone fixation. It describes the device, its intended use, and its comparison to predicate devices, focusing on demonstrating substantial equivalence based on non-clinical performance testing.

However, the document does NOT contain information regarding:

• Acceptance criteria for an AI/software device.
• Study details (test set, training set, ground truth, expert involvement, MRMC study, human-in-the-loop performance, standalone performance) that would be relevant to an AI/software device. The document explicitly states: "Clinical data was not needed for this device."

The TDM Screw Systems are a traditional hardware medical device (screws for bone fixation), not an AI/software device. Therefore, the questions related to AI/software performance validation and study design (like MRMC, ground truth establishment, sample sizes for training/test sets for AI, expert consensus, etc.) are not applicable to the information provided in this document.

The document primarily relies on non-clinical performance testing to demonstrate substantial equivalence, specifically referencing:

• ASTM F543-17: "Standard Specification and Test Methods for Metallic Medical Bone Screws"
• ASTM F1264-16: "Standard Specification and Test Methods for Intramedullary Fixation Devices" (used as a guideline for screw three-point bend testing)
• LAL bacterial endotoxin testing

Conclusion based on the provided text:

This document describes the regulatory clearance of a physical medical device (bone screws) and not an AI/software device. Therefore, none of the requested information regarding AI acceptance criteria or study methodologies (test set/training set sizes, expert involvement, MRMC, standalone performance, ground truth establishment, etc.) can be extracted from this text. The acceptance was based on mechanical performance testing in accordance with established ASTM standards for metallic bone screws.

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