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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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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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AFFINITY Proximal Tibia System is intended to treat fractures, nonunions of the proximal tibia including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures.

• · Simple metaphyseal fractures (Classification AO 41-A2)
• · Multifragmentary metaphyseal fractures (Classification AO 41-A3)
• · Simple bicondylar fractures (Classification AO41-C1, 41-C2)
• Multifragmentary bicondylar fractures (Classification AO 41-C3)
• · Simple joint, simple metaphyseal fractures (Classification AO 41-C1)
• · Diaphisary fractures (Classification AO 42A and 42B)

AFFINITY Proximal Tibia System consists of anatomical plates and screws for the placement of the proximal tibial condyles, improving the restoration of the original structure. Similarly, in combination with the variable angle technique, it allows for the placement of screws in different configurations providing appropriate support for the correct healing of fractures.
AFFINITY Proximal Tibia System consists of pre-contoured bone fixation plates and screws. The plates are made from biocompatible commercially pure titanium grade 4 according to ISO 5832-2 and ASTM F67 standard. The screws are made from biocompatible titanium alloy (Ti6Al4V) according to ISO 5832-3 and ASTM F136 standard.
The AFFINITY Proximal Tibia System plates can be fixed with variable angle technique.

The provided text is an FDA 510(k) summary for the AFFINITY Proximal Tibia System. This document describes a medical device (a bone plate and screw system for tibial fractures) and its claim of substantial equivalence to existing predicate devices.

Crucially, the document states that "Clinical testing was not necessary for the substantial equivalence determination." This means that the device's acceptance criteria and the proof it meets them do NOT involve human clinical studies or AI-driven performance metrics such as accuracy, sensitivity, specificity, or human-in-the-loop improvements.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study that proves the device meets the acceptance criteria in the context of AI/machine learning performance. The provided text details non-clinical performance testing for a medical implant, focusing on mechanical, biocompatibility, and sterilization aspects.

Here's why I cannot provide the requested information based on the given text:

• No AI or algorithm present: There is no mention of any AI component, algorithm, or software in the device description or its testing.
• No clinical performance data (e.g., accuracy, sensitivity): The document explicitly states "Clinical testing was not necessary." The performance testing described is mechanical (bend, torsion, pullout strength), biocompatibility, and sterilization, which are relevant for physical implants, not AI diagnostic or assistive devices.
• No human reader studies (MRMC): Since no AI is involved, there are no studies assessing how human readers improve with AI assistance.
• No ground truth establishment for diagnostic performance: The "ground truth" mentioned in your prompt (expert consensus, pathology, outcomes data) is typically for validating diagnostic or classification algorithms. For a bone plate, ground truth relates to its mechanical integrity and biological safety, which were assessed through laboratory tests.

In summary, the provided document describes the regulatory approval of a physical medical device (a bone plate and screw system) through established non-clinical testing and comparison to predicates, not the validation of an AI/ML medical device.

If you have a document describing an AI/ML medical device's performance study, I would be happy to analyze it according to your detailed criteria.

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The Goblin and Goblin LS Pedicle Screw Systems are intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications:

• · Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
• · Spondylolisthesis;
• · Trauma (i.e., fracture or dislocation);
• Spinal stenosis;
• · Curvatures (i.e., scoliosis, kyphosis and/or lordosis);
• · Tumor and pseudarthrosis

The Goblin and Goblin LS Pedicle Screw Systems are top-loading multiple component, posterior spinal fixation systems 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 "Goblin and Goblin LS Pedicle Screw Systems." It describes a traditional medical device (pedicle screw systems for spinal fixation), not an AI/ML medical device. Therefore, the acceptance criteria and study information typically provided for AI/ML device validation (e.g., sample size for test/training sets, adjudication methods, expert qualifications, MRMC studies, standalone performance, ground truth establishment) are not applicable and are not present in this document.

The performance data section for this device focuses on non-clinical testing to demonstrate substantial equivalence to predicate devices, specifically:

• Non-clinical testing performed in accordance with ASTM F1717:
  • Static compression
  • Dynamic compression
  • Static Torsion

This type of testing evaluates the mechanical integrity and performance of the physical implants, which is standard for pedicle screw systems.

Therefore, it is impossible to extract the requested information regarding acceptance criteria and studies that prove an AI/ML device meets those criteria from the provided document. The document concerns a hardware medical 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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