Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this 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) 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.

Ask a specific question about this device

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.

Ask a specific question about this 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, calcaneous, fibula and other small bones.

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, calcaneous, femur 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 70mm in length.

This document is a 510(k) summary for the TDM Plate and Screw System. It does not describe a study involving an AI/CADeX device or human readers. The acceptance criteria and the study to prove the device meets those criteria are entirely focused on mechanical and material properties of the bone plates and screws.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for the mechanical tests (e.g., how many plates or screws were tested). The provenance of this test data would be the testing facility that performed the ASTM standards and LAL testing, likely a laboratory associated with TDM Co. Ltd. or a contracted testing service. This testing is inherently prospective in nature, as it's performed specifically to demonstrate compliance for regulatory submission.

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

This information is not applicable as the device is a mechanical implant, not an AI/CADeX device requiring expert interpretation of images to establish ground truth. The "ground truth" for this device is based on established engineering standards for strength, durability, and biocompatibility.

4. Adjudication Method for the Test Set

This is not applicable for the same reasons as point 3. Mechanical testing results are objective measurements against defined standards, not subjective interpretations requiring adjudication.

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

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices where human readers' performance with and without AI assistance is evaluated. The TDM Plate and Screw System is a physical implant for bone fixation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable as the device is a physical bone plate and screw system, not an algorithm or AI product.

7. Type of Ground Truth Used

The ground truth used for this device's acceptance is based on adherence to established engineering standards (ASTM F382-14 and ASTM F543-13) and biocompatibility testing (LAL bacterial endotoxin testing). These standards define the acceptable mechanical properties and safety profiles for such medical devices.

8. Sample Size for the Training Set

This is not applicable. The TDM Plate and Screw System is a manufactured medical device, not a machine learning model that requires a training set.

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

This is not applicable as there is no training set for this device.

Ask a specific question about this device