Search Results

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.

Ask a specific question about this device

(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.

Ask a specific question about this device

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.

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 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.

Ask a specific question about this device