Search Results

The General Spinal System is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities deformities: (1) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, kyphosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion, (5) pseudarthrosis, (6) spinal stenosis. It is not intended for pedicle screw fixation above T8.

The General Spinal System consists of Fixed-Angle Screws, Fix-Angle Reduction Screws, Hooks, Rods, Cross Link and Set Screws. It is made of Titanium Alloy (Ti6Al4VELI), which meets ASTM F136-02a, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Allov for Surgical Implant Applications. which are widely used for surgical implants with well known biocompatibility. The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 10 by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices

This document describes the General Spinal System, a pedicle screw spinal system. The primary method of demonstrating acceptance criteria for this device is through non-clinical testing, specifically mechanical performance testing, and comparison to a legally marketed predicate device to establish substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not specify exact sample sizes (e.g., number of constructs tested) for each mechanical test performed under ASTM F1717-04. It only states that "Non clinical tests were conducted to verify that the proposed device met all design specifications."
• Data Provenance: The tests are non-clinical (laboratory tests) conducted by Tianjin Walkman Biomaterial Co., Ltd. in China. The data provenance is internal testing, not patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• This information is not applicable. The "ground truth" for non-clinical performance evaluations of medical devices like spinal systems is typically established by recognized national/international standards (e.g., ASTM, ISO), which define test methodologies, acceptance criteria, and performance limits. These standards are developed and maintained by committees of experts, but specific "experts" assigned to establish "ground truth" for a particular device's test set are not mentioned or required in this context.

4. Adjudication Method for the Test Set

• This information is not applicable. The non-clinical tests involve objective measurements (e.g., load, displacement) against specified performance criteria, rather than subjective interpretation requiring adjudication among multiple parties.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for diagnostic imaging devices where human interpretation of images is a key factor. This submission pertains to a surgical implant (pedicle screw spinal system), where performance is assessed through mechanical testing and material properties.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• This is not applicable. The device is a physical surgical implant, not a software algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for the device's performance in this context is defined by established engineering and material standards. Specifically:
  • Mechanical Integrity: ASTM F1717-04 defines the "ground truth" for appropriate mechanical performance characteristics (static/dynamic bending, torsion) expected of spinal implant constructs.
  • Material Biocompatibility: ASTM F136-02a defines the "ground truth" for the material properties and biocompatibility of the titanium alloy used.
  • Sterilization: ISO 17665-1:2006 defines the "ground truth" for a validated sterilization process to achieve a specified Sterility Assurance Level.

8. The Sample Size for the Training Set

• This information is not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a training set. The design and manufacturing process are informed by general engineering principles and material science, not a data-driven "training" process in the AI sense.

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

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

Ask a specific question about this device

• Simple, compound first- and second-degree tibial shaft fractures
• Pseudarthrosis and delayed union.

The Metallic Intramedullary Nail System, is a temporary fixation intramedullary nail designed for fracture fixation and stabilization of the tibia. The system consists of intramedullary nail, locking screw, end cap and instruments. The intramedullary nail is available in a variety of lengths and diameters to meet assorted anatomical needs. Each of the nails is secured by a series of screws that pass through holes manufactured into the proximal and distal sections of each nail.

The provided document describes the acceptance criteria and a study demonstrating the substantial equivalence of the "Metallic Intramedullary Nail System" to a predicate device. However, this is a premarket notification for a medical device (intramedullary nail), which is a physical implant, not an AI/ML-powered device or diagnostic tool. Therefore, many of the requested categories (like MRMC study, human reader improvement with AI assistance, ground truth establishment for AI models, training set details) are not applicable to this type of device and study.

The study performed is a non-clinical mechanical performance test, comparing the device to a predicate device based on engineering standards, not a clinical study involving patients or expert interpretation of diagnostic output.

Here's an analysis based on the information available, addressing the applicable categories:

Acceptance Criteria and Device Performance

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

The acceptance criterion for this device is "Substantial Equivalence" to the predicate device, specifically regarding its mechanical performance and other characteristics. The device performance is demonstrated through non-clinical testing.

Study Information (Applicable to Non-Clinical Mechanical Testing):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states "Non clinical tests were conducted to verify that the proposed device met all design specifications". It does not specify a "sample size" in terms of number of devices tested, but rather that the device was tested per ASTM F 1264-03(Reapproved 2007). This standard dictates the test methods for intramedullary fixation devices, including specimen preparation and required number of specimens for various tests (e.g., static bending, fatigue). The provenance of the data is from the manufacturer, Tianjin Walkman Biomaterial Co., Ltd, in China, as part of their 510(k) submission. These are prospective non-clinical tests.

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. Ground truth in this context refers to the physical properties and mechanical performance of the materials and devices as measured using standardized laboratory tests, not expert interpretation of images or clinical outcomes. The "ground truth" is established by the specifications in ASTM F1264 and ASTM F136.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used to resolve discrepancies in expert interpretation, which is not relevant for objective mechanical testing.

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 non-clinical mechanical performance study of a physical implant, not an AI/ML diagnostic device involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a non-clinical mechanical performance study of a physical implant, not an AI/ML diagnostic device with an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is derived from mechanical testing standards (ASTM F 1264-03(Reapproved 2007)) and material specifications (ASTM F136 Standard for Titanium Alloy). The device's performance is compared against these engineering standards and to the predicate device's performance under these same standards.

8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/ML model.

9. How the ground truth for the training set was established
Not applicable. There is no "training set." The performance of the predicate device serves as a benchmark for comparison, and both devices are evaluated against established engineering standards.

Ask a specific question about this device

Metallic Locking Compression Bone Plates and Screws System can be used for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur and tibia.

Metallic Locking Compression Bone Plates and Screws System contains (1) locking compression plates (LCPs) with various specifications, (2) two kinds of screws with various specifications and (3) various specific instruments. Locking Compression Plates that made of Titanium. They have combi-holes. the threaded hole sections on the plates for locking screws provides ability to create fixed-angle constructs; the un-threaded hole sections for cortex screws allows utilization of familiar AO plating techniques. The limited-contact design of LCPs reduces plate-to-bone contact, thus limiting vascular trauma.The screws are available in locking screws and cortex screws. There are various instruments specific to the proposed device intend for completing the surgery.

Here's a breakdown of the acceptance criteria and study information for the Metallic Locking Compression Bone Plates and Screws System, 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 provided document describes non-clinical tests performed to demonstrate that the device met design specifications and was substantially equivalent to predicate devices. It does not mention a traditional "test set" in the context of clinical data or a sample size of patients. Instead, the tests were conducted on the device components themselves.

• Sample Size for Test Set: Not applicable in the context of clinical data. The tests were performed on the device components.
• Data Provenance: The tests were conducted by the manufacturer, Tianjin Walkman Biomaterial Co., Ltd, located in Tianjin, P.R. China. The data would be considered "non-clinical" and laboratory-based, not patient-derived.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as there was no clinical test set requiring expert ground truth establishment. The performance was assessed against established engineering standards (ASTM F382 and F543).

4. Adjudication Method for the Test Set

This information is not applicable as there was no clinical test set requiring adjudication. The device performance was compared directly to the specifications outlined in the ASTM standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical study is included in this submission."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This question is not applicable as the device is a physical medical implant (bone plates and screws), not a software algorithm or AI-based diagnostic tool. Therefore, "standalone" performance in the context of an algorithm or AI is not relevant. The performance tests done were solely on the physical device components.

7. The Type of Ground Truth Used

The ground truth used for evaluating the device's performance was the specifications and requirements outlined in the relevant ASTM standards:

• ASTM F382-99 (Reapproved 2008) for metallic bone plates.
• ASTM F543-07 for metallic medical bone screws.

These standards define the acceptable mechanical properties and performance characteristics for such devices.

8. The Sample Size for the Training Set

This information is not applicable. As this is a submission for a physical medical device (bone plates and screws) and not a software/AI algorithm, there is no "training set" in the computational sense. The device's design and manufacturing are based on established engineering principles and materials science, not on machine learning from a dataset.

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

This information is not applicable for the same reason as point 8. There is no concept of a "training set" or "ground truth for a training set" for this type of device submission.

Ask a specific question about this device