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The GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System is a pedicle screw fixation system intended for immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: · Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) - · Spondylolisthesis - · Trauma (e.g., fracture or dislocation) - · Deformity or curvature (e.g., scoliosis, kyphosis, and/or lordosis) - Tumor - · Spinal stenosis - · Pseudarthrosis - · Failed previous fusion Paediatric Use: When used for posterior non-cervical screw fixation in paediatric patients, the GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System is indicated as an adjunct to treat adolescent idiopathic scoliosis. Additionally, it is intended to treat paediatric patients diagnosed with the following conditions: - · Spondylolisthesis - · Spondylolysis - Fracture caused by tumor and/or trauma. Paediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.

The posterior non-cervical pedicle screw spinal system consists of a body, bushing, and ball head screw. Inner Screw, rods complete the spinal construct. The body portion of the screw rotates about the ball head on the screw, which provides increased motion over a fixed post of the polyaxial screw. An increase in motion facilitates the capture of rods that are not perfectly aligned. The Screws, Rods are fabricated from Titanium alloy. These implants are supplied non-sterile; the products have to be sterilized prior to use.

This document is a 510(k) Pre-market Notification for a medical device called the "GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System." It is a submission to the FDA seeking clearance to market this device, demonstrating its substantial equivalence to already legally marketed predicate devices.

The document does not describe or conduct a clinical study with acceptance criteria related to a device's performance in diagnosing or treating patients using metrics like sensitivity, specificity, or accuracy.

Instead, this submission focuses on demonstrating substantial equivalence to existing predicate devices based on:

• Indications for Use: The intended medical conditions the device will treat.
• Material: The materials used in its construction.
• Mechanical Performance: How the device functions under various physical stresses.
• Dimensions: The physical size and shape of the device components.

The "acceptance criteria" discussed in this document refer to the performance standards that the device must meet to demonstrate its mechanical integrity and safety, not its clinical effectiveness in human subjects.

Here's a breakdown of the requested information based on the provided document:

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

The document does not provide a table with specific quantitative acceptance criteria values (e.g., specific load limits, displacement thresholds) and reported device performance values for a clinical study. Instead, it refers to compliance with established ASTM standards for mechanical testing. For the purpose of this type of submission, compliance with these standards serves as the "acceptance criteria" for mechanical performance.

Note: "Demonstrated performance" in this context means the device met the requirements of these standards. The document does not provide the specific numerical results of these tests, only that the device "has been demonstrated using the following performance testing" and "complied to following material standard."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as the submission relies on non-clinical mechanical testing of the device components, not on a clinical test set from human subjects. The "samples" would be the manufactured implant components themselves, and the testing is performed in a laboratory setting. There is no mention of data provenance in terms of country of origin or retrospective/prospective data collection for clinical outcomes.

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

This information is not applicable. Ground truth, in the context of clinical studies (e.g., for diagnostic accuracy), would typically be established by clinical experts. Since this submission focuses on mechanical and material equivalence, such experts are not involved in defining "ground truth" for the device's physical properties. The "ground truth" for mechanical properties is established by the ASTM standards themselves.

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

This information is not applicable. Adjudication methods are used in clinical studies, particularly for diagnostic imaging, to resolve discrepancies among expert readers. As this is a mechanical testing submission, no such adjudication method is used.

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

An MRMC comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic devices involving human interpretation of results, which is not the subject of this 510(k) submission. Therefore, there is no effect size reported.

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

This information is not applicable. This is a physical medical implant (pedicle screw system), not an algorithm or a software device, so the concept of standalone algorithm performance does not apply.

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

The "ground truth" for this device's mechanical and material properties is established by compliance with the internationally recognized ASTM material and performance standards (ASTM F136, ASTM F1717, ASTM F1798). These standards define the acceptable physical and mechanical characteristics for such spinal implants.

8. The sample size for the training set

This information is not applicable. This is a physical medical implant, not a machine learning or AI device that requires a training set.

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

This information is not applicable for the same reason as point 8.

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GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS Brand of DHS/ Dynamic Condylar Plates Plating System are provided non-sterile.

GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System are indicated for treating fractures of various bones including the clavicle, pelvis, scapula, long bone ( humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, phalanges).

GREENS Brand of DHS/ Dynamic Condylar Plating System is used to provide fixation of fractures to the proximal femur shaft and generally indicated for use in trochanteric, intertrochanteric fractures.

The system is indicated for use in adult patients only. All implants are for single use only.

GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS Brand of DHS/ Dynamic Condylar Plates Plating System consists of various shape and sizes of plates featuring compression and locking holes, full-threaded-cortical, locking self-tapping screws, compression and dynamic screws.

The plates and screws are fabricated from Stainless Steel And Titanium.

The system contains several models based on the size of the device and application site such as fixation/reconstruction of small fragment bones, forefoot, mid-foot, rear-foot, ankle, or other bones appropriate for the size of the device. The plate implants are in many models available: like, Reconstruction Plates, T- Plates, , Anatomical Plates, Clavicle Hook Plates.

These all are mainly divided into

• Large Fragment Plates
• Small Fragment Plates ●
• Mini Fragment Plates
• Hip Plates (DHS and Dynamic Condylar Plate)

The thickness of the plates varies from 1.0mm to 6mm; and the number of the holes varies from 2 to 22.

The Locking screw implants are in corresponding diameter ranges from 2.4mm, 2.7mm, 3.5mm, 5.0mm diameters with lengths varying as per the requirements and minimum length: 6 mm to maximum length 90mm

The Non-locking screw implants are in 3.5mm and 4.5mm diameter and length range from 10mm to 140mm.

These implants are supplied non-sterile, the products have to be sterilized prior to use.

The provided document is a 510(k) premarket notification for a medical device: "GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS Brand of DHS/Dynamic Condylar Plates Plating System." This document aims to demonstrate substantial equivalence to legally marketed predicate devices, not to prove the device's efficacy through clinical trials. Therefore, much of the requested information (like sample size for test sets, data provenance, number of experts for ground truth, MRMC studies, training set details) is not applicable or present in this type of submission.

The acceptance criteria provided are related to the mechanical and material properties of the bone plates and screws, demonstrating that the device conforms to established industry standards for such implants.

Here's a breakdown of the available information:

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

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 does not specify the exact sample sizes for the non-clinical tests (e.g., how many plates or screws were tested for each standard). The data provenance is implied to be from the manufacturer's internal testing as part of their 510(k) submission, confirming compliance with material and performance standards. It doesn't involve patient data (prospective or retrospective) or country of origin in the context of clinical studies.

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)

This is not applicable as this is a submission for a hardware medical device based on mechanical and material testing, not an AI or diagnostic device that requires expert-established ground truth from clinical data.

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

Not applicable for a non-clinical, mechanical/material testing submission.

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. No MRMC study was performed as this is a hardware device for bone fixation, not a diagnostic or AI-assisted system.

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

Not applicable. This is a hardware medical device, not an algorithm.

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

The "ground truth" in this context refers to the established requirements and specifications within the referenced ASTM (American Society for Testing and Materials) standards. The device's materials and performance metrics are compared against these predetermined, scientifically validated engineering and material specifications.

8. The sample size for the training set

Not applicable. There is no "training set" of data as this is a hardware device for bone fixation, not a machine learning model.

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

Not applicable, as there is no training set. The "ground truth" for the device's conformance is established by adherence to recognized ASTM standards, which are developed and validated through extensive engineering principles and consensus.

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