Search Results

The Jazz Claw System (hooks and rods) is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracic. Jumbar and/or sacral spine. The Jazz Claw System (hooks and rods) is intended for posterior fixation 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 (fracture or dislocation);
• spinal stenosis; ●
• spinal deformities (scoliosis, kyphosis and/or lordlosis) ●
• tumor:
• . pseudarthrosis; and
• revision of a failed fusion attempt. ●

The Jazz Claw System (hooks and rods) is indicated as an adjunct to freat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft.

The JAZZ CLAW connector consists of temporary implants to be used in orthopedic surgery. The JAZZ CLAW connector is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures.

The indications for use include the following applications:

• 1. Spinal trauma surgery, used in sublaminar or facet wiring techniques:
• Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities 2 such as adolescent idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis;
• 3. Spinal degenerative surgery, as an adjunct to spinal fusions.

The JAZZ CLAW connector may also be used in conjunction with other medical implants made of titanium alloy or Cobalt-chromium-molybdenum alloy whenever "wiring" may help secure the attachment of other implants.

The JAZZ CLAW System consists of the JAZZ CLAW hook and JAZZ CLAW rod.

The JAZZ CLAW connector and the cleared JAZZ braid are also separate components, as well as manual surgical instruments.

This looks like a 510(k) premarket notification for a medical device called the JAZZ CLAW System, which includes hooks, rods, and a connector. However, this document does not describe the acceptance criteria or a study proving the device meets specific performance criteria.

Instead, this document is a regulatory submission to the FDA for a substantial equivalence determination. This means the manufacturer is asserting that their new device is as safe and effective as a legally marketed predicate device, and therefore does not require a full Premarket Approval (PMA) application.

Here's why the requested information about acceptance criteria and study data is largely absent:

• Substantial Equivalence (510(k)) vs. Clinical Trials/Performance Studies: A 510(k) often relies on bench testing, comparison to predicates, and engineering rationale rather than extensive, de novo clinical trials or detailed performance studies with human subjects. The goal is to show similarity, not necessarily to independently prove a specific performance metric against a defined acceptance criterion through rigorous clinical data.
• Focus on Safety and Effectiveness: The FDA's letter states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration." This emphasizes regulatory compliance and similarity to existing devices, not a detailed breakdown of a device's specific acceptance criteria from a performance study.

Based on the provided text, I can extract the following, but many of your requested points are not present:

1. Table of acceptance criteria and the reported device performance

No explicit acceptance criteria or a table of specific performance metrics are provided in this document. The document states:

• "The strength of the overall construct (JAZZ CLAW connector used with hooks and rods) was assessed per ASTM F1717 dynamic axial compression testing and found to be equivalent to the predicate JAZZ system (K151740) and Implanet Spinal System (K143731)."
• "In addition, engineering rationales were performed to support device performance of the JAZZ CLAW connector and the JAZZ CLAW System (hooks and rods)."

This indicates that performance was evaluated against a standard (ASTM F1717) and compared for equivalence to predicate devices, rather than meeting predefined acceptance criteria for a new performance claim.

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

• Sample Size: Not specified for the ASTM F1717 testing.
• Data Provenance: Not specified. This would typically be bench testing, not human data.

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 as typically understood in AI/imaging studies is not relevant here. The "ground truth" for this type of device (spinal implant) is its mechanical integrity and biocompatibility, typically assessed through engineering tests and material science, not expert consensus on medical images.

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

Not applicable. This concept is typically used in clinical studies or expert review processes, not mechanical bench 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 spinal implant, not an AI diagnostic device.

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

Not applicable. This is a spinal implant, not an algorithm.

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

Not explicitly stated. For mechanical devices like this, the "ground truth" for performance would be objective measurements obtained through standard mechanical tests (e.g., force, displacement, fatigue cycles) that demonstrate structural integrity and durability. The document mentions "ASTM F1717 dynamic axial compression testing," which is a standardized test for spinal implant constructs.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

Not applicable.

Summary of what is available:

• Device: JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector
• Purpose of Evaluation: To demonstrate substantial equivalence to predicate devices for a 510(k) premarket notification.
• Testing Mentioned: ASTM F1717 dynamic axial compression testing.
• Outcome: Found to be "equivalent" to predicate devices (JAZZ system (K151740) and Implanet Spinal System (K143731)).
• Other Evidence: Engineering rationales to support device performance.
• Conclusion: Minor technological differences between the new device and predicate devices raise no new issues of safety or effectiveness.

Ask a specific question about this device

neon3™ is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine (T1 to T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

neon?™ is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

neon 3™ is a modular, posterior system used for the surgical stabilization and fixation of the cervical and thoracic regions of the spine. The system components include longitudinal members, anchors and interconnection devices.

The acceptance criteria and study proving the device meets the criteria are described below:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample size used for the test set and the data provenance: Not applicable. This study primarily involved mechanical testing of the device components, not human subject data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for mechanical testing is established by industry standards (ASTM F1717) and engineering principles rather than expert consensus.

3. Adjudication method for the test set: Not applicable. This was a mechanical testing study, not a clinical study requiring adjudication of expert opinions.

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 device is a spinal fixation system, not an AI software or imaging device that would involve human readers.

5. 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.

6. The type of ground truth used:

   • Mechanical performance: Established by adherence to ASTM F1717 (standard specification for spinal implant constructs) and engineering design principles.
   • Substantial Equivalence: Demonstrated by comparing the mechanical test results of neon3™ to those of the predicate devices.

7. The sample size for the training set: Not applicable. This refers to a medical device's mechanical performance evaluation, not a machine learning model.

8. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

Indications for the SIGN Hip Construct (SHC) include all peritrochanteric fractures of the hip with proper soft tissue management. This does not include femoral neck fractures and may include subtrochanteric fractures.

The SIGN Hip Construct (SHC) is composed of a Fin Nail Flat (Intramedullary Nail, a Rod Plate, a Rod Connector, an Interlocking Screw, two Compression Screws, a Unicortical Screw and a set of surgical instruments. Each implant component is made from stainless steel, per requirements in ASTM F138.

The provided document is a 510(k) summary for the SIGN Hip Construct (SHC). It describes a medical device, specifically a metallic bone fixation appliance, and its submission for regulatory clearance.

This document describes mechanical testing for the device, not a study involving human subjects or AI. Therefore, most of the requested information (related to AI, human readers, experts, ground truth methodologies, etc.) is not applicable.

Here's an analysis of the available information:

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

The document states: "Mechanical testing was performed on the SHC implant and the results demonstrated sufficient strength for static and dynamic compressive and torsional loading modes and resistance to subsidence and expulsion. The results did not raise any issues on the safety or effectiveness of the device."

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for the mechanical testing. It also does not provide details on "data provenance" as this typically refers to patient data, which is not relevant for this type of mechanical engineering study.

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

Not applicable. This was a mechanical engineering study, not a study requiring expert consensus for ground truth on clinical data.

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

Not applicable. This was a mechanical engineering study, not a study requiring adjudication of expert interpretations.

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. The device is a physical orthopedic implant, not an AI-assisted diagnostic tool.

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

Not applicable. The device is a physical orthopedic implant, not an algorithm.

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

The "ground truth" for this mechanical study would be established engineering standards and specifications for orthopedic implants (e.g., ASTM standards for material strength, fatigue testing protocols). The reported results indicate that the device met these intrinsic engineering performance metrics.

8. The sample size for the training set

Not applicable. This was a mechanical engineering study; there is no "training set" in the context of machine learning.

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

Not applicable.

Ask a specific question about this device