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JAZZ is a temporary implant to be used in orthopedic surgery. The JAZZ System 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;
2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as adolescent idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis;
3. Spinal degenerative surgery, as an adjunct to spinal fusions.

The JAZZ System 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 Systems consists of the following components: JAZZ Connector, JAZZ Claw Connector, JAZZ Claw hooks, JAZZ Lock Connector, various rods, and JAZZ Braid (a.k.a. Band) with buckle. The JAZZ Band is inserted into various JAZZ connectors and is used to attach them to the spine.

The provided document is a 510(k) summary for a medical device (JAZZ System, including JAZZ Band) and does not contain the level of detail required to answer all parts of your request regarding acceptance criteria and a detailed study proving device performance in the context of an Artificial Intelligence (AI) or machine learning device. This document describes a traditional medical device (a temporary implant for orthopedic surgery) and its regulatory clearance process, not an AI/ML powered medical device.

Therefore, for aspects related to AI/ML device evaluation (like sample sizes for test sets, data provenance, expert ground truth establishment, MRMC studies, standalone performance of an algorithm, and training set details), the information is not applicable as the JAZZ System is a physical implant, not a software-based diagnostic or predictive tool.

However, I can extract the relevant information regarding the performance data provided for this specific device:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
Not applicable. This is a physical implant, and the performance assessment described is based on testing the physical properties of the device, not a classification or prediction task on a "test set" of data in the AI/ML sense. Data for biocompatibility and mechanical testing would involve a certain number of test samples of the device and testing materials, but these are not disclosed in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically understood for AI/ML devices is not relevant here. Biocompatibility and mechanical performance are assessed through laboratory testing against established standards and engineering principles.

4. Adjudication method for the test set
Not applicable.

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 not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.

7. The type of ground truth used
For biocompatibility, the ground truth would be adherence to the ISO 10993 standard. For mechanical performance, the ground truth would be demonstrating equivalent or superior strength and integrity compared to the previously cleared predicate device, based on established engineering specifications and static tensile testing protocols.

8. The sample size for the training set
Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.

Additional Information from the Document:

• Device Name: JAZZ System, including JAZZ Band
• Purpose of 510(k): To modify the JAZZ Band component. Minor changes were made to the ultrasonic welding of the braid and the design of the metal buckle.
• Predicate Devices: Implanet's JAZZ System (K151740), Implanet's JAZZ Systems (K162764), Implanet's JAZZ Lock (K153348).
• Conclusion: The modified JAZZ Band is as safe and effective as the predicate JAZZ Braid. The JAZZ Band has the same intended uses and indications, and similar technological characteristics and principles of operation as its predicate device. Performance data (biocompatibility and mechanical performance) demonstrate that the modified JAZZ Band is substantially equivalent.

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JAZZ is a temporary implant to be used in orthopedic surgery. The JAZZ System 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:

• Spinal trauma surgery, used in sublaminar or facet wiring techniques: 1.
• 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;
• Spinal degenerative surgery, as an adjunct to spinal fusions.
  The JAZZ System may also be used in conjunction with other medical implants made of titanium alloy or cobaltchromium-molybdenum alloy whenever "wiring" may help secure the attachment of other implants.

The Implanet JAZZ System is part of a spinal posterior fixation system that is designed to provide a stable interface between spinal constructs and the rod used in spinal surgery. The device is secured around vertebral structures such as the lamina, facet, or transverse processes from T1 to L5.
The JAZZ System consists of the following components and accessories: polyester (polyethylene-terephthalate) braid; titanium alloy connector and screw; and stainless steel malleable strip and buckle.

The provided document is a 510(k) premarket notification for the JAZZ System, a bone fixation cerclage device. It primarily focuses on demonstrating substantial equivalence to predicate devices for a modification in indications for use. Crucially, the document explicitly states: "No new performance data was needed to support the change in indications."

Therefore, the comprehensive study information you requested (acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) is not available within this specific FDA submission. This submission relies on the previously established performance of the JAZZ System and its predicate devices.

Here's what can be extracted and inferred from the document regarding "acceptance criteria" in the context of this 510(k):

1. Table of Acceptance Criteria and Reported Device Performance:

Since no new performance data was generated for this specific 510(k), there isn't a table of new acceptance criteria and device performance results. The core acceptance criterion for this submission was demonstrating substantial equivalence to predicate devices by ensuring the modified indications did not alter the fundamental safety and effectiveness already established.

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

• Sample Size: Not applicable/Not provided as no new performance data was generated for this 510(k).
• Data Provenance: Not applicable/Not provided.

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

• Not applicable/Not provided as no new performance data was generated for this 510(k).

4. Adjudication method for the test set:

• Not applicable/Not provided as no new performance data was generated for this 510(k).

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 bone fixation cerclage device, not an AI-driven diagnostic or interpretative tool.

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

• Not applicable. This is a physical implant device, not an algorithm.

7. The type of ground truth used:

• Not applicable/Not provided as no new performance data was generated for this 510(k). For a physical device, ground truth would typically refer to established biomechanical testing standards, clinical outcomes, or material property verification.

8. The sample size for the training set:

• Not applicable/Not provided as no new performance data was generated for this 510(k).

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

• Not applicable/Not provided.

In summary, this 510(k) submission for the JAZZ System focuses on regulatory demonstration of substantial equivalence based on previous testing and predicate device comparisons, not on presenting new performance study data.

Ask a specific question about this device

JAZZ is a temporary implant to be used in orthopedic surgery. The JAZZ system 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;
• 2 Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as adolescent idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis;
• 3 Spinal degenerative surgery, as an adjunct to spinal fusions.

The JAZZ System may also be used in conjunction with other medical implants made of titanium alloy whenever "wiring" may help secure the attachment of other implants.

The JAZZ System is intended to be used with the Implanet Spine System.

The Implanet JAZZ System is part of a spinal posterior fixation system that is designed to provide a stable interface between spinal constructs and the rod used in spinal surgery. The device is secured around vertebral structures such as the lamina, facet, or transverse processes from T1 to L5. The modified JAZZ System is designed to function in the same manner as the cleared predicate device. The JAZZ System is intended to be used with the Implanet Spine System (K143731).

This document describes the Implanet S.A.'s JAZZ System, a temporary implant for orthopedic surgery, and its 510(k) premarket notification. The submission is for a modification to an already cleared device, primarily involving an expansion of connector sizes and minor instrument modifications.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

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 a "test set" in the context of clinical data or patient samples. The performance data section refers to mechanical testing, sterilization and shelf life validation, and biocompatibility testing. For these types of tests, individual components or prototypes are typically tested, not patient samples.

• Sample Size: Not explicitly stated for each test, but typically refers to a number of manufactured components/assemblies required by the test standard.
• Data Provenance: Not applicable in the context of patient data for this submission. The tests are laboratory-based and conducted by the manufacturer, Implanet S.A.

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

Not applicable. The reported performance data (mechanical, biocompatibility, sterilization, shelf life) refers to engineering and laboratory tests, not clinical studies involving human patients or interpretations by medical experts. Ground truth in this context is established by meeting predefined engineering specifications and international standards.

4. Adjudication Method for the Test Set:

Not applicable, as the performance data refers to objective engineering and lab tests, not subjective assessments requiring adjudication.

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

No, an MRMC comparative effectiveness study was not reported. This submission focuses on the substantial equivalence of a modified medical device to a predicate device, based on mechanical, biocompatibility, and sterilization testing, rather than a clinical effectiveness study involving human readers and AI assistance.

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

Not applicable. The JAZZ System is a physical medical implant (bone fixation cerclage), not an AI algorithm or a software device. Therefore, standalone algorithm performance is not relevant.

7. Type of Ground Truth Used:

The "ground truth" for the reported performance data is based on:

• Engineering Specifications: The device's design specifications for mechanical strength and function.
• International Standards: Compliance with recognized international standards such as ASTM F1717 (for spinal constructs) and ISO-10993 (for biocompatibility).
• Industry Standards: Compliance with recognized industry standards for sterilization and shelf life validation.

8. Sample Size for the Training Set:

Not applicable. The JAZZ System is a physical medical implant, not a machine learning model or algorithm that requires a "training set."

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

Not applicable, as there is no "training set" for this device.

Ask a specific question about this device

JAZZ is a temporary implant to be used in orthopedic surgery. The JAZZ System 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:

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

The JAZZ System may also be used in conjunction with other medical implants made of titanium alloy whenever "wiring" may help secure the attachment of other implants. The JAZZ System is intended to be used with the Implanet Spine System.

The Implanet JAZZ System is part of a spinal posterior fixation system that is designed to provide a stable interface between spinal constructs and the rod used in spinal surgery. The device is secured around vertebral structures such as the lamina, facet, or transverse processes from T1 to L5. The modified Jazz System is designed to function in the same manner as the cleared predicate device.

Here's a breakdown of the acceptance criteria and the study details for the JAZZ 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

• Sample Size: Not explicitly stated, but the document mentions "Four custom tests were performed to assess the minor manufacturing modification to the polyester braid distal tip." This implies a limited number of test units were used for each of the four tests.
• Data Provenance: Not specified, but the testing was conducted for Implanet S.A., a French company. The document does not indicate if the testing was retrospective or prospective. Given it was for a modification, it was likely conducted specifically for this submission.

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

• This information is not applicable as the study described is a bench test, not one involving human interpretation or clinical data. Therefore, there's no "ground truth" in the sense of expert consensus on medical findings.

4. Adjudication Method for the Test Set

• None applicable. This was a bench test on a device component, not a study requiring adjudication of expert opinions.

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

• No. An MRMC comparative effectiveness study was not done. The submission focuses on bench testing a minor design modification to an existing device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not applicable. This device is a physical medical implant, not an AI/software algorithm.

7. The Type of Ground Truth Used

• For the bench testing, the "ground truth" was essentially the pre-defined engineering specifications and functional requirements for the polyester braid distal tip. The tests confirmed that the manufacturing process change met these required performance criteria.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical medical implant, not an AI/software algorithm that requires a training set.

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

• Not applicable. No training set was used.

Ask a specific question about this device

JAZZ is a temporary implant to be used in orthopedic surgery. The JAZZ system 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;
2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as adolescent idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis;
3. Spinal degenerative surgery, as an adjunct to spinal fusions.

The JAZZ System may also be used in conjunction with other medical implants made of titanium allov whenever "wiring" may help secure the attachment of other implants.

The JAZZ System is intended to be used with the Implanet Spine System.

The Implanet JAZZ System is part of a spinal posterior fixation system that is designed to provide a stable interface between spinal constructs and the rod used in spinal surgery. The device is secured around vertebral structures such as the lamina, facet, or transverse processes from T1 to L5.

The JAZZ System consists of the following components and accessories: polyester (polyethylene-terephthalate) braid; titanium alloy connector and stainless steel malleable strip and buckle.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Implanet S.A.'s JAZZ System, structured according to your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes the JAZZ System as a bone fixation cerclage used in spinal surgery. The performance data focuses on mechanical and biocompatibility testing. The acceptance criteria generally state that the product met "necessary specifications" and "functioned as intended." Specific quantitative acceptance criteria are not detailed in the document, nor are specific quantitative performance results for each test.

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

The document does not specify the sample sizes used for the individual bench tests. It also does not explicitly state the provenance of the data (e.g., country of origin) or whether the tests were retrospective or prospective, although bench testing would inherently be prospective in nature.

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

This information is not applicable to the provided document. The "ground truth" in this context refers to the results of engineering and biocompatibility tests, not clinical evaluations by human experts.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving human interpretation or assessment, not for direct engineering bench testing.

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

No MRMC comparative effectiveness study was mentioned. The document focuses on the mechanical and biocompatibility performance of the device itself, rather than its impact on human reader performance.

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

This concept is not applicable to an orthopedic implant like the JAZZ System. The device is a physical implant, not an algorithm. Therefore, "standalone performance" refers to its mechanical and biological characteristics, which were assessed through the described bench testing.

7. Type of Ground Truth Used

The ground truth used for performance evaluation was based on engineering specifications and established test methodologies for mechanical performance (e.g., tensile strength, compression resistance, viscoelastic characteristics, dynamic loading) and recognized industry standards (ISO-10993) for biocompatibility.

8. Sample Size for the Training Set

This information is not applicable. The JAZZ System is a physical implant, not an AI or machine learning model that requires a training set.

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

This information is not applicable, as there is no training set mentioned for this medical device.

Ask a specific question about this device

The Jazz System is a temporary implant for use in orthopedic surgery. The system 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, interspinous, or facet wiring techniques;
• Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of 2. spinal deformities such as scoliosis, kyphosis, spondylolisthesis;
• 3. Spinal degenerative surgery, as an adjunct to spinal fusions.

The Jazz System may also be used in conjunction with other medical implants made of titanium alloy whenever "wiring" may help secure the attachment of other implants.

The JAZZ system is intended to be used with the CALYPSO pedicle screw system.

The device consists of the following components and accessories: polyester (polyethyleneterephthalate) braid; titanium alloy connector and screw; and stainless steel malleable strip and buckle.

The K121541 filing for Implanet S.A.'s Jazz System focuses on demonstrating substantial equivalence to a predicate device through bench testing and biocompatibility assessments, rather than clinical studies or reader performance evaluations. Therefore, many of the requested categories related to clinical study design, expert ground truth, and reader performance cannot be populated from the provided text.

Here's a breakdown of the information that can be extracted:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Jazz System were based on meeting the "necessary specifications" through bench testing. The specific quantitative acceptance criteria are not detailed in the provided document, but the general requirement was to confirm "adequate mechanical strength for its intended use."

Study Information

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified in the provided document. The testing described is bench testing, not human or image data.
   • Data Provenance: The document does not specify country of origin for any data beyond the manufacturer being located in Martillac, France. The studies are described as "bench testing," meaning they were conducted in a laboratory setting. This is a form of prospective testing of the device hardware.

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

   • Not applicable. This was a bench testing study, not one requiring expert human interpretation or ground truth establishment in a clinical context.

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

   • Not applicable. This was a bench testing study, not one requiring adjudication of human interpretations.

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:

   • No MRMC study was done. This filing is for a surgical implant (bone fixation cerclage) and relies on mechanical and biocompatibility testing, not AI or reader performance studies.

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

   • Not applicable. This device is a physical surgical implant, not an algorithm.

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

   • The "ground truth" for the bench testing was established through engineering specifications and industry standards for mechanical strength and biocompatibility (e.g., ISO-10993). There is no "expert consensus" in the clinical sense, pathology, or outcomes data mentioned for the performance testing.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that would require a training set.

8. How the ground truth for the training set was established:

   • Not applicable. This is not an AI/machine learning device.

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