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The Jazz Claw System (hooks and rods) and the Jazz Frame System are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The Jazz Claw System (hooks and rods) and the Jazz Frame System are 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 (i.e., fracture or dislocation), spinal stenosis, spinal deformities (i.e., scoliosis and/or lordosis), tumor, pseudarthrosis or revision of a failed fusion attempt.

The Jazz Claw System (hooks and rods) and the Jazz Frame System are indicated as an adjunct to fusion to treat adolescent idiopathic scolosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The JAZZ Frame spinal implants are spinal fixation devices consisting of the following components: T-bars, straight rods, connectors, and surgical instruments. The T-bars are fixed closed transverse connectors. The rods have been previously cleared as part of the ISS system and are used with the JAZZ Frame. The JAZZ Connector and JAZZ Braid have been previously cleared and are also used with the JAZZ Frame. There is no change to the previously cleared JAZZ instruments.

Once the fusion rods have been bent to the desired shape, a T-bar is positioned at the top and middle of the two bars, and then tightened in place using the screwdriver. The caudal parts of the rods are inserted into heads of pedicle screws that have been previously implanted. The cranial end of the construct is then secured with JAZZ Connectors, and the screws of the T-bars undergo final tightening.

The provided text describes the 510(k) premarket notification for the JAZZ Frame System, a spinal fixation device. However, it does not include detailed acceptance criteria or a study proving the device meets specific performance metrics in a clinical or analytical setting against such criteria.

The "Performance Data" section briefly mentions:

• Static axial, rotational, and bending testing per ASTM F1798.
• Bacterial endotoxin testing (BET) as specified in ANSI/AAMI:ST72:2011 to achieve an Endotoxin limit of <20EU/Device.

It also states: "Interconnection strength testing has shown the T-bars to possess at least equivalent gripping strength to the crosslink components of the JAZZ Frame has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices." This implies a comparative test was done but doesn't provide the detailed results or specific acceptance criteria met.

Therefore, most of the requested information cannot be extracted from this document as it focuses on regulatory clearance based on substantial equivalence to predicate devices, rather than a detailed performance study with defined acceptance criteria.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Acceptance Criteria Mentioned:
  • Static axial, rotational, and bending testing per ASTM F1798.
  • Bacterial endotoxin testing to achieve an Endotoxin limit of <20EU/Device per ANSI/AAMI:ST72:2011.
  • Interconnection strength: T-bars possess at least equivalent gripping strength to predicate device crosslink components.
• Reported Device Performance: The document generally states that "Performance data demonstrate that the JAZZ Frame is substantially equivalent to its predicates" and that the T-bars showed "at least equivalent gripping strength." Specific numerical results from the ASTM F1798 tests or the exact gripping strength values are not provided.

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

• Not provided. The document mentions mechanical and endotoxin testing, but no details on the number of samples tested or where the testing was conducted. This is not a clinical study, so provenance of patient data is not applicable.

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

• Not applicable. This device is a mechanical implant; ground truth for its performance would be established through engineering specifications and mechanical testing, not expert clinical consensus.

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

• Not applicable. This applies to clinical studies, not mechanical device 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 mechanical implant, not an AI diagnostic device where MRMC studies would be relevant.

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

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

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

• The "ground truth" for this device would be established by engineering design specifications and recognized international or national mechanical testing standards (e.g., ASTM F1798) to ensure biocompatibility and mechanical integrity.

8. The sample size for the training set

• Not applicable. This is a mechanical implant, not an AI algorithm requiring a training set.

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

• Not applicable. See point 8.

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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 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.

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The IMPLANET Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The IMPLANET Spine System is intended for posterior, non-cervical pedicle and non-pedicle 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 (i.e., fracture or dislocation), spinal deformities (i.e., scoliosis, kyphosis and/or lordlosis), tumor, pseudarthrosis, or revision of a failed fusion attempt. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the IMPLANET Spine System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The IMPLANET Spine System is a posterior instrumentation system. The polvaxial screws are made of Ti6Al4V titanium alloy compliant with ISO 5832-3. The polyaxial screw is comprised of three sections: the pedicle screw; the head; and a ring that connects the screw to the head. The polyaxial screws are offered in diameters ranging from 5.0 to 7.5 mm and in lengths ranging from 35 to 60 mm.

The monoaxial pedicle screws are made of Ti6Al4V titanium alloy compliant with ISO 5832-3 and are available in 5.0 mm. 7.0 mm. and 8.0 mm diameters. The screws range in length from 35 to 60 mm.

The system includes both straight and pre-bent rods made of Ti6AI4V titanium alloy.

The transverse connectors are composed of Ti6AI4V titanium alloy compliant with ISO 5832-3. These connectors are used to build a transverse connection between two union rods.

The hooks are made of Ti6Al4V titanium alloy and are provided in multiple configurations.

The purpose of this 510(k) is to extend the ISS line to include:

• New monoaxial and polyaxial screws .
• Cobalt Chromium rods
• New Ti6Al4V titanium alloy rods ●
• Offset connector and associated offset connector screws
• Rod to rod connectors
• . New instruments

The IMPLANET Spine System has principles of operation substantially similar to other pedicle screw-based systems for the indications listed.

The IMPLANET Spine System components may be used for posterior pedicle screw fixation in pediatric cases: polyaxial and monoaxial screws, rods, transverse connectors and rods. The purpose of the subject 510(k) notice is for a line extension to incorporate additional device dimensions and Cobalt Chromium rods, as well as compatible additional instruments, to the company's cleared system.

The provided document is a 510(k) summary for the IMPLANET Spine System, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device for regulatory purposes, rather than presenting a clinical study or performance study with defined acceptance criteria for an AI/algorithm-driven device.

Therefore, the information requested in your prompt (e.g., acceptance criteria, test set sample size, ground truth establishment, MRMC study, training set size) is not applicable to this type of regulatory submission and is not present in the provided text.

The document describes a mechanical performance study and biocompatibility testing for the physical spinal implant system. It confirms that:

• Acceptance Criteria for Performance Data: The goal was to confirm that modifications "do not adversely impact mechanical strength compared to the predicate" and that the device is "biocompatible." Specific numerical acceptance criteria are not provided in this summary, but the general criteria are comparative to the predicate.
• Reported Device Performance:
  • Static axial gripping capacity, static flexion/extension bending, static axial torque gripping capacity (ASTM F1798)
  • Static compression bending (ASTM F1717)
  • Static torsion (ASTM F1717)
  • Dynamic compression bending (ASTM F1717)
  • Cytotoxicity (ISO 10993-5)
  • Acute systemic toxicity (ISO 10993-11)
  • Results: "All results confirmed that the modifications to the device described in this submission do not adversely impact mechanical strength compared to the predicate. In addition, the device is biocompatible."

The other requested information (sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, type of ground truth for AI) is specific to the evaluation of AI/algorithmic devices and is not relevant to this 510(k) submission for a physical implant system.

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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;
• 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.

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The IMPLANET Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The IMPLANET Spine System is intended for posterior, non-cervical pedicle and non-pedicle 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 (i.e., fracture or dislocation), spinal stenosis, spinal deformities (i.e., scoliosis, kyphosis and/or lordosis), turnor, pseudarthrosis, or revision of a failed fusion attempt.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the IMPLANET Spine System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The IMPLANET Spine System is a posterior instrumentation system. The polyaxial screws are made of Ti6Al4V titanium alloy compliant with ISO 5832-3. The polyaxial screw is comprised of three sections: the pedicle screw; the head; and a ring that connects the screw to the head. The polyaxial screws are offered in diameters ranging from 5.0 to 7.5 mm and in lengths ranging from 35 to 60 mm.

The monoaxial pedicle screws are made of Ti6A!4V titanium alloy compliant with ISO 583203 and are available in 5.0 mm, 6.0 mm, 7.0 mm, and 8.0 mm diameters. The screws range in length from 35 to 60 mm.

The system includes both straight and pre-bent rods made of Ti6Al4V titanium alloy.

The transverse connectors are composed of Ti6Al4V titanium alloy compliant with ISO 5832-3. These connectors are used to build a transverse connection between two union rods.

The hooks are made of Ti6AI4V titanium alloy and are provided in multiple configurations.

The IMPLANET Spine System has principles of operation substantially similar to other pedicle screw-based systems for the indications listed.

The IMPLANET Spine System components may be used for posterior pedicle screw fixation in pediatric cases: polyaxial and monoaxial screws, rods, transverse connectors and rods.

The purpose of the subject 510(k) notice is the addition of new indications and the inclusion of intermediate screw sizes to the company's cleared system.

The provided text describes the Implanet S.A.'s IMPLANET Spine System, a spinal fixation device. However, it does not contain information related to software or AI/ML performance, acceptance criteria, or studies for such, as the device is a physical implant. The document is a 510(k) summary for a medical device (spinal fixation system) that primarily focuses on mechanical and material properties, biocompatibility, and manufacturing standards.

Therefore, I cannot provide the requested information about acceptance criteria and studies for a digital health device. The document describes:

1. Device Description: Physical components like polyaxial and monoaxial pedicle screws, rods, transverse connectors, and hooks, all made of Ti6Al4V titanium alloy.
2. Technological Characteristics: Substantially similar to other pedicle screw-based systems.
3. Performance Data: This section only refers to bench testing (static and dynamic mechanical tests), sterility validation, shelf life validation, and biocompatibility testing. It specifically states that these tests were performed on the previous version of the device (Calypso System) and some biocompatibility tests were reperformed on the current version.
4. Substantial Equivalence: Concludes that the device is substantially equivalent to predicate devices based on intended use, indications, technological characteristics, and principles of operation, with minor differences raising no new safety or effectiveness issues.

Conclusion:

The provided text does not contain any information about:

• Acceptance criteria related to AI/ML performance.
• Reported device performance for AI/ML.
• Sample size for test sets in an AI/ML context.
• Data provenance for AI/ML training/testing.
• Number or qualifications of experts for AI/ML ground truth.
• Adjudication methods for AI/ML ground truth.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies with AI assistance.
• Standalone algorithm-only performance studies.
• Type of ground truth used (expert consensus, pathology, outcomes data) in an AI/ML context.
• Sample size or establishment of ground truth for a training set in an AI/ML context.

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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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