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The SQUALE devices are indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The SQUALE devices are to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and are to be implanted via an open, anterior approach.

The SQUALE devices are intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

The SQUALE device consists of Polyetherketoneketone (PEKK) (compliant with ASTM F2820 standard) cervical cages of various widths and heights, which can be inserted between two cervical or cervico-thoracic vertebral bodies to give support and correction during cervical interbody fusion surgeries. The hollow geometry of the implants allows them to be filled with autogenous and/or allogenic bone graft.

This document is a 510(k) premarket notification from the FDA for a medical device called SQUALE. It determines that the SQUALE device is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the provided text in the context of your request for acceptance criteria and study details:

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

The provided FDA document does not explicitly state numerical acceptance criteria in a table format, nor does it present detailed numerical performance metrics for the SQUALE device against such criteria. Instead, it makes a general statement:

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 mentions "Performance testing was conducted per ASTM F2077 and ASTM F2267." These are standards for mechanical testing of intervertebral body fusion devices. These tests typically involve a specific number of devices to be tested to demonstrate compliance. However, the exact sample size (number of SQUALE devices tested) is not specified in this document.

The data provenance (country of origin, retrospective or prospective) is also not specified. Given it's bench testing, the concept of "country of origin of the data" might refer to where the testing was performed, which is not stated. These are typically prospective tests performed on newly manufactured devices.

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 information is not applicable as the SQUALE device is an implantable medical device, and the "ground truth" for its performance is established through mechanical bench testing against industry standards (ASTM F2077, ASTM F2267) and comparison to predicate devices, rather than through expert interpretation of clinical data. Therefore, there are no "experts" in the context of establishing ground truth for a test set based on human interpretation.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where human readers interpret data, and there's a need to resolve disagreements. For mechanical performance testing of an implantable device, the results are typically quantitative and objective; they either meet the standard or they don't. There's no human interpretation or adjudication process in the sense of a clinical trial.

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

There is no mention of an MRMC comparative effectiveness study, nor is there any indication that SQUALE is an AI-assisted device. The SQUALE is a physical intervertebral body fusion device.

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

This question is not applicable as SQUALE is not an algorithm or an AI-powered device. It is a physical implant.

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

For the SQUALE device, the "ground truth" for its performance is based on established engineering and biomechanical standards (ASTM F2077 and ASTM F2267). Compliance with these standards, along with demonstrating "substantial equivalence" to predicate devices through various mechanical tests, serves as the basis for its safety and effectiveness claims for regulatory purposes. There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for the device's functional performance in this document.

8. The sample size for the training set

This information is not applicable. The SQUALE device is not an AI/ML algorithm that requires a training set. It is a physical medical device.

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

This question is not applicable as there is no training set for a physical device like SQUALE.

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The Madison Knee System is intended for total knee replacement. Madison Knee components are for use in total knee arthroplasty to relieve pain and restore knee functions such as: painful, disabling joint disease of the knee resulting from degenerative arthritis , theumatoid arthritis; and revision of previous unsuccessful knee replacement or other procedure. These components are indicated for cemented fixation only.

The Madison Total Knee System is a modular knee system consisting of a femoral component, tibial insert, tibial baseplate, tibial stem extensions, and a patella. The system components are designed to be Cruciate-Retaining and Ultra-Congruent. The femoral component and tibial baseplate are manufactured from Cobalt Chrome and are to be implanted with cement. The tibial stem extensions are manufactured from titanium alloy, and the tibial insert and patella components are manufactured from UHMWPE. All implant components are provided sterile.

The provided document is a 510(k) summary for the Madison Total Knee System, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria in the context of diagnostic accuracy or performance against a predefined clinical threshold.

Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable to this type of regulatory submission, which primarily relies on non-clinical testing and comparison to an established predicate device.

Here's an attempt to answer based on the provided text, highlighting where information is absent or not relevant to the typical understanding of acceptance criteria for diagnostic devices:

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

The document does not explicitly present "acceptance criteria" in the sense of predefined thresholds for clinical performance (e.g., accuracy, sensitivity, specificity) for a diagnostic AI device. Instead, it describes non-clinical testing performed to demonstrate safety and effectiveness for a knee implant, primarily focused on mechanical properties and material characteristics. The reported "performance" is that the device passed these tests, indicating compliance with the relevant ASTM standards and demonstrating functionality.

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 provided for the non-clinical tests. The tests were performed on "test units representative of finished devices," implying laboratory testing of physical samples rather than data from human subjects. Therefore, provenance like country of origin or retrospective/prospective data collection is not applicable.

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 information is not applicable as the testing described is non-clinical, focusing on mechanical and material properties of an implant, not interpretive diagnostic performance requiring expert adjudication of ground truth.

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

This information is not applicable as it pertains to expert consensus for diagnostic ground truth, which is not relevant to the non-clinical testing of a knee implant.

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 diagnostic AI devices, not for a knee implant. The document explicitly states: "Clinical data were not needed to support the safety and effectiveness of the subject device."

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

This information is not applicable as the device is a knee implant, not an algorithm or AI system.

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

For the non-clinical testing, the "ground truth" would be established by the specified ASTM standards and engineering principles that define acceptable material properties and mechanical performance. There is no biological or diagnostic ground truth (like expert consensus or pathology) involved.

8. The sample size for the training set

This information is not applicable. As a physical implant, there is no "training set" in the context of machine learning.

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

This information is not applicable as there is no training set for a machine learning model.

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The JAZZ systems (including the JAZZ Claw Connector) are temporary implants to be used in orthopedic surgery. The JAZZ systems are 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 Systems 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.

JAZZ PF enables the passing of a JAZZ braid around or through the upper spinous process. The main difference with the JAZZ regular connector is that in the subject device the braid is locked horizontally, that is, along the spine axis, instead of vertically. On each side of the instrumented levels, a JAZZ PF connector is implanted on the union rod below the upper pedicle screw. A JAZZ braid is passed and locked through a 1st connector, above or through the spinous process and back through the second connector on the other side. The slack that can exist in the band is removed using the JAZZ PF Band Reducer (Enrouleur Instrument) without applying any tension in the band and the 2nd connector is locked. By doing so, flexion is controlled which helps in the primary stabilization of the levels where fusion has to be achieved.

The provided text describes a medical device, JAZZ PF, and its substantial equivalence determination by the FDA. However, it does not include detailed information regarding "acceptance criteria" for a study in the context of device performance, nor does it present a study that rigorously proves the device meets specific acceptance criteria in a quantitative sense as might be expected for an AI/CADe device.

Instead, the document focuses on regulatory approval based on substantial equivalence to predicate devices. This means the device is considered safe and effective because its technological characteristics and intended use are similar to those of devices already legally marketed. The performance data mentioned is for mechanical durability testing, not for diagnostic or analytical performance against ground truth.

Therefore, most of the requested information cannot be extracted directly from this document.

Here's what can be provided based on the text:

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

Based on the provided text, the primary "acceptance criterion" for this type of device (spinal implant) in a 510(k) submission is typically demonstrating mechanical durability and safety comparable to predicate devices. The study mentioned is a mechanical test.

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

• Sample Size for Test Set: Not explicitly stated as "test set" in the context of an analytical or diagnostic study. For the dynamic compression testing, the number of devices or constructs tested is not specified, only that "JAZZ PF constructs passed."
• Data Provenance: Not applicable in the context of clinical data for AI/CADe. The performance data is from mechanical testing of the device itself.

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

Not applicable. Ground truth in the context of a diagnostic or analytical AI study (e.g., expert consensus on medical images) is not relevant for this device's mechanical performance testing.

4. Adjudication method for the test set

Not applicable. There's no adjudication process mentioned for a mechanical test.

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. This is a spinal implant, not an AI/CADe device that assists human readers.

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

No. This is a spinal implant, not an algorithm.

7. The type of ground truth used

Not applicable in the context of an AI/CADe device. The "ground truth" for the mechanical test is adherence to engineering specifications for load and cycles.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

Summary of Device and Study from Text:

The JAZZ PF is a temporary spinal implant for stabilization during fusion and fracture repair. Its approval (K191217) was based on demonstrating substantial equivalence to existing predicate devices (NuVasive VersaTie System - K173117 and JAZZ System - K182771). The key performance data provided in the submission was a dynamic compression test where JAZZ PF constructs "passed 5 million cycles at a load of 600N," indicating its mechanical durability. The submission also addressed sterilization, cleaning, and biocompatibility by providing rationales that the device did not constitute a new worst-case compared to predicates. The document does not describe a study involving human readers, AI algorithms, or clinical performance against a diagnostic ground truth.

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The ISS-JAZZ Screw 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 ISS-JAZZ Screw 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 lordosis), tumor, pseudoarthrosis, or revision of a failed fusion attempt.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the ISS-JAZZ Screw 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 JAZZ systems (including the JAZZ Claw Connector) are temporary implants to be used in orthopedic surgery. The JAZZ systems are 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 Systems 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 CAP SP is composed of three components, the Cap SP, the Base SP, and the Insert Lock. The head shape ISS pedicle screws is modified from the current tulip shape to a cylindrical shape to match the Cap SP, resulting in the JAZZ Screw. The ISS-JAZZ Screw System is composed of monoaxial and polyaxial screws and straight and pre bent rods. The JAZZ CAP SP is added to the proximal end of the JAZZ Screw and provides for an alternate method to attach the JAZZ Band and JAZZ Passer Band to skeletal structures as compared to the current method of using a JAZZ Connector (K171881).

This document is a 510(k) summary for a medical device called the ISS-JAZZ Screw System and JAZZ CAP SP. It describes the device, its intended use, comparison to predicate devices, and performance data to demonstrate substantial equivalence.

Here's an analysis of the requested information based on the provided text, indicating when information is not provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative table format. Instead, it refers to performance testing conforming to a standard and demonstrating substantial equivalence.

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

• Sample Size: Not explicitly stated. The document mentions "worst-case construct" for dynamic compression testing, implying a limited number of samples representative of the most challenging configuration. For static axial load, it states "Additional static axial load testing" without specifying the number of samples.
• Data Provenance: Not provided, but generally, such performance testing for medical devices is conducted in a controlled laboratory environment. The document is for submission to the U.S. FDA, so the data is intended for U.S. regulatory review. It is a premarket notification, so the data would be based on pre-clinical testing, not clinical data from patients.

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

• This information is not applicable to this type of submission. This document describes the performance testing of a spinal implant system. The "ground truth" here is based on engineering principles, standardized mechanical tests (ASTM F1717), and material science, not clinical expert consensus on diagnostic images or patient outcomes.

4. Adjudication Method for the Test Set

• This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human readers/interpreters where there might be disagreement in interpretations. This document pertains to mechanical performance 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

• This information is not applicable. This is not an AI/software as a medical device (SaMD) submission. It is a traditional medical device (implant) submission.

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

• This information is not applicable. This is not an AI/software as a medical device (SaMD) submission.

7. The Type of Ground Truth Used

• The "ground truth" in this context is defined by engineering specifications, material properties, and established mechanical testing standards (ASTM F1717). The goal is to demonstrate that the device meets predefined physical and mechanical performance characteristics, and is substantially equivalent to predicate devices based on these objective measures.

8. The Sample Size for the Training Set

• This information is not applicable. This is not an AI/machine learning device. There is no "training set" in the context of mechanical performance testing for an implant.

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

• This information is not applicable. As there is no training set for an AI/ML model, there is no ground truth derivation process for such a set.

Ask a specific question about this device

The Jazz Systems are temporary implants to be used in orthopedic surgery. The Jazz Systems are 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 Systems may also be used in conjunction with other medical implants made of titanium alloy or cobaltchromium-molybdenum allov 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.

This document is a 510(k) summary for the JAZZ Passer Band. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study against specific acceptance criteria for a novel device. Therefore, much of the requested information (like expert-established ground truth, MRMC studies, or training set details) is not applicable or not provided in the given text.

Here's an analysis based on the provided input:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "static tensile testing," which inherently involves a test set of physical devices. However, the specific sample size (e.g., number of JAZZ Passer Bands tested) is not provided.

The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data. Given it's a 510(k) submission, the testing would generally be conducted by the manufacturer (Implanet, S.A., based in France) or a contracted lab.

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

This type of information is not applicable to this submission. The "ground truth" for mechanical testing is typically based on engineering specifications and material properties, not expert clinical consensus.

4. Adjudication Method for the Test Set

This is not applicable. Mechanical testing results are objectively measured and do not require an adjudication method like clinical assessments.

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 comparative effectiveness study was not done. This type of study is relevant for AI or imaging interpretation devices. The JAZZ Passer Band is a physical orthopedic implant.

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

No, a standalone algorithm performance study was not done. This is not relevant for a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is based on engineering specifications and established mechanical testing standards for medical implants. The specific and detailed acceptance criteria for the static tensile testing (e.g., passing a certain load threshold without failure) are not explicitly detailed in this summary but would be part of the full submission.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" of data in the context of this physical device's mechanical performance testing.

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

This information is not applicable as there is no training set.

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 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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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

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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.

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The JAZZ LOCK is a temporary implant to be used in orthopedic surgery. JAZZ LOCK is a bony anchor designed to provide temporary stabilization of the spine for bony fusion or consolidation of a fracture. JAZZ LOCK is designed for a posterior approach. The indications for use include the following applications:

1. Spinal trauma surgery: Jazz Lock implants can be used in sublaminar wiring technique;

2. Spinal degenerative surgery: Jazz Lock implants may be used as an adjunct to spinal fusions with bone graft (autograft or allograft) at level(s) of use.

The JAZZ LOCK consists of the following components and accessories: Titanium alloy Ti6Al4V locking base; PEEK Optima LT1 locking insert; polyester (polyethyleneterephthalate) braid; and stainless steel malleable strip and buckle. The braid is passed through the locking insert and around the pertinent spinal anatomy. The locking insert is compressed as it snaps into the locking base. locking the braid in place. The system also contains device-specific instrumentation used to position and tension the braid and lock the insert to the base.

The provided 510(k) summary for the JAZZ LOCK device focuses on establishing substantial equivalence to a predicate device through bench testing rather than clinical studies with human participants. Therefore, many of the requested categories related to clinical study design, ground truth establishment for patient data, and human reader performance are not applicable.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

Since this involves bench testing of a medical device, not a study on patient data, the concepts of "test set" sample size and "data provenance" (country of origin, retrospective/prospective) are not applicable. The "test set" would refer to the physical samples of the JAZZ LOCK device tested. The document does not specify the number of units tested for each bench test.

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

This is not applicable as the study is a bench test for mechanical properties and biocompatibility, not a clinical study requiring expert interpretation of patient data. The "ground truth" for bench testing is derived from engineering specifications and established test methodologies.

4. Adjudication Method for the Test Set

This is not applicable for bench testing. Adjudication methods are typically used in clinical studies where there's variability or disagreement among human readers or evaluators of patient data.

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

No, an MRMC comparative effectiveness study was not done. This type of study involves human readers evaluating cases, which is not relevant to the reported bench testing.

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

This is not applicable. The JAZZ LOCK is a physical implant, not an algorithm or AI.

7. The Type of Ground Truth Used

For the bench testing, the "ground truth" was established by engineering specifications, recognized industry standards (e.g., ISO 10993 for biocompatibility), and comparison with the mechanical properties and performance of the predicate device.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is not an AI/machine learning study or a clinical study with patient data.

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

This is not applicable for the reasons stated above.

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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.

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