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The CD HORIZON™ Spinal System with or without SEXTANT™ instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (DDD - 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, curvatures (i.e. scoliosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON™ Spinal System may also be used for the same indications as an adjunct to fusion.

With the exception of DDD, the CD HORIZON™ LEGACY™ 3.5mm rods and the CD HORIZON™ Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON™ Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD HORIZON™ Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The CD Horizon™ PEEK rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (1.2 - S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.

The CD HORIZON™ SPIRE™ Plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDD (as previously defined), spondylolisthesis, trauma, and/or tumor.

In order to achieve additional levels of fixation, the CD HORIZON™M System rods may be connected to the VERTEX™ Reconstruction System with the VERTEX™ rod connector. Refer to the VERTEX™ Reconstruction System Package Insert for a list of the VERTEX™ indications of use.

The subject CD HORIZON™ Spinal System consists of non-sterile domino connectors, made of Titanium Alloy, that are used to provide the surgeon with an efficient construct extension as well as connection options for multi-rod spinal constructs. The subject CD HORIZON™ Spinal System includes 1. Non-sterile Domino connectors 2. Trays and lid

The provided text is a 510(k) Summary for the Medtronic CD HORIZON™ Spinal System. It describes the device, its indications for use, and a comparison to predicate devices, focusing on the substantial equivalence argument for non-sterile domino connectors.

However, the document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of AI/ML or diagnostic performance.

The "Performance Data" section explicitly states:

"The purpose of this submission is to take the existing sterile domino connector designs, cleared in the predicate 2, and provide them non-sterile. The subject domino connectors are being created to provide additional rod connector options for surgeon convenience. No design changes have been made to the subject devices as a result of this submission. The subject devices remain identical to the designs cleared in the predicate 2 with the same intended use, materials, and fundamental technology. As a result, the subject CD HORIZON™ Spinal System does not represent a new worst case; therefore, no new bench performance testing is warranted."

And regarding biocompatibility, it states:

"Identical to the predicate devices, the subject domino connectors are made of Titanium Alloy. This material is considered biocompatible due to its long history of clinical use in medical devices."

Based on this information, the device discussed (CD HORIZON™ Spinal System domino connectors provided non-sterile) is a physical medical device (spinal fixation system component) and not an AI/ML-driven device or a diagnostic tool that would typically have acceptance criteria presented as sensitivity, specificity, or similar performance metrics derived from a study involving ground truth established by experts.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a study proving performance, as this type of information is not present in the provided text for this particular device submission. The submission relies on demonstrating substantial equivalence to previously cleared predicate devices due to no change in design or fundamental technology, other than the sterilization status of the component.

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The CD Horizon™ Astute™ Spinal System is intended to provide for posterior, supplemental fixation when used with an interbody fusion cage for patients diagnosed with degenerative disc disease (DDD- defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 - S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.

The CD Horizon™ Astute™ Spinal System consists of a variety of sizes of rods, as well as set screws, which are used with bone screws from the CD Horizon™ Solera™ Spinal System, to create a variety of rigidly locked configurations, with each construct being tailored to the individual case. The CD Horizon™ Astute™ Spinal System implant components are fabricated from medical grade titanium alloy, tantalum, or polyetheretherketone (PEEK).

This document describes the premarket notification (K191066) for the CD Horizon™ Astute™ Spinal System. However, it does not contain information related to an AI/ML powered device, nor does it present acceptance criteria or a study that proves a device meets those criteria in the context of AI/ML performance metrics.

The document is a 510(k) summary for a spinal implant system. The "Performance Data" section (VII) discusses mechanical testing of the device and reference to clinical literature and a retrospective study of the predicate device to support its clinical use.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves an AI device meets acceptance criteria, as this document is not about an AI device.

To directly answer the prompt's request given the content of this specific document:

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

• Acceptance Criteria: "The subject devices met the pre-determined acceptance criteria for all tests." (Page 5)
• Reported Device Performance:
  • Mechanical Testing (ASTM F1717 & F1798): The subject devices met the pre-determined acceptance criteria for static and dynamic compression bending, static torsion, static axial grip, static torsional grip, and static and dynamic flexion/extension.

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 (Test Set): Not specified for mechanical testing. For clinical performance, it refers to data from the predicate device's unspecified "retrospective study," so the sample size is unknown.
• Data Provenance: Unspecified for mechanical testing. For clinical performance, implies data from a retrospective study, country of origin is not mentioned.

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. This is a mechanical device, not an AI diagnostic/prognostic device requiring expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) 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

• No, an MRMC study was not done as this is not an AI device.

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

• Not applicable. This is a mechanical device.

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

• Mechanical Testing: Ground truth is based on the specifications and performance limits defined by ASTM F1717 and F1798 standards.
• Clinical Performance: Ground truth for clinical claims is supported by the outcomes of the predicate device's retrospective study and clinical literature, implying patient outcomes data.

8. The sample size for the training set

• Not applicable. This is not an AI device with a training set.

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

• Not applicable. This is not an AI device.

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The CD Horizon™ System with or without SEXTANT™ instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (DDD - 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, curvatures (i.e. scoliosis, tumor, pseudarthrosis, and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion. With the exception of DDD, the CD Horizon™ LEGACY™ 3.5mm rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD Horizon™ System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD Horizon™ System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft. Pediatric pediatric pedicle screw fixation is limited to a posterior approach.

The CD Horizon™ PEEK Rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 – S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.

The CD Horizon™ SPIRE™ Plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDD (as previously defined), spondylolisthesis, trauma, and/or tumor.

In order to achieve additional levels of fixation, the CD Horizon™ Spinal System rods may be connected to the VERTEX™ Reconstruction System with the VERTEX™ rod connector. Refer to the VERTEX™ Reconstruction System Package Insert for a list of the VERTEX™ indications of use.

The subject CD Horizon™ Spinal System is a multiple component device to allow the surgeon to build an implant system to fit the patients' anatomical and physiological requirements. The subject CD Horizon PEEK Rods consist of polyetheretherketone (PEEK) rods, multi-axial bone screws (MAS) and set screws to create a variety of semirigid configurations. The purpose of this traditional 510(k) is to modify the indications for the CD Horizon™ Spinal System.

The provided text describes the CD Horizon™ Spinal System and details its various components and indications for use. It also mentions non-clinical and clinical performance data used to demonstrate substantial equivalence to predicate devices, but it does not provide specific acceptance criteria or reported device performance in a numerical format.

However, based on the information provided, here's a breakdown of the requested information, focusing on what can be inferred or explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document states that "mechanical testing was performed on the subject and predicate devices in accordance with ASTM F1717, Standard test Methods for Spinal Implant Constructs in a Vertebrectomy Model and ASTM F1798, Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Sub-assemblies Used in Spinal Arthrodesis Implants." It also mentions "Biomechanical cadaver testing was also performed." However, the specific acceptance criteria (e.g., minimum load to failure, fatigue cycles survived) and the reported device performance metrics against those criteria are not detailed.

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

From the provided text:

• Clinical Performance Study: "A retrospective study was conducted..."
• Sample Size: The sample size for the retrospective clinical study is not explicitly stated in the provided text.
• Data Provenance: The text states, "A retrospective study was conducted and demonstrated that CD Horizon™ Spinal System PEEK Rod constructs are substantially equivalent when used to provide supplemental fixation in interbody fusion procedures for the treatment of DDD." The country of origin is not specified, but given the US FDA submission context, it is likely that the data pertains to a US patient population or has relevance to the US market. The study is explicitly stated as retrospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. For a retrospective clinical study, ground truth for diagnoses like DDD, spondylolisthesis, etc., would typically be established based on existing patient medical records, imaging reports, and potentially physician-recorded outcomes. The number and qualifications of experts involved in the initial diagnosis or in reviewing the retrospective data for the study are not mentioned.

4. Adjudication Method

This information is not provided in the document. It's likely that for a retrospective study using existing medical records, the "ground truth" was established by the original treating physicians or based on the documented diagnostic criteria in the medical charts, rather than a separate adjudication process for the study.

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

This information is not provided in the document. The study mentioned is a retrospective clinical study for the device itself, not a comparative effectiveness study involving human readers with and without AI assistance.

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

This question is not applicable to the described device. The CD Horizon™ Spinal System is a medical implant (a hardware device), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

Based on the description of the retrospective clinical study:

• The ground truth would likely be based on clinical diagnoses (e.g., degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudarthrosis, failed previous fusion, progressive spinal deformities, etc.) as recorded in patient medical records.
• It would also involve radiographic studies for DDD, and potentially surgical outcomes (e.g., fusion success, complication rates) and patient-reported outcomes to demonstrate the clinical effectiveness of the device as supplemental fixation.
• For the non-clinical mechanical testing, the ground truth would be the physical properties and performance characteristics of the device measured against established ASTM standards.

8. The Sample Size for the Training Set

This question is not applicable to the described device. As the CD Horizon™ Spinal System is a medical implant, it does not involve a "training set" in the context of machine learning algorithms.

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

This question is not applicable to the described device, as there is no "training set" for a hardware medical implant.

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When used as a pedicle screw fixation system in skeletally mature patients, the Dynesys Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, and failed previous fusion (pseudoarthrosis).

In addition, when used as a pedicle screw fixation system, the Dynesys Spinal System is indicated for use in patients:

• Who are receiving fusions with autogenous graft only;
• Who are having the device fixed or attached to the lumbar or sacral spine;
• Who are having the device removed after the development of a solid fusion mass.

When the Dynesys Spinal System and the OPTIMA ZS Spinal System are used on contiguous levels, they must be used with the Zimmer DTO implant, rod-cord combination implant, and the U&I Corporation OPTIMA ZS Transition Screw. The indications for use for each level is as specified for each system.

The Zimmer® Dynesys® Spinal System, including the Dynesys® Top-Loading Spinal System, is a temporary implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for non-cervical posterior use in the lumbar and sacral areas of the spine. Implants of this system consist of fixed pedicle screws of varying diameters and lengths, set screws, polycarbonate urethane (PCU) spacers and polyethylene terephthalate (PET) cords.

The Dynesys® pedicle screw consists of a top-loading solid or cannulated shank, either uncoated or coated with hydroxyapatite (HA). The Dynesys® Spinal System is also cleared for connection with the Zimmer® DTO™ implant. The Zimmer® DTO™ implant allows the connection of the Dynesys® Spinal System to the OPTIMA™ZS Spinal System when the two systems are used on contiguous levels.

This document primarily concerns a 510(k) submission for the Zimmer® Dynesys® Top-Loading Spinal System. The purpose of this submission is not to introduce a new device or evaluate its clinical performance in a standalone study or against specific acceptance criteria related to a device's performance. Instead, it's an update focusing on:

• Instrument labeling changes.
• Identifying an alternative material vendor for a non-implanted component.

The submission explicitly states: "This submission does not make any modifications to the subject dynamic stabilization device." and "Since this submission focuses on the instruments, no performance testing was performed on the implants."

Therefore, many of the requested details about acceptance criteria, device performance tables, sample sizes for test sets, expert adjudication, MRMC studies, standalone performance, and ground truth for clinical device performance are not applicable to this specific 510(k) submission.

However, the document does contain information about performance testing related to the changes being submitted.

Here's a breakdown of the available information based on your request:

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

• Acceptance Criteria: The underlying acceptance criteria for the original Dynesys® Top-Loading Spinal System (predicate device K092234) would have been established at that time, likely through mechanical testing and preclinical studies. For this submission, the acceptance criteria are related to validating the changes made (instrument design, material vendor for non-implanted parts). The general acceptance criterion is "substantial equivalence" to the predicate device.
• Reported Device Performance:
  • Cadaver lab testing: "to evaluate human factors regarding the combination of instrument design changes as well as interaction with implants to confirm the substantial equivalence of the changes compared to the identified predicate device."
  • Biocompatibility testing: "ensured the subject Dynesys® Top-Loading Spinal System materials are biocompatible after manufacturing based on the minor design changes made in comparison to the predicate devices."
  • Sterilization, Dry Time and Cleaning testing: "ensured the subject Dynesys® Top-Loading Spinal System steam sterilization, cleaning and dry time instructions are substantially equivalent to the predicate devices for the instruments."

2. Sample sizes 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 any of the tests mentioned (cadaver lab, biocompatibility, sterilization/cleaning).
• Data Provenance: Not specified. These are likely internal laboratory tests.

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 as this submission does not involve clinical data or "ground truth" derived from expert interpretation of medical images or patient outcomes. The "ground truth" here is the functionality and safety of the revised instruments and alternative material.

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

• Not applicable for the reasons stated above.

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 fixation system, not an AI-powered diagnostic device.

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

• Not applicable for the reasons stated above.

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

• For the tests performed:
  • Cadaver lab: Functional performance and human factors assessment (likely by trained personnel/surgeons).
  • Biocompatibility: Adherence to established standards (e.g., ISO 10993).
  • Sterilization/Cleaning: Validation against predefined protocols and industry standards.
• The "ground truth" for this submission is whether the updated components/instruments meet engineering and regulatory standards and perform equivalently to the predicate device.

8. The sample size for the training set

• Not applicable. This is not an AI/ML development.

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

• Not applicable.

Summary relevant to this submission:

The core "acceptance criterion" for this 510(k) submission is substantial equivalence to the predicate device (Dynesys® Top-Loading Spinal System, K092234) for the specific changes being made (instrument labeling and non-implant material vendor). The "study that proves the device meets the acceptance criteria" consists of:

• Cadaver lab testing: To validate instrument design changes and human factors, demonstrating equivalence.
• Biocompatibility testing: To ensure the materials remain biocompatible after manufacturing changes, demonstrating equivalence to standards.
• Sterilization, Dry Time and Cleaning testing: To ensure processing instructions remain equivalent and effective.

No specific quantitative "device performance" metrics or clinical studies are detailed in this summary because the submission explicitly states there are no changes to the implant itself or its functional scientific technology.

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When used as a pedicle screw fixation system in skeletally mature patients, the Dynesys Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic. lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment and failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the Dynesys system is indicated for use in patients:

• . Who are receiving fusions with autogenous graft only;
• . Who are having the device fixed or attached to the lumbar or sacral spine;
• . Who are having the device removed after the development of a solid fusion mass.

When the Dynesys Spinal System and the OPTIMA ZS Spinal System are used on contiguous levels, they must be used with the Zimmer DTO Implant, rodcord combination implant, and the U & I Corporation OPTIMA ZS Transition Screw. The indications for use for each level is as specified for each system.

The Zimmer DTO Pin press has been designed to be part of the Zimmer DTO Instruments. The Zimmer DTO Implant is provided partially assembled, in that the cord is placed in the connecting part and fixed with a needle during the manufacturing process; the mechanical integrity of the cord/rod connection is achieved immediately prior to implantation by fully inserting a pin to compress the cord with an intra-operative instrument, this step is performed with the Zimmer DTO Pin press.

This document is a 510(k) summary for the Zimmer DTO Pin Press, a medical instrument, and not a study describing a device that uses AI or machine learning. Therefore, most of the requested information (acceptance criteria for AI, sample sizes for AI training/test sets, expert ground truthing, MRMC studies, standalone AI performance) is not applicable.

This document describes the process of getting a medical instrument approved by the FDA, primarily by demonstrating its substantial equivalence to a previously approved predicate device.

Here's the relevant information that can be extracted from the provided text, related to the performance testing of the instrument (the Zimmer DTO Pin Press):

1. Table of Acceptance Criteria and Reported Device Performance:

Rationale: The document states, "It has been determined that the proposed Zimmer DTO Pin Press is substantially equivalent the predicate Zimmer DTO Hand Press. Based on the results following tests: - Durability and fatigue. - Interconnection strength . - Pull-out strength ." This implies that the device successfully met the performance expectations for these tests, demonstrating equivalent performance to the predicate. The specific quantitative acceptance criteria or detailed test results are not provided in this summary.

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

The document does not specify the sample sizes used for the durability, interconnection strength, and pull-out strength tests. It also does not mention data provenance in terms of country of origin or retrospective/prospective studies, as these are typically not relevant for mechanical device testing of this nature.

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

Not applicable. Ground truth, in the context of AI and diagnostic imaging, refers to a definitive diagnosis or finding. For a mechanical instrument, "ground truth" would involve established engineering standards and test methodologies, not expert consensus in the diagnostic sense.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or algorithmic output review, not for mechanical device testing.

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

Not applicable. This is an instrument, not a diagnostic or AI-driven system that would be evaluated for human reader improvement.

6. Standalone Performance Study:

Yes, in a sense. The performance testing (Durability and fatigue, Interconnection strength, Pull-out strength) evaluated the Zimmer DTO Pin Press instrument on its own to ensure it functions as intended and is substantially equivalent to its predicate. However, "standalone" in the context of AI usually refers to the algorithm's performance without human intervention, which is not relevant here.

7. Type of Ground Truth Used:

For the performance testing mentioned (durability, strength tests), the "ground truth" would be established engineering standards, material science properties, and established mechanical testing protocols. There isn't a "ground truth" in the diagnostic or clinical outcome sense for an instrument's performance validation.

8. Sample Size for the Training Set:

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

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

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

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The DSS™ Stabilization System - Rigid is intended as a single-level system for noncervical pedicle fixation from the T4 to S1 vertebrae in skeletally mature patients to help provide immobilization and stabilization of spinal segments as an adjunct to fusion 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; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor: pseudarthrosis; and failed previous fusion. The DSS™ Stabilization System - Rigid is intended to be used with autograft and/or allograft.

The DSS™ Stabilization System - Slotted is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, kyphosis, and failed previous fusion (pseudarthrosis).

In addition, the DSS™ Stabilization System - Slotted is indicated for use in patients:
Who are receiving fusions with autogenous graft only;
Who are having the device fixed or attached to the lumbar or sacral spine;
Who are having the device removed after the development of a solid fusion mass.

Note: The Rigid Coupler and Slotted Coupler are not intended to be used together.

The DSS™ Stabilization System -- Rigid is comprised of a variety of pedicle screws sizes, and couplers that act as longitudinal spacers that are uniquely fitted for each individual case. The pedicle screws and couplers are manufactured from medical grade titanium alloy (Ti6Al4V). This submission presents the addition of a 20mm long rigid coupler.

The provided text describes a medical device, the DSS™ Stabilization System -- Rigid, and its 510(k) premarket notification (K101083). The submission focuses on demonstrating substantial equivalence to predicate devices based on non-clinical mechanical testing.

Here's an analysis of the provided information against the requested categories:

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

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

The document describes non-clinical mechanical testing, not a clinical study involving human patients or data provenance in that sense. The "sample size" refers to the number of test articles used in the mechanical tests. The document states: "Static and dynamic mechanical testing was performed in conjunction with ASTM F1717." While it confirms that testing was done, the exact number of samples (test articles) used for each specific test (static flexion, extension, axial rotation, dynamic compression bending) is not explicitly stated.

The data provenance is from non-clinical laboratory testing of the device components, not from human subjects or clinical 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)

This question is not applicable to this type of submission. The "ground truth" for mechanical testing is established by engineering standards (ASTM F1717) and the physical properties and behavior of the materials and device constructs, not by expert human interpretation.

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

This question is not applicable. Adjudication methods are typically used in clinical studies for resolving discrepancies in expert opinions on clinical outcomes or image interpretations. For mechanical testing, the results are derived from physical measurements and engineering analyses, not subjective interpretation requiring "adjudication."

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 question is not applicable. An MRMC study is a type of clinical study used to evaluate diagnostic imaging devices or AI algorithms where multiple human readers interpret cases. This submission is for a spinal implant, which undergoes mechanical testing and not typically MRMC studies for its premarket clearance.

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

This question is not applicable. This device is a physical spinal implant, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

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

The "ground truth" for this submission's non-clinical testing is based on established engineering standards and material science principles, specifically ASTM F1717. The performance of the device is measured against the expected mechanical properties and behavior defined by this standard and compared to the performance of predicate devices.

8. The sample size for the training set

This question is not applicable. This is not an AI/machine learning device that requires a training set. The "training" for a mechanical device is its design and manufacturing process according to engineering principles.

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

This question is not applicable, as there is no "training set" in the context of this traditional medical device submission.

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When used as a pedicle screw fixation system in skeletally mature patients, the Dynesvs Spinal System is intended to provide immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondy|olisthesis with objective evidence of neurologic impairment, and failed previous fusion (pseudoarthrosis).

In addition, when used as a pedicle screw fixation system, the Dynesys Spinal System is indicated for use in patients:

• · Who are receiving fusions with autogenous graft only;
• · Who are having the device fixed or attached to the lumbar or sacral spine;
• · Who are having the device removed after the development of a solid fusion mass.

When the Dynesys Spinal System and the OPTIMA ZS Spinal System are used on contiguous levels, they must be used with the Zimmer DTO implant, rod-cord combination implant, and the U&I Corporation OPTIMA ZS Transition Screw. The indications for use for each level is as specified for each system.

The Zimmer® Dynesys® Spinal System, including the Dynesys Top-Loading Spinal System, is a temporary implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for non-cervical posterior use in the lumbar and sacral areas of the spine. Implants of this system consist of fixed pedicle screws of varying diameters and lengths, set screws, polycarbonate urethane (PCU) spacers, and polyethylene terephthalate (PET) cords.

The Dynesys pedicle screw consists of a top-loading solid or cannulated shank, either uncoated or coated with ceramic hydroxyapatite (HA). The Dynesys Spinal System is also cleared for connection with the Zimmer DTO implant. The Zimmer DTO implant allows the connection of the Dynesys Spinal System to the Optima ZS Spinal System when the two systems are used on contiguous levels.

This document is a 510(k) summary for a medical device (Zimmer Dynesys Top-Loading Spinal System), not a study report for an AI/ML device. Therefore, it does not contain information about acceptance criteria, device performance metrics (like sensitivity, specificity, AUC), sample sizes for test/training sets, expert qualifications, or adjudication methods typically found in AI/ML performance studies.

The document focuses on demonstrating substantial equivalence to predicate devices, primarily based on design, materials, and intended use, rather than clinical performance metrics that would be assessed for an AI/ML system.

Therefore, I cannot provide the requested information from this document.

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DSSTM Stabilization System - Rigid: The DSS™ Stabilization System - Rigid is intended as a single-level system for noncervical pedicle fixation from the T4 to S1 vertebrac in skeletally mature patients to help provide immobilization and stabilization of spinal segments as an adjunct to fusion 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; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion. The DSS™ Stabilization System - Rigid is intended to be used with autograft and/or allograft.

DSSTM Stabilization System - Slotted: The DSS™ Stabilization System - Slotted is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, kyphosis, and failed previous fusion (pseudarthrosis). In addition, the DSS™ Stabilization System - Slotted is indicated for use in patients: Who are receiving fusions with autogenous graft only; Who are having the device fixed or attached to the lumbar or sacral spine; . Who are having the device removed after the development of a solid fusion mass. Note: The Rigid Coupler and Slotted Coupler are not intended to be used together.

The DSS™ Stabilization System is comprised of a variety of pedicle screws sizes, and couplers that act as longitudinal spacers that are uniquely fitted for each individual case. The pedicle screws and couplers are manufactured from medical grade titanium alloy (Ti6AI4V).

The provided text describes a 510(k) submission for the DSS™ Stabilization System, a medical device. However, it does not include information about acceptance criteria, a specific study proving the device meets those criteria, or details regarding performance metrics, sample sizes, ground truth establishment, or expert involvement as typically found in clinical validation studies for AI/software devices.

This document describes a spinal pedicle screw system, which is a physical implant, not an AI or software-based device. The approval process for such devices relies heavily on demonstrating substantial equivalence to predicate devices through design, function, material comparison, and mechanical testing, rather than clinical efficacy studies with ground truth derived from expert consensus or pathology, as would be the case for AI systems.

Therefore, many of the requested categories are not applicable to the information contained in this 510(k) summary for the DSS™ Stabilization System.

Here's a breakdown of what can be extracted or inferred from the provided text, and what cannot:

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

Explanation: For a physical device like a pedicle screw system, "acceptance criteria" primarily revolve around demonstrating substantial equivalence to already-approved predicate devices in terms of safety and effectiveness. This is typically achieved through comparisons of design, materials, function, and mechanical testing results against established benchmarks or the predicate devices themselves. The document states that the device was shown to be "substantially equivalent" and "as mechanically sound" as predicates.

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

• Not applicable / Not provided. The document describes mechanical testing, not a clinical study involving human patients or data sets. "Sample size" in this context would refer to the number of devices or components subjected to mechanical tests, which is not specified. There is no "data provenance" in the sense of patient 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 / Not provided. This device's approval involved mechanical engineering assessments and regulatory review, not expert consensus on clinical data to establish a ground truth.

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

• Not applicable / Not provided. Adjudication methods are relevant for clinical studies where human experts interpret data, which is not described here.

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 physical medical device, not an AI system. Therefore, no MRMC study or assessment of AI assistance was performed.

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

• Not applicable. This is not an algorithm or AI device.

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

• Not applicable for clinical ground truth. The "truth" for this device's approval revolved around engineering specifications, materials science, and mechanical performance validation, demonstrated to be equivalent to existing, legally marketed devices.

8. The sample size for the training set

• Not applicable. This device does not use a training set as it is not an AI/machine learning system.

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

• Not applicable. No training set was used.

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The TRANSITION™ Stabilization System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine in skeletally mature patients: degenerative spondylolisthesis with objective evidence of neurologic impairment, kyphosis, and failed previous fusion (pseudoarthrosis).

In addition, the TRANSITION™ Stabilization System is indicated for use in patients: who are receiving fusions with autogenous graft only; who are having the device fixed or attached to the lumbar or sacral spine; and who are having the device removed after the development of a solid fusion mass.

TRANSITION™ is only indicated for use when fusion with autogenous bone graft is being performed at all instrumented levels.

The TRANSITION™ Stabilization System implants include pedicle screws and implant assemblies which are provided pre-assembled or can be assembled intraoperatively.

TRANSITION™ pedicle screws are coated with hydroxyapatite (HA). Either TRANSITION™ HA coated pedicle screws or specified REVERE® pedicle screws may be used in conjunction with the implant assemblies. Specifically, REVERE® polyaxial (solid, cannulated and dual outer diameter) screws and monoaxial screws 6.5mm diameter and larger, and 35mm length and larger, may be used with the TRANSITION™ implant assemblies.

Implant assemblies consist of a polyethylene terepthalate (PET) cord, polycarbonate urethane (PCU) spacers and bumpers, and titanium alloy spools, end spools and set screw ends. The cord passes through the entire implant such that the spools are positioned to sit within the screw heads and the spacer sits between the spools. The end spool includes one end of the secured cord. The bumper followed by a set screw end is positioned at the other end of the cord.

Implant assemblies are available in single or multi-level configurations. REVERE® locking caps with inner set screws are used to rigidly connect the pedicle screws to the implant assemblies.

TRANSITION™ implants are available in a variety of sizes to accommodate varied patient anatomy.

TRANSITION™ implants are manufactured from titanium alloy Ti6AI4V (ASTM F136) or Ti6Al7Nb (ASTM F1295), polyethylene terepthalate (PET), and/or polycarbonate urethane (PCU). Titanium alloy TRANSITION™ screws are hydroxyapatite (HA) coated (ASTM F1185).

The provided text is a 510(k) summary for the TRANSITION™ Stabilization System, which is a medical device. This type of document is a regulatory submission to the FDA (Food and Drug Administration) to demonstrate that a medical device is substantially equivalent to a legally marketed predicate device.

The context of this document is therefore not a study proving device performance against acceptance criteria in the way a research paper or clinical trial might. Instead, the "acceptance criteria" here refer to regulatory requirements for substantial equivalence, and the "study" is the information provided by the manufacturer to demonstrate that equivalence.

Consequently, many of the requested categories (like sample size for test/training sets, data provenance, number/qualification of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable or not present in a 510(k) summary as it is primarily focused on demonstrating equivalence to an already approved device through comparisons of indications, design, materials, and potentially some mechanical testing data (though not detailed here).

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for Substantial Equivalence (as understood in a 510(k) submission):
The primary "acceptance criteria" for a 510(k) submission like this are that the device is substantially equivalent to a legally marketed predicate device in terms of:

• Intended Use/Indications for Use: The new device has the same intended use as the predicate.
• Design and Function: The device has similar technological characteristics (e.g., materials, principle of operation, mechanical properties).
• Safety and Effectiveness: Differences in technological characteristics do not raise new questions of safety and effectiveness.

Reported Device Performance (as summarized in the document):

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

• Not applicable/Not provided in this 510(k) summary. This document does not detail specific clinical or analytical studies with test sets in the typical research sense. The "study" here is the comparison to predicate devices, usually supported by design specifications, material testing, and potentially bench testing data, none of which are detailed here with sample sizes or data provenance.

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/Not provided. Ground truth determination by experts is typically for diagnostic/AI devices, not for spinal implant systems demonstrating substantial equivalence to predicates.

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

• Not applicable/Not provided. This is not relevant for a 510(k) submission for a spinal implant device.

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/Not provided. MRMC studies are for diagnostic imaging devices, not spinal implants.

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

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

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

• Not applicable/Not provided in this summary. For a 510(k) of this nature, the "ground truth" for showing safety and effectiveness is largely based on the established safety and effectiveness of the predicate devices, combined with engineering analysis and bench testing to demonstrate similar performance characteristics.

8. The sample size for the training set

• Not applicable/Not provided. There is no "training set" in the context of an AI/machine learning model for this physical medical device.

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

• Not applicable/Not provided. As there is no training set, this question is not relevant.

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The DSSTM Stabilization System - Rigid Coupler is intended for noncervical pedicle fixation from the T4 to S1 vertebrae in skeletally mature patients to help provide immobilization and stabilization of spinal segments as an adjunct to fusion 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; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion. The DSS™ Stabilization System - Rigid Coupler is intended to be used with autografl and/or allograft.

The DSS™ Stabilization System – Rigid is intended as a single-level system for noncervical pedicle fixation from the T4 to S1 vertebrae in skeletally mature patients to help provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following indications: degenerative disc disease (defined as back opin of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal sterensis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); turnor; pseudarthrosis; and failed previous fusion. The DSS™ Stabilization System - Rigid is intended to be used with autograft and/or allograft.

The DSS™ Stabilization System is comprised of a variety of pedicle screws and Rigid Couplers that act as longitudinal spacers. This device is intended to be used with bone graft to provide immobilization and stabilization of a spinal segment as an adjunct to fusion.

The DSS™ Stabilization System consists of:

• DSS™ pedicle screw sets .
• DSS™ Rigid Couplers .

The DSS™ Stabilization System is fabricated from wrought Ti-6AI-4V (ISO 5832-3 and ASTM F136).

The provided text is a 510(k) Summary for the DSS™ Stabilization System - Rigid Coupler, a medical device. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria or performance metrics through a standalone clinical study.

Therefore, the input does not contain the information requested in the prompt regarding acceptance criteria, device performance, sample sizes for test and training sets, expert qualifications, or adjudication methods for ground truth, as these are typically part of a de novo classification or a Premarket Approval (PMA) application requiring clinical trial data.

Based on the provided text, here's what can be extracted and what cannot:

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

• Not available: The document asserts substantial equivalence to predicate devices based on "the same indications for use, design, function, and materials used." It does not define specific performance acceptance criteria or report quantitative device performance data against such criteria. The "Performance Standards" section only states that "Testing performed indicates the DSS™ Stabilization System is substantially equivalent to predicate devices."

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

• Not available: No test set or clinical study data is mentioned in this 510(k) summary. The equivalence is based on design, materials, and established predicate devices, not on a new clinical performance study.

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/Not available: As no test set from a clinical study is described, there's no mention of experts or ground truth establishment.

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

• Not applicable/Not available: No test set or clinical study is described.

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/Not available: This device is a pedicle screw spinal system, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study is irrelevant.

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

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

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

• Not applicable/Not available: No clinical study or ground truth establishment is described. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

• Not applicable/Not available: No training set for an algorithm is relevant to this device submission.

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

• Not applicable/Not available: No training set is relevant.

Summary of the Study (as described in the 510(k) summary):

The "study" presented in this 510(k) is a substantial equivalence comparison to legally marketed predicate devices. The manufacturer, Paradigm Spine, LLC, sought to demonstrate that their DSS™ Stabilization System - Rigid Coupler is as safe and effective as existing devices.

• Methodology: The comparison focused on general characteristics like indications for use, design, function, and materials used.
• Predicate Devices: Four predicate devices were identified:
  • DePuy MOSS Miami (K962628)
  • Biomet Synergy VLS Open (K973836)
  • Synthes Pangea (K052123)
  • Zimmer Silhouctte (K993067)
• Materials: The DSS™ Stabilization System is fabricated from wrought Ti-6AI-4V, which is a standard material (ISO 5832-3 and ASTM F136).
• Performance Standards (Testing): The document states that "Testing performed indicates the DSS™ Stabilization System is substantially equivalent to predicate devices." While this implies some form of engineering or mechanical testing was conducted, the specifics (e.g., specific test methods, number of samples, pass/fail criteria, or detailed results) are not provided in this summary. The "tests" would likely relate to mechanical properties, fatigue, and other biomechanical assessments required for spinal implants to ensure they meet established standards and are comparable to predicate devices.

In essence, the "acceptance criteria" here is the FDA's determination of substantial equivalence, which is based on a comparison to predicate devices rather than independent, quantitative performance metrics from a new clinical study.

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