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The Reform Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients 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 neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The Reform Pedicle Screw System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. The Reform Pedicle Screw System is also intended for non-cervical pedicle screw fixation (T1-S1/ilium) for the following indications: degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); spinal tumor; pseudoarthrosis; and failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Reform Pedicle Screw System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Reform Pedicle Screw System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Reform System is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross-connectors, locking cap screws, hooks, domino connectors, and lateral offset connectors. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All components are made from medical grade stainless steel, cobalt chromium alloys, titanium or titanium alloy described by such standards as ASTM F138, ASTM F1537, ISO 5832-12, ASTM F136 or ISO 5832-3.

The provided text is a 510(k) summary for a medical device (Reform Pedicle Screw System) and does not describe acceptance criteria or a study proving that an AI/device meets acceptance criteria. Instead, it details the indications for use, technical characteristics, and a performance testing summary related to demonstrating substantial equivalence to a predicate device.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance in the context of an AI device. The document describes a physical medical device (pedicle screw system) and its regulatory clearance process based on substantial equivalence, not the performance of an AI algorithm against defined acceptance criteria.

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The Dali Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. System components are to be used for immobilization and stabilization of the spine as an adjunct to fusion. These devices are indicated for all of the following indications regardless of the intended use:

• degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies);
• spondylolisthesis;
• trauma (i.e. fracture or dislocation);
• deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
• tumor;
• stenosis, and;
• failed previous fusion (pseudoarthrosis)

This system is comprised of screws, set screws, rods, crosslink and connectors. The components of this system are manufactured of Titanium alloy (Titanium-6Aluminum-4Vanadium ELI, per ASTM F136) and CoCrMo alloy (Cobalt-28Chromium-6Molybdenum, per ASTM F1537). The screws are available from 4.0 to 8.5mm diameters with lengths ranging from 20-150mm.

The provided text describes the "Dali Spinal Fixation System," a Class III medical device for spinal fixation. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

• Static compression bending
• Static torsion
• Dynamic compression bending (in accordance with ASTM F1717-10)
• Gripping-push down (in accordance with ASTM F1798) |
  | Material Equivalence | The components of this system are manufactured of Titanium alloy (Titanium-6Aluminum-4Vanadium ELI, per ASTM F136) and CoCrMo alloy (Cobalt-28Chromium-6Molybdenum, per ASTM F1537), which are the same materials used in predicate devices. |
  | Design Equivalence (substantially similar) | The Dali Spinal Fixation System shares technological characteristics similar to the predicate devices, including similar design. |
  | Intended Use / Indications for Use | The device's intended use and indications for use as a non-cervical spinal fixation device (posterior pedicle fixation T1-S2/ilium, or anterolateral fixation T8-L5) for skeletally mature patients as an adjunct to fusion for conditions like degenerative disc disease, spondylolisthesis, trauma, deformities, tumor, stenosis, and failed previous fusion are deemed substantially equivalent to legally marketed predicate devices. |
  | Overall Safety and Effectiveness | The Dali Spinal Fixation System is substantially equivalent to the device referenced above and is therefore safe and effective for its intended use. |

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

The document explicitly states: "Clinical data and conclusions were not needed for this device." This means there was no clinical test set involving human subjects. The evaluation was based on non-clinical (bench) testing. Therefore, there is no sample size for an clinical test set or data provenance (country of origin, retrospective/prospective clinical data).

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

Not applicable. As no clinical data was required or used, there was no need for experts to establish ground truth for a clinical test set. The acceptance was based on engineering and material equivalence to predicate devices.

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

Not applicable. No clinical test set with human data requiring adjudication was performed.

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 device is a spinal fixation system (physical implant), not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant and was not performed.

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

Not applicable. This device is a physical medical implant, not a software algorithm.

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

For the non-clinical performance evaluation, the "ground truth" was established by standardized mechanical testing protocols (e.g., ASTM F1717-10 for dynamic compression bending, and ASTM F1798 for gripping-push down) and material specifications (ASTM F136 for Titanium alloy, ASTM F1537 for CoCrMo alloy). The "truth" was that the device met or exceeded the performance of the predicate devices under these controlled, quantifiable conditions.

8. The sample size for the training set

Not applicable. This device is a physical implant evaluated through bench testing and comparison to predicate devices, not an AI or machine learning model that requires a training set.

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

Not applicable, as there was no training set.

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The Synthes USS are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis).

When treating patients with Degenerative Disc Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct.

When used with the 3.5/6.0 mm parallel connectors, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5 mm Systems. In addition, when used with 3.5/5.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5 mm Systems. When used with the 5.0/6.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0 mm rod systems.

When used with the 3.5/6.0 mm and 4.0/6.0 mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 3.5/5.5 mm and 4.0/5.5 mm tapered rods, Matrix can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 5.5/6.0 mm tapered rods, the Synthes USS 6.0 mm rod systems can be lined to the Matrix System.

In addition, Synthes USS 6.0 mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors.

Synthes USS

• 6.0 mm Rod Systems: USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea Monoaxial, USS Polyaxial, USS Iliosacral, ClampFix
• 5.5 mm Rod System: Matrix
• 5.0 mm Rod System: USS Small Stature

CerviFix

• 3.5 mm Rod Systems: CerviFix, Axon, Synapse
• 4.0 mm Rod System: Synapse

The Synthes Matrix System is an addition to Synthes' existing posterior thoracolumbar spine systems. The Matrix System consists of a family of non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2), posterior hook fixation (T1-L5) or anterolateral fixation (T8-L5). The implants include pedicle bone screws, polyaxial pedicle screws, monoaxial pedicle screws, polyaxial heads, reduction screws, reduction heads, locking caps, transconnectors, transverse bars, rods and hooks. The implants are primarily manufactured from titanium (ASTM F67 - 06), titanium alloy (ASTM F1295 - 05), cobalt-chromium-molybdenum alloy (ASTM F1537 - 08) or nitinol (ASTM F2063 - 05), similar to the predicates.

The subject of this submission is the addition of transverse bars and tapered rods.

The document describes the Synthes Matrix System, a spinal fixation device. The study provided focuses on non-clinical performance testing rather than clinical trials with human subjects or AI performance.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The document states "Synthes conducted the following non-clinical testing..." but does not detail the number of units tested for each type of test.
• Data Provenance: The testing was non-clinical, conducted by Synthes. It does not involve human subjects, so concepts like country of origin or retrospective/prospective don't apply in the medical imaging sense.

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

• This question is not applicable to the provided document. The study is a non-clinical, mechanical performance test, not a study evaluating human judgment or diagnostic accuracy. The "ground truth" here is compliance with ASTM standards, not expert consensus on medical images or patient outcomes.

4. Adjudication method for the test set

• Not applicable. As noted above, this is a mechanical performance test, not a study involving human readers or adjudicators of medical data.

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 non-clinical performance study of a spinal fixation device, not a study involving AI or human readers of medical images.

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

• No. This is a non-clinical performance study of a spinal fixation device, not an algorithm.

7. The type of ground truth used

• The "ground truth" implicitly used for this non-clinical testing is the mechanical performance requirements specified in ASTM F1717–09 standards for static compression bend, static torsion, and dynamic compression bend testing. The device's performance was compared against these established industry standards and against predicate devices.

8. The sample size for the training set

• Not applicable. This is a non-clinical performance study of a physical device, not an AI algorithm that requires a training set.

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

• Not applicable for the same reason as point 8.

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The Savannah Lumbar Percutaneous Stabilization System (SLPSS) is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows:

When used as a pedicle screw fixation system of the posterior lumbar spine in skeletally mature patients, the SLPSS is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment. (2) fracture, (3) dislocation, (4) spinal tumor, and/or (5) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the SLPSS is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

The Savannah Lumbar Percutaneous Stabilization System (SLPSS) is also intended to provide immobilization and stabilization of the spinal segments of the lumbar and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment.

The Savannah Lumbar Percutaneous Stabilization System is comprised of a variety of pedicle screws sizes, couplers, a ball swivel, rods and locking nuts that can be uniquely fitted for each individual case. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-Eli).

The provided text is a 510(k) summary for the Savannah Lumbar Percutaneous Stabilization System (SLPSS). It describes the device, its indications for use, and how it demonstrates substantial equivalence to predicate devices. However, the document does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria.

Instead, the document states:

"The pre-clinical testing performed indicated that the Savannah Lumbar Percutaneous Stabilization System is substantially equivalent to predicate devices."

This implies that the device's performance was compared to existing, legally marketed devices (predicates) rather than against specific, predefined acceptance criteria through a standalone clinical or performance study with detailed metrics. The regulatory pathway chosen, a 510(k), relies on demonstrating "substantial equivalence" to a predicate device, which often involves comparing technical characteristics and performance data to show that the new device is as safe and effective as the predicate.

Therefore, for your request, the following information is largely not present in the provided text:

1. A table of acceptance criteria and the reported device performance: No specific acceptance criteria or performance metrics are listed.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance: Not applicable, as this is a surgical implant, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a surgical implant.
7. The type of ground truth used: Not applicable, as it's not a diagnostic device.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

Summary of available information:

• Device Name: Savannah Lumbar Percutaneous Stabilization System (SLPSS)
• Regulatory Pathway: 510(k) Premarket Notification (K072116)
• Claim of Performance: "The pre-clinical testing performed indicated that the Savannah Lumbar Percutaneous Stabilization System is substantially equivalent to predicate devices."
• Predicate Devices Listed:
  • Synthes USS Pedicle Screw System (K022949, K010108, K010658, K994121, K982987)
  • DePuy Moss Miami Spinal System (K022623, K983583, K964024, K955348, K933881)
  • U&I Optima Spinal System (K031585)
  • Stryker Spine Xia Spinal System (K001319, K984251, K951725)
• Nature of Testing: "Pre-clinical testing" was performed to demonstrate substantial equivalence, but details of this testing (e.g., in-vitro, mechanical, benchtop) are not provided in this summary.

Conclusion:

The provided document relies on showing substantial equivalence to predicate devices based on pre-clinical testing, rather than presenting a study with specific acceptance criteria as you've requested for a device that might involve diagnostic performance or AI. Therefore, most of the detailed information you are seeking is not available in this 510(k) summary.

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It is intended that this device, in any system configuration be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral screw indications are limited to the sacrum only.

1. The ZODIAC Polyaxial Pedicle Screw System, when used as a hook and sacral screw fixation system (nonpedicle screw) is intended for:
   a. Patients having fractures of the thoracic and lumbar spine.
   b. Patients having deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
   c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis).
2. The ZODIAC Polyaxial Pedicle Screw System, when used as a pedicle screw system in the thoraco-lumbo-sacral region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
3. In addition, the ZODIAC Polyaxial Pedicle Screw System, when used as a pedicle screw fixation system is intended for:
   a. Patients receiving only autogenous bone graft.
   b. Patients having the device fixed or attached to the lumbar and sacral spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.
4. The ZODIAC Polyaxial Pedicle Screw System, when used as a laminar hook and bone screw system is intended for:
   a. Patients having fractures of thoracic and lumbar spine.
   b. Patients having thoracolumbar deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
   c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolistheses and acute pars fracture allowing spondylolisthesis).

The ZODIAC Polyaxial Pedicle Screw System is comprised of various types and sizes of implantable components that are assembled to create a rigid spinal construct. System components are manufactured from titanium alloy, Ti6Al-4V ELI (ASTM F 136). System rods are available in titanium alloy or commercially pure titanium, CP Grade 4 (ASTM G67). The ZODIAC Polyaxial Pedicle Screw System is designed to facilitate optimal screw and rod placement.

The provided text describes a medical device, the ZODIAC Polyaxial Pedicle Screw System, and its clearance through the 510(k) pathway. This pathway establishes substantial equivalence to already marketed predicate devices, primarily through performance data demonstrating comparable safety and effectiveness.

However, the 510(k) summary does not contain the level of detail requested for a typical AI/software device study (e.g., acceptance criteria, test set sample size, expert ground truth, MRMC study, standalone performance). This is because the ZODIAC system is a mechanical implant, and its performance evaluation relies on different methodologies, primarily mechanical and dynamic testing, rather than clinical efficacy studies with human readers or AI algorithms.

Therefore, many of the specific questions cannot be answered from the provided document. I will extract what information is present and indicate where the requested information is not available.

Acceptance Criteria and Device Performance (Based on Provided Text)

The "acceptance criteria" for a mechanical device like the ZODIAC system are met by demonstrating structural integrity and comparable mechanical performance to predicate devices. The document focuses on demonstrating substantial equivalence rather than listing specific numerical acceptance criteria.

Missing Information: Specific numerical thresholds for mechanical strength, fatigue life, or other mechanical properties that would constitute "acceptance criteria" are not provided in this 510(k) summary. These would typically be found in detailed test reports, not the summary itself.

Study Details (Based on Provided Text)

1. Sample size used for the test set and the data provenance: Not applicable in the context of mechanical testing. The "test set" would refer to the number of devices or components tested. This number is not specified in the 510(k) summary. The data provenance would be from laboratory testing.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For mechanical testing of implantable devices, "ground truth" is established through physical measurement and engineering analysis, not expert interpretation of data relevant to AI performance.

3. Adjudication method for the test set: Not applicable. Mechanical testing results are objective measurements and do not typically require adjudication in the way clinical diagnostic interpretations do.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done. This type of study is relevant for diagnostic devices or AI algorithms that assist human readers in interpretation, which is not the function of a pedicle screw system.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No, this is not applicable. The device is a mechanical implant, not an algorithm.

6. The type of ground truth used: For mechanical performance, the ground truth is derived from direct physical measurements (e.g., load-to-failure, cycles to fatigue) obtained in laboratory settings according to established industry standards or internal protocols.

7. The sample size for the training set: Not applicable. As a mechanical device, there is no "training set" in the context of machine learning. The design and manufacturing processes are informed by engineering principles and prior device experience, not by a data-driven training set.

8. How the ground truth for the training set was established: Not applicable. See point 7.

Summary of Non-Applicability:

The requested detailed information regarding acceptance criteria, study sample sizes, expert ground truth, and AI-specific study methodologies (MRMC, standalone performance, training sets) is largely not applicable to the ZODIAC Polyaxial Pedicle Screw System as described in this 510(k) summary. This is because it is a physical medical implant, and its regulatory clearance relies on demonstrating substantial equivalence through mechanical and dynamic testing against predicate devices, rather than clinical efficacy studies involving diagnostic interpretations or AI performance. The provided text indicates that mechanical and dynamic testing was performed and that the results demonstrated comparability to predicate devices.

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