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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 F1 - Modular Pedicle Screw System (F1-MPS) is intended for posterior, noncervical pedicle fixation (T1-S1) 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: severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal stenosis, fracture, dislocation, scoliosis or kyphotic deformities, spinal tumor, Schuermann's disease, and failed previous fusion.

The F1-MPS is intended for posterior, noncervical pedicle fixation (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment.

The F1-MPS is also intended for posterior, non-cervical fixation in pediatric patients indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft and/or allograft.

The F1-Modular Pedicle Screw System is composed of cannulated and non-cannulated pedicle screws which are designed to accept a 5.5mm rod and are available in various sizes. The components can be rigidly assembled in a variety of constructs, each corresponding to the needs and anatomy of a specific patient. The system is provided in both sterile and non-sterile versions. The system is constructed from Titanium and Titanium alloy (Ti-6Al-4V ELI) per ASTM F136 and F67 or cobalt-chromium-molybdenum per ASTM F1537.

This document is a 510(k) premarket notification for a medical device called the "F1-Modular Pedicle Screw System". It's not a study proving device performance against acceptance criteria in the way you're asking about for an AI/software device. This document is for a mechanical implant, and the "acceptance criteria" and "study" described are for non-clinical mechanical testing to demonstrate substantial equivalence to existing devices.

Therefore, many of your requested points (like sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set size, etc.) are not applicable to this type of medical device submission.

However, I can extract the relevant information regarding the non-clinical performance testing and substantial equivalence.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For this mechanical device, "acceptance criteria" are typically defined by recognized standards such as ASTM F1717 and ASTM F543, and the performance is demonstrated by meeting or exceeding the performance of predicate devices. Specific quantitative acceptance criteria are not provided in this summary, but the conclusion states the device meets or exceeds the performance of predicate devices.

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

• Sample Size: Not explicitly stated in this summary. For mechanical testing per ASTM standards, specific sample sizes are prescribed, but the exact number of screws/constructs tested is not given here.
• Data Provenance: Not applicable in the context of clinical data. This refers to laboratory-based mechanical testing.

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 this context refers to established mechanical testing standards and the comparison to predicate devices, not expert human interpretation of data for an AI.

4. Adjudication Method for the Test Set

Not applicable. This is mechanical testing against engineering standards.

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

No. This is not an AI/diagnostic imaging device.

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

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

7. The Type of Ground Truth Used

The "ground truth" for this device is based on established ASTM mechanical testing standards (F1717, F543) and the performance of existing, legally marketed predicate devices. The goal is to show substantial equivalence, meaning it performs at least as well as, if not better than, comparable devices already on the market.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" for this type of mechanical device.

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

Not applicable. There is no "training set."

Summary for this specific document related to your request:

This document describes a non-clinical performance testing study for a mechanical pedicle screw system. The purpose of the study was to demonstrate substantial equivalence to existing predicate devices based on recognized ASTM standards for mechanical testing. The "acceptance criteria" are implied by these standards and the performance of the predicate devices, which the subject device was found to meet or exceed. There are no elements related to AI, software performance, human reader studies, or ground truth derived from expert consensus on clinical data.

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When used as a pedicle screw fixation system in skeletally mature patients, the NGarde 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 lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment and kyphosis.

In addition, when used as a pedicle screw fixation system, the NGarde System is indicated 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.

The NGarde System is a posterior, non-cervical instrumentation system consisting of both pedicle screws and connecting rods. Screws are of polyaxial top-loading design, are composed of titanium 6Al-4V alloy or titanium 6A1-7Nb, and are available in a range of diameters and lengths to accommodate physiological requirements. The rods are composed of titanium 6A104V alloy and synthetic polycarbonate urethane (PCU) polymer, are 6.0mm in diameter, and are also available in a range of lengths, from 40mm to 200mm.

The modification which is the subject of this Special 510(k) consists of the addition to the NGarde System of two alternate pedicle screws, offered in commercial distribution, which may be used at the physician's discretion as an alternative to the NGarde Systems screws. These alternative pedicle screws are similar and comparable to the NGarde screws and are available in a range of diameters and lengths.

The provided document describes the NGarde System, a pedicle screw system, and its 510(k) summary for a modification. The document explicitly states that no clinical testing was conducted to support this submission. Therefore, it does not contain the detailed information requested regarding device performance, sample sizes, expert involvement, or comparative effectiveness studies.

However, it does provide some information about non-clinical performance and a general statement about acceptance criteria.

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

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

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. The document only mentions "verification and validation tests."
• Data Provenance: Not specified, as no clinical testing was conducted.

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

• This information is not applicable as no clinical testing was performed, and thus no "ground truth" was established in a clinical context for a test set. The validation was based on non-clinical performance data.

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

• Not applicable as no clinical testing 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

• No MRMC study was done. The device is a physical pedicle screw system, not an AI-powered diagnostic or assistive tool for human readers.

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

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

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

• Not applicable for clinical ground truth. For the non-clinical verification and validation, the "ground truth" would be defined by engineering specifications, material properties, and biomechanical standards against which the device performance was measured.

8. The sample size for the training set

• Not applicable as this is a physical medical device, not an AI/ML algorithm requiring a training set.

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

• Not applicable.

Summary of the Study:

The study referenced for the NGarde System's modification (a Special 510(k)) was primarily a non-clinical performance evaluation. The document states:

• "Non-Clinical Performance and Conclusions: Such verification and validation tests were identified as appropriate to address the results of a risk analysis for the subject Modification were completed, and met all acceptance criteria."
• "Clinical Performance: No clinical testing was conducted to support this submission."

Therefore, the "study" demonstrating that the device meets acceptance criteria was a series of non-clinical verification and validation tests. These tests were designed to address potential risks associated with the modification (addition of two alternate pedicle screws) and ensure that the modified system performed comparably to its predicate devices in terms of mechanical and material properties, as defined by "rigorous design control and risk analysis procedures." The specific acceptance criteria and detailed test results are not provided in this summary but were presumably part of the comprehensive submission to the FDA.

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The Synthes USS (including the Click'X®, and USS VAS variable axis components, and Pangea™), Click'X® Monoaxial, Dual-Opening and the Small Stature USS (which includes small stature and pediatric patients) are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2), a posterior hook fixation system (T1-L5), or as a anterolateral fixation system (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS. 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, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion.

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 (including the Click'X® and, USS VAS variable axis components, and Pangea™), Click'X® Monoaxial and Dual-Opening USS can be linked to the CerviFix® System. In addition, when used with 3.5/5.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS (including the Click'X®, and USS VAS variable axis components, and Pangea™), the Click' X® Monoaxial and Dual-Opening USS Systems.

In addition, Synthes USS (including the Click'X®, and USS VAS variable axis components, and Pangea™), Click'X® Monoaxial and the Dual-Opening USS can be interchanged with all USS 6.0 mm rods and transconnectors

The PangeaTM System is similar to the cleared Click'X (K992739). Both are components of the Universal Spinal System (USS).

The Pangea System includes polyaxial dual-core screws and a non threaded quarter turn in design locking cap.

The Synthes Pangea polyaxial screws and locking cap are fabricated from commercially pure titanium and titanium alloy, conforming to ASTM F67 and ASTM F-1295 respectively.

This document is a 510(k) summary for the Pangea™ System, a spinal fixation device. It describes the device, its intended use, and its classification, but it does not contain information about acceptance criteria or a study proving the device meets those criteria.

The provided text focuses on:

• Device Identification: Firm name, contact, trade name, common name, product codes, classification, and predicate device.
• Device Description: What the Pangea™ System is comprised of (polyaxial dual-core screws, non-threaded quarter-turn locking cap) and the materials used.
• Intended Use/Indications for Use: A detailed list of conditions and anatomical locations for which the device is intended (e.g., degenerative disc disease, spondylolisthesis, trauma, deformities, tumor, stenosis, pseudoarthrosis, failed previous fusion), and some limitations (e.g., pedicle screw fixation limited to skeletally mature patients, restrictions on transverse bars for DDD, interoperability with other systems).
• FDA Clearance Letter: Confirmation from the FDA that the device is substantially equivalent to a legally marketed predicate device.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving their fulfillment based solely on the provided text. The requested information (acceptance criteria table, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC study details, standalone performance, and training set information) is entirely absent from this 510(k) summary.

In summary, the provided content is a regulatory submission for device clearance, not a performance study report.

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