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510(k) Data Aggregation
(137 days)
Reform Pedicle Screw System
The Reform Pedicle Screw System is intended to provide immobilization and stabilization of spinal seqments 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 disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis; and/or lordosis); spinal tumor; pseudarthrosis; 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.
When used in conjunction with G21 V-Fast or V-Steady Bone Cement and PicoMix™ V and/or V-HP Gun with the G21 and Precision Spine Cement Cannula for mixing and injection of bone cements, the fenestrated Reform pedicle screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic, lumbar, or sacral spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The fenestrated Reform pedicle screws augmented with G21 V-Fast or V-Steady Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
The Reform Pedicle Screw System is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross-connectors, locking cap screws, hooks, dominoes, and lateral offsets. All of the components are available in a variety of sizes to match more closely the patient's anatomy. All components are made from medical grade stainless steel, cobalt chromium alloys, titanium alloy described by such standards as ASTM F158, ASTM F1537, ISO 5832-12, ASTM F136 or ISO 5832-3. The products are supplied clean and "non-sterile". The Fenestrated Screws allow the augmentation of PMMA bone cement to the insertion site. These modular Fenestrated Screws are assembled during surgery with the Reform Standard Modular Tulips or the Reform Reduction Modular Tulips which were cleared under K150856 and their compatible rods and set screws. The Fenestrated Screws are to be used with the G21 V-Fast Bone Cement or V-Steady Bone Cement cleared under K150408. Bone Cement is delivered into the pedicle screw and bone through the delivery instrumentation.
The provided text is a 510(k) summary for the Reform Pedicle Screw System. This document focuses on the mechanical testing and equivalence of a medical device, specifically a pedicle screw system, rather than a diagnostic AI/ML device that would have acceptance criteria related to classification metrics (e.g., sensitivity, specificity, AUC).
Therefore, the typical acceptance criteria and study design elements you're asking for (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) for an AI/ML device are not applicable to this submission.
Instead, the performance data provided is entirely about mechanical and material testing to demonstrate the physical characteristics and safety of the implanted device.
Here's a breakdown of the relevant information from the provided text, framed within the context of a traditional medical device submission, recognizing that it doesn't fit the AI/ML paradigm:
1. A table of acceptance criteria and the reported device performance:
The document describes performance testing rather than specific acceptance criteria in a tabular format with quantitative metrics for a pass/fail. However, it states the following tests were conducted:
| Test Mode | Description/Reported Performance |
|---|---|
| Dynamic Compression Bending | Performed per ASTM F1717 standard. The results "show that the performance of the Reform Pedicle Screw System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." |
| Bone Cement Injection Testing | Performed with the subject fenestrated screws. The testing "demonstrated successful injection of bone cement through the fenestrations." This test was conducted because of "difference in fenestration diameters and differences in quantity of fenestrations at the screw tip" compared to predicates, to ensure these differences "do not raise questions for safety and efficacy." |
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not specified in the summary. For mechanical testing, this would typically involve a specific number of test articles (e.g., screws, constructs) for each test.
- Data Provenance: The "study" is non-clinical mechanical bench testing performed according to ASTM standards. It's not human-centric data, so concepts like "country of origin" or "retrospective/prospective" studies are not applicable.
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 is established by engineering specifications, standard ASTM testing methodologies, and objective mechanical measurements. It does not involve expert readers reviewing images or clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication is relevant for subjective expert reviews, not for objective mechanical testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a physical implant, not an AI-powered diagnostic tool. MRMC studies are used to evaluate the diagnostic performance of AI or imaging modalities.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. There is no algorithm or AI component in this device. The testing is entirely for the physical device's characteristics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this type of device is established by engineering standards and physical test methodologies (e.g., ASTM F1717 for spinal implant constructs). The performance is measured against these established standards and compared to legally marketed predicate devices.
8. The sample size for the training set:
- Not applicable. This device does not involve machine learning; therefore, there is no training set.
9. How the ground truth for the training set was established:
- Not applicable. There is no training set for this type of device.
In summary, the provided document details the substantial equivalence of a physical medical implant through mechanical testing, not the performance claims or evaluation of an AI-powered diagnostic device.
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(103 days)
Reform Pedicle Screw System
The Reform Pedicle Screw System is intended for immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion. The Reform Pedicle Screw System is to be used with autograft and/or allograft.
When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Reform Pedicle Screw System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis. Additionally, the Reform Pedicle Screw System is intended to treat pediatric patients diagnosed with spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This 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. The pedicle screws are included with or without hydroxyapatite (HA) coating
The provided text is a 510(k) Summary for the "Reform Pedicle Screw System" and does not contain information about acceptance criteria for an AI/ML device or a study proving that an AI/ML device meets those criteria.
Instead, this document is a regulatory submission for a physical medical device (pedicle screws) and details its substantial equivalence to previously cleared predicate devices. The evaluation focuses on materials, design, intended use, dimensions, and mechanical strength, primarily through non-clinical (bench) testing.
Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device based on the given input. The requested categories of information (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are relevant to AI/ML device evaluations but are not present in this document about a traditional implantable medical device.
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(85 days)
Reform Pedicle Screw System
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; degenerative disc disease (DDD); 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 pedicle screws are included with or without hydroxyapatite (HA) coating.
This document is a 510(k) premarket notification for the "Reform Pedicle Screw System" by Precision Spine, Inc. It seeks to add hydroxyapatite (HA) coated pedicle screws to an already cleared system. As such, the document focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a novel study evaluating the performance against specific acceptance criteria.
Therefore, many of the requested elements for describing a study proving the device meets acceptance criteria are not present in this document. This submission relies on substantial equivalence and clinical literature assessment, not a dedicated performance study with specific acceptance criteria.
However, I can extract and infer some information based on the provided text:
1. A table of acceptance criteria and the reported device performance
This document does not present specific acceptance criteria in the typical sense (e.g., a specific numerical threshold for a performance metric). Instead, the "acceptance criteria" for a 510(k) submission is substantial equivalence to legally marketed predicate devices. The "reported device performance" in this context is the assertion that the device is substantially equivalent based on its technological characteristics and a clinical literature assessment.
| Acceptance Criteria (Implied for 510(k) Substantial Equivalence) | Reported Device Performance |
|---|---|
| Technological Characteristics: The subject device must have sufficiently similar technological characteristics to the predicate device(s) such that any differences do not raise new questions of safety or effectiveness. | "The intended use and technological features of the modifications/additions to the components of the PSS System (Reform Pedicle Screw System) do not substantially differ from the legally marketed predicate devices..." |
| "The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness." | |
| Specifically, identical indications for use, materials of manufacture, structural support mechanism, and sterilization are cited. | |
| Performance Data: If performance data is used to demonstrate equivalency, it must support the claim that the device is as safe and effective as the predicate. | "Analysis was performed to show that the subject devices are substantially equivalent to the predicate devices and do not require additional mechanical testing." |
| "To support substantial equivalence, a clinical literature assessment was conducted using published clinical data for pedicle screw fixation. The assessment concluded that pedicle screw fixation is safe and effective for use in pediatric patients." | |
| Indications for Use: The subject device must have the same or similar indications for use as the predicate device(s). | "Indications for Use" are listed and stated as identical between the subject and 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)
- Sample Size: Not applicable. This submission relies on a "clinical literature assessment" and "mechanical engineering analysis" to demonstrate substantial equivalence, not a specific test set. The literature assessment would draw from numerous studies, each with its own sample size.
- Data Provenance: The general provenance of the data would be from "published clinical data for pedicle screw fixation." The specific country of origin or whether it's retrospective or prospective is not detailed in this document, as it refers to a broad body of existing literature.
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. No "test set" and no "ground truth" were established by experts for this submission in the context of a performance study. The expertise involved would be in the "clinical literature assessment" but the number and qualifications of those performing that assessment are not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No "test set" or adjudication method described for performance evaluation.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted device, and no MRMC study was conducted. This is a spinal implant system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm, but a physical medical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable to a performance study with a test set. The "ground truth" for the submission's argument of substantial equivalence rests upon:
- The known safety and effectiveness of the predicate devices.
- The conclusion drawn from the "clinical literature assessment" that "pedicle screw fixation is safe and effective for use in pediatric patients" (which would be based on outcomes data, expert consensus, etc., from the reviewed literature).
8. The sample size for the training set
Not applicable. No "training set" is relevant here, as this is not a machine learning model.
9. How the ground truth for the training set was established
Not applicable. No "training set" is relevant here.
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(98 days)
Reform Pedicle Screw System
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.
Ask a specific question about this device
(37 days)
Reform Pedicle Screw System
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.
This document is a 510(k) premarket notification for the Reform Pedicle Screw System and does not provide acceptance criteria and detailed study data for a device's performance against specific metrics. Instead, it focuses on demonstrating substantial equivalence to previously cleared predicate devices.
Therefore, many of the requested sections regarding detailed acceptance criteria, specific performance tables, sample sizes for test and training sets, ground truth establishment, expert qualifications, and MRMC studies cannot be answered from the provided text. This document is a regulatory submission, not a research paper detailing the performance of an AI/ML-based medical device.
However, I can extract information related to the device itself and the general nature of the evidence provided for substantial equivalence, as well as highlight what information is missing.
The device in question is the "Reform Pedicle Screw System," a spinal implant, not an AI/ML diagnostic or measurement device. The "performance data" mentioned refers to mechanical engineering analysis to demonstrate substantial equivalence, not clinical performance metrics in the way AI models are evaluated.
Here's an analysis based on the provided text, addressing the points where information is available and noting where it is absent for AI/ML device evaluation:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail metrics for a specific performance study in the way an AI algorithm would have. The "acceptance" in this context is regulatory clearance based on substantial equivalence.
- Reported Device Performance: No specific numerical performance metrics (e.g., sensitivity, specificity, accuracy, precision) are reported for this device in the provided document. The performance is implied by its "substantial equivalence" to predicate devices, meaning it performs similarly in its mechanical function.
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. This document describes a mechanical device (pedicle screw system), not a software or AI device that would have a "test set" in the context of clinical data. The "tests" mentioned are mechanical analyses. The document does not specify details about these mechanical tests such as the number of devices tested or their origin, beyond stating "Analysis was performed."
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 is a mechanical spinal implant, there is no "ground truth" to be established by experts in the context of diagnostic accuracy. "Ground truth" for this device would relate to its physical properties, biocompatibility, and mechanical strength, typically evaluated through engineering standards and testing, not expert clinical interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No expert adjudication is described as the device is not based on interpreting clinical images or data that would require such a process.
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 hardware device (pedicle screw system), not an AI-assisted diagnostic or treatment planning tool. Therefore, an MRMC study related to AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical spinal implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the AI/ML sense. For a physical device like a pedicle screw system, "ground truth" generally refers to adherence to established engineering standards (e.g., ASTM, ISO for materials and mechanical properties) and proven clinical performance of predicate devices. The document implies reliance on these standards and the known safety and efficacy of the predicate devices for achieving substantial equivalence.
8. The sample size for the training set
- Not applicable. This is a mechanical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. (See point 8)
Summary of what the document does describe (relevant to substantial equivalence):
The document K143248 describes the Reform Pedicle Screw System and its submission for 510(k) clearance by Precision Spine, Incorporated.
Device Description:
The Reform System is a top-loading, multiple component, posterior spinal fixation system consisting of pedicle screws, rods, cross-connectors, locking cap screws, hooks, domino connectors, and lateral offset connectors. Components are made from medical-grade stainless steel, cobalt chromium alloys, titanium, or titanium alloy conforming to standards like ASTM F138, ASTM F1537, ISO 5832-12, ASTM F136 or ISO 5832-3. The implants are provided non-sterile with instructions for sterilization.
Change from Predicate:
The primary purpose of this specific 510(k) submission (K143248) is to:
- Make modifications to the indications for use.
- Add additional sizes to the already cleared PSS (Reform Pedicle Screw System) devices (referenced by K131343, K130279, K121172, K092128, K090033, K073240, and K071438).
Technological Characteristics for Substantial Equivalence:
The document states that the intended use and technological features of the modifications/additions do not substantially differ from the legally marketed predicate devices.
Specifically, the following characteristics are identical between the subject and predicates:
- Materials of manufacture
- Structural support mechanism
- Sterilization
Predicate Devices:
- Primary: PSS System (Reform Pedicle Screw System) from Precision Spine (Spinal USA) - multiple 510(k) numbers listed.
- Additional: Polaris Spinal System from Biomet Spine - K133746, K131615.
Performance Data (for Substantial Equivalence):
"Analysis was performed to show that the subject devices are substantially equivalent to the predicate devices and do not require additional mechanical testing." This implies that the engineering and material specifications of the new sizes and modifications were compared against the established mechanical performance of the predicate devices. This type of "performance data" is typically bench testing and material characterization to ensure the new components meet the safety and efficacy profiles of the established devices.
Conclusion:
The overall technology characteristics and mechanical engineering analysis led to the conclusion that the Reform Pedicle Screw System is substantially equivalent to the predicate device. This conclusion is a regulatory determination, not a clinical performance metric.
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(76 days)
REFORM PEDICLE SCREW SYSTEM
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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The ReForm Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: 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. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis; and/or lordosis) spinal tumor; pseudloarthrosis; and failed previous fusion.
The Reform System is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross-connectors, locking cap screws, and cross 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the ReForm Pedicle Screw System:
Based on the provided 510(k) summary, the device is a ReForm Pedicle Screw System, which is a medical device and not an AI/ML-based diagnostic or imaging device. Therefore, the questions related to AI/ML specific performance evaluation metrics, ground truth establishment for AI/ML models, and training/test set sample sizes in the context of AI/ML are not applicable.
The document describes a traditional medical device submission focusing on substantial equivalence to predicate devices, primarily through engineering analysis.
Description of Acceptance Criteria and Study:
The "acceptance criteria" for this device, in the context of a 510(k) submission, are met by demonstrating substantial equivalence to legally marketed predicate devices. The primary method used to prove this is through performance evaluation based on engineering analysis.
Essentially, the device is "accepted" if it can show that its technological characteristics and performance are comparable to (or do not represent a worst-case scenario compared to) already cleared devices with the same intended use.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied for 510(k) Equivalence) | Reported Device Performance |
|---|---|
| Mechanical Performance: Device components (pedicle screws, rods, cross-connectors, locking cap screws) must meet established mechanical and material standards for spinal fixation. | Engineering analysis was performed to show that the subject devices are substantially equivalent to the predicate devices and do not represent a new worst-case. |
Components are made from medical grade stainless steel, cobalt chromium alloys, titanium or titanium alloy described by standards such as ASTM F138, ASTM F1537, ISO 5832-12, ASTM F136 or ISO 5832-3. |
| Biocompatibility: Materials used must be biocompatible for implantation. | Materials are standard medical grade alloys (stainless steel, cobalt chromium, titanium/titanium alloy), implying accepted biocompatibility that is equivalent to predicate devices. |
| Fit and Function: New designs and sizes (specifically additional cross connectors) must integrate properly and maintain the intended function of the system. | The purpose of the submission is to make modifications by adding "an additional design and sizes of cross connectors." The engineering analysis confirms these modifications "do not substantially differ from the legally marketed predicate devices." |
| Intended Use: The device must perform effectively for its stated indications. | The intended use and technological features of the modifications/additions "do not substantially differ from the legally marketed predicate devices." The device is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for a range of spinal instabilities and deformities, consistent with the predicates. |
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 applicable in the traditional sense of a clinical or imaging study. The "test set" here refers to the specific modifications (additional design and sizes of cross connectors) and existing components that underwent engineering analysis. The number of physical units or designs tested is not specified but would typically involve a sufficient number to validate mechanical properties.
- Data Provenance: Not applicable. The "data" comes from engineering tests and material specifications, not from patient data or clinical trials.
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 is not applicable for this type of device submission. There is no "ground truth" established by medical experts for a test set in a clinical or diagnostic context. The ground truth for mechanical performance relies on established engineering principles, material science, and regulatory standards. Experts involved would be engineers and material scientists conducting the tests and analyses. Their qualifications are not specified in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or reader studies where human interpretation or diagnostic accuracy is being assessed. This submission focuses on engineering equivalence.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI/ML device, nor is it a diagnostic tool where human readers' performance with/without AI assistance would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" in this context refers to established engineering standards, material specifications, and the mechanical performance of the predicate devices. The new device's components are evaluated against these validated benchmarks.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. Since there is no training set, the establishment of its ground truth is irrelevant.
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(135 days)
REFORM PEDICLE SCREW SYSTEM
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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The ReForm Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3and 4of 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. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis) spinal tumor; pseudloarthrosis; and failed previous fusion.
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 describes a 510(k) premarket notification for the ReForm Pedicle Screw System, specifically focusing on modifications and additions to its components. This type of submission is for medical devices, not AI/ML algorithms, and therefore the concepts of acceptance criteria, study design for performance evaluation, sample sizes, expert ground truth, adjudication methods, MRMC studies, or training sets do not apply in the way they would for a software-as-a-medical-device (SaMD) or AI-driven diagnostic tool.
The study described is a mechanical performance test for physical implant components, not a clinical or AI performance study.
Here's a breakdown of the relevant information from the provided text, adapted as much as possible to the requested format, to highlight why most of the questions are not applicable:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not create a new worst-case construct per ASTM F1717-12 (dynamic axial compression) | "proved to not create a new worst-case construct." |
Study Details (Mechanical Performance Testing)
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Sample size used for the test set and the data provenance: This refers to the number of physical components tested in dynamic axial compression. The specific number of components/constructs tested is not explicitly stated in the provided text. The data provenance is mechanical testing conducted according to ASTM F1717-12 standards, likely in a laboratory setting.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on engineering standards and measurements, not expert consensus as in diagnostic imaging.
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Adjudication method for the test set: Not applicable. Mechanical testing involves objective measurements against predefined standards.
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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 study is for a physical orthopedic implant system, not a diagnostic AI/ML system.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
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The type of ground truth used: For mechanical performance, the "ground truth" is defined by the objective measurements obtained through the specified test method (dynamic axial compression) and the compliance with the ASTM F1717-12 standard, particularly its requirements for not creating a "new worst-case construct" compared to predicate devices.
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The sample size for the training set: Not applicable. There is no concept of a "training set" for this type of mechanical device testing.
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How the ground truth for the training set was established: Not applicable. There is no training set.
Conclusion from the text: The study indicates that the modified ReForm Pedicle Screw System maintains substantial equivalence to its predicate devices based on its mechanical performance. The performance data, specifically the dynamic axial compression testing per ASTM F1717-12, showed that the changes did not introduce a new worst-case construct, thus meeting the required standard for this type of device modification.
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(113 days)
REFORM PEDICLE SCREW SYSTEM
The ReForm Pedicle Screw System is intended to provide immobilization and stabilization of spinal re relevels in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and obginonic in sittlies or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spiral tumor, and failed previous fusion (pseudarthrosis).
The ReForm Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4 of the L5-S1 vertebra in skeletally mature patiently includion 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. It is also intended opine (Le to Gaeran) man reveal (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis) spinal tumor; pseudoarthrosis; and failed previous fusion.
The ReForm Pedicle Screw System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross links, locking cap screws. All of the components are available in a variety of sizes to match more closely the patient's anatomy.
The ReForm Pedicle Screw System is a medical device, and the provided text is a 510(k) summary for its clearance. Medical devices, especially implants like pedicle screw systems, typically demonstrate performance through mechanical testing rather than clinical studies or AI algorithm evaluations. Therefore, many of the requested categories related to AI performance, expert consensus, and human reader studies are not applicable to this device submission.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Type) | Reported Device Performance (Results) |
|---|---|
| Static compression per ASTM F1717 | Equivalent to predicate device(s) |
| Dynamic compression per ASTM F1717 | Equivalent to predicate device(s) |
| Static torsion per ASTM F1717 | Equivalent to predicate device(s) |
Note: The specific quantitative acceptance limits (e.g., minimum load, cycles to failure) are not provided in this 510(k) summary, but the general outcome is stated as "equivalent to predicate device(s)". Equivalence implies that the ReForm Pedicle Screw System achieved performance comparable to, or better than, the predicate devices in these mechanical tests.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. For mechanical tests, the "sample size" refers to the number of test specimens (e.g., screw constructs, rod-screw assemblies) subjected to testing. This information is typically found in the full test report, not usually in the 510(k) summary.
- Data Provenance: Not applicable in the context of geographical origin or retrospective/prospective clinical data, as this concerns mechanical testing of manufactured components. The data originates from non-clinical laboratory testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable. This device is evaluated using objective mechanical engineering tests (ASTM F1717). There is no "ground truth" in the sense of expert medical diagnosis or interpretation required for these performance assessments. The performance is determined by physical measurements and engineering standards.
4. Adjudication Method for the Test Set
- Not applicable. As the performance is determined by objective mechanical testing against engineering standards, there is no need for an adjudication method by medical experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. The document explicitly states: "No clinical studies were performed." Therefore, no MRMC study was conducted.
- Effect Size of Human Readers with AI vs. Without AI Assistance: Not applicable, as this is a mechanical spinal fixation system, not an AI-driven diagnostic or assistive device for human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No. This is a hardware medical device, not a software algorithm. Therefore, a standalone algorithm performance study is not applicable.
7. Type of Ground Truth Used
- Engineering Standards and Predicate Device Performance. The "ground truth" for this device's performance is established by its ability to meet standardized mechanical test requirements (ASTM F1717) and demonstrate equivalence to the performance of previously cleared predicate devices.
8. Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm that requires a training set. Its design and materials undergo engineering validation.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, this device does not utilize a "training set" in the context of AI/ML. The "ground truth" for its design and materials is established through engineering principles, material science, and compliance with relevant ASTM standards.
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