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510(k) Data Aggregation
(29 days)
MODIFICATION TO ISOLA SPINAL SYSTEM
The ISOLA Spinal System is a pedicle screw system 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 (pseudarthrosis).
The ISOLA Spinal 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 ISOLA Spinal System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with deqeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).
The ISOLA Spinal System when used with pedicle screws is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.
The additional ISOLA Spinal components are connectors, open and closed iliac screws, iliac bolts, and anqled closed iliac screws. These components have been designed to allow for rigid fixation of the sacral, iliac and pelvic regions of the spine. The ISOLA Spinal System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
The provided text is a 510(k) summary for the ISOLA Spinal System, a medical device. It describes the device, its intended use, and indicates that performance data was submitted. However, it does not contain specific acceptance criteria or a detailed study description to prove the device meets said criteria.
The document states: "PERFORMANCE Performance data were submitted to characterize the DATA: ISOLA Spinal System components." This indicates that performance testing was conducted and the results were provided to the FDA, but the summary itself does not elaborate on the specific tests, criteria, or outcomes.
Therefore, I cannot provide the requested information based solely on the input text. The information regarding acceptance criteria, study details, sample sizes, ground truth, and expert qualifications is not present in this document.
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(19 days)
CROSSOVER CROSS CONNECTOR (ISOLA SPINAL SYSTEM)
The ISOLA Spinal System is a pedicle screw system 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 (pseudarthrosis).
The ISOLA Spinal 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 ISOLA Spinal System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).
The ISOLA Spinal System when used with pedicle screws is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.
The CrossOver Cross Connector is designed to transversely connect two rods used in spinal instrumentation constructs. The connector minimizes the torsional forces on the construct, thus reducing the micromotion and the probability of the construct shifting after placement. It is designed to accommodate the 4.75mm and 6.35mm spinal rods of the ISOLA Spinal System
The provided text is a 510(k) summary for the CrossOver Cross Connector. It describes the device, its intended use, and indicates that performance data was submitted, but it does not explicitly detail acceptance criteria or the specific study that proves the device meets those criteria, especially in a way that aligns with AI/ML device testing standards.
The document is from 2002, which predates the widespread use of AI/ML in medical devices and the associated regulatory requirements for describing AI/ML performance evaluation studies. Therefore, many of the requested fields related to AI/ML device testing (e.g., sample size for test/training sets, expert adjudication methods, MRMC studies, standalone performance) are not applicable or not present in this type of regulatory submission.
Based on the information provided, here's what can be extracted and what cannot:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the provided text. The document states "Performance data were submitted to characterize the CrossOver Cross Connector," but does not detail the criteria or the results. | Not explicitly stated in the provided text. The document indicates that the device was found substantially equivalent to predicate devices, implying its performance was considered acceptable for its intended use. |
2. Sample size used for the test set and the data provenance:
- Sample size: Not applicable/Not provided. The "performance data" mentioned likely refers to mechanical testing or other non-clinical evaluations rather than a clinical "test set" in the context of AI/ML.
- Data provenance: Not applicable/Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a mechanical implant; it does not involve expert interpretation for establishing a ground truth in the way an AI/ML diagnostic or prognostic device would.
4. Adjudication method for the test set:
- Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a mechanical device, not an AI-assisted diagnostic tool.
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:
- For a mechanical device like this, ground truth would typically relate to established engineering standards (e.g., material strength, fatigue life, mechanical stability) and biomechanical testing results rather than clinical "ground truth" derived from patient outcomes or expert consensus. The document does not specify the exact nature of the performance data, but it likely involved bench testing confirming structural integrity and biomechanical properties.
8. The sample size for the training set:
- Not applicable. This is a mechanical device, not an AI/ML algorithm.
9. How the ground truth for the training set was established:
- Not applicable.
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(30 days)
ISOLA SPINAL SYSTEMS
The ISOLA Spine System is a pedicle screw system 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 (pseudarthrosis).
The ISOLA Spine 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 ISOLA Spine System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).
The ISOLA Spinal System when used with pedicle screws is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.
The CrossOver Cross Connector is designed to transversely connect two rods used in spinal instrumentation constructs. The connector minimizes the torsional forces on the construct, thus reducing the micromotion and the probability of the construct shifting after placement.
The provided text is a 510(k) summary for the ISOLA Spine System and primarily focuses on its intended use, materials, and substantial equivalence to predicate devices. It states that "Performance data were submitted to characterize the CrossOver Cross Connector," which is part of the ISOLA Spine System. However, the document does not detail specific acceptance criteria or the study that proves the device meets those criteria, nor does it provide performance metrics.
Therefore, I cannot populate most of the requested tables and sections with the information available in the given text.
Here's a breakdown of what can and cannot be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. | Not specified in the document. |
The document broadly states: "Performance data were submitted to characterize the CrossOver Cross Connector." However, it does not provide details on what those performance data were, what the acceptance criteria for those data were, or the actual results.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not specified in the document. The document mentions "Performance data were submitted," but gives no details about the sample size, type of study (e.g., in vitro, in vivo), 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 specified in the document. This type of information is usually relevant for studies involving subjective assessment (e.g., image interpretation for AI devices). For a spinal fixation system, performance data would likely involve mechanical testing, not expert assessment of ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not specified in the document. As above, this is typically for studies involving subjective data interpretation, which is not described for this 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 specified in the document. This device is a physical spinal implant, not an AI or imaging device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/Not specified in the document. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not specified in the document. For a mechanical device, "ground truth" would likely be based on physical measurements of strength, fatigue, stability, etc., against predefined engineering standards. The document only mentions "Performance data were submitted to characterize the CrossOver Cross Connector" without elaborating on the type of data or how "truth" was established.
8. The sample size for the training set
Not applicable/Not specified in the document. This is a physical medical device. The concept of a "training set" typically applies to AI/machine learning models, which is not relevant here.
9. How the ground truth for the training set was established
Not applicable/Not specified in the document. As above, this is not relevant for a physical medical device.
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(113 days)
MODIFICATION TO ISOLA SPINAL SYSTEM
The Posterior ISOLA Spinal System, when used with pedicle screws, is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.
The Posterior ISOLA Spinal System is also indicated for pedicle screw fixation for severe spondylolisthesis (Grades 3 and 4) at L5-S1, when autogenous bone graft is used, when affixed to the posterior lumosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.
The Posterior ISOLA Spine System, when not used with pedicle screws, is intended for hook, wire, and/or sacral/iliac screw fixation from T1 to the ilium/sacrum. The nonpedicle screw indications are spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture, and previous failed fusion surgery.
The Anterior ISOLA Spine System is intended for use in correcting scolictic, lordotic or kyphotic spinal deformities by establishing an axially and rotationally rigid fixation bridge parallel to the long axis of the system is indicated in situations where loss of correction is expected, where severe scoliosis exists or where pelvic obliquity is present.
The Anterior ISOLA Spine System is used for the correction and stabilization of scoliotic curves, for the prevention or recurrence of undesired scoliotic curves, and for the stabilization of weakened trunks. Specific indications include:
- Collapsing and unstable paralytic deformity
- Progressively increasing scollosis.
- Decreasing cardio-respiratory function, secondary to spinal or rib deformity or collapse.
- Inability to maintain sitting balance, necessitating the use of the hands.
- Increasing pelvic obliquity coincident with back pain or loss of sitting balance.
- Spinal fractures (acute reduction or late deformity).
- Degenerative Disc Disease (Defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).
- Spinal turnor.
- Previous failed fusion surgery.
Spinal levels for Anterior ISOLA are from T5-L4.
The primary purpose of this premarket notification is to add indications to the marketing clearance for the pedicle screws which may be used as a spinal anchor in the ISOLA Spinal System. The ISOLA Spine System is manufactured from either stainless steel conforming to ASTM F-138 or F-1314 specifications, or titanium alloy conforming to ASTM F-136 specifications.
Here's an analysis of the provided text regarding the ISOLA Spinal System's acceptance criteria and studies:
Based on the provided document, the "ISOLA Spinal System" is a medical device, specifically a spinal fixation system, cleared through a 510(k) premarket notification process. This process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to prove efficacy and safety in the same way a PMA (Premarket Approval) submission would.
Therefore, the "acceptance criteria" and "study" described in the input refer to the performance data provided to demonstrate substantial equivalence to previously cleared devices, not a clinical study proving device performance against specific, pre-defined outcome criteria in a patient population.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria (Implicit - based on 510(k) requirements for spinal fixation systems):
For spinal fixation systems in a 510(k) submission, the primary acceptance criteria for performance data revolve around demonstrating that the mechanical properties of the new device are at least equivalent to or better than those of previously cleared predicate devices under similar testing conditions. This typically involves:
- Static Mechanical Performance: Ability to withstand applied loads without permanent deformation or failure.
- Fatigue Mechanical Performance: Ability to withstand cyclic loading for a specified number of cycles without failure, simulating the stresses of in vivo use over time.
Reported Device Performance:
| Acceptance Criteria Category | Specific Metric (Implicit) | Reported Performance |
|---|---|---|
| Mechanical Performance | Static strength and resistance to deformation | "perform consistently with previously cleared components" |
| Durability/Longevity | Fatigue life under cyclic loading (e.g., number of cycles) | "perform consistently with previously cleared components" |
| Material Compatibility | Biocompatibility and material properties | Conforming to ASTM F-138/F-1314 (stainless steel) or ASTM F-136 (titanium alloy) specifications. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in terms of the number of device constructs tested. The description simply refers to "constructs of the ISOLA Spinal System."
- Data Provenance: Not explicitly stated. This "performance data" refers to in-vitro mechanical testing, not clinical data from patients. Therefore, terms like "country of origin" or "retrospective/prospective" are not applicable in this context.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. The performance data is based on engineering mechanical tests, not expert interpretation of clinical data or images.
4. Adjudication Method for the Test Set
- Not applicable. As this involves mechanical testing, there is no "adjudication method" in the sense of reconciling different expert opinions. The outcome is determined by physical measurements and material science principles.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This document describes a 510(k) submission for a spinal implant, which relies on mechanical testing to demonstrate substantial equivalence, not clinical effectiveness studies comparing human readers with and without AI. AI is not mentioned in this document.
6. Standalone Performance (Algorithm Only)
- No. This is not an AI-driven device. The "performance data" relates to the mechanical properties of the physical spinal implant.
7. Type of Ground Truth Used
- Mechanical Testing Standards/Specifications: The "ground truth" for this device's performance is established by recognized engineering and material science standards (e.g., ASTM standards for materials) and internal test protocols designed to simulate in vivo conditions, allowing for comparison to predicate devices' performance data. The explicit statement is "Static and fatigue testing show the constructs of the ISOLA Spinal System to perform consistently with previously cleared components."
8. Sample Size for the Training Set
- Not applicable. This is not a machine learning or AI device that requires "training data."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. Again, this is not an AI/machine learning device.
Summary and Context:
The 510(k) process is primarily about demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. For implants like the ISOLA Spinal System, this typically means showing that its materials, design, and mechanical performance are comparable to devices already on the market. The provided text confirms this through the statement: "Static and fatigue testing show the constructs of the ISOLA Spinal System to perform consistently with previously cleared components." This demonstrates that the device meets the implicit acceptance criteria of being mechanically equivalent to established devices in its class.
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(254 days)
ISOLA SPINAL SYSTEM
The Posterior ISOLA Spinal System, when used with pedicle screws, is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.
The Posterior ISOLA Spinal System is also indicated for pedicle screw fixation for severe spondylolisthesis (Grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.
The Posterior ISOLA Spinal System, when not used with pedicle screws, is intended for hook, wire, and/or sacral/iliac screw fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture and previous failed fusion surgery.
The Anterior ISOLA system is intended for use in correcting scoliotic, lordotic or kyphotic spinal deformities by establishing an axially and rotationally rigid fixation bridge parallel to the long axis of the spine. The system is indicated in situations where loss of correction is expected, where severe scoliosis exists or where pelvic obliquity is present.
The Anterior ISOLA system is used for the correction and stabilization of scoliotic curves, for the prevention or recurrence of undesired scoliotic curves, and for the stabilization of weakened trunks. Specific indications include:
- Collapsing and unstable paralytic deformity.
- Progressively increasing scoliosis.
- Decreasing cardio-respiratory function, secondary to spinal or rib deformity or collapse.
- Inability to maintain sitting balance, necessitating the use of the hands.
- Increasing pelvic obliquity coincident with back pain or loss of sitting balance.
- Spinal fractures (acute reduction or late deformity)
- Degenerative Disc Disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).
- Spinal tumor
- Previous failed fusion surgery.
Spinal levels for Anterior ISOLA instrumentation are from T5-L4.
The primary purpose of this premarket notification is to add indications to the marketing clearance for the pedicle screws which may be used as a spinal anchor in the ISOLA Spine System. All implant components are manufactured of either ASTM F-138 or F-1314 stainless steel or ASTM F-136 titanium alloy.
The provided documentation describes the ISOLA Spinal System, specifically focusing on the addition of indications for its pedicle screws. However, it does not contain information related to an AI/ML medical device, nor does it conduct a study with acceptance criteria in the manner requested (e.g., performance metrics like sensitivity, specificity, or reader improvement).
Therefore, I cannot provide the requested table and information about acceptance criteria or a study proving the device meets them, as the document details a traditional medical device (spinal system) and not an AI/ML-driven one. The performance data section only states: "Static and fatigue testing shows the constructs of the ISOLA Spinal System to perform consistently with previously cleared components." This indicates mechanical testing, not a clinical study to establish diagnostic or interpretive performance.
The document is a 510(k) summary for a spinal implant system seeking expanded indications for use. It primarily addresses substantial equivalence to existing predicate devices based on material, design, and indications, and mentions static and fatigue testing for mechanical performance, not AI/ML-related performance.
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