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Found 9 results
510(k) Data Aggregation
(226 days)
Innovative Surgical Designs, Inc.
True Tulip is intended for posterior, noncervical (T1-S1) pedicle fixation to provide immobilization in skeletally mature patients as an adjunct to fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, kyphosis, lordosis, spinal tumor, pseudoarthrosis, and failed previous fusion.
When used for posterior non-cervical pediation in pediatic patients, the True Tulip is indicated as an adjunct to fusion in the treatment of progressive spinal deformities (i.e., scoliosis, or lordosis) including adolescent idopathic scoliosis (AIS), neuromuscular scoliosis, and congental scoliosis. Additionally, the True Tulip is intended to treat pediatric patients diagnosed with spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatric pedicle screw fixation is limited to a posterior approach. The True Tulip is intended to be used with autograft and/or allograft.
Not Found
This looks like regulatory correspondence for a medical device and does not contain information about the acceptance criteria or a study proving the device meets them. The document is primarily an FDA 510(k) clearance letter for a "Thoracolumbosacral Pedicle Screw System" and details the indications for use for the device. It does not include information about the performance of any AI/ML component, clinical study data, or acceptance criteria related to a study.
Therefore, I cannot extract the requested information from the provided text.
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(183 days)
Innovative Surgical Designs, Inc.
True Tulip and True M.I.S. are intended for posterical (TI-S1) pedicle fixation to provide immobilization and stabilization in skeletally mature patients as an adjunct to fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, sooliosis, spinal tumor, pseudoarthrosis, and failed previous fusion.
When used for posterior non-cervical pediatic patients, True Tulip and True M.I.S. are indicated as an adjunct to fusion in the treatment of progressive spinal deformities (i.e., scoliosis, including adolescent idiopathic scoliosis (AIS), neuromuscular scoliosis. Additionally, True Tulip and True M.I.S. are intended to treat pediatric patients diagnosed with spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pedicle screw fixation is limited to a posterior approach. True Tulip and True M.I.S. are intended to be used with autograft and/or allograft.
Not Found
I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device (True Tulip, True M.I.S. pedicle screw system). It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements.
However, the document does NOT contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any other data related to a clinical study or performance evaluation of the device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.
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(61 days)
Innovative Surgical Designs, Inc.
True Tulip is intended for posterior, noncervical (T1-S1) pedicle fixation to provide immobilization in skeletally mature patients as an adjunct to fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, kyphosis, lordosis, spinal tumor, pseudoarthrosis, and failed previous fusion.
When used for posterior non-cervical pediation in pediatic patients, the True Tulip is indicated as an adjunct to fusion in the treatment of progressive spinal deformities (i.e., scoliosis, or lordosis) including adolescent idiopathic scoliosis (AIS), neuromuscular scoliosis, and congenital scoliosis. Additionally, the True Tulip is intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatric pedicle screw fixation is limited to a posterior approach. The True Tulip is intended to be used with autograft and/or allograft.
True M.I.S. is intended for posterior, noncervical (T1-S1) pedicle fixation to provide immobilization in skeletally mature patients as an adjunct to fusion for the following acute and chronic instabilities or deformities of the thoracic. lumbar. and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tracture or dislocation), spinal stenosis, scoliosis, kyphosis, spinal tumor, pseudoarthrosis, and failed previous fusion.
When used for posterior non-cervical pediatic patients, the True M.I.S. is indicated as an adjunct to fusion in the treatment of progressive spinal deformities (i.e., scoliosis, or lordosis) including adolescent idionathic scoliosis (AIS), neuromuscular scoliosis. Additionally, the True M.I.S. is intended to treat pediatric patients diagnosed with spondylolysis, fracture caused by tumor and/or trauma. pseudarthrosis, and/or failed previous fusion. Pediatric pedicle screw fixation is limited to a posterior approach. The True M.I.S. is intended to be used with autograft and/or allograft.
Not Found
The provided text is an FDA 510(k) clearance letter for two medical devices, "True Tulip" and "True M.I.S.", which are Thoracolumbosacral Pedicle Screw Systems. This document outlines the FDA's determination of substantial equivalence to predicate devices and provides information about the intended use of the devices.
However, this document does NOT contain any information regarding: acceptance criteria, device performance testing data, sample sizes for test or training sets, data provenance, expert qualifications, ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.
Therefore, I cannot fulfill your request using the provided text. The requested information pertains to performance studies and validation, which are not detailed in this FDA clearance letter.
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(22 days)
Innovative Surgical Designs, Inc.
True Tulip and True M.I.S. are intended for posterior, noncervical (T1-S1) pedicle fixation to provide immobilization and stabilization in skeletally mature patients as an adjunct to fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, lordosis, spinal tumor, pseudoarthrosis, and failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, True Tulip and True M.I.S. are indicated as an adjunct to fusion in the treatment of progressive spinal deformities (i.e., scoliosis, or lordosis) including adolescent idiopathic scoliosis (AIS), neuromuscular scoliosis, and congenital scoliosis. Additionally, True Tulip and True M.I.S. are intended to treat pediatic patients diagnosed with spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pedicle screw fixation is limited to a posterior approach. True Tulip and True M.I.S. are intended to be used with autograft and/or allograft.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a medical device called the "True Tulip System" and "True M.I.S. System," which are thoracolumbar-sacral pedicle screw systems.
This document focuses on regulatory clearance based on substantial equivalence to predicate devices, rather than presenting a study demonstrating the device meets specific performance acceptance criteria for an AI or imaging diagnostic device.
Therefore, I cannot extract the information required to populate the fields you requested, such as:
- A table of acceptance criteria and reported device performance: The document does not define performance acceptance criteria for an AI/imaging device, nor does it report any performance metrics against such criteria.
- Sample size and data provenance for the test set: There is no mention of a test set, its size, or data provenance.
- Number of experts and qualifications for ground truth: No expert involvement for establishing ground truth is mentioned.
- Adjudication method: Not applicable as there's no mention of expert review or ground truth adjudication.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is described.
- Standalone (algorithm only) performance: The device described is a physical surgical implant, not an algorithm.
- Type of ground truth used: Not applicable.
- Sample size for training set: Not applicable (no AI/machine learning training involved).
- How ground truth for training set was established: Not applicable.
The document entirely pertains to the regulatory process for a physical medical device, highlighting its intended use and classification based on substantial equivalence to existing devices. It does not contain information about the development or validation of an AI/imaging diagnostic algorithm.
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(56 days)
Innovative Surgical Designs, Inc.
Redi-Spine is intended for posterior, noncervical (T1-S1) pedicle fixation to provide immobilization in skeletally mature patients as an adjunct to fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, syphosis, lordosis, spinal tumor, pseudoarthrosis, and failed previous fusion.
When used for posterior non-cervical pediatic patients, the Redi-Spine is indicated as an adjunct to fusion in the treatment of progressive spinal deformities (i.e., scoliosis, or lordosis) including adolescent idiopathic scoliosis (AIS), neuromuscular scoliosis. Additionally, the Redi-Spine is intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatic pedicle screw fixation is limited to a posterior approach. The Redi-Spine is intended to be used with autograft and/or allograft.
Not Found
This document is a 510(k) clearance letter for the Redi-Spine Thoracolumbosacral pedicle screw system, indicating it has been found substantially equivalent to a legally marketed predicate device. This type of document describes the intended use and regulatory classification of the device, but it does not contain information about acceptance criteria or the study that proves the device meets specific performance criteria.
Therefore, I cannot extract the requested information from the provided text. The document does not include details on:
- A table of acceptance criteria and reported device performance.
- Sample size for the test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
- Results of a standalone algorithm-only performance study.
- Type of ground truth used.
- Sample size for the training set.
- How the ground truth for the training set was established.
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(55 days)
Innovative Surgical Designs, Inc.
The True Spinal Fixation System is intended for posterior, noncervical (T1-S1) pedicle fixation to provide immobilization and stabilization in skeletally mature patients as an adjunct to the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the LS-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion.
Not Found
I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a surgical fixation system, indicating that the device is substantially equivalent to a predicate device. It specifies the indications for use but does not delve into performance metrics or supporting studies.
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(128 days)
Innovative Surgical Designs, Inc.
The True Spinal Fixation System is intended for posterior, noncervical (T1-S1) pedicle fixation to provide immobilization and stabilization in skeletally mature patients as an adjunct to the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the LS-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion.
Not Found
This is an FDA 510(k) clearance letter for a spinal fixation system, which is a physical medical device, not an AI/ML-driven software device. Therefore, the information requested about acceptance criteria, study details, ground truth, and human-in-the-loop performance is not applicable to this document. The letter simply states the device's substantial equivalence to a predicate device based on its indications for use.
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(156 days)
INNOVATIVE SURGICAL DESIGNS
The True™ Spinal Fixation System is intended for posterior, noncervical (T1-S1) pedicle fixation to provide immobilization and stabilization in skeletally mature patients as an adjunct to fusion for the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion.
The True™ Spinal Fixation System consists of pairs of longitudinal members (rods), anchors (polyaxial pedicle screws) and interconnections (rod-rod connectors). The changes include a rod to rod connector for ease of delivery, thermoformed instruments to replace the stainless steel instruments, a lower final torque value of 7.5Nm previously 8.5 Nm
The provided document describes a 510(k) submission for the True™ Spinal Fixation System, which is a medical device, not an AI/ML algorithm. Therefore, many of the typical acceptance criteria and study details relevant to AI/ML performance (like sample size for test sets, expert consensus for ground truth, MRMC studies, standalone performance, training sets, etc.) are not applicable here.
However, I can extract the relevant "acceptance criteria" and "study" details for this medical device as presented in the document, which primarily revolve around mechanical performance and substantial equivalence to predicate devices.
Here's the information based on the provided text, structured to best fit your request:
Acceptance Criteria and Device Performance for True™ Spinal Fixation System
Given that this is a 510(k) submission for a traditional medical device (spinal fixation system) and not an AI/ML algorithm, the "acceptance criteria" relate to mechanical performance and "substantial equivalence" to legally marketed predicate devices. The "study" refers to mechanical testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Benchtop Mechanical Tests) | Reported Device Performance (Worst Case Construct) |
|---|---|
| Static Compression Bending (per ASTM F1717) | Demonstrates performance substantially equivalent to predicate devices. |
| Static Torsion (per ASTM F1717) | Demonstrates performance substantially equivalent to predicate devices. |
| Dynamic Compression Bending (per ASTM F1717) | Demonstrates performance substantially equivalent to predicate devices. |
| Torque Value (Final) | Lower final torque value of 7.5Nm (previously 8.5 Nm) - This is a design change, not explicitly an acceptance criterion for performance itself, but part of the changed characteristics being evaluated. |
| Material | Titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136 - Matches predicate device material. |
| Basic Design | Rod-based pedicle screw fixation system - Matches predicate device design. |
| Anatomic Location | Posterior, noncervical (T1-S1) pedicle fixation - Matches predicate device's use. |
| Intended Use | Adjunct to fusion for various spinal instabilities/deformities (e.g., severe spondylolisthesis, fracture, dislocation, scoliosis, etc.) - Matches predicate device's intended use. |
Note: The primary "acceptance criterion" for 510(k) submissions is demonstrating "substantial equivalence" to one or more legally marketed predicate devices in terms of intended use, technological characteristics, and safety and effectiveness. The performance tests are conducted to support this claim, especially for any technological differences.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in the document. Mechanical tests typically involve multiple samples to ensure statistical validity, but the exact number for "worst case construct" is not provided.
- Data Provenance: The tests were "performed according to ASTM F1717 and ASTM 1798." This implies the tests were conducted in a controlled environment, likely a lab, following standardized testing protocols. There is no information regarding country of origin or whether it was retrospective or prospective, as these terms typically apply to clinical data, not benchtop mechanical testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not Applicable. For mechanical testing of a spinal fixation system, ground truth is established by objective physical measurements using calibrated equipment according to design specifications and industry standards (ASTM), not by expert human graders or medical professionals.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods like "2+1" typically apply to human expert review of clinical cases. For mechanical testing, quantitative measurements are taken, and compliance is determined against predefined physical specifications and standards.
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 medical device for spinal fixation, not an AI/ML algorithm requiring human reader performance evaluation.
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 a software algorithm.
7. The Type of Ground Truth Used
- Benchtop Mechanical Measurement against ASTM Standards and Predicate Device Performance. The "ground truth" for the device's performance is established by its ability to meet the defined mechanical properties and safety profiles as set by FDA guidelines, industry standards (ASTM F1717, ASTM 1798), and by demonstrating "substantial equivalence" to the mechanical performance of legally marketed predicate devices.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" as this is not an AI/ML algorithm.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. There is no "training set" or corresponding ground truth for this type of device.
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(195 days)
INNOVATIVE SURGICAL DESIGNS
The True™ Spinal Fixation System is intended for posterior, noncervical (T1-S1) pedicle fixation to provide immobilization and stabilization in skeletally mature patients as an adjunct to fusion for the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion.
The True™ Spinal Fixation System consists of pairs of longitudinal members (rods), anchors (polyaxial pedicle screws) and interconnections (rod-rod connectors). These are available in a variety of sizes to accommodate differing patient anatomy. Dual Rod use Only. The True™ Spinal Fixation System is intended to be used only as a dual rod system and must be used with two rods per connector in all cases. Do not use one rod per connector.
The provided text describes a 510(k) summary for the True™ Spinal Fixation System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through performance data showing similar mechanical characteristics. It does not involve clinical studies with human participants that would typically assess diagnostic accuracy or the direct clinical impact of AI-assisted systems, which are the focus of most of the requested information.
Therefore, many of the requested categories are not applicable to the documentation provided.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (True™ Spinal Fixation System) |
|---|---|
| Mechanical performance of predicate devices: HORIZON® (K031655/K041460), Moss® Miami (K992168/K022623), and Synergy™ VLS (K950099/K974749) under ASTM F1717 (Static Compression Bending) and ASTM 1798 (Dynamic Compression Bending) standards. | "The mechanical test results demonstrate that the True™ Spinal Fixation System performance is substantially equivalent to the predicate devices." |
Study Proving Device Meets Acceptance Criteria:
A mechanical testing study was performed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not specified in terms of number of constructs tested, but referred to as "the worst case True™ construct."
- Data Provenance: The device is manufactured by Innovative Surgical Designs, Inc. in Bloomington, Indiana, USA. The mechanical tests would have been performed in a laboratory setting, likely in the US, but specific details are not provided. The study is prospective in the sense that the tests were conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device's ground truth for demonstrating substantial equivalence is based on established engineering standards (ASTM F1717 and ASTM 1798) and direct comparison to the mechanical performance of predicate devices, not expert human assessment or clinical ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This was a mechanical engineering study, not an imaging or clinical diagnostic study involving human interpretation.
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 diagnostic device, nor does it involve human readers/interpreters in its primary function for which performance was assessed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical implant device and not an algorithm or software. The "standalone" performance here refers to the mechanical integrity of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for demonstrating substantial equivalence was the established mechanical performance of legally marketed predicate spinal fixation systems, as measured by standard ASTM material testing methods. This represents a comparative engineering "ground truth."
8. The sample size for the training set
Not applicable. This device did not involve any machine learning algorithms or a "training set."
9. How the ground truth for the training set was established
Not applicable. There was no training set.
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