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510(k) Data Aggregation
(127 days)
The Whistler Modular 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 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; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The Whistler Modular Pedicle Screw System is a multiple component, posterior spinal fixation system which consists of pedicle screws, rods, and locking cap set screws. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All implant components are made from titanium alloy (ASTM F136). The Whistler Modular Pedicle Screw System is provided in both non-sterile and sterile forms. All implants are intended for single use only.
The provided document is a 510(k) Premarket Notification from the FDA for the Whistler Modular Pedicle Screw System. It describes the device, its indications for use, and a comparison to predicate devices, but it does not contain information regarding an AI/ML-driven device or studies proving its performance against acceptance criteria in the context of diagnostic accuracy, image analysis, or similar AI-related applications.
Instead, this document focuses on a physical medical device (pedicle screw system) and its mechanical performance testing to demonstrate substantial equivalence to existing devices. The performance data listed (Static Axial Compression Bending, Static Torsion, Dynamic Axial Compression Bending, Static A-P load) are standard mechanical tests for spinal implants, not AI performance metrics.
Therefore, I cannot fulfill the request to describe acceptance criteria and a study that proves a device meets acceptance criteria in an AI/ML context using the provided text. The document is entirely about a hardware implant.
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(110 days)
The FloSpine Canaveral Pedicle System is intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
When used for posterior non-cervical pediction in pediatric patients, the Canaveral Pedicle Screw System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Canaveral Pedicle Screw System for pediatric use is intended to be used with autograft. Pediatric pedicle screw fixation is limited to the posterior approach.
The Canaveral Pedicle Screw System is indicated to provide the surgeon with a minimally invasive approach for posterior spine surgery.
The FloSpine Canaveral Pedicle Screw System comprises non-sterile, single use, titanium alloy components for creating a posterior spinal implant construct. The system attaches to the spine through a component system comprising of pedicle screw assemblies for open and minimally invasive procedures, rods, hooks and set screws. The system is designed to stabilize the spine during the fusion process. The screws are available as monoaxial, uniplanar and polyaxial screws in both cannulated and non-cannulated forms. The rods are available as straight and precurved rods and are available in 2 diameters and multiple lengths. Components are made of Ti6Al4V ELI, a titanium based alloy, which complies with ASTM F136. Some rods are made from cobalt chrome which complies with ASTM F1537.
The provided text is a 510(k) Summary for the Canaveral Pedicle Screw System. It outlines the device description, indications for use, and a comparison to predicate devices, along with performance standards for pre-clinical testing.
However, the document does not contain information on acceptance criteria, a study proving the device meets acceptance criteria, sample sizes, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth used, or details about training sets. The primary focus of this document is to establish substantial equivalence to predicate devices for regulatory clearance based on materials, function, sizes, and mechanical test results, as per ASTM F1717-10.
Therefore,Based on the provided document, the following is what can be extracted:
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Table of acceptance criteria and the reported device performance:
The document refers to mechanical testing as per ASTM F1717-10, but does not provide specific acceptance criteria values or the device's reported performance against those criteria in a table format. It states that the device is substantially equivalent to predicate devices based on "mechanical test results." -
Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not available in the provided text. The document refers to "pre-clinical testing" for mechanical performance but does not specify sample sizes or data provenance. -
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 information is not applicable and not available. The document describes mechanical performance testing, not a study involving human assessment of images or clinical outcomes that would require expert-established ground truth. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable and not available. As above, the testing described is mechanical, not involving human adjudication. -
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:
This information is not applicable and not available. The device is a "Pedicle Screw Spinal System," a physical implant, not an AI-powered diagnostic or assistive tool for human readers. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable and not available, as the device is a physical implant, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the mechanical testing would be defined by the specified parameters and methodologies of the ASTM F1717-10 standard itself. It's about engineering specifications and material properties, not clinical ground truth. -
The sample size for the training set:
This information is not applicable and not available. The document describes a physical medical device, not an AI or machine learning model that would require a training set. -
How the ground truth for the training set was established:
This information is not applicable and not available, for the same reason as point 8.
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(339 days)
The MSFX 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 (T1 to S2): 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; spinal tumor; and failed previous fusion (pseudarthrosis).
Mikron Spinal Fixation System is a top-loading multiple component, posterior spinal fixation system consisting of polyaxial pedicle screws, rods, and set screws. The Mikron Spinal Fixation System will allow surgeons to build a spinal implant construction to stabilize and promote spinal fusion and it functions to build a spinal implant construct to stabilize and promote spinal fusion. The Mikron Spinal Fixation System components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136-11. Various sizes of these components are available.
Here's a breakdown of the acceptance criteria and study information for the Mikron Spinal Fixation System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Standard Applied | Acceptance Criteria (Implied by equivalence) | Reported Device Performance |
|---|---|---|---|
| Determining Torsional Properties of Metallic Bone Screws | ASTM F 543 | Equivalent to or better than predicate devices (4S Spinal System K063708, Optima Spinal System K031585) in torsional properties. The specific quantitative criteria are not provided but are implied to be met through comparison to the predicate's performance. | "The results of these mechanical tests demonstrate that the Mikron Spinal Fixation System is as safe, as effective, and performs as well as or better than the predicate devices." |
| Flexion-Extension Test of Subassembly | ASTM F 1798-97(2008) | Equivalent to or better than predicate devices in flexion-extension stability and fatigue resistance. | "The results of these mechanical tests demonstrate that the Mikron Spinal Fixation System is as safe, as effective, and performs as well as or better than the predicate devices." |
| Axial Torque Gripping Capacity Test for Subassembly | ASTM F 1798-97(2008) | Equivalent to or better than predicate devices in axial torque gripping capacity. | "The results of these mechanical tests demonstrate that the Mikron Spinal Fixation System is as safe, as effective, and performs as well as or better than the predicate devices." |
| Axial Gripping Capacity Test | ASTM F 1798-97(2008) | Equivalent to or better than predicate devices in axial gripping capacity. | "The results of these mechanical tests demonstrate that the Mikron Spinal Fixation System is as safe, as effective, and performs as well as or better than the predicate devices." |
| Static Compression Test for Subassembly | ASTM F 1717-10 | Equivalent to or better than predicate devices in static compression strength. | "The results of these mechanical tests demonstrate that the Mikron Spinal Fixation System is as safe, as effective, and performs as well as or better than the predicate devices." |
| Fatigue Test for Subassembly | ASTM F 1717-10 | Equivalent to or better than predicate devices in fatigue life under cyclic loading. | "The results of these mechanical tests demonstrate that the Mikron Spinal Fixation System is as safe, as effective, and performs as well as or better than the predicate devices." |
| Static Torsion Test | ASTM F 1717-10 | Equivalent to or better than predicate devices in static torsional strength. | "The results of these mechanical tests demonstrate that the Mikron Spinal Fixation System is as safe, as effective, and performs as well as or better than the predicate devices." |
| Single Cycle Bend Testing of Metallic Spinal Rods | ASTM F 2193 | Equivalent to or better than predicate devices in resistance to single-cycle bending. | "The results of these mechanical tests demonstrate that the Mikron Spinal Fixation System is as safe, as effective, and performs as well as or better than the predicate devices." |
Explanation of Acceptance Criteria: The acceptance criteria for this medical device (Mikron Spinal Fixation System) are based on demonstrating substantial equivalence to existing legally marketed predicate devices (4S Spinal System K063708 and Optima Spinal System K031585). This means the device must perform "as well as or better than" the predicate devices in the described non-clinical mechanical tests. The specific quantitative values for acceptance are not explicitly stated but are determined by successful comparison to the predicate devices under the specified ASTM standards.
2. Sample Size Used for the Test Set and Data Provenance
The provided text describes non-clinical performance testing (mechanical tests), not a clinical study involving human patients or data from patient test sets. Therefore:
- Sample size used for the test set: Not applicable in the context of human data. For mechanical testing, the sample size would refer to the number of physical device components tested for each test. This specific number is not provided in the document.
- Data provenance: Not applicable. The "data" are results from mechanical tests performed on the physical device components, not from patient populations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device's evaluation is based on non-clinical mechanical testing for substantial equivalence, not on interpretation of patient data by experts. Ground truth in this context would refer to objective mechanical properties rather than expert consensus on medical conditions.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" of patient data requiring adjudication. The evaluation is based on direct comparison of mechanical test results against performance of predicate devices.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study involves human readers interpreting cases (e.g., medical images) with and without AI assistance. This document describes a 510(k) submission for a spinal fixation system, relying on mechanical testing for substantial equivalence, not a study of AI-assisted human reading.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This is a physical medical device (spinal fixation system), not an algorithm or AI. Standalone performance testing typically applies to software or AI devices.
7. The Type of Ground Truth Used
The "ground truth" used is the mechanical performance and material characteristics of the legally marketed predicate devices. The Mikron Spinal Fixation System's performance is compared directly against the established performance of the 4S Spinal System (K063708) and Optima Spinal System (K031585) in rigorous laboratory mechanical tests designed to ASTM standards.
8. The Sample Size for the Training Set
Not applicable. As this is a physical medical device and not an AI/machine learning algorithm, 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 submission.
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(118 days)
The flamenco™ is a spinal fixation system intended to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion.
When used as posterior, pedicle screw fixation, the system is intended for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients. In addition, when used as a pedicle screw fixation system in the non-cervical posterior spine (T1 to S2), the system is intended for the treatment of the following acute and chronic instabilities or deformities: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion in skeletally mature patients.
When used as a posterior, non-cervical, hook and/or sacral/iliac fixation system (i.e., nonpedicle screw), the flamenco™ is intended for the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (as conformed by patient history and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, lordosis, spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion.
The flamenco™ consists of rods, monoaxial and polyaxial pedicle screws, hooks and transverse connectors with locking set screws. The components are available in various sizes to accommodate differing patient anatomy. Rods are available in one diameter and a variety of lengths. Monoaxial and polyaxial screws are available in a variety of diameter-length combinations. Hooks are offered in a variety shapes and sizes.
The provided text describes the "flamenco™ spinal fixation system," a Class II medical device. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a comprehensive study report for standalone performance or comparative effectiveness with AI.
Based on the provided information, the following can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical integrity under "worst case" conditions based on ASTM F1717 for static and dynamic tests. | "The mechanical test results demonstrated that flamenco™ performs as well as or better than the predicate devices." |
Note: The acceptance criteria are implied to be achieving performance at least on par with the predicate devices under the specified ASTM F1717 mechanical tests.
2. Sample Size Used for the Test Set and Data Provenance:
The document reports mechanical performance data, not clinical performance data from a test set of patient cases. Therefore, information regarding "sample size used for the test set" (referring to patient data) and "data provenance" (country of origin, retrospective/prospective) is not applicable in this context. The testing was laboratory-based mechanical testing of "worst case" device constructs.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
As this is a mechanical testing study, there were no human experts involved in establishing "ground truth" in the clinical sense. The "ground truth" for the mechanical tests would be the physical properties and performance measured by standardized mechanical testing equipment.
4. Adjudication Method for the Test Set:
Not applicable, as this was a mechanical test, not a clinical study requiring adjudication of expert interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This device is a spinal fixation system, not an AI diagnostic or therapeutic software that would typically be evaluated with MRMC studies comparing human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, in spirit, a standalone performance was done for the device's mechanical properties. The mechanical tests were performed on the device "constructs" themselves, independent of human interaction during the test. This is not "standalone algorithm performance" in the context of AI, but rather standalone performance of the physical device.
7. The Type of Ground Truth Used:
The "ground truth" for the mechanical performance study was physical measurements and adherence to engineering standards (ASTM F1717). The performance was compared against the measured performance of predicate devices.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical medical implant, not an AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for a physical device.
Summary of Study:
The study described is a mechanical performance study conducted according to ASTM F1717. This standard specifies methods for static and dynamic testing of spinal implant constructs. The "flamenco™" system's "worst case" construct was subjected to static compression bending, torsion, and dynamic compression bending. The objective of the study was to demonstrate that the mechanical performance of the flamenco™ system is equivalent to or superior to that of legally marketed predicate devices. The study concluded that the "flamenco™ performs as well as or better than the predicate devices," thereby meeting the implied acceptance criteria for mechanical equivalence.
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(267 days)
The AEGIS and AEGIS II Spinal Systems are 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
When used as an anterior screw fixation system, The AEGIS I and AEGIS II Spinal Systems are indicated for patients with deqenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, Spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, lordosis, turnor, pseudoarthrosis, or revision of failed fusion attempts.
The AEGIS® Pedicle Screw System is comprised of pedicle screw with diameters from 4.5mm to 8.5mm with increments of 1mm and length ranging from 20mm to 55 mm with increments of 5mm, a sleeve of standard diameter of 14 mm, and a set screw of M10XP1.0 & rods with standard diameter of 6 mm. All the components are manufactured from medical grade titanium alloy (Ti6Al4V-Eli).
The mono axial pedicle screw is used as an adjunct to spinal fusion surgery, provides a means of gripping a spinal segment. The screws themselves do not fixate the spinal segment, but act as firm anchor points that can then be connected with a rod. The screws are placed at two or three consecutive spine segments (e.g. lumbar segment 4 and 5) and then a short rod is used to connect the screws. This construct prevents motion at the segments that are being fused.
The Corentec® AEGIS II® Spinal system consists of various Pedicle Screws (mono / poly) with standard and guided type designs, Rod and Rod Link with a set screw, the assembly of which is intended to provide temporary stabilization following surgery to fuse the spine. This system is designed on the basis of long standing spinal technology which is already in the market for more than few decades.
The provided text describes mechanical performance testing for the AEGIS & AEGIS II Spinal Systems. This is not a study involving AI, human readers, or image analysis, but rather physical stress tests on the device itself. Therefore, many of the requested categories are not applicable.
Here's the information that can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Method) | Reported Device Performance |
|---|---|
| Static test (ASTM F1717-04): Tension | Demonstrated equivalence to legally marketed predicate devices. |
| Static test (ASTM F1717-04): Compression | Demonstrated equivalence to legally marketed predicate devices. |
| Static test (ASTM F1717-04): Torsion | Demonstrated equivalence to legally marketed predicate devices. |
| Dynamic test (ASTM F1717-04): Fatigue | Demonstrated equivalence to legally marketed predicate devices. |
| Axial pull-out strength test (ASTM 543-07) | Demonstrated equivalence to legally marketed predicate devices. |
| Axial Gripping Capacity test (ASTM F1798-97) | Demonstrated equivalence to legally marketed predicate devices. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample size for each mechanical test. The "data provenance" in this context refers to the manufacturing and testing of the physical device components. The tests were performed on the AEGIS and AEGIS II Spinal Systems themselves. The country of origin for the submitter is Korea. The tests are prospective in the sense that they are conducted on newly manufactured devices to ensure they meet standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was mechanical testing of a medical device, not a human reader study or clinical evaluation requiring expert interpretation of data. The ground truth refers to the physical properties and performance of the device under stress, as measured by standard engineering tests.
4. Adjudication method for the test set
Not applicable. This was mechanical testing against established ASTM standards, not a diagnostic or interpretive study requiring adjudication of human readings.
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 was a mechanical performance study of a spinal implant system, not a study involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This was mechanical testing of a physical medical device, not an algorithm.
7. The type of ground truth used
The ground truth used was the performance of the device under specific mechanical stress tests, compared against the performance of "legally marketed predicate devices" as defined by established ASTM (American Society for Testing and Materials) standards (F1717-04, 543-07, F1798-97).
8. The sample size for the training set
Not applicable. This was not a machine learning study with 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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(87 days)
The MonoPoly Pedicle Screw System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine (T1-S1), specifically as follows:
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the is indicated for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (4) dislocation, (5) spinal tumor, and/or (6) failed previous fusion (pseudarthrosis).
When used as a non-cervical and non-pedicle screw fixation system, the MonoPoly Pedicle Screw System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) trauma (fracture, dislocation), (5) pseudarthrosis, (6) tumor resection and/or (7) failed previous fusion.
The MonoPoly Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle screws sizes, couplers, a set screw, cross links, a washer, rods and hooks. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-Eli).
This document describes a medical device, the MonoPoly Pedicle Screw System, and its regulatory filing, but it does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.
Instead, the provided text is a 510(k) summary and associated FDA correspondence, which focuses on demonstrating substantial equivalence to previously cleared predicate devices. This means the manufacturer is asserting their device is as safe and effective as existing legally marketed devices, rather than establishing de novo performance criteria.
Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and performance studies. The "Performance Testing" section explicitly states: "The pre-clinical testing performed indicated that the MonoPoly Pedicle Screw System is substantially equivalent to predicate devices." This implies the testing was comparative in nature against existing devices, not against a predefined set of acceptance criteria for a new device.
Here's a breakdown of what is and is not present in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not present. The document does not define specific performance acceptance criteria (e.g., in terms of strength, fatigue life, or other biomechanical properties). It also does not report specific quantitative performance data for the device against such criteria. The "Performance Testing" section only states that the testing indicated substantial equivalence to predicate devices.
2. Sample Size Used for the Test Set and Data Provenance:
- Not present. The document does not describe a clinical "test set" for performance evaluation in the way you're asking. The testing mentioned is "pre-clinical," likely referring to mechanical or biomechanical bench testing. No sample sizes for any test sets are provided, nor is any information about data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable. Ground truth is generally relevant for diagnostic or AI-driven devices where a human expert's judgment is used to label data. This document describes a mechanical implant, not a diagnostic device.
4. Adjudication Method:
- Not applicable. See point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable. This type of study is used for diagnostic imaging devices to assess human reader performance with and without AI assistance. The MonoPoly Pedicle Screw System is a surgical implant.
6. Standalone (Algorithm Only) Performance Study:
- Not applicable. This is a mechanical implant, not an algorithm or AI system.
7. Type of Ground Truth Used:
- Not applicable. See point 3.
8. Sample Size for the Training Set:
- Not applicable. A "training set" is relevant for machine learning algorithms. This document describes a physical medical device.
9. How Ground Truth for the Training Set Was Established:
- Not applicable. See point 8.
Summary from the provided text:
The MonoPoly Pedicle Screw System is a Class III spinal implant comprising various screws, rods, and connectors made from titanium alloy. It is intended to aid in spinal segment immobilization and stabilization as an adjunct to fusion for various spinal conditions. The pre-clinical testing indicated substantial equivalence to four predicate devices: Cross Medical Synergy VLS System (K974749), U&I Optima Xia System (K031585), GSS Medical GS System (K053573), and Signus Medical OvalTwist System (K061577). The document does not provide details of specific performance criteria or a study demonstrating the device meets such criteria, as its 510(k) clearance path relies on equivalence to existing devices.
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(232 days)
The Savannah Lumbar Percutaneous Stabilization System (SLPSS) is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows:
When used as a pedicle screw fixation system of the posterior lumbar spine in skeletally mature patients, the SLPSS is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment. (2) fracture, (3) dislocation, (4) spinal tumor, and/or (5) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the SLPSS is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.
The Savannah Lumbar Percutaneous Stabilization System (SLPSS) is also intended to provide immobilization and stabilization of the spinal segments of the lumbar and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment.
The Savannah Lumbar Percutaneous Stabilization System is comprised of a variety of pedicle screws sizes, couplers, a ball swivel, rods and locking nuts that can be uniquely fitted for each individual case. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-Eli).
The provided text is a 510(k) summary for the Savannah Lumbar Percutaneous Stabilization System (SLPSS). It describes the device, its indications for use, and how it demonstrates substantial equivalence to predicate devices. However, the document does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria.
Instead, the document states:
"The pre-clinical testing performed indicated that the Savannah Lumbar Percutaneous Stabilization System is substantially equivalent to predicate devices."
This implies that the device's performance was compared to existing, legally marketed devices (predicates) rather than against specific, predefined acceptance criteria through a standalone clinical or performance study with detailed metrics. The regulatory pathway chosen, a 510(k), relies on demonstrating "substantial equivalence" to a predicate device, which often involves comparing technical characteristics and performance data to show that the new device is as safe and effective as the predicate.
Therefore, for your request, the following information is largely not present in the provided text:
- A table of acceptance criteria and the reported device performance: No specific acceptance criteria or performance metrics are listed.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance: Not applicable, as this is a surgical implant, not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a surgical implant.
- The type of ground truth used: Not applicable, as it's not a diagnostic device.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
Summary of available information:
- Device Name: Savannah Lumbar Percutaneous Stabilization System (SLPSS)
- Regulatory Pathway: 510(k) Premarket Notification (K072116)
- Claim of Performance: "The pre-clinical testing performed indicated that the Savannah Lumbar Percutaneous Stabilization System is substantially equivalent to predicate devices."
- Predicate Devices Listed:
- Nature of Testing: "Pre-clinical testing" was performed to demonstrate substantial equivalence, but details of this testing (e.g., in-vitro, mechanical, benchtop) are not provided in this summary.
Conclusion:
The provided document relies on showing substantial equivalence to predicate devices based on pre-clinical testing, rather than presenting a study with specific acceptance criteria as you've requested for a device that might involve diagnostic performance or AI. Therefore, most of the detailed information you are seeking is not available in this 510(k) summary.
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(69 days)
The ISSYS LP Spinal Fixation System is intended to help provide immobilization and stabilization of the spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows:
For pedicular use: When used as pedicle screw fixation system of the non cervical posterior spine in skeletally mature patients, these systems are indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
In addition, this system is indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (grade 3 & 4) at the L5-S1 joint having fusion with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass.
When used as non pedicular fixation system:
The ISSYS LP Spinal Fixation Systems, when used as an anterior screw fixation system and posterior sacral/iliac screw fixation system are indicated for the following:
- Degenerative disc disease of the thoracic and lumbar spine (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
- Spondylolisthesis
- Fracture
- Spinal deformities such as scoliosis, kyphosis, lordosis
- Tumor
- Revision of failed fusion attempts
- Pseudarthrosis
- Spinal stenosis
When used in the anterior indication the ISSYS LP Spinal Fixation Systems are indicated for use in the thoracic and lumbar spine.
The subject ISSYS LP Polyaxial Spinal Fixation System includes 5.5 mm diameter rods (preformed rod or straight rod configuration) in addition to the selection of the cleared 6.0 mm and 6.35 mm diameter rods. It is to be used with both the Polyaxial and Monoaxial screws.
This is a 510(k) premarket notification for a spinal fixation system, not an AI/ML medical device. Therefore, much of the requested information regarding AI device performance, such as sample sizes for test and training sets, expert ground truth establishment, adjudication methods, and MRMC studies, is not applicable. The provided document focuses on demonstrating substantial equivalence to predicate devices through material, design, and performance data for a new component (5.5 mm diameter rod) of an existing spinal fixation system.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured) | Reported Device Performance (How the device performed) |
|---|---|
| Compliance with FDA's Guidance For Spinal System 510(k) | "Engineering analysis and testing to demonstrate compliance with FDA's Guidance For Spinal System 510(k) May 3, 2004 was completed for the ISSYS LP Spinal Fixation System, included the subject component." |
| Material Properties | "Manufactured from ASTM F-136 implant grade titanium alloy." This implicitly implies the material meets the acceptance criteria for implant grade titanium alloy as defined by ASTM F-136. |
| Mechanical Performance as per ASTM F 1717 | "Performance data per ASTM F 1717 were submitted to characterize the subject ISSYS™ LP Spinal Fixation System components address in this notification." This indicates that the device's mechanical performance was tested according to this standard, and the submitted data (though not detailed here) would demonstrate compliance with the standard's requirements for spinal implant constructs. |
| Substantial Equivalence to Predicate Devices (Material) | "Documentation is provided which demonstrates the additional 5.5 mm diameter rod of the ISSYS LP Spinal Fixation System to be substantially equivalent to the predicate devices in terms of material..." |
| Substantial Equivalence to Predicate Devices (Design) | "Documentation is provided which demonstrates the additional 5.5 mm diameter rod of the ISSYS LP Spinal Fixation System to be substantially equivalent to the predicate devices in terms of... design..." |
| Substantial Equivalence to Predicate Devices (Indications) | "Documentation is provided which demonstrates the additional 5.5 mm diameter rod of the ISSYS LP Spinal Fixation System to be substantially equivalent to the predicate devices in terms of... indications for use." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. This submission is for a physical medical device (spinal fixation system component), not a diagnostic algorithm that uses a "test set" of data in the typical sense. The "testing" refers to mechanical and material characterization.
- Data Provenance: Not applicable in the context of clinical/imaging data. The data provenance refers to materials testing and engineering analysis performed according to recognized standards (ASTM F-136, ASTM F 1717). This would typically be conducted in a laboratory setting by the manufacturer or contracted labs.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This is not an AI/ML device requiring expert-established ground truth from clinical data. The "ground truth" for this device relates to established engineering standards for material properties and mechanical performance.
4. Adjudication Method for the Test Set
- Not applicable. There is no "adjudication method" as would be used for clinical data interpretation. Compliance is assessed against engineering 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 not an AI/ML device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is not an AI/ML device.
7. The Type of Ground Truth Used
The "ground truth" for this medical device submission is based on:
- Established engineering and material standards: Specifically, ASTM F-136 for material composition (implant grade titanium alloy) and ASTM F 1717 for mechanical performance of spinal implant constructs.
- FDA Guidance: The device's design and testing adhered to the "FDA's Guidance For Spinal System 510(k) May 3, 2004."
- Predicate Device Characteristics: The core of a 510(k) is demonstrating substantial equivalence to legally marketed predicate devices in terms of material, design, and indications for use. The characteristics of these predicate devices serve as a benchmark.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This is not an AI/ML device.
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(63 days)
The MEGA Spine System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 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.
In addition, the MEGA Spine 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 (pseudarthrosis).
The MEGA Spine System is a top-loading multiple component, posterior spinal fixation systems which consist of pedicle screws, rods, locking bolt, and a cross(transverse) linking mechanism.
The MEGA Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The MEGA Spine System implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to the ASTM F136. Various sizes of these implants are available. Specialized instruments are also available for the application and removal of the MEGA Spine System.
The provided document is a 510(k) summary for the MEGA Spine System, a medical device for spinal fixation. It describes the device, its indications for use, and its substantial equivalence to predicate devices based on mechanical testing. However, it does not contain the specific information required to complete the table and answer the study-related questions as it is not a study report on device performance but a premarket notification for regulatory approval.
Based on the provided text, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "Mechanical testing as listed in APPENDIX 9 that was conducted in accordance with ASTM F1717 demonstrates equivalence to the above listed predicate devices." However, it does not provide the specific acceptance criteria or the reported device performance metrics. Therefore, this table cannot be filled with the requested level of detail.
| Acceptance Criteria (e.g., Specific Mechanical Strength, Durability Thresholds) | Reported Device Performance (e.g., Achieved Mechanical Strength, Durability Cycles) | Met/Not Met (Based on Predicate Equivalence) |
|---|---|---|
| Not specified in the provided document. | Not specified in the provided document. | Stated as equivalent to predicate devices. |
Missing Information for Complete Answer:
The following information is not present in the provided 510(k) summary:
- Sample size used for the test set and the data provenance: This document does not detail specific sample sizes for mechanical testing or the origin of any data (e.g., country of origin, retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This document is about mechanical testing of a medical device, not a performance study involving human interpretation or ground truth establishment by experts.
- Adjudication method for the test set: Not applicable for mechanical testing.
- 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 not an AI-assisted diagnostic tool.
- 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.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for mechanical testing. The "ground truth" would be the ASTM standard and predicate device performance.
- The sample size for the training set: Not applicable to this type of device and study.
- How the ground truth for the training set was established: Not applicable to this type of device and study.
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(88 days)
When used as a pedicle screw fixation system in skeletally mature patients, the Dynesys® Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment and failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the Dynesys system is indicated for use in patients:
- Who are receiving fusions with autogenous graft only; ●
- Who are having the device fixed or attached to the lumbar or sacral spine; .
- Who are having the device removed after the development of a solid fusion . mass.
When the Dynesys Spinal System and the OPTIMA ZS Spinal System are used on contiguous levels, they must be used with the Zimmer® DTO™ Implant, rodacord combination implant, and the U & I Corporation OPTIMA ZS Transition Screw. The indications for use for each level is as specified for each system.
The Zimmer DTO Implant is a cord-rod combination implant that is assembled intraoperatively by the final tightening of the fastening pin that secures the connection of the cord and the rod. The U & I Corporation OPTIMA ZS Transition Screw is a pedicle screw that is part of the OPTIMA ZS Spinal System. When the Dynesys Spinal System and the OPTIMA ZS Spinal System are implanted on contiguous levels the Zimmer DTO Implant and the OPTIMA ZS Transition Screw are used at the interface of these two systems. The cord portion of the Zimmer DTO Implant interfaces with the Dynesys Spinal System. The rod portion of the Zimmer DTO Implant interfaces with the OPTIMA ZS Transition Screw and with the OPTIMA ZS Spinal System.
The provided text is a 510(k) summary for the Zimmer® DTO™ Implant, a spinal fixation system. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
The 510(k) summary focuses on demonstrating substantial equivalence to previously cleared devices based on design, materials, function, and intended use, rather than presenting a detailed clinical or performance study with defined acceptance criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them using the provided text. The requested information is simply not present in this regulatory submission.
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