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The LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. This device is an adjunct to fusion for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); deformities or curvatures (i.e., scoliosis, kyphosis); tumor; stenosis, and failed previous fusion (pseudoarthrosis).

The AccelFix Spinal Fixation System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); deformities or curvatures (i.e., scoliosis, kyphosis); tumor; stenosis, and failed previous fusion (pseudoarthrosis).

The LNK SPINAL FIXATION SYSTEM, OPENLOC-L SPINAL FIXATION SYSTEM are available in various sizes. This system is comprised of screws, rods, crosslinks, connectors and hooks. The screws are available from 4.0 mm to 10.5 mm diameters with lengths ranging from 20 mm to 150 mm. The rods are available from 5.0 mm, 6.0 mm and 6.35 mm diameter with lengths ranging from 40 mm to 600 mm. Both straight rods and curved rods have four types of design that consist of standard type, hex type, stopper type and double stopper.

The AccelFix Spinal Fixation System consists of screws, rods, crosslinks, set screws, cross-link connectors, and hooks. The screws are available from 5.0 mm, 6.0 mm, 7.0, 7.5, 8.0, 8.5, 9.0 and 9.5mm diameters with working lengths ranging from 20 mm. The rods are available from 5.5 mm, 6.0mm and 6.35mm diameter with lengths ranging from 40 mm to 600 mm. Both straight rods and curved rods have four types of design that consist of standard type, hex type, stopper type and double stopper.

The document provided does not contain information about the acceptance criteria or a study proving the device meets specific performance criteria. This document is a 510(k) summary for a medical device (Spinal Fixation System), which focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting performance criteria and results from a clinical study or specific performance testing against those criteria.

Therefore, I cannot provide the requested table and study details. The document explicitly states that:

• No additional mechanical testing was required for the new components because they are not considered "worst-case" scenarios.
• The manufacturer "substitute[s] mechanical test data of additional components... with the predicate device".
• The primary argument for clearance is substantial equivalence based on identical indications for use, design with components, materials, dimensions, and sterilization methods with predicate devices.

In summary, the provided text does not contain information on:

1. Specific acceptance criteria for device performance.
2. A study proving the device meets acceptance criteria.
3. Sample sizes for test sets or data provenance of a performance study.
4. Number or qualifications of experts for ground truth establishment.
5. Adjudication methods.
6. MRMC comparative effectiveness study results.
7. Standalone algorithm performance.
8. Type of ground truth used (as it's not a diagnostic AI device).
9. Training set sample size or how ground truth for a training set was established.

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The LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. This device is an adjunct to fusion for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; stenosis, and failed previous fusion (pseudoarthrosis).

The AccelFix Spinal Fixation System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); deformities or curvatures (i.e., scoliosis, kyphosis); tumor; stenosis, and failed previous fusion (pseudoarthrosis).

LNK SPINAL FIXATION SYSTEM /OPENLOC-L SPINAL FIXATION SYSTEM: The LNK SPINAL FIXATION SYSTEM, OPENLOC-L SPINAL FIXATION SYSTEM are available in various sizes. This system is comprised of screws, rods, crosslinks, connectors and hooks. The screws are available from 4.0 mm to 10.5 mm diameters with lengths ranging from 20 mm to 150 mm. The rods are available from 5.0 mm, 6.0 mm and 6.35 mm diameter with lengths ranging from 40 mm to 600 mm. Both straight rods and curved rods have four types of design that consist of standard type, hex type, stopper type and double stopper.

ACCELFIX SPINAL FIXATION SYSTEM: The AccelFix Spinal Fixation System consists of screws, rods, crosslinks, set screws, cross-link connectors, and hooks. The screws are available from 5.0 mm, 6.0 mm, 7.0, 7.5, 8.0, 8.5, 9.0 and 9.5mm diameters with working lengths ranging from 20 mm. The rods are available from 5.5 mm, 6.0mm and 6.35mm diameter with lengths ranging from 40 mm to 600 mm. Both straight rods and curved rods have four types of design that consist of standard type, hex type, stopper type and double stopper.

The provided text is a 510(k) summary for spinal fixation systems. It discusses the substantial equivalence of new components to previously cleared predicate devices.

Crucially, this document does not describe testing related to software or AI-powered devices, nor does it include information about the performance criteria, study design, or ground truth establishment typically associated with such devices.

The performance data section explicitly states: "The additional components to be added through this submission do not require additional mechanical testing. None of the additional components is the worst case of the LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System and AccelFix Spinal Fixation System. Therefore, we substitute mechanical test data of additional components of LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System and AccelFix Spinal Fixation System with the predicate device (LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System -K120270, K143363, K171813, K183168, K200790, K223565, K230245 / AccelFix Spinal Fixation System: K182544, K200794, K223565, K230245)."

Therefore, I cannot provide the requested information about acceptance criteria or a study that proves a device meets these criteria in the context of an AI/software device. The document is for a physical medical device (spinal fixation system) and relies on demonstrating substantial equivalence to predicate devices through material and design similarities, rather than performance studies with quantitative metrics, test sets, or expert reviews as would be relevant for AI.

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The LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. This device is an adjunct to fusion for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); deformities or curvatures (i.e., scoliosis, and/or lordosis); tumor; stenosis, and failed previous fusion (pseudoarthrosis).

The AccelFix Spinal Fixation System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); deformities or curvatures (i.e., scoliosis, kyphosis); tumor, stenosis, and failed previous fusion (pseudoarthrosis).

The LNK SPINAL FIXATION SYSTEM, OPENLOC-L SPINAL FIXATION SYSTEM are available in various sizes. This system is comprised of screws, rods, crosslinks, connectors and hooks. The screws are available from 4.0 mm to 10.5 mm diameters with lengths ranging from 20 mm to 150 mm. The rods are available from 5.0 mm, 6.0 mm and 6.35 mm diameter with lengths ranging from 40 mm to 600 mm. Both straight rods and curved rods have four types of design that consist of standard type, hex type, stopper type and double stopper.

The AccelFix Spinal Fixation System consists of screws, rods, crosslinks, set screws, cross-link connectors, and hooks. The screws are available from 5.0 mm, 6.0 mm, 7.0. 7.5. 8.0. 8.5. 9.0 and 9.5mm diameters with working lengths ranging from 20 mm. The rods are available from 5.5 mm, 6.0mm and 6.35mm diameter with lengths ranging from 40 mm to 600 mm. Both straight rods and curved rods have four types of design that consist of standard type, hex type, stopper type and double stopper.

This 510(k) submission describes a spinal fixation system, not an AI/ML device. Therefore, the details requested about acceptance criteria and study design for AI/ML devices (e.g., ground truth, reader study, effect size) are not applicable and are not present in the provided text.

The document focuses on demonstrating substantial equivalence to predicate spinal fixation systems based on material, design, dimensions, and sterilization methods.

Here's a summary of the relevant performance data and criteria from the provided text, adapted to reflect what is actually presented:

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

The submission does not specify numerical "acceptance criteria" for performance in the way an AI/ML device would. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to legally marketed predicate devices. The reported device performance is presented as being "similar" or "identical" to the predicates across key technical characteristics.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable and not provided. The submission relies on mechanical testing data from existing predicate devices and a comparison of technical characteristics, not a clinical test set from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. Since this is a spinal fixation system, the "ground truth" is typically established through engineering and biocompatibility testing, and comparison to existing devices, rather than expert interpretation of medical images.

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

This information is not applicable and not provided.

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

This information is not applicable and not provided. This is a medical device, not an AI/ML algorithm requiring a reader study.

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

This information is not applicable and not provided. This is not an AI/ML algorithm.

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

The "ground truth" for this type of device is demonstrated through robust engineering analysis, material characterization, and mechanical testing to ensure safety and performance, and crucially, by demonstrating substantial equivalence to predicate devices that have already met these standards. The submission explicitly states: "The additional components to be added through this submission do not require additional mechanical testing. None of the additional components is the worst case of the LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System and AccelFix Spinal Fixation System. Therefore, we substitute mechanical test data of additional components of LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System and AccelFix Spinal Fixation System with the predicate device (LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System -K120270, K143363, K171813, K183168, K200790, K223560 / AccelFix Spinal Fixation System: K182544, K200794, K223565)."

8. The sample size for the training set

This information is not applicable and not provided. This is not an AI/ML device that requires a training set.

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

This information is not applicable and not provided.

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The LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. This device is an adjunct to fusion for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); deformities or curvatures (i.e., scoliosis, kyphosis); tumor; stenosis, and failed previous fusion (pseudoarthrosis).

The AccelFix Spinal Fixation System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); deformities or curvatures (i.e., scoliosis, kyphosis); tumor; stenosis, and failed previous fusion (pseudoarthrosis).

The LNK SPINAL FIXATION SYSTEM, OPENLOC-L SPINAL FIXATION SYSTEM are available in various sizes. This system is comprised of screws, rods, crosslinks, connectors and hooks. The screws are available from 4.0 mm to 10.5 mm diameters with lengths ranging from 20 mm to 150 mm. The rods are available from 5.0 mm, 5.0 mm and 6.35 mm diameter with lengths ranging from 40 mm to 600 mm. Both straight rods and curved rods have four types of design that consist of standard type, hex type, stopper type and double stopper.

The AccelFix Spinal Fixation System consists of screws, rods, crosslinks, set screws, cross-link connectors, and hooks. The screws are available from 5.0 mm, 6.0 mm, 7.0, 7.5, 8.0, 8.5, 9.0 and 9.5mm diameters with lengths ranging from 30 mm to 150 mm. The rods are available from 5.5 mm, 6.0mm and 6.35mm diameter with lengths ranging from 40 mm. Both straight rods and curved rods have four types of design that consist of standard type, hex type, stopper type and double stopper.

This document describes the 510(k) premarket notification for the LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System, and AccelFix Spinal Fixation System. However, it does not contain the specific information required to complete your request regarding acceptance criteria and the study that proves the device meets the acceptance criteria.

The provided text primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, indications for use, and manufacturing processes. It explicitly states in section 7, "PERFORMANCE DATA," that:

"The additional components to be added through this submission do not require additional mechanical testing. None of the additional components is the worst case of the LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System and AccelFix Spinal Fixation System. Therefore, we substitute mechanical test data of additional components of LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System and AccelFix Spinal Fixation System with the predicate device (LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System -K120270, K143363, K171813, K183168, K200790, / AccelFix Spinal Fixation System: K182544, K200794)."

This means that no new studies were conducted for these specific additional components to prove they meet specific acceptance criteria. Instead, the submission relies on the existing performance data and substantial equivalence of the predicate devices.

Therefore, I cannot provide:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set or its provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Information about standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are intended as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or curvatures (i.e., scollosis, kyphosis, and/or lordosis); tumor; stenosis, and failed previous fusion (pseudoarthrosis)

The Spinal Fixation System is available in various lengths. This system is comprised of screws, set screws, rods, crosslinks, connectors and hooks. The screws are available from 4.0 mm to 10.5 mm diameters with lengths ranging from 20 mm to 150 mm. The rods are available from 5.0 mm, 5.5 mm, 6.0 mm and 6.35 mm diameter with lengths ranging from 40 mm to 600 mm. Both straight rods and curved rods have four types of design that consist of standard type, hex type, stopper type and double stopper.

Here's a breakdown of the requested information, based on the provided text:

Important Note: The provided document is a 510(k) summary for a spinal fixation system, which is a medical device. It does not describe an AI/ML-based device or a study involving human readers and AI assistance. Therefore, many of the requested points related to AI/ML device performance, ground truth establishment for AI, and MRMC studies cannot be found in this document and will be explicitly stated as "Not Applicable (N/A)" or "Not mentioned in the provided text."

Device Acceptance Criteria and Performance Study Summary

The device in question is the LnK Spinal Fixation System and OpenLoc-L Spinal Fixation System, which are non-cervical spinal fixation devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are focused on substantial equivalence to existing predicate devices, rather than specific performance metrics like sensitivity, specificity, or accuracy (which would be typical for an AI/ML device). The performance is demonstrated through the equivalence of design, materials, and intended use, along with mechanical testing data, which is here substituted from predicate devices.

• Design
• Materials
• Scientific Technology
• Indications for Use
• Performance (specifically mechanical testing) | The additional components of the LnK Spinal Fixation System and OpenLoc-L Spinal Fixation System are considered substantially equivalent to the predicate devices. The systems have the same design, materials, scientific technology, and indications for use. |
  | Material Composition | Manufactured from Ti-6Al-4V ELI titanium alloy (ASTM F136) or Cobalt-28Chromium-6Molybdenum-4Vanadium ELI (ASTM F1537). This must be the same material used in the predicate devices. | The devices are manufactured from Ti-6Al-4V ELI titanium alloy (ASTM F136) or Cobalt-28Chromium-6Molybdenum-4Vanadium ELI (ASTM F1537), which is the same material used in the predicate devices. |
  | Mechanical Performance | The additional components do not require additional mechanical testing if they are not the "worst case" and can substitute mechanical test data from predicate devices. (Implicit criterion is that the mechanical performance is equivalent to cleared predicate devices). | Mechanical test data for the additional components are substituted with data from predicate devices (K120270, K143363, K171813, K183168) because the additional components are not the worst case. The conclusion states they "perform as well as the predicate devices." |
  | Intended Use | Non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). Limited to skeletally mature patients and intended as an adjunct to fusion for: degenerative disc disease, spondylolisthesis, trauma (fracture or dislocation), deformities or curvatures (scoliosis, kyphosis, lordosis), tumor, stenosis, and failed previous fusion (pseudoarthrosis). | The device's indications for use match the specified criteria and are consistent with the predicate devices. |

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

• Sample Size: Not applicable. This submission relies on substituting mechanical testing data from predicate devices and demonstrating material and design equivalence, rather than a new test set of patient data or images for performance evaluation.
• Data Provenance: Not applicable. The "data" here refers to the design, materials, and previous mechanical testing of predicate devices. The country of origin for the predicate device's data is not specified. The nature of the "data" is not retrospective or prospective in the sense of clinical study data for an AI/ML device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not Applicable. As established, this is not an AI/ML device performance study requiring expert annotation for ground truth.

4. Adjudication Method for the Test Set

• Not Applicable. No test set requiring adjudication of "ground truth" labels.

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

• No, not mentioned. This document does not describe an AI/ML device and therefore no MRMC study was performed or is relevant to this submission.

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

• Not Applicable. This is not an algorithm-based device. Its "performance" is mechanical and related to its physical properties and design.

7. The Type of Ground Truth Used

• Not Applicable. The "ground truth" for this device is effectively the demonstrated safe and effective performance of its predicate devices through their established properties (design, materials, mechanical testing results) that it is substantially equivalent to. There is no "ground truth" derived from expert consensus, pathology, or outcomes data in the context of diagnostic accuracy.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device, and thus there is no "training set."

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

• Not Applicable. No training set exists for this type of device.

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