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The LigaPASS™ system is an implant for use in orthopaedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and id in the repair of bone fractures. The indications for use are as follows:

· Spinal trauma surgery, used in sublaminar or facet wiring techniques;

· Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adults scoliosis and kyphosis;

· Spine degenerative surgery as an adjunct to spinal fusions.

· Intended for use with a posterior spinal instrumentation construct when ligamentation is needed.

The LigaPASS™ system may also be used in conjunction with other medical implants made of titanium or cobalt-chrome alloy whenever "wiring" may help secure the attachment of other implants.

The purpose of this submission is to expand the indications of the LigaPASS™ system to include the use with a posterior spinal instrumentation construct when ligament augmentation is needed.

The LigaPASS™ 2.0 Ligament Augmentation System provides surgeons the ability to mimic anatomical muscle and ligament functionality and stabilization between vertebrae that are collapsed during surgery before fusion. The LigaPASS™ 2.0 Ligament Augmentation System is designed to restore balance and stability as a complement to a posterior thoracolumbar fixation system. Ergonomic instrumentation provides smooth assembly with self-stabilizing tensioners and torque-limiting locking tools. The LigaPASS™ 2.0 Ligament Augmentation System consists of a polyester (PET) band and titanium alloy medial open connector with 2 set screws.

LigaPASS™ bands allow the surgeon to create a posterior vertebra anchorage without theuse of a pedicle screw or hook. Instead of a pedicle screw or hook, the LigaPASS™ bands are laced around the vertebra independently of the vertebra anatomy and then connected to a LigaPASSTM connector to make the rod-bone connection.

The LigaPASS™ 2.0 bands are comprised of a PET braid and pure titanium (T40) malleable leads at the ends of the bands. The malleable tips help the surgeon to lace the band around the vertebra. They can be bent by the surgeon to make it pass under and through the vertebral body easier.

The LigaPASS™ connectors allow surgeons to attach a rod to a vertebral body without the use of the pedicle. Instead of a pedicle screw, the LigaPASS™ connector use a facet band to make the rod-bone connection. The connectors are comprised of a connector body, a rod set screw, a locking set screw for the band and a polyester band. The body of these connectors is manufactured from titanium allov (Ti-6Al-4V). The part is compatible with any rods made of titanium or cobalt chromium alloys between diameters 5.5 mm and 6.0 mm.

The provided text is a 510(k) premarket notification decision letter and summary for the LigaPASS™ 2.0 Ligament Augmentation System. It does not contain information about acceptance criteria or a study proving that an AI/Software as a Medical Device (SaMD) meets acceptance criteria.

The document pertains to a physical medical device (ligament augmentation system) used in orthopedic surgery, not a diagnostic or AI-powered device. The "Performance Testing Summary" explicitly states:

"No additional bench or animal testing was completed for the purpose of this 510(k) submission. The non-clinical performance of the LigaPASS™ 2.0 Medial System has been validated through a series of 510(k) submissions (K172021, K173506). Clinical data published in the literature were provided to support the use of ligament augmentation with the LigaPASS™ system in adult spinal deformity surgery."

Therefore, I cannot extract the requested information regarding AI device acceptance criteria and study details from this document.

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The LigaPASS is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bory fusion and aid in the repart of bone fractures. The include the following applications:

-Spinal trauma, used in sublaminar, or facet wiring techniques

-Spinal reconstruction surgery, incorporated into construction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, and kyphosis; -Spinal degenerative surgery, as an adjunct to spinal fusions;

The LigaPASS system may also be used in conjunction with other medical implants made of titanium or cobalt chrome alloy whenever "wiring" may help secure the attachment of other implants.

The CD Horizon™ Spinal System with or without Sextant™ intended for posterior, non-cervical fixation as an adjunct o fusion for the following indications: degenerative disc disease (DDD - defined as back pain with degeneration of the disc confirmed by history and radios). spondylolisthesis, trauma (i.e. fracture or dislocation), soinal stenosis, curvatures (i.e. scoliosis, kyphosis, or lordosis). tumor, pseudarthrosis, and or failed previous fusion. Except for hooks, when used as an anterclateral the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion.

With the exception of DDD, the CD Horizon™ 3.5mm rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediativ indications noted below.

When used for posterior non-cervical pediation in pediatric patients, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to freat progressive spinal deformities (i.e. scolosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis. Additionally, the CD Horizon™ Spinal System is intended to tred pediativ patients diagnosed with the following conditions: spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and or failed previous fision. These cevices are to be allograft. Pediatic pedicle screw fixation is limited to a posterior approach.

The CD Horizon™ PEEK rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 – S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use. The CD Horizon™ plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the (TI-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to spinous processes for the ing supplemental fixation in the following conditions: DDD (as reviously defined), spondylolisthesis, trauma, and/or tumor.

In order to achieve additional levels of fixation™ Spinal System rods may be connected to the Vertex™ Reconstruction System with the Vertex™ rod connector. Refer to the Vertex™ Reconstruction System package insert indications of use . Vertex™ rod connector. Refer to the Vertex™ Reconstruction System package insert for a list of the Vertex™ indications of use.

The purpose of this submission is to expand use of the previously cleared LigaPASS® Spinal System with the previously cleared CD Horizon™ 5.5/6.0 Spinal System rods.

LigaPASS® Spinal System: The LigaPASS® MEDICREA® INTERNATIONAL S.A. spinal system is composed of four components: a connector, two set screws and a band. The LigaPASS® system is designed to stabilize a vertebra in the same manner as a hook around the vertebra during development of solid bony fusion. The LigaPASS® system must be implanted via a posterior approach to complete a thoraco-lumbar fixation system as the PASS LP® MEDICREA® INTERNATIONAL S.A. spinal system. The implants are manufactured in titanium alloy Ti-6Al-4V ELI conforming to ISO 5832-3 specifications and ASTM F136, with the exception of the band which is manufactured in polyethylene terephtalate (PET) and titanium T40 conforming to ISO 5832-2 specifications and ASTM F67.

CD Horizon™ Spinal System: The CD Horizon™ Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, Crosslink™ plates, staples and connecting components, as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

I am sorry, but there is no information about acceptance criteria or a study proving device performance in the provided text. The document is a 510(k) premarket notification clearance letter from the FDA for a spinal system, discussing its substantial equivalence to predicate devices and detailing its indications for use, product description, and a general statement about performance testing. It mentions mechanical testing in accordance with ASTM 1798 but does not provide specific acceptance criteria or study results.

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The LigaPASS is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:

-Spinal trauma, used in sublaminar, or facet wiring techniques

-Spinal reconstruction surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, and kyphosis; -Spinal degenerative surgery, as an adjunct to spinal fusions;

The LigaPASS system may also be used in conjunction with other medical implants made of titanium or cobalt chrome alloy whenever "wiring" may help secure the attachment of other implants.

The LigaPASS System connects a rod to a vertebral body using a specific type of connector and a flexible band. This connector can independently tighten the rod and the bone anchor. It is comprised by a connector body, a rod set screw, a locking set screw for the band and a polyester band.

The purpose of this submission is to introduce the LigaPASS 2.0 Band - B08110005 and the LigaPASS 2.0 Dual Band - B08110010.

MATERIALS: Components in these bands are manufactured from pure titanium that conforms to ASTM F67 and biocompatible Polyethylene Terephthalate (PET).

Function: The LigaPASS spinal system was developed as an implant:

• To provide temporary stabilization as bone anchor during the development of solid bony fusion.

• To aid the repair of bone fracture.

This document is a 510(k) summary for the Medica International's LigaPASS additional components (LigaPASS 2.0 Band - B08110005 and LigaPASS 2.0 Dual Band - B08110010). It focuses on establishing substantial equivalence to previously cleared LigaPASS devices (K172021). The information provided primarily pertains to the design and material comparisons, and non-clinical testing. It does not include data from a study that typically measures specific performance metrics against pre-defined acceptance criteria in the context of medical device AI or diagnostic accuracy, nor does it involve human readers, ground truth establishment by experts, or training/test sets for an algorithm.

Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, expert qualifications, and AI-related studies are not applicable to the content of this 510(k) summary.

However, I can extract the relevant information from the provided text regarding the non-clinical testing and the basis for substantial equivalence.

Here's an interpretation based on the provided document, acknowledging the limitations:

This document is a 510(k) Summary, which aims to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device. In such cases, the "acceptance criteria" are generally that the new device performs at least as well as, or is technologically similar to, the predicate device in terms of safety and effectiveness, supported by non-clinical (and sometimes clinical) data. There isn't a table of numerical "acceptance criteria" against which a new device's performance is explicitly measured in the way one might expect for a diagnostic or AI-driven device's sensitivity/specificity.

The "study" undertaken here is a comparative analysis and non-clinical testing to demonstrate substantial equivalence.

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

As this is a 510(k) for device modifications (additional components to an existing system) and not a novel diagnostic AI product, there aren't explicit numerical acceptance criteria for diagnostic performance (e.g., sensitivity, specificity). The "acceptance criteria" are implied by the demonstration of substantial equivalence to the predicate device, particularly regarding material properties and mechanical performance.

2. Sample size used for the test set and the data provenance

For the mechanical testing:

• Sample Size: Not explicitly stated in terms of number of units tested, but the document refers to "the LigaPASS 2.0 Dual Band – B08110010" being tested. Typically, mechanical tests would involve a statistically relevant number of samples, but this specific number is not provided in the summary.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This is non-clinical laboratory testing, not human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a mechanical implant, not an AI or diagnostic device requiring expert interpretation for ground truth.

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

Not applicable. There is no "test set" requiring adjudication by experts in this context.

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 or imaging device.

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

Not applicable. This device is a mechanical implant.

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

Not applicable. For mechanical non-clinical testing, the "ground truth" is typically the physical and material properties measured against established engineering standards (e.g., ASTM F67 for titanium, NF EN ISO 13934-1 for static traction) and comparison to the predicate device's known performance.

8. The sample size for the training set

Not applicable. This is a mechanical implant, not an AI-driven device requiring a training set.

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

Not applicable.

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The LigaPASS is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of a solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:

• Spinal trauma surgery, used in sublaminar, or facet wiring techniques;

• Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, and kyphosis; -Spinal degenerative surgery, as an adjunct to spinal fusions.

The LigaPASS system may also be used in conjunction with other medical implants made of titanium or cobalt chrome alloy whenever "wiring" may help secure the attachment of other implants.

The LigaPASS System connects a rod to a vertebral body using a specific type of connector and a flexible band. This connector can independently tighten the rod and the bone anchor. It is comprised by a connector body, a rod set screw, a locking set screw for the band and a polyester band.

The purpose of this submission is 1) to introduce the LigaPASS 2.0 Medial Connector and 2) to introduce the LigaPASS 2.0 Medial Open Connector.

MATERIALS: Components in this connector are manufactured from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136, pure titanium that conforms to ASTM F67 and Polyethylene Terephthalate (PET).

The provided document is a 510(k) summary for the LigaPASS system, which describes its indications for use, materials, and substantial equivalence to previously cleared devices. It is for a bone fixation cerclage device, not an AI/ML device. Therefore, the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies, which are typical for AI/ML device approvals, is not present in this document.

The document states:

• No additional mechanical testing. Finite element analysis and device descriptive information were sufficient to establish the substantially equivalent mechanical performance of the subject components.

This indicates that a study with explicit acceptance criteria for device performance, as would be expected for a novel AI/ML device, was not conducted or required for this submission. The evaluation was based on similarity to existing devices and existing mechanical data for those predicate devices.

Ask a specific question about this device

The LigaPASS is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:

• Spinal trauma surgery, used in sublaminar, or facet wiring techniques;

• Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, and kyphosis;

• Spinal degenerative surgery, as an adjunct to spinal fusions;

The LigaPASS system may also be used in conjunction with other medical implant grade implants made of titanium or cobalt chrome alloy whenever "wiring" may help secure the attachment of other implants.

The LigaPASS System connects a rod to a vertebral body using a specific type of connector and a flexible band. This connector can independently tighten the rod and the bone anchor. It is comprised by a connector body, a rod set screw, a locking set screw for the band and a polyester band. Components in this connector are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136, pure titanium that conforms to ASTM F67 and Polyethylene Terephthalate (PET).

The purpose of this submission is 1) to introduce the LigaPASS 2.0 XS Connector which accommodates a 4.5mm rod and 2) to modify the LigaPASS indications to align with those of its primary predicate.

This document is a 510(k) premarket notification for the LigaPASS bone fixation cerclage device. The device is a "temporary implant for use in orthopedic surgery" intended for "temporary stabilization as a bone anchor during the development of solid bony fusion and [to] aid in the repair of bone fractures."

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a structured table with quantifiable thresholds that the device had to meet to be accepted. However, it states that the device was deemed "substantially equivalent" to predicate devices based on:

• Mechanical testing: "The tests performed on the LigaPASS 2.0 XS connector (axial and torsional grip, and static and dynamic band tension according to ASTM F1798) indicate that the product is as mechanically sound as other devices commercially available." This implies that the performance in these mechanical tests met or was comparable to the performance of the predicate devices.
• Biocompatibility: "The LigaPASS 2.0 XS is made from the same materials as its predicates." This implies that it met the same biocompatibility standards as the predicate devices.

Since specific numerical acceptance criteria and a table of reported performance against those criteria are not provided, we can infer the acceptance was based on comparability to predicate devices.

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

• Sample Size: The document does not specify the sample size used for the mechanical testing. The tests conducted were "axial and torsional grip, and static and dynamic band tension according to ASTM F1798." These are in-vitro mechanical tests, not tests on biological samples.
• Data Provenance: The data provenance is from laboratory mechanical testing of the device components. It is not listed as retrospective or prospective patient data, nor does it refer to a specific country of origin of patient data.

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

This question is not applicable. The "ground truth" for mechanical testing is established by engineering specifications and recognized ASTM standards (F1798), not by expert consensus in clinical interpretation.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods like 2+1 or 3+1 refer to clinical review processes for establishing ground truth in image interpretation or clinical outcomes, which is not relevant to mechanical testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states: "No clinical studies were performed." Therefore, no MRMC study was conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This question is not applicable as the device is a physical medical implant, not an AI algorithm. The performance evaluation was mechanical testing of the device itself.

7. Type of Ground Truth Used

The ground truth used for performance validation was based on established ASTM F1798 standards for mechanical testing of spinal devices and the comparative performance of legally marketed predicate devices.

8. Sample Size for the Training Set

This question is not applicable. The device is a physical implant, not an AI algorithm, so there is no "training set" in the machine learning sense. The "training" in mechanical design would involve iterative testing and refinement, but a specific "training set" of data for an algorithm is not relevant here.

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

This question is not applicable for the reasons stated above (not an AI algorithm).

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The LigaPASS is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. LigaPASS system is indicated for the following applications:

• Spinal trauma surgery, used in sublaminar, or facet wiring techniques;

• Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 10 years of age and older, adult scoliosis, and kyphosis;

• Spinal degenerative surgery, as an adjunct to spinal fusions;

The LigaPASS connectors connect a rod to a vertebra. These connectors can independently tighten the rod and the bone anchor. The LigaPASS connectors are composed by a connector body, a rod set screw, a locking set screw for the band and a polyester band.

The MEDICREA® INTERNATIONAL LigaPASS is a temporary orthopedic implant designed to provide stabilization during spinal fusion and aid in bone fracture repair. The submission details its substantial equivalence to predicate devices, focusing on the expanded indications for use to include idiopathic and neuromuscular scoliosis treatment in patients 10 years of age and older.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

• Aid in repair of bone fractures.
• Spinal trauma surgery (sublaminar or facet wiring).
• Spinal reconstructive surgery for spinal deformities (scoliosis, kyphosis, spondylolisthesis).
• Spinal degenerative surgery (adjunct to spinal fusions).
• Used with other titanium/cobalt chrome implants for "wiring" to secure attachment. | - Same as criteria, plus expanded indication for idiopathic and neuromuscular scoliosis in patients 10 years of age and older. |
  | Materials | - Connector: Titanium alloy (ASTM F136 or ISO 5832-3).
• Band: Polyethylene terephthalate (PET) and pure titanium (ASTM F67). | - LigaPASS connectors are made from titanium alloy conforming to ASTM F136 or ISO 5832-3.
• The band is manufactured from polyethylene terephthalate (PET) and pure titanium conforming to ASTM F67. (Identical to predicate and other cleared MEDICREA products). |
  | Design/Components | - Connector with polyester band.
• To circle a vertebra as a bone anchor.
• Connect to a Ø5.5mm or Ø6mm rod. | - Connectors with polyester band.
• To circle a vertebra as a bone anchor.
• Connect to a Ø5.5mm or Ø6mm rod.
• The LigaPASS connectors are composed of a connector body, a rod set screw, a locking set screw for the band, and a polyester band. (Similar design and components to the predicate device).
• No other changes in terms of design characteristics, principles of operation, packaging, sterility, or biocompatibility have undergone since the previous 510(k). |
  | Mechanical Performance | - Meets ASTM F1717 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model".
• Meets ASTM F1798 "Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanism and Subassemblies Used In Spinal Arthrodesis Implants".
• Comparable mechanical performance to predicate devices (Universal Clamp System K110348, LigaPASS K112736). | - Mechanical testing of LigaPASS implants was conducted following ASTM F1717 and ASTM F1798.
• Data was compared to the mechanical performance of other cleared devices (LigaPASS, MEDICREA INTERNATIONAL, K112736).
• Mechanical performance established via these cleared devices. |

2. Sample Size for the Test Set and Data Provenance

• Sample Size: The document does not specify a separate "test set" for performance evaluation in the context of clinical data. Mechanical testing was performed on LigaPASS implants, and data was compared to previously cleared devices (LigaPASS, MEDICREA INTERNATIONAL, K112736). No clinical studies were conducted for this submission.
• Data Provenance: The document does not provide details on the specific number of units tested for mechanical performance, or any particular provenance for those tested units (e.g., country of origin). The comparison data is derived from previously cleared predicate devices.

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

• This is not applicable. No clinical studies were performed, and thus no expert-established ground truth for a clinical test set was required. The substantial equivalence claim is based on non-clinical (mechanical) testing and comparison to predicate devices, as well as material composition.

4. Adjudication Method for the Test Set

• This is not applicable. As no clinical studies or human-in-the-loop evaluations were conducted, there was no need for an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. The device is a medical implant, and its evaluation relies on non-clinical mechanical testing and comparison to predicate devices, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance

• Not applicable. This device is a physical medical implant (bone fixation cerclage), not an AI algorithm or software device. Therefore, standalone algorithm performance is not relevant.

7. Type of Ground Truth Used

• The primary "ground truth" for demonstrating acceptance was established by industry standards for mechanical testing (ASTM F1717, ASTM F1798) and the performance of legally marketed predicate devices. The material composition also relies on established standards (ASTM F136, ISO 5832-3, ASTM F67). There was no clinical ground truth (e.g., pathology, outcomes data) used as no clinical studies were conducted.

8. Sample Size for the Training Set

• Not applicable. This device is a physical medical implant, not an AI/ML system that requires a training set.

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

• Not applicable. As there is no training set, this question is not relevant.

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