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The CD Horizon™ Spinal System with or without Sextant™ instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: 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), tumor, pseudarthrosis, and or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, 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, CD Horizon™ Legacy™ 3.5mm rods and associated components may be used for indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediativ indications noted.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD Horizon™ System is intended to treat pediatic patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft. Pediatric 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 or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 – S1) in skeletally mature patients. Devices are intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.

The CD Horizon™ Spire™ plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDD, spondylolisthesis, trauma, and/or tumor.

To achieve additional levels of fixation, CD Horizon™M Spinal System rods may be connected to the Vertex™ Reconstruction System with the Vertex™ rod connector. Refer to the Vertex™ Reconstruction System package insert for a list of Vertex™ indications

The PASS LP™ Spinal System is a pedicle screw fixation system intended for immobilization 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 disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tracture or dislocation), deformity or curvature (e.g., scoliosis, and/or lordosis), tumor, spinal stenosis, pseudarthrosis, or failed previous fusion.

Except for rod plates and caps for sacral plates, when non-cervical pedicle screw fixation in pediatric patients, the PASS LP™ Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis and fracture caused by tumor and/or trauma. The PASS LP™ Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The CD Horizon Spinal System and PASS LP™ Spinal System (including UNiD™ Patient Specific Rods) consist of a variety of shapes and size of rods, hooks, screws, crosslink, plates, staples and connecting components, as well as implants 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.

The purposes of this submission are to:

• Add the UNiD™ Patient Specific Rods (new diameter 4.75mm) to the previously cleared CD Horizon™ Spinal System (K113174, cleared 11/21/2011) and PASS LP™ Spinal System (K140738, cleared 11/04/2014)
• Change the propriety Trade Name from "PASS LP™ Patient Specific Rods" to "UNiD™ Patient י Specific Rods"

UNiD™ Patient Specific Rods are manufactured in titanium alloy Ti-6AI-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications, or in cobalt chrome alloy Co-Cr28Mo6 conforming to ISO 5832-12 specifications and ASTM F1537 specifications.

UNiD™ Patient Specific Rods are differentiated in two subgroups: UNiD™ Patient Specific Standard Rods (UNiD ROD) and UNiD™ Patient Specific Percutaneous Rods (UNiD™ Patient Specific Rods have been designed and manufactured for one specific patient. UNiD™ Patient Specific Rods must be used during surgery for this patient only and must not be reused (single use only). The UNiD™ Patient Specific Rods 4.75 diameter rods are not compatible with the PASS LP system. For a complete guide to the system, it is important to refer to the surgical technique.

Please find the information regarding the acceptance criteria and study for the device below.

The provided text is a 510(k) Summary for the CD Horizon™ Spinal System and PASS LP™ Spinal System, which are pedicle screw fixation systems. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, particularly for UNiD™ Patient Specific Rods. The primary purpose of this submission is to add UNiD™ Patient Specific Rods (new diameter 4.75mm) and to change the proprietary Trade Name from "PASS LP™ Patient Specific Rods" to "UNiD™ Patient Specific Rods."

The testing conducted is for mechanical equivalence, not clinical performance or diagnostic accuracy. Therefore, concepts like sensitivity, specificity, accuracy, and reader studies (MRMC, standalone algorithm performance) are not applicable to this type of device submission. The acceptance criteria and "performance" here refer to mechanical strength and durability.

Here's a breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device (implantable spinal system), the acceptance criteria are based on mechanical properties as per a recognized standard. The document does not provide specific numerical acceptance criteria (e.g., minimum load values) but rather states that testing was conducted in accordance with a standard and demonstrated mechanical equivalence.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated. Mechanical testing typically involves a sufficient number of samples (e.g., typically n=5 or n=6 per test condition for medical device mechanical testing) to provide statistically significant results according to the chosen standard (ASTM F1717-18).
• Data Provenance: The testing was conducted by Medicrea (Medtronic). It's scientific/engineering test data, not patient data, so 'country of origin' of data or 'retrospective/prospective' doesn't apply in the common clinical sense. The manufacturer is based in France.

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

• Number of Experts: Not applicable. Ground truth for mechanical testing is established by recognized engineering standards (ASTM F1717-18) and measured physical properties, not expert consensus.
• Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This is mechanical testing data, not human-interpreted data. Results are quantified using laboratory equipment.

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

• MRMC Study Done: No. This type of study is for evaluating the impact of a diagnostic or assistive AI device on human reader performance. This submission is for an implantable medical device, not a diagnostic or AI-driven system.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• Standalone Study Done: No. This also refers to AI algorithm performance, which is not relevant to this mechanical device submission.

7. Type of Ground Truth Used

• Type of Ground Truth: Engineering standards and measurements of mechanical properties. The "ground truth" is adherence to established, validated mechanical test methods (ASTM F1717-18) that ensure the device is "substantially equivalent" in performance to predicate devices.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This concept applies to machine learning models. The manufacturing process of UNiD™ Patient Specific Rods involves patient-specific design (i.e., custom bending for one specific patient based on their anatomy), but this is not an AI "training set."

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

• How Ground Truth for Training Set Was Established: Not applicable. No "training set" in the machine learning sense is used here. For the patient-specific rods, the "ground truth" for each rod's design is the specific patient's anatomical requirements, which are determined via medical imaging and planning, not a training set.

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The PASS LP™ Spinal System is a pedicle screw fixation system intended for immobilization 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 disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tracture or dislocation), deformity or curvature (e.g., scoliosis, and/or lordosis), tumor, spinal stenosis, pseudarthrosis, or failed previous fusion.

Except for rod plates and caps for sacral plates, when used for posterior non-cervical pediative patients, the PASS LP™ Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis and fracture caused by tumor and/or trauma. The PASS LPTM Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The CD Horizon™ Spinal System without Sextant™ instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: 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), tumor, pseudarthrosis, and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, 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, CD Horizon™ Legacy™ 3.5mm rods and associated components may be used for indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediativ indications noted.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD Horizon™ System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft. Pediatric 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 or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 – S1) in skeletally mature patients. Devices are intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.

The CD Horizon™ Spire™ plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDD, spondylolisthesis, trauma, and/or tumor.

To achieve additional levels of fixation, CD Horizon™ Spinal System rods may be connected to the Vertex™ Reconstruction System with the Vertex™ rod connector. Refer to the Vertex™ Reconstruction System package insert for a list of Vertex™ indications.

The PASS LP" Spinal System is composed of screws, hooks, rods, plates, cross links, connection and locking devices. The range of different sizes and shapes of the implants allows the surgeon to adapt to the pathology and morphology of each of his patients.

The implants are manufactured in titanium alloy Ti-6Al-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications, with the exception of the rods intended for in situ bending which are manufactured in non-alloyed titanium (CP titanium) conforming to ISO 5832-2 specifications and ASTM F67 specifications.

CoCr rods and implants are manufactured in Cobalt-Chromium Molybdenum alloy Co-Cr28Mo6 conforming to ISO 5832-12 specifications and ASTM F1537 specifications. Under no circumstances are the implants reusable.

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.

The purpose of this submission following:

• introduce new PASS LP™ Spinal System 'Universal Crosslinks' components
• expand use of the previously cleared CD Horizon™ Spinal System rods with the subject PASS LP™ Universal Crosslinks
• expand use of previously cleared CD Horizon™ Spinal System hooks with previously cleared PASS LP™ Spinal System components

The provided text is an FDA 510(k) summary for a spinal system device. It does not describe or contain information about a study that proves a device meets acceptance criteria related to AI/ML device performance, which is what the prompt is asking for when it refers to "acceptance criteria," "sample size for test set," "data provenance," "experts," "adjudication," "MRMC study," "standalone performance," "ground truth," and "training set."

This document describes a spinal fixation system, its components, indications for use, and a comparison to predicate devices, primarily focusing on mechanical testing to demonstrate substantial equivalence for a physical medical device. The "acceptance criteria" mentioned in this document refer to the mechanical performance of the spinal system components (e.g., dynamic compression bending) as per ASTM F1717, to ensure the device is safe and effective when compared to existing devices.

Therefore, it's impossible to extract the requested information (related to AI/ML device performance studies) from the provided text.

The closest relevant information from the text to the prompt's structure is:

1. A table of acceptance criteria and the reported device performance:
* Acceptance Criteria (Mechanical): Mechanical equivalence of the subject PASS LP™ universal crosslinks when used with the CD Horizon™ 5.5/6.0 Spinal System, as demonstrated by testing in accordance with ASTM F1717.
* Reported Device Performance: "The performance testing demonstrates mechanical equivalence of the subject PASS LP™ universal crosslinks when used with the CD Horizon™ 5.5/6.0 Spinal System." and "The mechanical testing (e.g., dynamic compression bending) and an engineering analysis were performed to demonstrate substantial equivalence."
* Note: No specific numerical values for performance are provided in this summary.

The following information cannot be found in the provided text as it pertains to AI/ML device validation, not mechanical device testing:

• Sample sized used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
• Adjudication method for the test set.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc).
• The sample size for the training set.
• How the ground truth for the training set was established.

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The PASS LP Spinal System is a pedicle screw fixation system intended for immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tracture or dislocation), deformity or curvature (e.g., scoliosis, and/or lordosis), tumor, spinal stenosis, pseudarthrosis, or failed previous fusion.

Except for rod plates and caps for sacral plates, when used for posterior non-cervical pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct to treat adolescent idiopathic scollosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis and fracture caused by tumor and/or trauma. The PASS LP Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The PASS LP is designed to contribute to correction and surgical stabilization of the thoracic, lumbar and sacral spine.

The system consists of pedicle screws, hooks, sacral plates, iliac screws, clamps, rods, nuts, rod plates and crosslink components. It can be used for single or multiple level fixations. Components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136 and ISO 5832-3.

A subset of PASS LP components may be used for posterior pedicle screw fixation in pediatrics cases. These constructs may be comprised of a variety of shapes and sizes of rods, hooks, sacral plates, iliac screws, clamps, nuts and crosslink components. The PASS LP components can be rigidly locked into a variety of configurations, with each construct being tailored made for the individual case.

The purpose of this submission is to extend to the PASS LP range, with the addition of those new components:

• TULIP GENESIS Non-cannulated Pedicle Screws
• TULIP GENESIS Non-cannulated Iliac Screws
• TULIP GENESIS Cannulated Pedicle Screws
• TULIP GENESIS Cannulated Iliac Screws
• TULIP GENESIS Breakable Setscrew

This document is a 510(k) Pre-Market Notification from the FDA for the PASS LP Spinal System. It is an approval letter and a summary of the device and its intended use, not a study evaluating its performance against acceptance criteria in the context of an AI/ML medical device.

Therefore, I cannot provide the requested information as the document does not contain details about:

1. Acceptance criteria and reported device performance related to an AI/ML model. This document is for a medical implant (spinal fixation system), not a software device that relies on performance metrics like accuracy, sensitivity, or specificity.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
6. Stand-alone algorithm performance.
7. Type of ground truth used (e.g., pathology, outcomes data) for an AI/ML model.
8. Sample size for a training set.
9. How ground truth for the training set was established.

The "Performance Data" section (g) only mentions mechanical testing according to ASTM F1717-18 for static compression bending, static torsion, and dynamic compression bending tests, concluding that the products are "as mechanically sound as other devices commercially available." This refers to the physical properties of the spinal implants, not the performance of an AI or Machine Learning algorithm.

Ask a specific question about this device

The PASS LP Spinal System is a pedicle screw fixation system intended for immobilization 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 disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tracture or dislocation), deformity or curvature (e.g., scoliosis, and/or lordosis), tumor, spinal stenosis, pseudarthrosis, or failed previous fusion.

Except for rod plates, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the system is intended to treat pediatic patients diagnosed with the following conditions: spondylolistis and fracture caused by tumor and/or trauma. The PASS LP Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The PASS LP is designed to contribute to correction and surgical stabilization of the thoracic, lumbar and sacral spine.

The system consists of pedicle screws, hooks, sacral plates, iliac screws, clamps, rods, nuts, rod plates and crosslink components. It can be used for single or multiple level fixations. Components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136 or cobalt-chromium molybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537.

A subset of PASS LP components may be used for posterior pedicle screw fixation in pediatrics cases. These constructs may be comprised of a variety of shapes and sizes of rods, hooks, sacral plates, iliac screws, clamps, nuts and crosslink components. The PASS LP components can be rigidly locked into a variety of configurations, with each construct being tailored made for the individual case.

The purpose of this submission is to extend to the PASS LP, with the addition of new components: 'Dominoes & Iliac Connectors'.

The provided document is a 510(k) summary for the Medicrea International S.A. PASS LP Spinal System, specifically for the addition of new components ('Dominoes & Iliac Connectors'). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel performance against acceptance criteria in the context of an AI/ML medical device.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets these criteria for an AI/ML product. Specifically:

• No AI/ML device: The PASS LP Spinal System is a physical spinal implant system, not an AI/ML-driven medical device.
• No acceptance criteria for AI/ML performance: The "acceptance criteria" discussed in the document relate to biocompatibility and mechanical engineering standards for physical implants (e.g., ASTM F1717-15, ISO 10993).
• No study demonstrating AI/ML performance: The document explicitly states "No clinical studies were performed" and "No animal studies were performed." The "performance data" section refers to engineering and biocompatibility testing of the physical components.
• No data provenance, expert panels, or MRMC studies: These concepts are relevant to the evaluation of AI/ML diagnostic or prognostic devices, which is not what this 510(k) submission addresses.

In summary, the provided text describes a medical device approval pathway for a physical orthopedic implant and does not contain any of the information requested about AI/ML device acceptance criteria or performance studies.

Ask a specific question about this device

The PASS LP Spinal System is a pedicle screw fixation system intended for immobilization 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 disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tracture or dislocation), deformity or curvature (e.g., scoliosis, and/or lordosis), tumor, spinal stenosis, pseudarthrosis, or failed previous fusion.

Except for rod plates, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct to treat adolescent idiopathic scolosis. Additionally, the system is intended to treat pediatic patients diagnosed with the following conditions: spondylolistis and fracture caused by tumor and/or trauma. The PASS LP Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The PASS LP Spinal System is designed to contribute to correction and surgical stabilization of the thoracic, lumbar and sacral spine.

The system consists of pedicle screws, hooks, sacral plates, iliac screws, connectors, clamps, rods, nuts, rod plates and crosslink components. It can be used for single or multiple level fixations. Components are manufactured from titanium allov (Ti-6Al-4V ELI) that conforms to ISO 5832-3 ASTM F136 and cobaltchromium molybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537.

A subset of PASS LP Spinal System components may be used for posterior pedicle screw fixation in pediatrics cases. These constructs may be comprised of a variety of shapes and sizes of rods, hooks, sacral plates, iliac screws, clamps, nuts and crosslink components. The PASS LP components can be rigidly locked into a variety of configurations, with each construct being tailored made for the individual case.

The purpose of this submission is to extend the PASS LP Spinal System, with the addition of new components:

• । 'Top loading Pedicle hooks'
• -'Top loading Transverse Process hooks'

The provided text describes a 510(k) premarket notification for the "PASS LP Spinal System," a medical device. This document is a regulatory submission to the FDA, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with defined acceptance criteria in the manner one might expect for a novel AI/software device.

Therefore, the input document does not contain the requested information regarding acceptance criteria and a study proving a device meets those criteria for software or AI performance.

The document is about a spinal implant system and discusses:

• Its intended use.
• Comparison of its technological characteristics (design, materials) to predicate devices.
• Biocompatibility testing (which followed standards like ISO 10993) and mechanical testing (using Finite Element Analysis based on ASTM F1798 standards to compare with predicate devices).
• Explicitly states "No clinical studies were performed" and "No animal studies were performed."

Given the nature of the document, the following points based on your request cannot be extracted:

1. A table of acceptance criteria and the reported device performance: Not applicable for this type of medical device submission where "performance" is primarily structural integrity and biocompatibility, demonstrated through testing against relevant standards rather than a clinical performance metric.
2. Sample size used for the test set and the data provenance: Not applicable. The "tests" here are biomechanical and biocompatibility tests, not a clinical test set for AI/software performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable. No ground truth in the context of data labeling is mentioned.
4. Adjudication method: Not applicable.
5. Multi reader multi case (MRMC) comparative effectiveness study: Explicitly stated "No clinical studies were performed."
6. Standalone (i.e. algorithm only without human-in-the-loop performance) study: This device is a physical implant, not an algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The PASS LP Spinal System is a pedicle screw fixation system intended for immobilization 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 disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tracture or dislocation), deformity or curvature (e.g., scoliosis, and/or lordosis), tumor, spinal stenosis, pseudarthrosis, or failed previous fusion.

Except for rod plates, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct to treat adolescent idiopathic scolosis. Additionally, the system is intended to treat pediatic patients diagnosed with the following conditions: spondylolisthesis/spondylolysis and fracture caused by tumor and/or trauma. The PASS LP Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The PASS LP Spinal System is designed to contribute to correction and surgical stabilization of the thoracic, lumbar and sacral spine.

The system consists of pedicle screws, hooks, sacral plates, iliac screws, connectors, clamps, rods, nuts, rod plates and crosslink components. It can be used for single or multiple level fixations. Components are manufactured from titanium alloy (Ti-6AI-4V ELI) that conforms to ISO 5832-3 ASTM F136 and cobalt-chromium molybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537.

A subset of PASS LP Spinal System components may be used for posterior pedicle screw fixation in pediatrics cases. These constructs may be comprised of a variety of shapes and sizes of rods, hooks, sacral plates, iliac screws, connectors, clamps, nuts and crosslink components. The PASS LP components can be rigidly locked into a variety of configurations, with each construct being tailored made for the individual case.

The purpose of this submission is to extend the PASS LP Spinal System, with the addition of new components:

• -'Top loading, cannulated pedicle screws'
• -'Top loading, non-cannulated pedicle screws'
• -'Top loading, cannulated iliac screws'
• -'Top loading, non-cannulated iliac screws'
• 'Closed, cannulated iliac screws' -
• 'Closed, non-cannulated iliac screws' -

The provided document is a 510(k) premarket notification for a medical device called the "PASS LP Spinal System". It describes the device, its intended use, comparison to predicate devices, and performance data. However, the document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/algorithm performance.

The performance data section (page 7) lists:

• Biocompatibility Testing: Conducted according to FDA blue book Memorandum #G95-1 and ISO 10993-1. Specific tests included Cytotoxicity, Sensitization, Irritation, Systemic toxicity, and Pyrogen Testing.
• Mechanical Testing: Performed on additional components (static bending, static torsion, dynamic compression bending according to ASTM F1717). The document states these tests indicate "the products are as mechanically sound as other devices commercially available."
• No Finite Element Analysis were performed.
• No Clinical Study was performed.
• No Animal Study was performed.

This information relates to the physical and biological properties of the spinal implant system, not the performance of an AI or algorithm. Therefore, I cannot provide the requested details regarding acceptance criteria for AI performance, sample sizes for test/training sets, expert qualifications, or adjudication methods, as these are not present in the provided text.

Ask a specific question about this device

The PASS LP Spinal System is a pedicle screw fixation system intended for immobilization 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 disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tracture or dislocation), deformity or curvature (e.g., scoliosis, and/or lordosis), tumor, spinal stenosis, pseudarthrosis, or failed previous fusion.

Except for rod plates, when used for posterical pedicle screw fixation in pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis and fracture caused by tumor and/or trauma. The PASS LP Spinal System is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The PASS LP Spinal System is designed to contribute to correction and surgical stabilization of the thoracic, lumbar and sacral spine.

The system consists of pedicle screws, hooks, sacral plates, iliac screws, clamps, rod plates and crosslink components. It can be used for single or multiple level fixations. Components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136 or cobaltchromium molybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537.

A subset of PASS LP Spinal System components may be used for posterior pedicle screw fixation in pediatrics cases. These constructs may be comprised of a variety of shapes and sizes of rods, hooks, sacral plates, iliac screws, clamps, nuts and crosslink components. The PASS LP components can be rigidly locked into a variety of configurations, with each construct being tailored made for the individual case.

The purpose of this submission is to extend to the PASS LP Spinal System, with the addition of new components: Polyaxial Cannulated Pedicle Screws.

The provided text is a 510(k) Summary for a medical device (PASS LP Spinal System) and does not contain information about the acceptance criteria and a study proving the device meets those criteria in the way a performance study for an AI/ML diagnostic device usually would.

This document describes a premarket notification for a spinal implant system, which is a physical device, not an AI/ML algorithm. Therefore, the typical "acceptance criteria" and "performance study" as they pertain to AI/ML diagnostic tools (e.g., sensitivity, specificity, AUC, human reader improvement) are not applicable here.

Instead, the performance data provided focuses on:

• Biocompatibility Testing: Ensuring the materials are safe for use in the human body.
• Mechanical Testing: Demonstrating the structural integrity and strength of the physical components.

Here's an analysis of the provided information based on the typical categories for AI/ML device performance, highlighting why much of it is not present in this physical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "No clinical studies were performed. No animal studies were performed." for this 510(k) submission, as it relies on substantial equivalence to predicate devices for its intended use.

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

• Not Applicable: This pertains to an AI/ML algorithm trained and tested on data. The PASS LP Spinal System is a physical implant. The biocompatibility and mechanical tests are performed on materials and components, not a "test set" of patient data.

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

• Not Applicable: Ground truth establishment by experts is relevant for AI/ML diagnostic devices. For a physical spinal system, the safety and performance are assessed through laboratory and material testing against established engineering standards (ASTM, ISO).

4. Adjudication method for the test set

• Not Applicable: Adjudication is for resolving discrepancies in expert interpretations for AI/ML ground truth.

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: An MRMC study is for evaluating human performance with and without an AI diagnostic aid. This device is a physical implant.

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

• Not Applicable: Standalone performance refers to an AI algorithm's diagnostic accuracy without human interaction. This is a physical device.

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

• For the physical device, the "ground truth" for its safety and efficacy is established through a combination of:
  • Adherence to Material Standards: Conformance to ASTM F136 and ISO 5832-3 for titanium alloy and ISO 5832-12 and ASTM F1537 for cobalt-chromium molybdenum alloy.
  • Biocompatibility Testing Standards: Following FDA Memorandum #G95-1 and ISO 10993-1.
  • Mechanical Testing Standards: Specific ASTM standards (F543 for pull-out, F2193 for static torsion and bending).
  • Substantial Equivalence: The primary basis for this 510(k) clearance is that the device is substantially equivalent to previously cleared predicate devices (K141398 and K112493) in terms of indications for use, design, material, and function. The "ground truth" for its clinical safety and effectiveness is inferred from the established track record of these predicate devices.

8. The sample size for the training set

• Not Applicable: This device is not an AI/ML algorithm that requires a training set.

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

• Not Applicable: There is no training set for this physical device.

Summary for the provided document:

The document describes the PASS LP Spinal System, an orthopedic implant. The "performance data" section in this 510(k) summary focuses entirely on the biocompatibility of the materials and the mechanical strength of the components, tested against established industry standards. The submission relies on substantial equivalence to predicate devices. The concepts of acceptance criteria, test sets, ground truth, expert adjudication, MRMC studies, and training sets are specific to AI/ML diagnostic software and are not applicable to this type of device submission.

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The PASS LP Spinal System includes a pedicle system intended to provide immobilization 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: Fractures Dislocation Failed previous fusion (Pseudoarthrosis) Spinal stenosis Degenerative spondylolisthesis with objective evidence of neurological impairment Spinal deformations such as scoliosis or kyphosis. Loss of stability due to tumors.

The PASS LP Spinal Systems is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the LS-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having, implants attached to the lumbar and sacral spine (13 to sacrum) with removal of the implants after the attainment of a solid fusion.

The PASS LP also includes hooks and sacral/iliac screws indicated for 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, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

Except for rod plates, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PASS LP Spinal System is intended to be used with allograft and/or autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The PASS LP Spinal System is designed to contribute to correction and surgical stabilization of the thoracic, lumbar and sacral spine.

The system consists of pedicle screws, hooks, sacral plates, iliac screws, clamps, rods, nuts, rod plates and crosslink components. It can be used for single or multiple level fixations. Components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136 or cobaltchromium molybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537.

A subset of PASS LP Spinal System components may be used for posterior pedicle screw fixation in pediatrics cases. These constructs may be comprised of a variety of shapes and sizes of rods, hooks, sacral plates, iliac screws, clamps, nuts and crosslink components. The PASS LP components can be rigidly locked into a variety of configurations, with each construct being tailored made for the individual case.

The purpose of this submission is to extend to the PASS LP Spinal System, with the addition of new components: "Monoaxial Pedicle Screws' and 'Rod Connectors'.

The provided text is a 510(k) summary for the PASS LP Spinal System, which is a premarket notification to the FDA for a medical device. This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.

The document states that no clinical studies, animal studies, or performance data in the context of acceptance criteria demonstrating device performance were conducted or provided in support of substantial equivalence beyond biocompatibility and mechanical testing. The submission relies on the substantial equivalence principle, meaning the device is similar enough to an already approved device that it does not raise new questions of safety and effectiveness.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in this document because a traditional comparative effectiveness study or controlled clinical trial, as implied by your request, was not performed for this 510(k) submission.

However, I can extract the information that is present:

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

This information is not provided in the document as no specific acceptance criteria for a clinical or performance study are detailed, nor is there reported device performance against such criteria. The document states "no clinical studies were performed."

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

Not applicable. No test set (in the context of clinical or performance data against specific criteria) was used for this 510(k) submission.

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

Not applicable. No ground truth was established for a test set as no clinical or performance study was conducted.

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

Not applicable. No test set required adjudication.

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. No MRMC study was conducted. The device is a spinal implant, not an AI-assisted diagnostic tool.

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

Not applicable. This is a spinal implant, not an algorithm or AI device.

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

Not applicable. No ground truth for a clinical study was required or established.

8. The sample size for the training set:

Not applicable. This is a spinal implant, not a machine learning algorithm that requires a training set.

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

Not applicable.

Summary of available "Performance Data" and "Acceptance Criteria" type information from the document:

The "Performance Data" section (Page 7) describes the types of testing that were performed to support the substantial equivalence:

• Biocompatibility Testing:

  • Tests Performed: Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Pyrogen Testing.
  • Standards Followed: FDA blue book Memorandum #G95-1 "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995," and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
  • Device Classification for Biocompatibility: Defined as an implantable device in contact with tissue and bone, with permanent contact.
  • Material Conformance: Ti-6Al-4V ELI, following standards ASTM F136 and ISO 5832-3 for chemical composition.
  • Acceptance Criteria (Implied): Conformance to the cited standards and demonstration of biocompatibility (i.e., no adverse findings in the specified tests).

• Mechanical Testing:

  • Tests Performed: Dynamic axial compression according to ASTM F1717 (when applicable to the new components).
  • Acceptance Criteria (Implied/Stated Performance): The products are "as mechanically sound as other devices commercially available." This is a comparative statement rather than a specific numeric acceptance criterion.

This 510(k) submission primarily establishes substantial equivalence based on the device's similarity in design, materials, intended use, and mechanical/biocompatibility performance to a previously cleared predicate device, rather than through new clinical performance studies with specific acceptance criteria that would typically be seen in a de novo or PMA submission for a novel device.

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The PASS LP Spinal Systems include a pedicle system intended to provide immobilization 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:

• · Fractures
• · Dislocation
• · Failed previous fusion (Pseudarthrosis)
• · Spinal Stenosis
• · Degenerative spondylolisthesis with objective evidence of neurological impairment
• · Spinal deformations such as scoliosis or kyphosis.
• · Loss of stability due to tumors.

The PASS LP Spinal Systems are also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The PASS LP also include hooks and sacral/iliac screws indicated for 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, deformities or curvatures (i.e., scoliosis, kyhosis, and/or lordosis), tumor. Pseudarthrosis and failed previous fusion.

Except for rod plates, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PASS LP Spinal System is intended to be used with allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The UNiD Rods have to be used with the PASS LP Spinal System designed to contribute to correction and surqical stabilization of the thoracic, lumbar and sacral spine. The Patient Specific Rod is a rod bent before the surgery by MEDICREA, following the profile defined by the surgeon only, specific to a unique patient.

The system consists of pedicle screws, hooks, sacral plates, iliac screws, clamps, rod plates and crosslink components. It can be used for single or multiple level fixations. Components are manufactured from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136 and ISO 5832-3 or cobalt-chromium molybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537.

The purpose of this submission is to offer the existing cleared reference in sterile version.

A subset of PASS LP Spinal System components may be used for posterior pedicle screw fixation. These constructs may be comprised of a variety of shapes and sizes of rods, hooks, sacral hooks, sacral plates, iliac screws, clamps, nuts and crosslink components. These components can be rigidly locked into a variety of configurations, with each construct being tailored made for the individual case.

Materials: Titanium alloy and Cobalt-chromium-molybdenum alloy

This Special 510(k) premarket notification is submitted for the additional offering of gamma sterilzed UNiD Rods.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) premarket notification response from the FDA regarding the "PASS LP Spinal System." It details the device's classification, predicate devices, description, and indications for use. It does not include any performance data, clinical study results, or acceptance criteria.

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The PASS LP Spinal System is a pedicle screw fixation system intended for immobilization 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 disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondy lolisthesis, tracture or dislocation), deformity or curvature (e.g., scoliosis, and/or lordosis), tumor, spinal stenosis, pseudoarthrosis, or failed previous fusion.

Except for rod plates, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis and fracture caused by tumor and/or trauma. The PASS LP Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The PASS LP Spinal System is designed to contribute to correction and surgical stabilization of the thoracic, lumbar and sacral spine.

The system consists of pedicle screws, hooks, sacral plates, iliac screws, clamps, rod plates and crosslink components. It can be used for single or multiple level fixations. Components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136 or cobaltchromium molybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537.

The purpose of this submission is to add components to the PASS LP implant range to treat Pars interarticularis fracture.

A subset of PASS LP Spinal System components may be used for posterior pedicle screw fixation in pediatrics cases. These constructs may be comprised of a variety of shapes and sizes of rods, hooks, sacral hooks, sacral plates, iliac screws, clamps, nuts and crosslink components. These components can be rigidly locked into a variety of configurations.

The provided text describes the 510(k) premarket notification for the PASS LP Spinal System. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study to prove acceptance criteria for a new device's performance characteristics. Therefore, many of the requested categories related to clinical studies, ground truth establishment, expert adjudication, and MRMC studies are not applicable or cannot be extracted directly from this type of regulatory submission.

However, I can extract information regarding the performance data provided to support the substantial equivalence.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative table for device performance in the way one might expect for a new diagnostic or AI intervention. Instead, it relies on demonstrating substantial equivalence to existing predicate devices through mechanical testing. The implicit acceptance criterion is that the new components perform comparably to the predicates in standard mechanical tests.

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

The document mentions "Dynamic Compression Bending Tests, following the ASTM F1717 'Standard Test Methods for Spinal Implants Constructs in a Vertebrectomy Model' were carried out."

• Sample Size: The specific number of devices tested in the Dynamic Compression Bending Tests (n for each test group) is not provided in this document.
• Data Provenance: The tests were "carried out" as part of the submission process, implying these were prospective bench tests conducted specifically for this regulatory submission. The country of origin for the data is implicitly France, where Medicrea® International S.A. is based.

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

This section is not applicable. The "ground truth" for the mechanical performance of a spinal implant is determined by established engineering standards (ASTM F1717) and the physical properties observed in the bench tests, not by expert consensus in a clinical setting.

4. Adjudication method for the test set

This section is not applicable. Mechanical tests against a standard do not typically involve human adjudication in the same way clinical or image-based studies do. The results are quantitative measurements against predetermined pass/fail criteria (often, remaining within a certain deviation of predicate performance).

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 section is not applicable. This document concerns a spinal implant system, not a diagnostic device or AI system that assists human readers.

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

This section is not applicable. This document concerns a spinal implant system, not an AI algorithm.

7. The type of ground truth used

The ground truth used for evaluating the device's performance was:

• Mechanical performance metrics as defined by the ASTM F1717 standard for "Spinal Implants Constructs in a Vertebrectomy Model." This involves quantitative measurements of force, displacement, and cycles to failure under defined loading conditions.
• Performance of legally marketed predicate devices (CD Horizon Spinal System - K140449, and PASS LP Spinal System - K123138) against the same standard, effectively setting the "ground truth" for acceptable performance.

8. The sample size for the training set

This section is not applicable. This document concerns a spinal implant system, not a device that utilizes a "training set" in the context of machine learning or AI.

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

This section is not applicable. There is no "training set" in the context of this device and evaluation.

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