Search Results

Manufacturer

MEDOS INTERNATIONAL SARL

Date Cleared

2013-06-20

(83 days)

Product Code

NKB,KWP,KWQ,MNH,MNI,OSH

Regulation Number

Type

Panel

K132644,K141291,K170163,K210963

Reference & Predicate Devices

K041119,K062174,K071495,K073364,K082942,K090230,K101070,K111136

Predicate For

Intended Use

The EXPEDIUM Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (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, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM System metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The EXPEDIUM system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Device Description

The subject additions to the EXPEDIUM 4.5mm, 5.5mm, and 6.35mm Spine Systems consist of open angled extended, slotted connectors and various rods. The connectors are available in titanium alloy with lengths of 5, 10, 15, and 20mm. The rods vary in size and geometries to accommodate patient anatomy and are available in materials of titanium, stainless steel, and cobalt chrome.

AI/ML Overview

The provided text is a 510(k) summary for the EXPEDIUM® Spine System and primarily focuses on establishing substantial equivalence to predicate devices, rather than describing a study with acceptance criteria for device performance in a clinical or AI context. The performance data mentioned is for mechanical testing per ASTM F 1798.

Therefore, many of the requested fields cannot be filled as they pertain to clinical or AI-based performance studies, which are not detailed in this document.

Here's an attempt to answer the questions based on the provided text:

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

Acceptance Criteria	Reported Device Performance
Mechanical Performance per ASTM F 1798	Performance data per ASTM F 1798 was submitted to characterize the subject EXPEDIUM Spine System connector. This testing comprised of static axial slip and both static and dynamic cantilever beam bending.
Substantial Equivalence to Predicate Devices	Both the Performance Testing and Substantial Equivalence Justification demonstrate that the subject devices are as safe, as effective, and perform as well as the predicate devices.

Note: The document specifies that "a rationale is provided in place for performance testing for the subject rods of this submission," implying that not all aspects underwent direct performance testing, but justification was provided for equivalence based on existing data or design similarities.

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

This information is not provided in the document. The testing described is mechanical, not clinical, and details on sample sizes for mechanical tests are not included. Data provenance is also not mentioned.

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. The ground truth for mechanical testing is based on engineering standards and measurement, not expert review of clinical data.

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

Not applicable. This is for mechanical testing, not a clinical study requiring adjudication of expert opinions.

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 document describes a medical device (spinal implant), not an AI system.

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

Not applicable. This document describes a medical device (spinal implant), not an AI system.

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

For the mechanical performance testing, the ground truth would be the established engineering standards and specifications defined by ASTM F 1798. For substantial equivalence, the ground truth is the performance of the predicate devices.

8. The sample size for the training set

Not applicable. This document describes a medical device (spinal implant) and its mechanical testing, not a machine learning model.

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

Not applicable. This document describes a medical device (spinal implant) and its mechanical testing, not a machine learning model.

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K Number

K111136

Device Name

EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM

Manufacturer

DEPUY SPINE, INC.

Date Cleared

2012-06-14

(419 days)

Product Code

NKB,KWP,KWQ,MNH,MNI,OSH

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

K122877,K124058,K130877,K131802,K141509,K142185,K142460,K153446,K160904,K172808,K181139,K190471,K191212,K231655

Intended Use

The EXPEDIUM and VIPER/VIPER2 Spine Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The EXPEDIUM and VIPER/VIPER2 Spine System metallic components are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used in a posterior percutaneous approach with MIS instrumentation, the VIPER/VIPER2 System metallic components are intended for noncervical pedicle fixation and nonpedicle fixation for fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM and VIPER/VIPER2 System metallic implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The EXPEDIUM and VIPER/VIPER2 systems are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The EXPEDIUM and VIPER/VIPER2 PEEK rods are only indicated for fusion procedures for spinal stenosis with instability (no greater than Grade I spondylolisthesis) from LI-SI in skeletally mature patients.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM and VIPER/VIPER2 System metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The EXPEDIUM and VIPER/VIPER2 systems are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Device Description

The subject EXPEDIUM® Spine System and VIPER®/VIPER®2 Systems are pedicle screw scoliosis systems for the treatment of pediatric patients consisting of a wide range of components in a variety of geometries and sizes.

AI/ML Overview

The provided document does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in terms of diagnostic accuracy or algorithmic performance.

Instead, this is a 510(k) summary for the "EXPEDIUM® Spine System, VIPER® System, VIPER®2 System," which are pedicle screw spinal systems. The document focuses on demonstrating substantial equivalence to previously cleared predicate devices, an approval pathway primarily concerned with the safety and effectiveness of a new device compared to an existing one, rather than novel performance benchmarks.

Here's a breakdown of what the document does state regarding performance:

A table of acceptance criteria and the reported device performance: This information is not present. The document does not define specific performance metrics or acceptance criteria for the device's function or a study comparing it to those criteria.
Sample size used for the test set and the data provenance: Not applicable. No test set or data provenance for performance evaluation is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment is described.
Adjudication method for the test set: Not applicable. No test set adjudication is described.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a surgical implant (pedicle screw system), not an AI-assisted diagnostic tool, so an MRMC study is irrelevant in this context.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic or AI device.
The type of ground truth used: Not applicable. No ground truth is mentioned.
The sample size for the training set: Not applicable. No training set is mentioned.
How the ground truth for the training set was established: Not applicable. No training set ground truth is mentioned.

Key statements from the document regarding performance:

"No new testing was performed. Published clinical results and engineering analysis supported the expansion of indications." (Page 2, section "Performance Data")
"The substantial equivalence justification demonstrates that the device is as effective, and performs as well as the predicate device." (Page 3, Conclusion)

In summary, this 510(k) submission relies on demonstrating substantial equivalence to predicate devices, drawing on existing clinical results and engineering analyses, rather than presenting a performance study with defined acceptance criteria for the device itself.

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K Number

K110551

Device Name

Manufacturer

JOHNSON & JOHNSON

Date Cleared

2011-10-26

(240 days)

Product Code

Regulation Number

Type

Panel

EXPEDIUM SPINE SYSTEM, MOSS MIAMI SPINE SYSTEM

Reference & Predicate Devices

K063772,K090230,K092473,K011182,K023804

Predicate For

N/A

Intended Use

The EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.

Device Description

The EXPEDIUM® 4.5mm Spine System is a rod-hook-screw system. The EXPEDIUM 4.5mm Spine System proposed single and dual diameter rods are offered in titanium, stainless steel, and cobalt-chromiummolybdenum. They are available in various geometries and sizes to accommodate patient anatomy.

AI/ML Overview

The provided text describes a 510(k) summary for the EXPEDIUM Spine System, which is a medical device for spinal fixation. It details the device's characteristics, intended use, and comparison to predicate devices, but it does not contain any information about a study that would establish acceptance criteria for device performance based on clinical or AI-driven evaluation, nor does it provide performance data in the context of diagnostic accuracy or expert consensus.

The "Performance Data" section specifically states:
"Performance data per ASTM F 1717 were submitted to characterize the subject EXPEDIUM Spine System components addressed in this notification. Specifically, static and dynamic compression testing as well as static torsion testing were performed."

This indicates that the performance data submitted relates to mechanical testing of the device components (e.g., strength, durability), not to a study assessing the device's diagnostic or clinical performance in comparison to a ground truth or human experts. Therefore, most of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment is not present in the provided document.

Here's an attempt to address the points based on the available information, highlighting what is not present:

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

Acceptance Criteria (Type of Performance)	Reported Device Performance
Mechanical Performance (ASTM F 1717)	Passed (Implied by conclusion of substantial equivalence)
- Static Compression	Performed
- Dynamic Compression	Performed
- Static Torsion	Performed
Clinical Performance (e.g., diagnostic accuracy, human reader improvement)	Not Applicable/Not Provided

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

Not Provided. The document refers to mechanical testing data, not clinical test set data.

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/Not Provided. The study described is mechanical testing, not a study involving expert assessment of a test set.

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

Not Applicable/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

Not Applicable/Not Provided. This document describes a traditional medical device (spine system), not an AI-driven or diagnostic device.

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

Not Applicable/Not Provided.

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

For the mechanical performance, the "ground truth" or standard would be the requirements of ASTM F 1717 for spinal implant testing. The document states that performance data per ASTM F 1717 was submitted, implying compliance with the test standards.

8. The sample size for the training set

Not Applicable/Not Provided. There is no mention of a "training set" as this is not an AI/ML device or a diagnostic performance study.

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

Not Applicable/Not Provided.

In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence for a physical spinal implant device based on its design, materials, intended use, and mechanical performance testing according to ASTM F 1717 standards. It does not describe any studies related to clinical diagnostic performance, expert evaluations, or AI system performance, which are the typical contexts for the requested information.

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K Number

K103490

Device Name

Manufacturer

JOHNSON & JOHNSON

Date Cleared

2011-02-17

(83 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K033901,K955348

Predicate For

K113396,K120091,K121786,K122229,K141282,K143230,K151704,K160820,K191212

Intended Use

The MOSS® MIAMI Spine System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The MOSS® MIAMI Spine Systems is 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 MOSS® MIAMI Spine Systems is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The MOSS® MIAM! Spine Systems when used as anterior thoracic/lumbar screw fixation systems, is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The EXPEDIUM® Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The EXPEDIUM® Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

Device Description

The Moss® Miami and Expedium® Spine Systems consists of rods, hooks, pedicle screws, and other components. A subset of the Moss Miami and Expedium systems, which is the basis of this submission, includes titanium pedicle screws and rods that are now sterilized via gamma radiation. Previously, these devices were commercialized as clean, but non-sterile, and the end-user would need to sterilize the units prior to use via steam sterilization. Certain pedicle screws and rods will be packaged in sterile multi-packs for customer convenience.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of device performance metrics like sensitivity, specificity, accuracy, or diagnostic ability.

Instead, the document is a 510(k) summary for a medical device (Moss® Miami and Expedium® Spine Systems) that describes a change in sterilization method (from non-sterile to terminally sterilized via gamma radiation). The key aspect of this submission is demonstrating substantial equivalence to predicate devices.

Here's a breakdown of why the requested information isn't present in this document:

"Acceptance criteria and the reported device performance": This document does not outline numerical performance criteria (e.g., "The device must achieve X% sensitivity and Y% specificity"). The "performance" being discussed is the effect of the new sterilization method.
"Study that proves the device meets the acceptance criteria": There isn't a clinical or analytical performance study in this document that would measure diagnostic accuracy or similar metrics. The focus is on demonstrating that the sterilization change does not alter the fundamental characteristics or safety/effectiveness of the device compared to its non-sterile predecessors.
"Sample size used for the test set and the data provenance": Not applicable, as there's no diagnostic test set being evaluated.
"Number of experts used to establish the ground truth... and qualifications": Not applicable.
"Adjudication method": Not applicable.
"Multi reader multi case (MRMC) comparative effectiveness study": Not applicable. Such studies are typically for diagnostic imaging devices or AI-powered algorithms where human reader performance is a key metric.
"Standalone (i.e. algorithm only without human-in-the-loop performance) was done": Not applicable, as this device (spinal fixation system) is not an algorithm.
"Type of ground truth used": Not applicable.
"Sample size for the training set": Not applicable.
"How the ground truth for the training set was established": Not applicable.

What the document does state regarding the "study" for acceptance:

The document explains that the sterilization process itself was conducted in compliance with a standard:

Study described: The gamma sterilization is performed in compliance with ISO 11137:2006 (VDMax method).
"Acceptance Criteria" implicitly met: By complying with ISO 11137:2006, the device is accepted to achieve a predefined sterility assurance level (SAL), which is the primary "acceptance criterion" for the sterilization process. The "performance" is that the device is now terminally sterilized to this recognized standard.

Conclusion from the document:

The final conclusion is that the "Substantial Equivalence Justification demonstrates that the device is as safe, as effective, and performs as well as the predicate device." This means the change in sterilization method did not negatively impact the device's safety, effectiveness, or performance, which were already established for the predicate devices.

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K Number

K102249

Device Name

DEPUY SPINE, A JOHNSON & JOHNSON COMPANY

Manufacturer

Date Cleared

2010-12-16

(129 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K033901,K051024,K062174,K070387,K980485

Predicate For

K111571,K142835,K182239,K182240,K230961

Intended Use

The EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.

Device Description

The EXPEDIUM Spine System is a 5.5mm rod-based and platebased system offered in both titanium and stainless steel. The system consists of monoaxial screws, polyaxial screws, uni-planar screws, reduction screws, reduction hooks, hooks, extended tab implants, sacral extenders, lateral connectors, washers, fixed bolts, polyaxial bolts, closed screws, slotted connectors, plates, nuts, washers, drop-entry connectors, modular cross connectors, transverse rod connectors, and wires.

The proposed addition to the EXPEDIUM 5.5mm Spine System is an increased favored angle polyaxial screw. The polyaxial screw head opens posteriorly for placement of a rod which is secured to a screw by either a dual inner or unitized set screw. This additional component is available in various geometries and sizes to accommodate patient anatomy. It will be provided non-sterile.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the K102249 submission, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes a Special 510(k) submission for an addition to an existing spinal system, the EXPEDIUM® Spine System. The acceptance criteria and "device performance" (in this context, demonstrating that the new component meets the same performance standards as the predicate device) are based on mechanical non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Static cantilever beam in accordance with ASTM F1798-97	Not explicitly stated (implied to be meeting the standard's requirements for strength/stability)	"The acceptance criteria was/were met."
Static axial slip in accordance with ASTM F1798-97	Not explicitly stated (implied to be meeting the standard's requirements for resistance to slip)	"The acceptance criteria was/were met."
Dynamic cantilever beam in accordance with ASTM F1798-97	Not explicitly stated (implied to be meeting the standard's requirements for fatigue life/durability)	"The acceptance criteria was/were met."

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

Sample Size: The document does not specify the exact sample size (number of devices/components tested) for each mechanical test. It only states that the tests were conducted in accordance with ASTM F1798-97.
Data Provenance: The data is from non-clinical mechanical testing performed by the manufacturer, DePuy Spine, Inc., presumably in their labs. This is not patient-derived data, so terms like "country of origin" or "retrospective/prospective" are not applicable.

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

This question is not applicable to this submission. The "ground truth" for mechanical testing is established by the specified ASTM standard (F1798-97), which outlines the methodology and performance metrics. There are no "experts establishing ground truth" in the sense of clinical interpretation or diagnosis for this type of non-clinical mechanical evaluation.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication typically refers to the process of resolving discrepancies in expert opinions, often in clinical studies. For mechanical testing against an ASTM standard, the results are objectively measured and compared to the predefined criteria of the standard.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No clinical tests were performed."

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

This question is not applicable. This submission is for a physical medical device (spinal implant components), not a software algorithm or AI-driven system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating the device meets acceptance criteria is adherence to established mechanical testing standards (ASTM F1798-97). The performance of the new components was compared to these standards to ensure they are equivalent to the predicate devices.

8. The Sample Size for the Training Set

This question is not applicable. This submission is for a physical medical device, not a machine learning model. Therefore, there is no "training set."

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

This question is not applicable. As there is no training set for a machine learning model, there is no ground truth for a training set to be established.

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K Number

K101070

Device Name

Manufacturer

MEDOS INTERNATIONAL SARL

Date Cleared

2010-08-31

(137 days)

Product Code

Regulation Number

Type

Panel

K130877,K131250,K170861,K173508

Reference & Predicate Devices

K092473,K090230,K080313,K062174,K071495,K013441,K010972,K980485,K024348,K010576,K984350,K981274

Predicate For

Intended Use

The EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

Device Description

The EXPEDIUM Spine System is a 5.5mm and 6.35mm rod based system offered in both titanium and stainless steel. Both systems consist of the following: Monoaxial Screws, Polyaxial Screws, Reduction screws, Reduction hooks, Hooks, Extended Tab Implants, Sacral Extenders, Lateral connectors, Washers.

The proposed addition to the EXPEDIUM Spine System is a 5.5 and 6.35mm rod and plate offset system offered in both titanium and stainless steel. The EXPEDIUM Spine System will also include the following: Fixed Bolts, Polyaxial Bolts, Closed screws, Slotted connectors, Plates, Nuts, Washers, Drop-entry connectors, Modular cross connectors, Transverse rod connectors, Wires.

These additional components are available in various geometries and sizes to accommodate patient anatomy. They will be provided non-sterile and sterile.

AI/ML Overview

The provided document is a 510(k) premarket notification for additions to the EXPEDIUM® Spine System. This document describes a medical device (spinal implant components) and its substantial equivalence to previously cleared predicate devices, rather than a diagnostic device or AI/ML-driven system. Therefore, many of the requested criteria such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable to this type of submission.

However, I can extract the acceptance criteria and the "study" (in this case, mechanical testing) that demonstrates the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

Test Type	Acceptance Criteria	Reported Device Performance
Static compression bending	The acceptance criteria was/were met (as per ASTM F1717-04 standard).	Met
Static torsion	The acceptance criteria was/were met (as per ASTM F1717-04 standard).	Met
Dynamic compression bending	The acceptance criteria was/were met (as per ASTM F1717-04 standard).	Met

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

Test Set Sample Size: Not specified in terms of number of samples, but the "test set" refers to the new components of the EXPEDIUM Spine System (closed screws, fixed bolts, polyaxial bolts, cross connectors, nuts, washers, wires, and plates) that underwent mechanical testing.
Data Provenance: The tests were conducted according to ASTM F1717-04 standard, which is an international standard. The submission is from Medos International Sárl, located in Switzerland, with a contact person in the US.

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

Not applicable. This is a mechanical device, and "ground truth" is established by adherence to engineering performance standards (ASTM F1717-04) rather than expert consensus on medical images or diagnoses.

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

Not applicable. Mechanical testing results are objective measurements against a standard, not subject to 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. This is a physical spinal implant system, not a diagnostic or AI-assisted system.

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

Not applicable. This is a physical spinal implant system.

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

The "ground truth" for this device is based on established mechanical engineering performance standards, specifically ASTM F1717-04, for spinal implant constructs in a vertebrectomy model.

8. The sample size for the training set:

Not applicable. This is a physical device, not an AI/ML system.

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

Not applicable. This is a physical device, not an AI/ML system.

In summary, the study proving the device meets its acceptance criteria involved nonclinical mechanical testing (Static compression bending, Static torsion, Dynamic compression bending) in accordance with the ASTM F1717-04 standard. The acceptance criteria for these tests were simply "the acceptance criteria was/were met" as defined by that standard. No clinical testing was performed for this 510(k) submission. The submission relies on substantial equivalence to predicate devices and the successful completion of these mechanical tests to demonstrate safety and effectiveness.

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K Number

K092473

Device Name

Manufacturer

DEPUY SPINE,INC

Date Cleared

2009-11-25

(105 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K071495,K073364,K063772,K082195,K090230,K953915,K023804

Predicate For

K101070,K110551

Intended Use

The EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.

Device Description

Additional Component of the EXPEDIUM Spine System.

The EXPEDIUM Spine System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

AI/ML Overview

This document is a 510(k) summary for the EXPEDIUM™ Spine System, specifically for additional components. It is a submission to the FDA for market clearance, not typically a publication of a clinical study with detailed performance metrics against acceptance criteria. Therefore, the information provided is limited to what's available in such a regulatory document.

Based on the provided text, a table of acceptance criteria and reported device performance from a clinical study cannot be constructed because the document does not describe acceptance criteria for diagnostic performance or a clinical study in the way typically seen for AI/software devices.

Instead, the document states:

"PERFORMANCE DATA:
Performance data were submitted to characterize the additional components of the EXPEDIUM Spine System."

This refers to engineering performance data for a physical medical device (spinal implants), not typically diagnostic performance as would be expected for an AI/software device. The FDA's 510(k) clearance in this context relies on demonstrating substantial equivalence to predicate devices, often through mechanical testing, biocompatibility, and material characterization, rather than clinical efficacy studies with ground truth.

Therefore, many of the requested details about acceptance criteria, sample sizes for test/training sets, expert qualifications, and adjudication methods are not applicable or not present in this type of regulatory submission for a physical implantable device.

Here's an attempt to answer the questions based only on the provided text, noting where information is missing or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not Explicitly Stated for this Device in the provided text. The document describes a "Performance Data" section for "characterizing the additional components" which refers to engineering performance (mechanical, material, biocompatibility) rather than diagnostic accuracy or clinical efficacy.	Not Explicitly Stated for this Device in the provided text. The document only states "Performance data were submitted to characterize the additional components of the EXPEDIUM Spine System." No specific performance metrics (e.g., accuracy, sensitivity, specificity, or mechanical thresholds) are provided in this regulatory summary.

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

Sample Size for Test Set: Not applicable/Not provided. This document describes a physical medical device (spinal implant), not a diagnostic algorithm that would typically have a test set of data.
Data Provenance: Not applicable/Not provided.

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

Not applicable/Not provided. Ground truth establishment by experts is typically for diagnostic or AI devices, not for the performance data of a spinal implant.

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

Not applicable/Not provided. This relates to diagnostic image interpretation or algorithm output, not the mechanical or material performance of a spinal implant.

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/Not provided. MRMC studies are for diagnostic interpretation (often with imaging and AI assistance), which is not the subject of this 510(k) summary.

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

Not applicable/Not provided. This document is not about an algorithm or AI device.

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

Not applicable/Not provided. The "performance data" mentioned would likely be based on physical measurements, material properties, and mechanical tests, not a clinical ground truth as defined for diagnostic studies.

8. The sample size for the training set

Not applicable/Not provided. This document is not about an algorithm or AI device that would have a training set.

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

Not applicable/Not provided. This document is not about an algorithm or AI device that would have a training set with established ground truth.

Summary based on the provided text:

The provided document is a 510(k) summary for a physical medical device, the EXPEDIUM™ Spine System, an implantable spinal fixation device. The performance data mentioned refers to engineering tests and characterization (e.g., mechanical strength, biocompatibility, material properties) to demonstrate substantial equivalence to previously cleared predicate devices, not clinical efficacy or diagnostic performance. Therefore, the typical criteria and study design elements requested for an AI/software device or a diagnostic device are not present in this document.

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K Number

K090230

Device Name

Manufacturer

DEPUY SPINE, INC.

Date Cleared

2009-03-06

(35 days)

Product Code

Regulation Number

Type

Panel