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The MOJAVE Expandable Interbody System implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DOD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the MOJAVE lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. MOJAVE lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

Device Description

The MOJAVE Expandable Interbody System is comprised of expandable titanium implants designed to allow for intraoperative adjustment to aid the surgeon in matching implant fit to the vertebral anatomy in the lumbar spine. The implants have titanium endplates designed to allow for bone ingrowth and engagement with the vertebral body end plates. The implants are manufactured from medical grade titanium alloy (ASTM F1472, ASTM F136, ASTM F3001) and cobalt chromium alloy (ASTM F1537) and are available in a variety of heights to accommodate anatomical variations.

AI/ML Overview

The provided document describes an FDA 510(k) clearance for the MOJAVE Expandable Interbody System. This is a medical device, not an AI/software product, and the information provided does not include acceptance criteria or a study proving that an AI/software device meets acceptance criteria.

The document discusses the substantial equivalence of the MOJAVE Expandable Interbody System to predicate devices based on:

Technological Comparison to Predicate: Minor modifications to enhance user experience, comparable in design, function, intended use, materials, and size.
Non-clinical Performance Evaluation: Risk assessment, including benchtop and mechanical testing, to confirm no new issues of safety or effectiveness.

Therefore, I cannot provide the requested information for an AI/software device from this text as it is not applicable.

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K Number

K171097

Device Name

MOJAVE Expandable Interbody System

Manufacturer

K2M, Inc.

Date Cleared

2017-05-10

(27 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K163364

Intended Use

The MOJAVE Expandable Interbody System implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of carcellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the MOJAVE lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. MOJAVE lumbar are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

Device Description

AI/ML Overview

This is a 510(k) summary for a medical device called the "MOJAVE Expandable Interbody System," which is an implant used in spinal fusion surgery. This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing details of a study against specific acceptance criteria for performance metrics.

Therefore, many of the requested details, such as acceptance criteria table with device performance, sample sizes for test sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information, are not present in this summary. These types of studies are typically not required for 510(k) submissions focusing on substantial equivalence for orthopedic implants.

Here's what can be inferred from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Not explicitly provided as a table with specific performance metrics and acceptance criteria. The "Non-clinical Performance Evaluation" section vaguely describes the types of tests performed.

Acceptance Criteria (Inferred)	Reported Device Performance (Inferred)
Meet or exceed predicate device performance in static compression, static torsion, etc.	"Confirmatory (static and dynamic) mechanical testing and simulated use (cadaver) testing was performed on the subject device verifying that the subject devices were not a new worst case."
Meet bacterial endotoxin limits	"bacterial endotoxin testing (BET)... was conducted in accordance with ANSI/AAMI/ST72:2011."

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

Sample Size for Test Set: Not specified. The document mentions "worst case MOJAVE Expandable Interbody System implants" for mechanical testing and "simulated use (cadaver) testing." The number of cadavers or implants tested is not provided.
Data Provenance: The mechanical and simulated use testing would be laboratory/pre-clinical data, not human patient data. No country of origin is mentioned for this testing.

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

Not applicable. The tests performed are mechanical and simulated use, not those requiring expert interpretation of patient data for ground truth.

4. Adjudication method for the test set:

Not applicable.

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 device is an implant, not an AI diagnostic tool.

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

Not applicable. This device is an implant, not an algorithm.

7. The type of ground truth used:

For mechanical testing: Engineering specifications and measurements of force, torque, displacement, and cycles.
For bacterial endotoxin testing: Laboratory measurement of LAL activity against established endotoxin limits.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable.

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K Number

K163364

Device Name

MOJAVE Expandable Interbody System

Manufacturer

K2M

Date Cleared

2017-03-15

(105 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K102293,K082698,K133614,K150481,K160125

Intended Use

Device Description

AI/ML Overview

This is a 510(k) premarket notification for a medical device called the "MOJAVE Expandable Interbody System". This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a study to prove the device meets these criteria in the way a clinical trial or a performance study for an AI/CADe device would.

Therefore, many of the requested categories are not applicable or cannot be extracted directly from this type of regulatory submission. This document aims to show the new device is as safe and effective as a legally marketed predicate device, primarily through non-clinical performance evaluations and comparative analysis of design, materials, and intended use.

Here's an analysis based on the provided text, indicating "N/A" (Not Applicable) or "Not Provided" where the information is not present in this 510(k) summary:

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

Acceptance Criteria (from predicate/standards)	Reported Device Performance (MOJAVE)
Static Compression, Torsion, Compression Shear (per ASTM F2077, implied)	Performed similarly to or better than predicate devices.
Dynamic Compression Shear (per ASTM F2077)	Performed similarly to or better than predicate devices.
Subsidence (per ASTM F2267)	Performed similarly to or better than predicate devices.
Expulsion (per ASTM F2267, implied)	Performed similarly to or better than predicate devices.
Bacterial Endotoxin Testing (BET) / Limulus Amebocyte Lysate (LAL) testing (per ANSI/AAMI/ST72:2011)	Testing was conducted in accordance with the standard. (Specific results not provided but implied to meet acceptance).

Note: The "acceptance criteria" here are implied by the performance of predicate devices and adherence to relevant ASTM and ANSI/AAMI standards for intervertebral body fusion devices. The exact numerical thresholds for "similarly to or better than" are not specified in this summary.

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

Sample Size for Test Set: Not provided. The non-clinical testing typically involves a specific number of devices per test, but this detail is not included in the summary.
Data Provenance: Not provided, but all testing would be conducted in a laboratory setting, likely in the US, as K2M, Inc. is based in Leesburg, Virginia. The data is non-clinical/pre-clinical.

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)

N/A. This information is for clinical studies or studies establishing ground truth for diagnostic AI/CADe devices. This document describes mechanical and biological compatibility testing of an implantable device, not diagnostic performance.

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

N/A. Not applicable for non-clinical performance evaluation of an implantable device.

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

N/A. This device is an intervertebral body fusion implant, not an AI/CADe diagnostic tool. Therefore, MRMC studies are not applicable.

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

N/A. This device is a physical implant, not an algorithm.

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

For non-clinical testing: The "ground truth" or reference for evaluating performance in a 510(k) for an implantable device like this typically comes from:
- Validated ASTM standards: These standards define how to perform tests (e.g., static compression, dynamic compression shear) and often include performance benchmarks or methodologies for comparison.
- Performance of legally marketed predicate devices: The new device must perform "similarly to or better than" established predicate devices under the same testing conditions.
The "ground truth" is not clinical pathology or outcomes data in this context, but rather engineering and material performance specifications.

8. The sample size for the training set

N/A. This refers to machine learning models. This document describes a physical medical device.

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

N/A. This refers to machine learning models. This document describes a physical medical device.

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