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The Minuteman G5 MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single interspace in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving instrumented posterior arthrodesis (i.e., fusion) in the following conditions:
• Lumbar spinal stenosis;
· degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); and/or
• spondylolisthesis.
The Minuteman G5 MIS Fusion Plate is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1) or a posterior approach (T1-S1).

The Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate) is a posterior, non-pedicle fusion device, intended for use at a single interspace in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving instrumented posterior arthrodesis (i.e., fusion) in the following conditions:
· Lumbar spinal stenosis;
· degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); and/or
· spondylolisthesis.
The Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate) is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1) or a posterior approach (T1-S1).

The HA Minuteman G3-R MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single interspace in the non-cervical spine (T1-S1). It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving instrumented posterior arthrodesis (i.e., fusion) in the following conditions:
• Lumbar spinal stenosis;
· degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); and/or
• spondylolisthesis.
The HA Minuteman G3-R MIS Fusion Plate is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1).

The Minuteman G3/HA Minuteman G3 MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single interspace in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving instrumented posterior arthrodesis (i.e., fusion) in the following conditions:

• · Lumbar spinal stenosis;
  · degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); and/or
• · spondylolisthesis.
  The Minuteman G3/HA Minuteman G3 MIS Fusion Plate is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1) or a posterior approach (T1-S1).

The Minuteman MIS Fusion Plate Implants consist of bilateral Plates and a Body/Post that connects the Plate components include several gripping features for attachment of the spinous processes. The Minuteman MIS Fusion Plate Implants are available in multiple sizes to accommodate varying patient anatomy. The Minuteman MIS Fusion Plate Implants are made from Ti6A4V and Ti6A4V ELI. The HA Minuteman MS Fusion Plate have an additional hydroxyapatite coating on the distal regions of the device.

The provided text is a 510(k) Premarket Notification from the FDA for a spinal fusion plate. It describes the device, its intended use, and states that non-clinical evaluations were performed to support substantial equivalence to a predicate device.

However, the document does not contain any information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, or specific performance metrics typically associated with studies proving device performance against acceptance criteria for an AI/ML medical device.

The essential conclusion from the document is that:

• The device is a physical medical device (spinal fusion plate), not an AI/ML-based software device.
• Substantial equivalence was established through non-clinical evaluations against a predicate device, not through a study involving acceptance criteria and performance metrics described in the prompt.

Therefore, I cannot provide the requested information from the given text because it is not relevant to the type of device and evaluation described in the document.

To directly answer your prompt, based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document refers to physical device testing for "substantial equivalence" to a predicate, not performance against specific acceptance criteria for an AI/ML output.
2. Sample sized 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 or data provenance for an AI/ML device is 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. No ground truth establishment for an AI/ML device is mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) 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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): 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.

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The Minuteman G5 MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single interspace in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving instrumented posterior arthrodesis (i.e., fusion) in the following conditions:
• Lumbar spinal stenosis;
• degenerative disc disease (DDD) (defined as back pain with degeneration of the disc confirmed by history and radiographic studies); and/or
• spondylolisthesis.
The Minuteman G5 MIS Fusion Plate is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1) or a posterior approach (T1-S1).

The Minuteman G1 (Posterior Fusion Plate) is a posterior, non-pedicle fusion device, intended for use at a single interspace in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving instrumented posterior arthrodesis (i.e., fusion) in the following conditions:
• Lumbar spinal stenosis;
• degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); and/or
• spondylolisthesis.
The Minuteman G1 (Posterior Fusion Plate) is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1) or a posterior approach (T1-S1).

The HA Minuteman G3-R MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single interspace in the noncervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving instrumented posterior arthrodesis (i.e., fusion) in the following conditions:
• Lumbar spinal stenosis;
• degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); and/or
• spondylolisthesis.
The HA Minuteman G3-R MIS Fusion Plate is intended for use with bone graft may be implanted via a lateral transverse approach (L1-S1).

The Minuteman G3/HA Minuteman G3 MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single interspace in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving instrumented posterior arthrodesis (i.e., fusion) in the following conditions:
• Lumbar spinal stenosis;
• degenerative disc disease (DDD) (defined as back pain with degeneration of the disc confirmed by history and radiographic studies); and/or
• spondylolisthesis.
The Minuteman G3/HA Minuteman G3 MIS Fusion Plate is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1) or a posterior approach (T1-S1).

The Minuteman MIS Fusion Plate Implants consist of bilateral Plates and a Body/Post that connects the Plate components include several gripping features for attachment of the spinous processes. The Minuteman MIS Fusion Plate Implants are available in multiple sizes to accommodate varying patient anatomy. The Minuteman MIS Fusion Plate Implants are made from Ti6A4V and Ti6A4V ELI. The HA versions of the Minuteman MS Fusion Plate Inplants have an additional hydroxyapatite coating on the distal regions of the device.

This is a 510(k) premarket notification for a medical device called the Minuteman MIS Fusion Plate Implants. The submission aims to update the Indications for Use for existing devices, rather than introducing a new device or making significant technological changes. As such, the typical detailed studies and acceptance criteria related to device performance in terms of accuracy, sensitivity, or specificity are not applicable or required in this document.

The document explicitly states:
"Non-Clinical and/or Clinical Tests were not performed as part of this submission. The Minuteman MIS Fusion Plate Implants with the updated Indications for Use are substantially equivalent to the previously cleared predicate devices."

Therefore, I cannot provide information on acceptance criteria or studies as requested in your prompt because this type of information is generally not included in a 510(k) submission focused solely on updating the indications for use of an already cleared device, especially when no technological or performance changes have been made. The "acceptance criteria" here refer to the FDA's determination that the updated indications do not alter the substantial equivalence to previously cleared devices.

Instead, the documentation focuses on demonstrating substantial equivalence to predicate devices (K221023 Minuteman MIS Fusion Plate Implants) based on:

• Same technological characteristics: "same design, packaging, principles of operations"
• No new intended use: "The modifications to the Indications for Use statement do not affect the safety and effectiveness of the Minuteman MIS Fusion Plate Implants."

There are no details on software, AI, or specific performance metrics that would necessitate the information you requested about human readers, ground truth establishment, or test set characteristics.

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The Spinal Simplicity Minuteman G5 MIS Fusion Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions:

· Lumbar spinal stenosis;

· 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); and/or

• tumor.

The Minuteman G5 MIS Fusion Plate is intended for use with bone graft material and is not intended for standalone use. The device may be implanted via a minimally invasive lateral approach (L1-S1) or a minimally invasive posterior approach (T1-S1).

The Minuteman G5 consists of bilateral Plates and a Body/Post that connects the Plates, identical to the predicate construct. The Plate components include gripping features on the boneinterfacing surfaces of each Plate for attachment to the spinous processes. The Minuteman G5 device is available in multiple sizes to accommodate varying patient anatomy. The Minuteman G5 is made from titanium alloy Ti6A14V ELI and has a hydroxyapatite coating on the distal regions of the device.

The provided text is a 510(k) premarket notification for a medical device called the "Minuteman G5 MIS Fusion Plate." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with strict acceptance criteria often seen with novel Class III devices or AI/imaging software.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria in the context of an AI/imaging software device. Specifically, it lacks:

• A table of acceptance criteria and reported device performance (for an AI system)
• Sample sizes for test sets, data provenance, expert ground truth establishment, or adjudication methods for an AI study.
• Information on MRMC comparative effectiveness studies or standalone performance for an AI system.
• Details about training sets or how ground truth was established for training (relevant for AI).

Instead, this document focuses on mechanical performance testing for a physical implantable device. The "Performance Data" section discusses:

• Mechanical Testing: ASTM F1717 Static Axial Compression, ASTM F1717 Dynamic Axial Compression, Custom Static Plate Dissociation, and Cadaveric Fatigue Testing.
• Device Material: Titanium alloy Ti6Al4V ELI with a hydroxyapatite coating.
• Comparison to Predicate: The data "demonstrates that the subject Minuteman G5 device presents substantially equivalent mechanical performance compared to the predicate device."

To answer your request based on the provided text, while acknowledging it's not about AI/imaging software and thus most of your specific questions are not applicable:

Acceptance Criteria and Study for Minuteman G5 MIS Fusion Plate (Based on Provided Document)

The "Minuteman G5 MIS Fusion Plate" is a physical implantable medical device, not an AI or imaging software. Its acceptance criteria and study proving it meets them are primarily based on demonstrating substantial equivalence to an existing predicate device through mechanical performance testing, rather than clinical efficacy or accuracy in the way an AI system would be evaluated.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of specific acceptance criteria values (e.g., "Load X must withstand Y N of force") or exact reported performance values. Instead, it indicates that the device's performance in standard mechanical tests was substantially equivalent to the predicate device.

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

The document does not specify exact sample sizes for the mechanical tests (e.g., number of devices tested for ASTM F1717). The data provenance is implied to be from laboratory mechanical testing and cadaveric testing, typical for orthopedic implants. No country of origin for data is specified, but as an FDA submission, the tests would conform to U.S. or international standards recognized by the FDA. The data is inherently prospective in the context of device testing before market clearance.

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

This question is not applicable to a physical mechanical device test. There is no concept of "experts establishing ground truth" in the way an AI algorithm analyzes medical images. The "ground truth" for mechanical testing is defined by the physical properties measured under specified test conditions according to ASTM standards.

4. Adjudication Method for the Test Set

Not applicable. Mechanical tests follow predefined protocols and objective measurements.

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

Not applicable. This is a study type for AI/imaging software, not for a physical implantable device.

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

Not applicable. This concept pertains to AI algorithms.

7. The Type of Ground Truth Used

For this device, the "ground truth" is established by objective mechanical performance metrics (e.g., load to failure, fatigue life) measured according to industry-standard test protocols (ASTM F1717, Custom Static Plate Dissociation, Cadaveric Fatigue Testing). The "ground truth" is that the device performs mechanically equal to or better than the predicate device under these standardized conditions.

8. The Sample Size for the Training Set

Not applicable. There is no AI model or "training set" for this physical device.

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

Not applicable since there is no AI model or training set.

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