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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 Posterior 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 Posterior 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 Spinal Simplicity Minuteman G3 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 G3 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 Spinal Simplicity HA Minuteman G3 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 HA Minuteman G3 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 mimimally invasive posterior approach (T1-S1).

The Spinal Simplicity HA Minuteman G3-R MIS Fusion Plate is a posterior, nonpedicle supplemental fixation device, intended for use at a single level in the noncervical 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 HA Minuteman G3-R 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).

The Minuteman devices consist of bilateral Plates and a Body/Post that connects the Plates, identical to the predicate constructs. The Plate components include several spiked grips at the ends of each Plate for attachment to the spinous processes. The Minuteman devices are available in multiple sizes to accommodate varying patient anatomy. The Minuteman devices are made from Ti6Al4V and Ti6Al4V ELI. The HA versions of the Minuteman devices have an additional hydroxyapatite coating on the distal regions of the device.

This document describes the marketing approval for the Spinal Simplicity Minuteman G3 MIS Fusion Plate system. It is a 510(k) submission, meaning the manufacturer is demonstrating that its device is substantially equivalent to legally marketed predicate devices, rather than proving its safety and effectiveness from scratch. Therefore, the information provided focuses on the equivalence to existing devices and updates to indications for use, rather than a detailed study proving novel acceptance criteria for the device itself.

Based on the provided text, here's a summary of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states: "There are no changes to the functional characteristics from the previously cleared versions of each Minuteman device. The only differences are labeling updates. Therefore, no non-clinical performance data has been submitted." and "The only difference is regarding updated Indications for Use."

This indicates that the acceptance criteria for the device's performance are implicitly met by its substantial equivalence to previously cleared devices. Specific numerical performance criteria (e.g., tensile strength, fatigue life) are not detailed in this regulatory summary because the device itself hasn't changed. The acceptance for this 510(k) is based on the updated Indications for Use being supported by existing data and the design being identical to cleared predicates.

The "reported device performance" is essentially that it performs identically to its predicate devices, which have already met their respective acceptance criteria.

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

• Test set sample size: Not applicable or not explicitly stated in the context of this 510(k) summary for this submission. This submission is for an updated Indications for Use on an already cleared device, where the device itself hasn't changed technologically or functionally.
• Data provenance: "Clinical data from a prospective, randomized clinical study of the Minuteman was presented." No country of origin is specified. The study was prospective.

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

This information is not provided in the document. The clinical study mentioned would have involved clinical endpoints, but the method for establishing "ground truth" (e.g., through expert diagnosis or objective measures) is not detailed.

4. Adjudication method for the test set:

This information is not provided in the document.

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 a physical spinal implant, not an AI-powered diagnostic or assistive technology.

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

Not applicable. This is a physical medical device.

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

The clinical study evaluated "satisfactory clinical outcomes." This implies that outcomes data (e.g., patient-reported outcomes, objective measures of fusion, reduction in pain) were used, likely assessed by clinical experts.

8. The sample size for the training set:

Not applicable. As a physical device, there is no "training set" in the context of machine learning. The clinical study described in section 9 would represent the data used to support the device's indications.

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

Not applicable for a training set. For the clinical study that supported the device, the summary states: "The Minuteman was compared to surgical decompression in the treatment of skeletally-mature patients diagnosed with lumbar spinal stenosis with or without accompanying spondylolisthesis. The data showed that the Minuteman provided satisfactory clinical outcomes." This suggests the efficacy was established by comparing clinical outcomes between the Minuteman device and surgical decompression in a prospective, randomized clinical trial. The specific metrics for "satisfactory clinical outcomes" are not elaborated upon in this document but would typically involve patient-reported pain scores, functional assessments, and potentially radiographic evidence of fusion.

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The Spinal Simplicity HA Minuteman G3 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:

• degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radio-graphic studies);
• spondylolisthesis;
• trauma (i.e., fracture or dislocation); and/or
• tumor.

The HA Minuteman G3 MIS Fusion Plate is intended for use with bone graft material and is not intended for stand-alone use. The device may be implanted via a minimally invasive posterior approach (T1-S1) or a minimally invasive lateral approach (L1-S1).

The HA Minuteman G3 MIS Fusion Plate consists of bilateral Plates and a Body/Post that connects the Plates, identical to the predicate construct. The Plate components include several spikes at the ends of each Plate for attachment to the spinous processes. The HA Minuteman G3 device is available in multiple sizes to accommodate varying patient anatomy. The HA Minuteman G3 is made from Ti6Al4V (per ASTM F1472) and Ti6Al4V ELI (per ASTM F136) and has a hydroxyapatite coating (per ASTM F1185) at the distal regions of the plate.

The FDA Premarket Notification (510(k)) K151741 for the Spinal Simplicity HA Minuteman G3 MIS Fusion Plate does not contain the typical information about acceptance criteria and study design for AI/Software as a Medical Device (SaMD) as requested in the prompt. This document pertains to a physical medical device (spinal implant) and focuses on demonstrating substantial equivalence to a predicate device based on material characterization and mechanical testing, not software performance.

Therefore, I cannot fulfill the request for information on acceptance criteria, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these concepts are not applicable to the content of the provided document.

The document discusses the following:

1. A table of acceptance criteria and the reported device performance:
This information is not presented in a table format for a "device performance" in the way one would for a diagnostic AI. Instead, the document describes characterization of the HA powder and coating, and mechanical testing.

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. This is not a study involving patient data or test sets for an AI. The testing described relates to material properties and mechanical performance.

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. This document does not describe a study involving expert assessment or ground truth establishment in the context of an AI/SaMD.

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 concensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" here would be established scientific standards for material characterization and mechanical testing.

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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