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The Patriot SI Implant System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The Patriot SI Implant System is a minimally invasive sacroiliac joint fusion implant that pierces the cortical bone of the ilium and sacrum and is intended for the purpose of stabilizing and fusing the sacroiliac joint with intrinsic fixation features. It is available in one size and may be implanted using the designated surgical instruments into the SI joint space. Bone graft materials may be used with the Patriot SI Implant System. The Patriot SI Implant System device is made from additively manufactured titanium alloy, Ti-6Al-4V-ELI per ASTM F3001 and is offered with or without a hydroxyapatite (HA) coating per ASTM F1185. The Patriot SI Implant System device is provided sterile and individually packed.

The provided FDA 510(k) clearance letter for the Patriot SI Implant System does not contain any information regarding acceptance criteria or the study that proves the device meets those criteria for the purposes of an AI/software device.

The document is for a physical medical implant device (sacroiliac joint fusion implant). The information it provides is:

• Device Type: Patriot SI Implant System (a physical implantable device)
• Intended Use: Sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
• Materials: Additively manufactured titanium alloy, Ti-6Al-4V-ELI, with or without hydroxyapatite (HA) coating.
• Testing Information: "Non-clinical cadaveric biomechanical testing was performed to support substantial equivalence of the Patriot SI Implant system." This type of testing is relevant for mechanical implants, not AI/software.
• Predicate Device: Patriot-SI Posterior Implant System (K232259).

Therefore, I cannot provide details on acceptance criteria and study design for an AI/software device based on this document. The questions posed in your request (sample size, expert qualifications, MRMC studies, standalone performance, ground truth types) are universally applicable to AI/software performance studies, but the source document is entirely about a physical hardware device.

If you have a document describing an AI/software medical device, I would be happy to analyze it according to your criteria.

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The Wolff's Law Anterior Cervical Plate System is indicated for use in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following:

• Degenerative Disc Disease (DDD) – as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies;

• · Spondylolisthesis;
• Spinal Stenosis:
• · Trauma (including fractures);
• · Tumor;
• · Deformity (i.e., scoliosis, kyphosis, and/or lordosis);
• · Pseudoarthrosis; and
• · Failed previous fusions

The Spinal Simplicity Wolff's Law Anterior Cervical Plate System is a dynamic cervical plate designed for the anterior cervical spine (C2-C7). The Wolff's Law Plate System consists of one-level plates in multiple lengths with both fixed- and variable-angle screws. The plates are translatable and use a nitinol Compression Element to provide continuous compression at each level. The Wolff's Law Cervical Plate consists of components made from titanium alloy Ti6Al4V ELI per ASTM F136 and superelastic nitinol per ASTM F2063. The fixed and variable screws are made from Titanium alloy Ti6Al4V ELI per ASTM F136. The Anterior Cervical Plate System is provided to the end-user sterile and is single use.

The FDA 510(k) summary for the "Wolff's Law Anterior Cervical Plate System" describes non-clinical performance testing rather than a study involving an AI/CAD software device with specific acceptance criteria and human readers.

Therefore, I cannot provide information on the following as it is not present in the provided document:

• A table of acceptance criteria and the reported device performance for an AI/CAD device.
• Sample size used for the test set and data provenance.
• Number of experts used to establish the ground truth and their qualifications.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
• Standalone performance (algorithm only) of an AI/CAD device.
• Type of ground truth used for an AI/CAD device.
• Sample size for the training set.
• How the ground truth for the training set was established.

However, based on the provided document, I can extract information related to the performance study of the Wolff's Law Anterior Cervical Plate System (a medical device, not an AI/CAD software):

1. Type of Study:
Non-clinical mechanical tests were performed to establish substantial equivalence for the Wolff's Law Anterior Cervical Plate System. Clinical performance testing was explicitly not performed for this submission.

2. Tests Performed and Guidance:
The study utilized FDA Guidance Document "Spinal Plating Systems - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff" and the following ASTM tests:

• ASTM F1717 Static Compression Bending
• ASTM F1717 Static Torsion
• ASTM F1717 Static Tension Bending
• ASTM F1717 Dynamic Compression Bending
• ASTM F543 Axial Screw Pullout/Pushout
• ASTM F2129 & ASTM F3044 Corrosion Testing
• ASTM F1877 Particulate Analysis
• ASTM F2004 Transformational Temperature

3. Purpose of the Study:
The purpose of these non-clinical tests was to demonstrate that the Wolff's Law Anterior Cervical Plate System is capable of performing as intended and is substantially equivalent to the legally marketed predicate device. The document explicitly states: "Performance testing device has mechanical performance substantially equivalent to that of the predicate."

4. Acceptance Criteria (Implied):
While not explicitly presented in a table in the provided text, the acceptance criteria for these mechanical tests are implicitly that the Wolff's Law Anterior Cervical Plate System must have mechanical performance substantially equivalent to the predicate device(s). This substantial equivalence is assessed against the standards outlined in the FDA Guidance Document and the specific ASTM standards listed. The document does not provide specific numerical thresholds or target values that define "substantial equivalence" in this summary.

5. Predicate Devices:
The predicate devices used for comparison are:

• K083020 DynaTran™ Anterior Cervical Plating (ACP) System
• K143626 SC-AcuFix® Ant-Cer Dynamic Cervical Plating System
• K051665 Synthes Vectra-T System

In summary, the provided document details non-clinical mechanical testing for a spinal implant, not an AI/CAD system. Therefore, most of the requested information regarding AI/CAD specific acceptance criteria and study details are not applicable or available in this text.

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The Patriot-SI Posterior Implant System is intended for sacroiliac joint fusion including sacroiliac joint disruptions and degenerative sacroiliitis. When the Patriot Implant System (i.e., an "in-line" or "in-line" or "intraarticular" device) is implanted, it must be used with a Spinal Simplicity Liberty-SI Lateral System device (i.e., a "transfixing" device) implanted across the same sacroiliac joint to create a hybrid SI joint fusion construct.

The Patriot-Sl Posterior Implant System is a minimally invasive sacrolliac joint fusion implant that is intended for implantation on a trajectory in line with the joint space (i.e., the device is an in-line or intra-articular implant). The Patriot Implant System device is required to be implanted with the Spinal Simplicity Liberty-Sl Lateral System device implanted across the same sacroiliac joint to create a hybrid SI joint fusion construct for the purpose of stabilizing and fusing the sacroiliac joint. It is available in one size and may be implanted using the designated surgical instruments through a posterior approach into the Sl joint space, fixating on both the sacrum and ilium via external threads. Bone graft materials may be used with the Patriot-Sl Posterior Implant System. The Patriot-SI Posterior Implant System device is manufactured titanium alloy, Ti-6AI-4V-ELI per ASTM F3001 and is offered with or without a hydroxyapatite (HA) coating per ASTM F1185. The Patriot-SI Posterior Implant System device is provided sterile and individually packed.

This document describes a spinal implant device, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, ground truth, and AI-specific metrics (like MRMC studies or standalone AI performance) is not applicable.

The document is a 510(k) premarket notification for the "Patriot-SI Posterior Implant System," which is a physical medical device for sacroiliac joint fusion. The FDA letter confirms that the device is substantially equivalent to a legally marketed predicate device (NADIA® SI Fusion System, K190580) based on non-clinical mechanical tests and cadaver testing.

Here's a breakdown of the provided information, emphasizing why the AI/ML-specific questions are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a physical implant, "acceptance criteria" and "reported device performance" are based on mechanical properties and safety/effectiveness relative to its predicate, rather than AI model metrics like sensitivity, specificity, or AUC. The document lists the types of non-clinical mechanical tests performed to support substantial equivalence:

The conclusion states that "performance testing provided in this 510(k) application demonstrates that the Patriot SJ Posterior Implant System is capable of performing as intended and is as safe and effective as the legally marketed predicate device." Specific numerical acceptance criteria or performance values are not included in this summary document.

2. Sample Size for Test Set and Data Provenance:

Not applicable, as this is a physical device. Mechanical tests involve test specimens, and cadaver testing involves human cadavers, but these are not "datasets" in the AI/ML sense. Data provenance regarding country of origin or retrospective/prospective is not relevant here.

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

Not applicable. Ground truth for mechanical testing is derived from engineering principles and standards, and for cadaver testing, it pertains to the anatomical and biomechanical performance, typically evaluated by biomechanical engineers and potentially surgeons. There isn't a "ground truth" established by a panel of medical experts in the way it would be for an AI diagnostic algorithm.

4. Adjudication Method:

Not applicable. This concept pertains to resolving discrepancies in expert labeling or diagnoses for AI training/testing, which is not relevant for a physical implant's mechanical and cadaver testing.

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

Not applicable. This type of study assesses the impact of AI on human reader performance for diagnostic tasks. The Patriot-SI system is a surgical implant, not a diagnostic AI.

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

Not applicable. There is no algorithm to evaluate in a standalone manner.

7. Type of Ground Truth Used:

For the mechanical tests, the "ground truth" is defined by the requirements of the ASTM standards (F3574 and F2077) and the performance characteristics of the predicate device. For cadaver testing, it relates to the successful implantation and biomechanical stability observed. This is distinct from pathology, expert consensus, or outcomes data used for AI models.

8. Sample Size for the Training Set:

Not applicable. There is no AI model, and therefore no training set.

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

Not applicable. As there's no training set, there's no ground truth to establish for one.

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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 Liberty SI Lateral Implant System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The Liberty SI Lateral Implant System is a minimally invasive sacroliac joint fusion implantation across the joint space (i.e., the implant transfixes the Sl Lateral Implant System is composed of Ti-6Al-4V ELI titanium alloy per ASTM F136 and is partially coated with hydroxyapatite (HA) per ASTM F1185. To accommodate varying patient anatomy, the Liberty Sl Lateral Implants are available in multiple diameters and length offerings. The Liberty Sl Lateral Implants consist of a cannulated central threaded body that has deployable Wings and a Compressive Body. Using the designated instrument system, one or two implants may be inserted across the SI Joint to apply a compressive force across the joint and to provide stabilization and fusion. The Liberty SI Lateral Implants are single use devices that are provided sterile.

The provided text is a 510(k) summary for the Liberty SI Lateral Implant System. It describes the device, its intended use, and a comparison to a predicate device. However, it does not contain information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML powered device.

The document states: "Clinical performance testing was not performed for this submission." This explicitly indicates that no studies were conducted to assess the clinical performance of the device in a manner that would generate the kind of data typically associated with acceptance criteria for an AI/ML powered medical device.

Therefore, I cannot provide the requested information for the following reasons:

• No Acceptance Criteria: The document does not define any specific performance metrics or acceptance criteria for an AI/ML component.
• No Reported Device Performance for AI/ML: There is no reported performance for an AI/ML device, as the submission appears to be for a physical implant system.
• No Test Set Details: Information on sample size, data provenance, expert ground truth establishment, or adjudication methods for a test set is absent.
• No MRMC Study: There is no mention of a multi-reader multi-case comparative effectiveness study.
• No Standalone Performance: No standalone (algorithm-only) performance is discussed.
• No Ground Truth Type: No ground truth type for an AI/ML model is specified.
• No Training Set Details: There is no information regarding a training set or its ground truth establishment.

In summary, the provided document describes a medical device clearance for a sacroiliac joint implant system, not an AI/ML software device. Therefore, the requested information pertaining to AI/ML device acceptance criteria and performance studies is not available within this text.

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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 Edge upper cervical system is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine (T1 to T3):

· Traumatic spinal fractures and/or traumatic dislocations;

• · instability or deformity:
• · failed previous fusions (e.g., pseudarthrosis);
• · tumors involving the cervical/thoracic spine;

· degenerative disease, including intractable radiculopathy and/or arm pain of discogenic origin as confirmed by radiographic studies, and

· degenerative disease of the facets with instability.

The Edge UCS is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The Edge UCS is intended for use only with the Innosys Anax™ OCT Spinal System.

The Edge UCS consists of a main body that clamps on to the posterior arch of C1 to provide fixation and stability. The Edge UCS is then connected to the Innosys Anax OCT instrumentation using polyaxial rods to form a posterior cervical construct, similar to that of the predicate devices. The Edge device is an additively manufactured clamp composed of two fixation jaws superior to the C1 posterior arch, an inferior jaw base, and two receiving joints for polyaxial rods. The Edge UCS accommodates varying patient anatomy by providing three implant sizes. The Edge UCS is additively manufactured from titanium alloy Ti6Al4V ELI and is designed with areas for bone graft to be placed on the medial and lateral bone contacting regions of the device.

The provided text describes a medical device, the "Edge Upper Cervical System," and its clearance by the FDA based on a determination of substantial equivalence to predicate devices. However, the document does not contain the information requested regarding the acceptance criteria, specific study details, sample sizes, expert qualifications, or ground truth establishment for AI/algorithm performance.

The "Performance Data" section solely outlines mechanical performance tests conducted on the physical device (e.g., ASTM F1717 Static Axial Compression, ASTM F1717 Dynamic Torsion, Custom Sawbones Pull Off Test) to demonstrate its structural integrity and suitability for its intended use. These tests are not related to an AI/algorithm's performance.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance for an AI/algorithm.
2. Sample sizes for a test set or data provenance related to AI.
3. Number of experts and their qualifications for AI ground truth.
4. Adjudication method for an AI test set.
5. MRMC comparative effectiveness study results for AI.
6. Standalone performance of an AI algorithm.
7. Type of ground truth used for AI.
8. Sample size for an AI training set.
9. How ground truth for an AI training set was established.

This document is for a physical spinal implant system, not a software or AI-driven medical device.

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The Spinal Simplicity Posterior Fusion Plate/HA Posterior Flate is a posterior, non-pedicle fusion 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 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 Posterior Fusion Plate/HA Posterior Fusion Plate is intended for use with bone graft material. 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 fusion 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 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 MIS Fusion Plate is intended for use with bone graft material. 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 fusion 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 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 MIS Fusion Plate is intended for use with bone graft material. 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-R MIS Fusion Plate is a posterior, non-pedicle fusion 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 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 minimally invasive lateral approach (L1-S1).

The Spinal Simplicity Minuteman G5 MIS Fusion Plate is a posterior, non-pedicle fusion 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 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 minimally invasive lateral approach (L1-S1) or a minimally invasive posterior approach (T1-S1).

The Minuteman devices consist of bilateral Plates and a Body/Post that connects the Plates. The Plate components include several gripping features for attachment of the device to the spinous processes. The Minuteman devices are available in multiple sizes to accommodate varying patient anatomy. The Minuteman devices are made from Ti6A14V and Ti6A14V ELI. The HA versions of the Minuteman devices have an additional hydroxyapatite coating on the distal regions of the device.

The provided text is a 510(k) summary for the Spinal Simplicity Minuteman family of implants. It focuses on updating the Indications for Use for these devices. The document explicitly states that no technological, engineering, performance, or material changes have been made to the devices, and no performance bench testing data has been submitted in this particular 510(k) submission because the changes are primarily to the Indications for Use.

Therefore, the information required to populate the acceptance criteria and study details for device performance as typically associated with a new device or significant modification is largely absent or explicitly stated as not applicable in this summary.

However, the document does mention "Clinical data were provided to demonstrate satisfactory clinical and radiological outcomes to support the modified Indications for Use." This implies that a study was conducted to support the clinical effectiveness for the updated indications, but the detailed methodology and results of that study are not included in this 510(k) summary.

Based on the provided text, here is the information:

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

   • Acceptance Criteria for Device Performance: Not explicitly stated in this document as the submission focuses on updated Indications for Use rather than new device performance evaluation. The document indicates "no performance bench testing data has been submitted."
   • Reported Device Performance: Not explicitly reported in terms of specific metrics like sensitivity, specificity, accuracy, etc., as this 510(k) is not for a new device or performance claim change. The core claim is that since no changes were made to the device itself, its performance remains substantially equivalent to the previously cleared predicate devices.

2. Sample size 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 specified in the provided text. The document only mentions "Clinical data were provided."
   • Data Provenance: Not specified in the provided text.

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 specified in the provided text.

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

   • Not specified in the provided text.

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 is not applicable. The device is a spinal fusion plate, not an AI or imaging diagnostic device.

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

   • This is not applicable. The device is a spinal fusion plate, a physical implant, not an algorithm.

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

   • The document mentions "satisfactory clinical and radiological outcomes." This suggests that the ground truth would be based on clinical outcomes relevant to spinal fusion (e.g., fusion rates, pain reduction, functional improvement) and radiological assessment of fusion, but the specific methodologies are not detailed.

8. The sample size for the training set:

   • Not applicable/not specified. The device is a physical implant, not a machine learning model requiring a training set in the typical sense. The "clinical data" mentioned would likely be for validation/support.

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

   • Not applicable.

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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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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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