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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 FloSpine KeyLift™ Expandable Interlaminar Stabilization System is a posterior non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (TI-S1). It is intended for plate fixation/attachment to the spinous processes/lamina for the purpose of achieving supplemental fusion in the following conditions: Lumbar spinal stenosis, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The KeyLif("M Expandable Interlaminar Stabilization System is intended for use with allograft bone and is not intended for stand-alone use.

The KeyLift™ implant is an expandable, interlaminar stabilization device that is implanted posteriorly between the lamina and spinous processes of the thoracic and lumbar region. The implant features an expanding distal end which increases the height between the vertebral bodies. The superior and inferior wings are crimped to the spinous process, and a clamp is attached to the implant for final fixation. The components of the KeyLift™ system of implants and reusable instruments are manufactured from titanium alloy per ASTM F136 and stainless steel per ASTM F138 and A564. KeyLift™ implants are available in a range of sizes to accommodate surgeon and patient needs. Both the KeyLift implant and KeyLift Clamp are provided pre-assembled.

This 510(k) summary does not contain information about a study proving device performance against acceptance criteria. The submission is for a medical device (KeyLift™ Expandable Interlaminar Stabilization System), not a diagnostic algorithm or AI system that would typically undergo such a study.

The "PERFORMANCE DATA" section mentions:

• "Axial dynamic and static compression, static and dynamic offset torsion, static axial torsion, static and dynamic compression-bending, ring pushout, and axial pulloff testing demonstrated substantially equivalence mechanical performance."
• "Worst-case implants were identified using FEA and/or engineering analyses."
• "Surgeon-user cadaver evaluation demonstrated the KeyLift™ system of implants and instruments performs as described in the surgical technique and instructions for use."

These describe common mechanical and usability testing for orthopedic implants, aiming to show substantial equivalence to existing predicate devices, rather than meeting specific performance criteria related to diagnostic accuracy or AI model performance.

Therefore, I cannot provide the requested information regarding acceptance criteria, sample sizes, ground truth, or MRMC studies, as these types of studies are not relevant to the content of this 510(k) summary for a physical medical implant.

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The primaLOK™ SP Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), tumor, and/or lumbar spinal stenosis. The primaLOK™ SP Interspinous Fusion System is intended for use with bone graft material and not intended for stand-alone use.

The primaLOK™ SP Interspinous Fusion System is a bilateral locking plate system intended for fixation to the spinous process for the purpose of achieving supplemental fusion. It is available in various interspinous heights and can accommodate a variety of spinous process widths. The device, as a system, consists of longitudinal member/anchor components (base and polyaxial locking plates) and an interconnection component (connecting post).

This document (K231807 510(k) Summary) is a premarket notification for a medical device and, as such, does not contain the level of detail typically found in a clinical study report or a publication describing a study proving a device meets acceptance criteria. It primarily focuses on demonstrating "substantial equivalence" to predicate devices rather than proving specific performance metrics derived from a study with defined acceptance criteria.

Therefore, many of the requested details, such as a table of "acceptance criteria" and "reported device performance" in the context of a robust clinical study, sample sizes for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment methods for training sets, are not present in this 510(k) summary.

The document mentions "A variety of clinical data and biomechanical evaluations have been conducted in order to support the substantial equivalence," but it does not present these data or evaluations with the specificity required to answer your questions.

Here's an attempt to answer your questions based only on the provided text, highlighting what is not available:

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

   • Not Available: This document does not present acceptance criteria for performance metrics in a table format, nor does it provide detailed reported device performance against such criteria. The "performance testing" mentioned is to support "substantial equivalence," not necessarily to meet specific, quantifiable acceptance criteria for a new clinical claim or feature.

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

   • Not Available: The document mentions "clinical data" but provides no details on sample size, study design (retrospective/prospective), or data provenance (country of origin).

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 Available: The document does not describe the establishment of a "ground truth" for a test set, nor does it mention experts or their qualifications in this context.

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

   • Not Available: There is no mention of an adjudication method for a test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   • Not Applicable/Not Available: This device is a physical interspinous fusion system, not an AI-assisted diagnostic device. Therefore, an MRMC study related to human readers improving with AI assistance would not be relevant.

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

   • Not Applicable/Not Available: As a physical medical device (interspinous fusion system), the concept of "standalone algorithm performance" does not apply.

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

   • Not Available: The document informally refers to "clinical data" to support substantial equivalence but does not specify the type of ground truth used from any study data. For an orthopedic implant, "outcomes data" would be the most relevant, but no details are provided.

8. The sample size for the training set

   • Not Applicable/Not Available: This document is about a physical implant, not a machine learning model, so there is no "training set" in the context of AI/ML.

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

   • Not Applicable/Not Available: As above, this concept does not apply to this type of device.

Summary of Device Performance (as stated in the document, which is limited):

The document broadly states that "A variety of clinical data and biomechanical evaluations have been conducted in order to support the substantial equivalence of the primaLOK™ SP System to the predicate devices cited within this Traditional 510(k)." The "performance" in this context is the determination of substantial equivalence itself, based on comparing the new device's indications, intended use, technological characteristics, principles of operation, materials, biocompatibility, sterility, shelf-life, and packaging to the predicate devices.

Key takeaway: This 510(k) summary focuses on regulatory clearance via substantial equivalence, not detailed performance metrics from a rigorous clinical trial against pre-defined acceptance criteria. The "proof" is the FDA's determination of substantial equivalence based on the provided information, which includes unspecified "clinical data and biomechanical evaluations."

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The Huvex Interspinous Fusion System is a single-level, posterior, non-pedicle supplemental fixation device intended for use in the lumbar spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to the Huvex Interspinous Fusion System for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The Huvex Interspinous Fusion System is intended for use at one level, in conjunction with autogenous bone graft, and not intended for stand-alone use.

The HUVEX Interspinous Fusion System consists of a left plate, a right plate, pin, bolt, inner cap, center bar, and set screw. Each of these components is provided in several sizes to allow for the construction of five different HUVEX Interspinous Fusion implant sizes. The left plate is provided assembled with the poly axial bar. The bar has a bone graft window to allow fusion between spinous process. Poly axial bar is also designed to fit the anatomical characteristics of the spinous process. The right plate is designed to be combined with left plate fixed to spinous process. Right plate contains a set screw to lock the right plate to the poly axial bar. The HUVEX Interspinous Fusion System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F 136. In addition to the implants a set of reusable surgical instruments are provided. Both implant and instruments have trays that are used for handling and storage.

This is a 510(k) premarket notification for a medical device called the "Huvex Interspinous Fusion System." This document is a clearance letter from the FDA, and as such, it does not include the detailed study reports or acceptance criteria for the device's technical performance. Instead, it confirms that the FDA has found the device to be substantially equivalent to a previously marketed predicate device.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for this specific submission (K223790).

Here's what the document does state regarding performance data and equivalence:

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

• No specific acceptance criteria or performance data are provided in this document directly from a study for device K223790.
• The document states: "The subject and predicate devices are identical and therefore, no performance testing is required. Submission is only transferring name of a system that has already been cleared under K162849."

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 as no performance testing was conducted for K223790. The device is claimed to be identical to a previously cleared device (K162849).

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 as no performance testing was conducted for K223790.

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

• Not applicable as no performance testing was conducted for K223790.

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 implant, not an AI software.

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

• Not applicable. This device is a physical implant, not an algorithm.

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

• Not applicable as no performance testing was conducted for K223790.

8. The sample size for the training set

• Not applicable as no algorithmic training dataset is relevant for this physical implant.

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

• Not applicable as no algorithmic training dataset is relevant for this physical implant.

Key takeaway from the document:

The FDA determined that the Dio Medical Huvex Interspinous Fusion System (K223790) is substantially equivalent to the Huvexel Co. Ltd. - Huvex Interspinous Fusion System (K162849). This determination is based on the claim that the current device is identical to the predicate device in its intended uses, indications, technological characteristics, and principles of operation. Therefore, no new performance testing was deemed necessary for this submission. The detailed performance data and acceptance criteria would have been part of the original K162849 submission.

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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 Aurora Spine ZIP™ MIS Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), lumbar spinal stenosis, spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The Aurora Spine ZIP™ MIS Interspinous Fusion System is intended for use with bone graft material and is not intended for stand-alone use.

The Aurora Spine ZIP™ MIS Interspinous Fusion System is a bilateral locking plate system which attaches to the posterior noncervical spine at the spinous processes. The implants have superior and inferior surfaces and a central chamber for receiving bone graft. The devices are available in a variety of cylinders to accommodate variations in pathology and patient anatomy. The Aurora Spine ZIPTM MIS Interspinous Fusion System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic. lumbar and/or sacral spine.

The provided text describes a 510(k) premarket notification for the Aurora Spine ZIP™ MIS Interspinous Fusion System. This document is a regulatory submission for a medical device and does not contain information about clinical performance testing or studies evaluating the device's adherence to specific acceptance criteria for AI/ML performance.

Specifically, the "Clinical Performance Testing Summary" section states: "A literature review of was performed to support the expanded indications." This implies that no new clinical study was conducted for this specific 510(k) submission to assess performance against acceptance criteria. The submission focuses on demonstrating substantial equivalence to previously cleared devices based on design, materials, and a literature review for an expanded indication (lumbar spinal stenosis).

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment, as this data is not present in the provided document.

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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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The Inspan ScrewLES Fusion System is a posterior non-pedicle supplemental fixation system intended for use in the noncervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion for the following indications: spondylolisthesis, trauma (fracture or dislocation), tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radios), or lumbar spinal stenosis. The device is intended for use with bone graft material and is not intended for stand-alone use.

The Inspan ScrewLES Fusion System, previously cleared (under K102020) and marketed as, "Vega™ SPANTM Spinous Process Plate System", consists of varying length and hub diameters, set screws, and instruments required for implantation. Spikes are present on the sides of the plate that interface with the spinous process to restrain the plate from rotating postoperatively. The device is offered with varying lengths and hub diameters to accommodate anatomical needs. Set screws are used to secure the two sides of the device into the final compressed and implanted construct.

System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136.

This document describes the 510(k) premarket notification for the Inspan® ScrewLES® Fusion System. However, it does not contain the specific information required to complete a table of acceptance criteria and reported device performance with performance metrics, or details about the studies involving AI algorithms.

The document discusses the substantial equivalence of the Inspan® ScrewLES® Fusion System to a predicate device, the Vega™ SPAN™ Spinous Process Plate System. It provides information about:

• Indications for Use: Posterior non-pedicle supplemental fixation in the non-cervical spine (T1-S1) for supplemental fusion due to spondylolisthesis, trauma, tumor, degenerative disc disease, or lumbar spinal stenosis.
• Device Description: Consists of varying length/hub diameter plates, set screws, and instruments, manufactured from titanium alloy (Ti-6AI-4V ELI).
• Non-Clinical Performance Testing: Biocompatibility, sterilization, and non-clinical testing data were submitted.
• Clinical Performance Testing: A retrospective review of prospectively collected data by Chin et al. (2020) involving 56 patients treated for degenerative disc disease with lumbar spinal stenosis. This study reported statistically significant improvements in VAS back pain and ODI at 24 months postoperatively.

However, the provided text does NOT include information on:

1. Acceptance criteria directly linking to performance metrics. The document states the device was found "substantially equivalent" based on indications, design, materials, function, manufacturing, and performance, but it does not specify quantitative acceptance criteria or detailed performance metrics.
2. AI-specific study details. The document describes a medical device for spinal fixation, not an AI/ML-driven device. Therefore, the questions related to AI device performance, sample sizes for test/training sets, ground truth establishment for AI, expert qualifications, and MRMC studies are not applicable to this particular document.

To answer your request, I would need a document related to an AI/ML medical device submission.

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