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

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

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

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

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

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

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

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

The essential conclusion from the document is that:

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

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

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

1. A table of acceptance criteria and the reported device performance: Not applicable. The document refers to physical device testing for "substantial equivalence" to a predicate, not performance against specific acceptance criteria for an AI/ML output.
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. No test set or data provenance for an AI/ML device is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable. No ground truth establishment for an AI/ML device is mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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

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

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

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

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

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

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

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

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

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

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

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The Spinal Simplicity 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 Posterior Fusion Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions:
· Lumbar spinal stenosis;
· degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);

• · spondylolisthesis;
• · trauma (i.e., fracture or dislocation); and/or
  • tumor.
  The Posterior Fusion Plate is intended for use with bone graft material and is not intended for standalone use. The device may be implanted via a minimally invasive lateral approach (L1-S1) or a minimally invasive posterior approach (T1-S1).

The Spinal Simplicity Minuteman G3 MIS Fusion Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions:
· Lumbar spinal stenosis;
· degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);

• · spondylolisthesis;
• · trauma (i.e., fracture or dislocation); and/or
  • tumor.
  The Minuteman G3 MIS Fusion Plate is intended for use with bone graft material and is not intended for standalone use. The device may be implanted via a minimally invasive lateral approach (L1-S1) or a minimally invasive posterior approach (T1-S1).

The Spinal Simplicity HA Minuteman G3 MIS Fusion Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions:
· Lumbar spinal stenosis;
· degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);

• · spondylolisthesis;
• · trauma (i.e., fracture or dislocation); and/or
  • tumor.
  The HA Minuteman G3 MIS Fusion Plate is intended for use with bone graft material and is not intended for standalone use. The device may be implanted via a minimally invasive lateral approach (L1-S1) or a mimimally invasive posterior approach (T1-S1).

The Spinal Simplicity HA Minuteman G3-R MIS Fusion Plate is a posterior, nonpedicle supplemental fixation device, intended for use at a single level in the noncervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions:

• Lumbar spinal stenosis;
• degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
• spondylolisthesis;
• trauma (i.e., fracture or dislocation); and/or
• tumor.
  The HA Minuteman G3-R MIS Fusion Plate is intended for use with bone graft material and is not intended for standalone use. The device may be implanted via a minimally invasive lateral approach (L1-S1).

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

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

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

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

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

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

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

4. Adjudication method for the test set:

This information is not provided in the document.

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

Not applicable. This device is a physical spinal implant, not an AI-powered diagnostic or assistive technology.

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

Not applicable. This is a physical medical device.

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

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

8. The sample size for the training set:

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

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

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

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The Spinal Simplicity 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:

· 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 posterior approach (T1-S1) or a minimally invasive lateral approach (L1-S1).

The Posterior Fusion Plate consists of bilateral Plates and a Body/Post that connects the Plates, identical to the predicate construct. The Plate components include several spiked grips at the ends of each Plate for attachment to the spinous processes. The Posterior Fusion Plate device is available in multiple sizes to accommodate varying patient anatomy. The Posterior Fusion Plate is made from Ti6Al4V and Ti6Al4V ELI. The HA Posterior Fusion Plate has an additional hydroxyapatite coating on the distal regions of the device.

The document provided is a 510(k) summary for a medical device called the "Posterior Fusion Plate." This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a new AI/software-based device. Hence, most of the requested information regarding acceptance criteria, specific study designs for performance metrics, ground truth, and reader studies is not explicitly available in this document as it pertains to a different type of device and regulatory submission.

However, I can extract the information that is present and indicate where the requested information is not applicable or not provided in this specific context.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Mechanical Testing (ASTM F1717): Not specified. These are typically in-vitro lab tests, not using human data.
• Cadaveric Insertion Data: Not specified. This would be a prospective study, likely conducted in a controlled lab setting.
• Surgeon-involved Cadaveric Implantation Study: Not specified. Prospective, controlled lab setting.
• Survey Data from Surgeons:
  • Sample Size: Not specified (number of surgeons).
  • Data Provenance: "outside the United States," retrospective from the perspective of the survey, gathering past observations.
• Clinical Data (migration, dislodgement, fracture):
  • Sample Size: Not specified.
  • Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The term "clinical data" implies human patient data, but details are lacking.

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

• Mechanical Testing: No human experts establish ground truth for these physical tests. Standards like ASTM F1717 define the methodology.
• Cadaveric Insertion Data: The "minimal risk of spinous process fracture" would likely be judged by the testing personnel and/or surgical experts involved in the study. The number and qualifications are not specified.
• Surgeon-involved Cadaveric Implantation Study: Similar to above, "suitable device function and performance" would be assessed by the involved surgeons. The number and qualifications are not specified.
• Survey Data: The "ground truth" (observations of failures) relies on the reporting surgeons themselves. Their qualifications are implied as surgeons who implant the device, but specific experience levels are not detailed.
• Clinical Data: While "clinical data" is mentioned, the method for establishing "ground truth" for risks like migration, dislodgement, and fracture (e.g., by independent medical reviewers, imaging, etc.) is not detailed, nor are the number or qualifications of experts.

4. Adjudication Method for the Test Set

Not specified for any of the studies mentioned.

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

No, this document describes a physical medical device (spinal implant), not an AI/software device that would typically undergo an MRMC study comparing human readers with and without AI assistance. Therefore, this section is not applicable, and no effect size for human readers improving with AI is mentioned.

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

This is not applicable as the device is a physical implant, not an algorithm or AI.

7. The Type of Ground Truth Used

• Mechanical Testing: Defined by physical measurements and adherence to ASTM standards.
• Cadaveric Data: Observations of physical outcomes (e.g., presence/absence of fracture) during surgical simulation.
• Survey Data: Self-reported observations by implanting surgeons.
• Clinical Data: Observations of clinical outcomes (e.g., migration, dislodgement, fracture) in patients. Whether this involved expert consensus, pathology, or direct outcome data is not specified.

8. The Sample Size for the Training Set

This concept is primarily relevant for AI/machine learning models. Since this is a physical medical device, there isn't a "training set" in the AI sense. The design and manufacturing process would involve internal testing and refinement, but not a formally labeled "training set" of data.

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

Not applicable for the same reason as above.

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