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The Blue Topaz Sacroiliac Screw System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The Blue Topaz Sacroiliac Screw System consists of cannulated, fully threaded screws intended to facilitate fusion of the sacroiliac joint. The Blue Topaz Sacroiliac Screw System is fabricated from medical grade titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The Blue Topaz System implants come in various sizes and lengths to accommodate patient anatomy. Optional washers are included for each screw diameter to aid in conforming to patient anatomy.

The provided document is a 510(k) summary for the "Blue Topaz Sacroiliac Screw System" which is a medical device. It does not describe an AI/ML powered device, nor does it contain information about clinical studies with human readers or AI-assistance. Therefore, I cannot provide details on most of the requested points, as they are specific to AI/ML device evaluations.

However, I can extract information related to the device's performance data based on non-clinical testing.

Here's what can be extracted from the provided text:

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

The document mentions that the device was tested to demonstrate its strength for its intended use and substantial equivalence to predicate devices. However, specific numerical acceptance criteria and reported performance values are not explicitly stated in the provided text. It only lists the types of tests performed.

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

This information is not applicable as the document describes non-clinical mechanical testing of a physical medical device, not a study involving a test set of data or human subjects.

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)

This information is not applicable as the document describes non-clinical mechanical testing of a physical medical device. Ground truth, in the context of expert review, is not relevant for this type of evaluation.

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

This information is not applicable as the document describes non-clinical mechanical testing of a physical medical device. Adjudication methods are typically used in clinical studies or expert reviews.

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 information is not applicable as the document describes a physical medical device (sacroiliac screw system) and its non-clinical mechanical testing. There is no mention of AI assistance or human readers.

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

This information is not applicable as the document describes a physical medical device and its mechanical performance, not an algorithm or AI system.

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

This information is not applicable as the document describes non-clinical mechanical testing. The "ground truth" for mechanical performance would be the direct measurement outcomes from the specified ASTM standards.

8. The sample size for the training set

This information is not applicable as the document describes a physical medical device and its non-clinical mechanical testing. There is no training set involved.

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

This information is not applicable as the document describes a physical medical device and its non-clinical mechanical testing. There is no training set or ground truth in that context.

Summary of available information regarding the device itself (not AI/ML related):

The Blue Topaz Sacroiliac Screw System underwent the following non-clinical (mechanical) tests:

• Static and Dynamic Cantilever Bending per ASTM F2193
• Driving Torque per ASTM F543
• Static Torsion per ASTM F543
• Pullout per ASTM F543

The conclusion from this testing was that the device's strength is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

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The Aries® Lumbar Interbodies (Aries®-TS, Aries®-TC, Aries®-O, Aries®-A, and Aries®-L) are interbody fusion devices intended for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2 to S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Aries® Lumbar Interbodies are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The Aries® Lumbar Interbodies are interbody fusion devices used to provide structural stability in skeletally mature patients. The implants were developed for the substitution of the classical autogenous bone graft blocks. The cages assist to avoid complications related to the bone graft donation site (chronic pain, hematoma, infection, bone removal from the donor site making it impossible to remove bone again, quality of the iliac bone, accessing a healthy donor site that may become an unhealthy site, hernias by the incision). The system is comprised of interbodies of various fixed heights and footprints to fit the anatomical needs of a wide variety of patients and multiple surgical approaches. Each interbody has an axial hole to allow grafting material to be placed inside of the interbody. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

This document describes Aries® Lumbar Interbodies, an intervertebral body fusion device, and its acceptance criteria for FDA clearance.

Here's an analysis of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not include information on sample size for a test set or data provenance for any clinical studies. It explicitly states, "No clinical studies were performed." The testing conducted was non-clinical (mechanical and pyrogenicity).

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

This information is not applicable as no clinical studies were performed, and thus no expert-established ground truth for a test set was required in this submission. The "ground truth" for the non-clinical tests was established through adherence to recognized ASTM standards.

4. Adjudication Method for the Test Set

This information is not applicable as no clinical studies requiring human adjudication were performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. The submission explicitly states "No clinical studies were performed."

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

This information is not applicable. The device is an intervertebral body fusion device, which is a physical implant, not an algorithm or AI system. Therefore, standalone algorithm performance is irrelevant.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" was based on established industry standards and specifications (ASTM F2077, ASTM F2267, ASTM F3001, and pyrogenicity limits). The goal was to demonstrate equivalence to predicate devices, meaning the device performed within the acceptable parameters defined by these standards, similar to already cleared devices.

8. The Sample Size for the Training Set

This information is not applicable as there was no algorithm or AI component requiring a training set. The device is a physical medical implant.

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

This information is not applicable as there was no algorithm or AI component requiring a training set or its associated ground truth.

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The Gemini-C Hybrid Cervical Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels within the cervical spine at disc levels from C2 to T1. Degenerative disc disease (DDD) is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. This device is intended for use with autogenous bone graft and/or allograft comprised of cancellous bone graft and supplemental fixation (i.e. anterior cervical plate such as the White Pearl Preferred Angle Anterior Cervical Plate). Patients should have had at least six weeks of non-operative treatment prior to treatment with intervertebral cages.

The Osseus Fusion Systems' Gemini-C Hybrid Cervical Interbody System is used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. This system includes three design configurations: 1) PEEK, 2) Titanium alloy (Ti-6Al-4V ELI), and 3) Hybrid PEEK/Titanium alloy. The implants are available in a range of footprints and heights to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of bone graft.

This document is a 510(k) premarket notification for a medical device and therefore describes a medical device (intervertebral body fusion device) rather than an AI/ML powered device. As such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed in terms of mechanical and material performance standards and non-clinical testing, rather than AI/ML performance metrics, ground truth, or reader studies.

Here's an analysis based on the provided document, addressing the closest equivalents to your prompts for a traditional medical device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on demonstrating substantial equivalence to predicate devices through a series of standardized non-clinical mechanical tests. The performance is deemed acceptable if the device meets or exceeds the requirements of these ASTM standards, indicating similar mechanical safety and performance to the legally marketed 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: Not explicitly stated in terms of the number of device units tested. For mechanical testing, samples are typically device prototypes or finished products. ASTM standards dictate the number of samples required for each test.
• Data Provenance: The document does not specify the country of origin of the data beyond the fact that the testing was conducted for a device seeking approval in the United States. The testing is prospective in the sense that physical devices were manufactured and subjected to controlled laboratory tests, rather than analyzing historical patient data.

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

This question is not applicable to a non-AI/ML medical device. Ground truth, in the context of device performance, is established by adherence to engineering principles, material science, and the relevant ASTM (American Society for Testing and Materials) standards. The "experts" would be the engineers and technicians skilled in conducting the mechanical tests and interpreting the results according to the specified standards.

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

Not applicable. Mechanical testing involves quantitative measurements against defined standards, not subjective interpretations requiring adjudication among human observers.

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 is a traditional medical device, not an AI-powered diagnostic or assistive tool. No human reader studies were conducted or are relevant to its approval.

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

Not applicable. This is a physical intervertebral body fusion device, not an algorithm.

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

The "ground truth" for this device's performance is established by validated mechanical testing standards (ASTM standards). These standards define the expected physical properties and responses of materials and devices under simulated conditions relevant to their intended use. For example, the "ground truth" for compression strength is the maximum force the device can withstand before failure, measured according to ASTM F2077.

8. The sample size for the training set

Not applicable. This device does not involve a training set as it is not an AI/ML algorithm.

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

Not applicable.

Summary of Relevant Information from the Document:

The provided document describes the Gemini-C Hybrid Cervical Interbody System, an intervertebral body fusion device.

• Acceptance Criteria for Device Type: Substantial equivalence to predicate devices regarding intended use, design, materials, mechanical safety, and performance, demonstrated through non-clinical testing.
• Study Proving Acceptance: A series of non-clinical, mechanical tests were conducted per established ASTM standards:
  • Static and dynamic compression (ASTM F2077)
  • Static and dynamic compression shear (ASTM F2077)
  • Static and dynamic torsion (ASTM F2077)
  • Subsidence (ASTM F2267)
  • Expulsion testing (ASTM Draft Standard F-04.25.02.02)
• Conclusion: The results of these evaluations indicated that the Gemini-C Hybrid Cervical Interbody System is equivalent to predicate devices, thus meeting the acceptance criteria for market clearance.
• Clinical Studies: "No clinical studies were performed." This is common for 510(k) devices when substantial equivalence can be demonstrated through non-clinical means.

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The White Pearl Preferred Angle Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spinal stenosis

The White Pearl Preferred Angle Anterior Cervical Plate consist of cervical plates, locking caps, bone screws, and the instruments necessary to implant this specific system. All implant components are made from a titanium alloy (Ti-6Al-4V ELI). The White Pearl Preferred Angle Anterior Cervical Plate is intended to provide stabilization of the cervical vertebrae for various indications. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping and/or self-drilling bone screws using an anterior approach. Bone screws are available for fixed angle or variable angle implantation. The White Pearl Preferred Angle Anterior Cervical Plate is intended to be removed after solid fusion has occurred.

This document is a 510(k) Pre-Market Notification for a medical device called the "White Pearl Preferred Angle Anterior Cervical Plate." It outlines the device's characteristics, intended use, and a comparison to predicate devices to establish substantial equivalence.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

Acceptance Criteria and Reported Device Performance

This document primarily focuses on establishing substantial equivalence to predicate devices rather than defining specific performance acceptance criteria for a novel device with clinical endpoints like sensitivity or specificity. Instead, the acceptance criteria are based on mechanical performance standards to demonstrate that the new device performs as safely and effectively as existing, legally marketed devices.

Study Details:

The provided document describes non-clinical testing to support the substantial equivalence claim.

1. Sample Size used for the test set and the data provenance:

   • The document does not specify the sample size (number of constructs or units) used for the mechanical "test set." It only mentions the types of tests performed.
   • Data provenance is not explicitly stated in terms of country of origin. The tests are described as non-clinical (laboratory-based mechanical testing), not involving patient data.

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

   • This question is not applicable to this type of submission. Mechanical testing of a medical device does not typically involve expert review to establish "ground truth" in the way clinical studies or diagnostic AI algorithms do. The "ground truth" for mechanical testing is defined by the physical loads and deformation measurements under established ASTM standards (ASTM F1717).

3. Adjudication method for the test set:

   • This question is not applicable. Adjudication methods (like 2+1 or 3+1 consensus) are used in clinical studies or for diagnostic image interpretation where there's variability in expert opinion. For mechanical testing, the results are quantitative measurements against predefined standards.

4. 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:

   • No MRMC comparative effectiveness study was done. This document is for a spinal implant, which is a physical medical device, not a diagnostic imaging AI algorithm. Therefore, "human readers" and "AI assistance" are irrelevant in this context.

5. 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.

6. The type of ground truth used:

   • For the non-clinical mechanical testing, the "ground truth" is established by the definitions and requirements of the ASTM F1717 standard for static and dynamic compression and static torsion testing. This standard specifies how to conduct the tests and how to measure the mechanical properties of the device.

7. The sample size for the training set:

   • Not applicable. This document describes the testing of a physical medical device. There is no concept of a "training set" as would be used for machine learning.

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

   • Not applicable, as there is no training set for this type of device submission.

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The Osseus Black Diamond Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.

The Osseus Black Diamond Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor; pseudoarthrosis; and failed previous fusion.

The Osseus Black Diamond Pedicle Screw System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods and cross links. All of the components are available in a variety of sizes to match more closely the patient's anatomy.

This is a 510(k) summary for a spinal implant system and as such, it does not involve AI/ML device performance testing. The 'acceptance criteria' and 'device performance' in this context refer to mechanical and material performance rather than diagnostic accuracy or classification metrics.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "The results of this testing indicate that the Osseus Black Diamond Pedicle Screw System is equivalent to predicate devices." This implies that the device met the performance standards established by the predicate devices through these ASTM tests. The specific numerical acceptance criteria (e.g., maximum load, fatigue life) are not detailed in this summary document but would have been part of the full submission.

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

Given this is a mechanical engineering test of a physical device, not an AI/ML system:

• Sample Size for Test Set: The document does not specify the exact number of units or replicates tested for each static and dynamic test. These would typically be defined by the ASTM F1717 standard and the test protocol.
• Data Provenance: The tests are non-clinical, meaning they were performed in a laboratory setting on manufactured devices, not on human patients or data derived from them. The data is generated from physical mechanical testing.

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

• This question is not applicable to this type of device submission. Ground truth, in the context of device performance described here, is established by adherence to ASTM standards for mechanical testing, not by expert interpretation of data or images.

4. Adjudication Method for the Test Set

• This question is not applicable. Mechanical tests according to ASTM standards do not involve adjudication by multiple experts in the same way clinical or AI/ML studies do. The results are quantitative measurements against predefined engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant to diagnostic imaging devices or AI systems where human readers interpret medical images. This submission is for a physical orthopedic implant.
• Effect Size: Not applicable as no such study was performed.

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

• This question is not applicable. This device is a physical pedicle screw system, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is established by engineering standards and specifications (specifically ASTM F136 for materials and ASTM F1717 for mechanical performance). The device's performance is compared against the known performance of legally marketed predicate devices through these standardized mechanical tests.

8. The Sample Size for the Training Set

• This question is not applicable. There is no "training set" in the context of a pedicle screw system's mechanical testing. This concept applies to AI/ML devices.

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

• This question is not applicable. As there is no training set, there is no ground truth establishment for it.

In summary, the provided 510(k) summary describes a traditional medical device (a spinal implant) and its non-clinical mechanical testing, not an AI/ML-driven diagnostic or therapeutic device. Therefore, many of the questions related to AI/ML study design, readers, and ground truth are not relevant to this specific document. The "study" referenced is a series of mechanical tests to demonstrate substantial equivalence to predicate devices.

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