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The G Surgical Marksman MIS System is intended to provide immobilization of the posterior noncervical spine (T1-S2/llium) in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities: 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), spinal stenosis, curvatures (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis, and/or failed previous fusion. The G Surgical Marksman MIS System can be used in an open approach or a percutaneous approach with MIS instrumentation.

The G Surgical Marksman MIS System consists of longitudinal members (rods), anchors (screws) and fasteners in a variety of sizes to accommodate differing anatomic requirements. The devices are sold nonsterile.

The provided text describes a 510(k) premarket notification for the G Surgical Marksman MIS System. It details the device's indications for use, materials, and references mechanical testing. However, it does not provide specific acceptance criteria or the full study details in the format requested for an AI/software device.

The G Surgical Marksman MIS System is a medical device (a thoracolumbosacral pedicle screw system), not an AI/software device. The performance data mentioned refers to mechanical testing (ASTM F1717) to demonstrate structural integrity and durability, which is standard for orthopedic implants. It does not involve AI performance metrics like accuracy, sensitivity, or specificity, nor does it involve human readers or ground truth established by experts in the context of diagnostic or interpretive tasks.

Therefore, most of the requested information regarding AI/software device performance, such as sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types for AI, is not applicable to this submission.

Here is the information that can be extracted or derived from the provided text, acknowledging the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: Not explicitly stated, as this refers to mechanical test constructs, not patient data or images for AI. The text mentions "worst-case G Surgical Marksman MIS System constructs."
• Data provenance: Not applicable in the context of patient data for AI. The "data" refers to the results of mechanical laboratory tests.

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

• Not applicable. Ground truth in this context would refer to material science and mechanical engineering standards, not expert medical opinion for diagnostic accuracy.

4. Adjudication method for the test set:

• Not applicable. Adjudication is relevant for expert disagreement in AI ground truth establishment. Mechanical testing follows standardized protocols.

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 not an AI-assisted diagnostic device.

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

• Not applicable. This is not an AI algorithm.

7. The type of ground truth used:

• Ground truth: Adherence to ASTM F1717 standards for mechanical safety and performance, as assessed through laboratory testing.

8. The sample size for the training set:

• Not applicable. This is not an AI device that requires a training set.

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

• Not applicable.

In summary: The provided document is a 510(k) clearance letter for a physical medical device (spinal implant components), not for an AI/software device. The performance data refers to mechanical testing for physical properties, not diagnostic accuracy or human-AI interaction. Therefore, many of the requested details are not relevant to this specific submission.

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The G Surgical Marksman Spinal Deformity System is intended to provide immobilization of the posterior non-cervical spine (T1-S2/Ilium) in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: 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), spinal stenosis, curvatures (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

The G Surgical Marksman Spinal Deformity System consists of longitudinal members (rods), anchors (screws), connectors (crosslinks) and fasteners in a variety of sizes to accommodate differing anatomic requirements.

Unfortunately, I cannot fulfill your request to describe the acceptance criteria and study proving the device meets them, nor any of the other numbered items.

The provided document is a 510(k) clearance letter from the FDA for a medical device called the "G Surgical Marksman Spinal Deformity System." This type of document primarily confirms that the FDA has found the device to be "substantially equivalent" to predicate devices already on the market.

It explicitly states that the device is a "Thoracolumbosacral Pedicle Screw System" and is manufactured from specific titanium and cobalt chrome alloys.

The document details the device's indications for use (spinal immobilization and stabilization as an adjunct to fusion for various conditions), describes its components (rods, screws, connectors, fasteners), and mentions the materials used.

However, the provided text does not contain any information about acceptance criteria, clinical study results, performance data (beyond mechanical testing to ASTM F1717 and sterilization validations), sample sizes for testing, expert qualifications, ground truth establishment, or any details related to AI assistance or multi-reader multi-case studies.

Therefore, I cannot extract the information you've requested from this document. It appears to be a clearance for a physical orthopedic implant, not a diagnostic or AI-driven device that would typically involve the types of performance studies and metrics you've listed.

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The GPS™ Cervical Spacers are indicated for use at multiple contiguous levels, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment. The device is intended to treat cervical disc degeneration and/or cervical spinal instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or pain. The device is to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and in combination with supplemental fixation cleared for use in the cervical spine.

The basic shape of the GPS™ Cervical Spacers is a structural column having upper and lower implant openings and a central cavity for autograft bone. The devices have a have a "B" shaped cross-section. Surface teeth assist in the seating the implant between the vertebral bodies. Devices are available in a variety of size and angulation combinations to accommodate the diversity in patient anatomy.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called "GPS™ Cervical Spacers". This document does not describe or include a study proving that the device meets specific performance acceptance criteria.

Instead, the document details:

• The FDA's determination of substantial equivalence (K210890) to a legally marketed predicate device (K142456).
• The device's indications for use: treating cervical disc degeneration and/or cervical spinal instability at multiple contiguous levels (C2-T1) in skeletally mature patients who have had non-operative treatment, to be used with autogenous and/or allogeneic bone graft and supplemental fixation.
• The device's description, materials (PEEK and tantalum), and technological characteristics (hollow structural frame, material, basic design, sizes).
• The fact that no new mechanical testing was performed for the current submission (K210890) because the change to a non-sterile condition does not create a mechanical worst-case scenario. It states: "Performance data remains unchanged for the subject devices as compared to the predicate versions of the device."

Therefore, based solely on the provided text, I cannot answer the questions about acceptance criteria and a study proving the device meets those criteria, a sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details. The document explicitly states that performance data remains unchanged from "the predicate versions of the device," implying that any such performance studies would have been associated with the original predicate device (K142456), not the current submission (K210890).

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The G Surgical Marksman System is intended to provide immobilization of the posterior non-cervical spine (T1-S2/Ilium) in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: 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), spinal stenosis, curvatures (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

The G Surgical Marksman MIS System consists of longitudinal members (rods), anchors (screws), connectors (crosslinks) and fasteners in a variety of sizes to accommodate differing anatomic requirements.

The provided text is a 510(k) summary for the G Surgical Marksman System, which is a thoracolumbosacral pedicle screw system. This type of device is an implant used to stabilize the spine and is regulated as a Class II medical device.

Crucially, a 510(k) submission for this class of device primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through mechanical testing and comparison of technological characteristics, rather than clinical efficacy studies on patient outcomes.

Therefore, most of the requested information regarding acceptance criteria, device performance from a study, sample sizes for test/training sets, expert consensus, and stand-alone performance for an AI/algorithm-based device is not applicable to this specific submission because it's for a mechanical implant, not an AI-driven diagnostic or therapeutic system.

Here's a breakdown of the information that is available and why other parts are not:

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

Explanation: The acceptance criteria for this type of device are primarily based on established mechanical testing standards (ASTM F1717) to ensure the implant's structural integrity and durability. The device is considered to meet the acceptance criteria if its mechanical performance is comparable to or better than predicate devices. The document explicitly states that the "mechanical test results demonstrate that G Surgical Marksman System performance is substantially equivalent to the 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)

• Not Applicable. The "test set" for this device refers to the physical specimens of the implant components that underwent mechanical testing, not a dataset of patient information. The document does not specify the number of samples tested for each mechanical test. Data provenance (country, retrospective/prospective) is not relevant for mechanical device testing.

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. "Ground truth" in the context of expert consensus or pathology is relevant for diagnostic or AI-based devices. For a mechanical implant, the "ground truth" for performance is determined by adherence to engineering specifications and performance in standardized mechanical tests, not expert medical opinion on a dataset.

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

• Not Applicable. Adjudication methods are used in studies involving human interpretation or subjective assessments, typically for clinical data and diagnostic accuracy. This is not relevant to the mechanical testing of an implant.

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

• No, not done. MRMC studies and the effect size of AI assistance are relevant for AI-powered diagnostic or interpretive tools, where human readers (e.g., radiologists) are involved. This device is a surgical implant and does not involve "human readers" in the context of interpretation.

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

• No, not applicable. The G Surgical Marksman System is a physical medical device (pedicle screw system), not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm is not relevant.

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

• Mechanical Standards and Predicate Device Performance. The "ground truth" for this device's performance is established by its ability to meet specified mechanical properties (e.g., strength, durability) as defined by ASTM F1717 and by demonstrating equivalence to the performance of legally marketed predicate devices. There is no biological or diagnostic "ground truth" involved in this type of submission.

8. The sample size for the training set

• Not Applicable. There is no "training set" for this device. This term refers to data used to train machine learning algorithms.

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

• Not Applicable. As there is no training set, there is no ground truth for it to be established.

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The G Surgical OCT Spinal System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, cervical spine (C1 to C7) and the thoracic spine (T1 to T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

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

In order to achieve additional levels of fixation, the G Surgical OCT Spinal System may be connected to the G Surgical Pedicle System (GPS™) using 3.5mm/6.0mm axial connectors, domino connectors and transition rods.

G Surgical OCT Spinal System consists of longitudinal members, anchors, interconnecting devices and fasteners in a variety of sizes to accommodate differing anatomic requirements. The implants are sold non-sterile.

The provided text describes a 510(k) premarket notification for the G Surgical OCT Spinal System. This document focuses on demonstrating substantial equivalence to predicate devices based on mechanical testing benchmarks, not on clinical performance or diagnostic accuracy of an AI-powered device. Therefore, much of the requested information regarding AI device performance, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is not applicable or cannot be extracted from this document.

However, I can provide the available information regarding the device's performance data as it relates to mechanical testing.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the G Surgical OCT Spinal System are not explicitly stated in a quantitative table within this document. Instead, the document refers to industry standards for mechanical testing and implies that performance equivalent to predicate devices is the acceptance criterion.

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

This document describes a medical device (surgical implant) and its mechanical performance, not an AI device or a diagnostic test. Therefore, the concept of a "test set" in the context of clinical data, along with data provenance (country of origin, retrospective/prospective) is not applicable to the information provided. The "test set" here refers to the physical samples of the device constructs used for mechanical testing. The sample size for these mechanical tests is not specified in this summary.

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

This information is not applicable. Ground truth, in the context of this document, refers to the physical properties and mechanical behavior of the device components as tested against established engineering standards (ASTM F1717, ASTM F2706). The "ground truth" is verified through engineering testing, not by expert interpretation of clinical data.

4. Adjudication Method for the Test Set

This information is not applicable. Given that this concerns mechanical testing of an orthopedic implant, there is no expert adjudication process for a "test set" of clinical data.

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. The device described is a spinal implant for surgical use, not an AI-assisted diagnostic tool or an imaging system requiring 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 device is a physical surgical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation in this document is primarily based on engineering standards and mechanical test results. The device's performance is compared against the performance of legally marketed predicate devices, as demonstrated through adherence to ASTM F1717 and ASTM F2706 standards for spinal implant testing.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of an AI device for this document. The mechanical testing does not involve machine learning or AI.

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

This information is not applicable. As explained above, there is no training set for an AI device in this context.

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The G Surgical Marksman MIS System is intended to provide immobilization of the posterior non-cervical spine (T1-S2/Ilium) in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, kyphosis and/or lordosis), tumor, pseudarthrosis, and/or failed previous fusion. The G Surgical Marksman MIS System can be used in an open approach or a percutaneous approach with MIS instrumentation.

The G Surgical Marksman MIS System consists of longitudinal members (rods), anchors (screws) and fasteners in a variety of sizes to accommodate differing anatomic requirements.

The provided document is a 510(k) premarket notification for a medical device called the "G Surgical Marksman MIS System." This document primarily focuses on establishing "substantial equivalence" to predicate devices based on mechanical testing and technological characteristics. It does not contain information about acceptance criteria for an AI/CADe device, a study proving such a device meets acceptance criteria, or any of the detailed information regarding AI algorithm training or testing as requested.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the input document does not pertain to an AI-powered device or its performance evaluation in the way you've outlined.

The document discusses:

• Device: G Surgical Marksman MIS System (a pedicle screw spinal system)
• Purpose: To provide immobilization and stabilization of the posterior non-cervical spine as an adjunct to fusion.
• Regulatory Focus: Demonstrating substantial equivalence to existing predicate devices (Firebird with Phoenix MIS Spinal Fixation System, Zodiac® Spinal Fixation System, Moss Miami™ Spinal System, Optima™ Spinal System).
• Performance Data: Mechanical testing of worst-case constructs according to ASTM F1717 (static and dynamic compression bending, static torsion) to show performance is "substantially equivalent to the predicate devices."

The questions posed (acceptance criteria, sample sizes, ground truth, experts, adjudication, MRMC, standalone performance, training set details) are relevant to the evaluation of an AI or CADe device, which is not what this document describes.

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