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When used as a vertebral body replacement, the TASMIN® R devices are indicated for use to replace a vertebral body that has been resected or excised due to tumor or traumaffracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation.

When used as an intervertebral fusion device, the TASMIN® R devices are intended for use at one level in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment. The devices are intended for use with a supplemental internal fixation system and with autograft to facilitate fusion.

The basic shape of the TASMIN® R devices is a hollow structural frame having a rounded, tapered leading face. The upper and lower aspects of the implant are open with peaked teeth that assist in anchoring and seating the implant between the vertebral bodies. There are lateral fenestrations for bony in-growth. The device is available in a variety of sizes and angulations thereby enabling the surgeon to choose the size best suited to the individual pathology and anatomical condition.

The TASMIN® R device is a spinal intervertebral body fixation orthosis and intervertebral body fusion device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The documentation refers to "worst case TETRIS™ and TASMIN® R devices" for finite element analysis and "worst case TASMIN® R devices" for physical testing. It does not specify the exact number of devices or scenarios considered. It is implied that representative "worst-case" configurations were selected for the evaluation.
• Data Provenance: The studies are described as "Finite element analysis simulations" and "Static and dynamic compression testing." This indicates the data was generated from engineering analyses and laboratory bench testing performed by the sponsor, SIGNUS Medizintechnik GmbH. The country of origin of the data is not explicitly stated, but the sponsor is based in Germany. The data is prospective in the sense that it was generated specifically for the premarket submission.

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

This information is not applicable as the studies performed were bench testing and finite element analysis, not clinical studies requiring expert consensus on patient data. The "ground truth" for these types of studies is established by adherence to recognized ASTM standards and engineering principles.

4. Adjudication Method for the Test Set

This information is not applicable for bench testing and finite element analysis. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for interpretation of imaging or clinical outcomes.

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

An MRMC comparative effectiveness study was not conducted. The device is a medical implant, not an AI-assisted diagnostic or therapeutic tool.

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

This information is not applicable. The device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for these studies was derived from:

• Recognized Industry Standards: ASTM F2077 (for compression, torsion, compression-shear) and ASTM F2267 (for subsidence properties). These standards define the methodology and expected performance for intervertebral body fusion devices.
• Engineering Principles: Finite element analysis relies on established biomechanical and engineering principles to simulate mechanical behavior.
• Material Specifications: ASTM F2026 for PEEK-OPTIMA® LT1 and ASTM F560 for Tantalum, defining the accepted properties of the materials.

8. The Sample Size for the Training Set

This information is not applicable. The studies performed were bench testing and simulations, not machine learning studies that require a training set.

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

This information is not applicable as there was no training set for a machine learning algorithm. The "ground truth" for the device's performance was established by adherence to ASTM standards and engineering principles as described in point 7.

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The CAPSTONE CONTROL™ Spinal System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

The CAPSTONE CONTROL™ Spinal System consists of PEEK cages of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The CAPSTONE CONTROL™ Spinal System implants will be available in heights of 8mm to 18mm, lengths of 22mm, 27, mm, and 32mm, and widths of 9mm or 10mm. In addition, the implants will be available with 0°, 6°, 12°, and 18° of lordosis.

The CAPSTONE CONTROL™ Spinal System is an intervertebral body fusion device.

Here's an analysis of the provided text in relation to acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

• Static compression testing
• Dynamic compression fatigue testing
• Static compression shear testing
• Dynamic compression shear fatigue testing
• Subsidence
• Rotational testing (due to "insert and rotate" feature) | Demonstrated that the subject device was as safe and effective as the predicate devices. |
  | Material Equivalence | Use of the same fundamental technology and material (Zeniva ZA-500 PEEK with tantalum markers) as predicate devices. | The CAPSTONE CONTROL™ Spinal System implants use Zeniva ZA-500 PEEK material with tantalum markers, identical to the predicate CAPSTONE® Spinal System. |
  | Design Equivalence | Similar convex, bullet-nosed interbody design to contain graft material and facilitate fusion. | Both the predicate and subject devices are convex, bullet-nosed interbody devices designed to contain graft material and facilitate a fusion. |
  | Indications for Use Equivalence | Same indications for use as the predicate CAPSTONE® Spinal System: interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1 (with or without Grade 1 Spondylolisthesis/retrolisthesis), skeletally mature, 6 months non-operative treatment, used with supplemental fixation. | The CAPSTONE CONTROL™ Spinal System has the same indications for use as the predicate CAPSTONE® Spinal System. |
  | Overall Equivalence | Demonstrating substantial equivalence to predicate devices (CAPSTONE® Spinal System (K073291, K103731), BoneBac™ T-PLIF, HOURGLASS®, CoRoent™, PERIMETER®, CRESCENT™) based on risk analysis and test results. | The subject CAPSTONE CONTROL™ Spinal System is determined to be as safe and effective as the predicates. |

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

The document does not explicitly state the sample size for the test set. However, it indicates mechanical testing was conducted. For such devices, samples typically refer to individual devices or components tested according to the standards. The provenance of this mechanical performance data would be laboratory testing performed by Medtronic Sofamor Danek, USA Inc.

The document does not provide details on the geographical origin of the data or whether it was retrospective or prospective, as it pertains to engineering-focused mechanical tests rather than patient studies.

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

This information is not applicable as the studies described are mechanical engineering tests rather than clinical or observational studies requiring expert consensus for ground truth. The "ground truth" here is defined by established engineering standards (ASTM F2077-11 and ASTM F2267-04) and FDA guidance.

4. Adjudication Method for the Test Set

This information is also not applicable for the same reasons as above. Adjudication methods like "2+1" or "3+1" are typical for clinical trials or image interpretation studies to resolve discrepancies in expert opinions. For mechanical testing, the results are objectively measured against predefined pass/fail criteria based on the standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Improvement with AI vs. Without AI Assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an intervertebral body fusion device (an implantable medical device), not an Artificial Intelligence (AI) or diagnostic imaging system. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.

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

No, a standalone algorithm-only performance study was not done. As mentioned, this is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for demonstrating device performance was engineering standards and regulatory guidance. Specifically:

• ASTM F2077-11: Test Methods for Intervertebral Body Fusion Devices
• ASTM F2267-04: Standard Test Method for Measuring Load Induced Subsidence of the Intervertebral Body Fusion Device under Static Axial Compression
• FDA's Guidance document: Class II Special Controls Guidance Document: Intervertebral Body Fusion Device issued June 12, 2007.

The "ground truth" for this submission is performance that meets the established mechanical requirements outlined in these standards and guidance documents.

8. The Sample Size for the Training Set

This information is not applicable. This submission describes the testing of a finished medical device against established standards, not the training of a machine learning algorithm.

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

This information is not applicable for the same reason as above. There is no training set mentioned in the context of this device submission for machine learning.

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When used as a vertebral body replacement, BASIS™ Vertebral Body Spacers are intended to be used in partial corpectomy procedures to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1-L5) to replace and restore height of a resected vertebral body or portion thereof, excised for the treatment of tumor or trauma (i.e., fracture). BASIS™ Vertebral Body Spacers must be used with supplemental fixation. Additionally, BASIS™ Vertebral Body Spacers are intended to be used with bone graft.

The BASIS™ Spinal System components included in this submission consist of various lengths and widths of vertebral body spacers as well as ancillary instrument sets. The BASIS™ Device is a spacer that inserts between vertebral bodies in the anterior thoracic and lumbar spine. The BASIS™ Spinal System implant components are made from titanium alloy. BASIS™ Vertebral Body Spacers must be used with additional anterior and/or posterior spinal instrumentation to augment stability.

The provided text is a 510(k) summary for the BASIS™ Spinal System – Vertebral Body Spacers. It describes a medical device and its intended use, but it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-based device.

The document is a premarket notification for a physical medical implant (vertebral body spacers made of titanium alloy) and focuses on demonstrating substantial equivalence to a legally marketed predicate device (HOURGLASS™ VBS K033926).

Therefore, I cannot provide the requested information from the given text as it is not relevant to AI/ML device testing and validation.

Here's why the requested information cannot be extracted from the provided text:

• Device Type: The BASIS™ Spinal System is a physical implant (vertebral body spacer), not an AI/ML-based diagnostic or assistive device.
• Approval Pathway: The document describes a 510(k) clearance based on "substantial equivalence" to a predicate device, a pathway that typically focuses on material safety, mechanical properties, and comparability to existing devices, rather than performance metrics for an AI algorithm.
• Lack of Study Details: There is no mention of accuracy, sensitivity, specificity, or other performance metrics, nor details about a test set, ground truth, experts, or statistical methodologies commonly associated with AI/ML device studies.
• No "AI" or "Algorithm" Related Terminology: The document does not use any terms related to artificial intelligence, machine learning, algorithms, or software performance evaluation.

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