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Mikron Spinal Fixation System is a pedicle screw system indicated for the treatment of 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 ittachment of a solid fusion.

Mikron Spinal Fixation System is also intended to provide immobilization 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 the thoracic, lumbar and sacral spine: Degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Proposed Device is a top-loading multiple component, posterior spinal fixation system consisting of polyaxial pedicle screws, rods (Straight and pre-bent) and setscrews. The Mikron Spinal Fixation System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The Mikron Spinal Fixation System is supplied non-sterile, single use and fabricated from titanium alloy (Ti6Al4V-ELI) that conforms to ASTM F136.

The provided text describes a 510(k) premarket notification for a medical device called the Mikron Spinal Fixation System. This type of submission primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through the kind of clinical study typically associated with AI/software-as-a-medical-device (SaMD) clearances.

Therefore, the information required to answer your questions regarding acceptance criteria and performance studies for an AI/SaMD product (such as a table of accuracy, sample sizes for test/training sets, expert adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not present in this document.

This document details:

• The device's intended use (spinal fixation)
• Its material (titanium alloy)
• Its design (pedicle screws, rods, setscrews)
• Its technological characteristics compared to predicate devices
• Non-clinical performance testing: static compressive, torsion, and dynamic compressive tests according to ASTM F1717; torsion and pullout tests for screws according to ASTM F543; axial and torsional gripping capacity according to ASTM F1798; and static and dynamic 4-point bending according to ASTM F2193. These are mechanical tests to ensure the physical properties and strength of the implant, not a study of algorithm performance.
• Risk Analysis.

The key takeaway is that for a traditional hardware medical device like a spinal fixation system, "acceptance criteria" are typically met through mechanical and material testing to established industry standards (e.g., ASTM standards) and comparison to predicate devices, rather than the kind of clinical performance study with human readers and ground truth data that would be relevant for an AI/SaMD product.

In summary, the document does not contain the information needed to answer the specific questions about AI/SaMD acceptance criteria and study data.

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The LumFix Spinal Fixation System, a posterior spinal fixation device, indicated for skeletally mature patients receiving fusion by autogenous bone graft with removal of the implants after the attainment of a solid fusion and is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The LumFix Spinal Fixation System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, set screws, rods and a crosslink linking mechanism.

The LumFix Spinal Fixation System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. LumFix Spinal Fixation System components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) that conforming to ISO 5832-3 or ASTM F136, with a cobalt-chromium-molybdenum rod option conforming to ASTM F1537 (Co-28Cr-6Mo). Various sizes of these implants are available.

The provided text describes a medical device submission, specifically a 510(k) premarket notification for the "LumFix Spinal Fixation System." This document is focused on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria or performance through a clinical study for a novel AI/software device.

Therefore, the information required to answer your request (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in the provided text.

The document discusses:

• Device Name: LumFix Spinal Fixation System
• Regulation Number: 21 CFR 888.3070
• Regulation Name: Pedicle screw spinal system
• Regulatory Class: Class II
• Product Code: MNI, MNH
• Indications for Use: Spinal fusion for various acute and chronic instabilities/deformities of the thoracic, lumbar, and sacral spine in skeletally mature patients.
• Predicate Devices: Zenius™ Spinal System (K093104) and ANAX™ 5.5 Spinal System (K132101).
• Non-clinical testing: Mechanical testing according to ASTM F1717 and ASTM F1798 to demonstrate equivalence. This includes static (tension, compression, torsion) and dynamic (fatigue) tests.

This is a submission for a physical medical device (spinal fixation system) and relies on mechanical testing to prove substantial equivalence to existing devices, not a clinical study to establish performance against acceptance criteria for an AI or software-based medical device.

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Double Medical Universal Spine System is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.

Double Medical Universal Spine System consists of pedicle screws, rods, transconnector and nut etc. It is made of Ti-6A1-4V ELI, which meets ASTM F 136 "Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications" and is widely used for surgical implants. The proposed devices are provided non-sterile but sterilized by the end user.

The provided document is a 510(k) premarket notification for a medical device called the "Double Medical Universal Spine System." This type of document is for a medical device that has been deemed substantially equivalent to a previously cleared device. It focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific acceptance criteria like a novel AI/software medical device would.

Therefore, much of the requested information, such as multi-reader multi-case studies, standalone algorithm performance, number of experts for ground truth establishment, training set details, and adjudication methods, is not applicable to this type of traditional medical device submission.

Here's a breakdown of the relevant information from the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set: For the bench tests (ASTM F 1717-14 and ASTM F 1798-13), the "sample size" refers to the number of physical devices or constructs tested. This information is not provided in the summary document. It would typically be detailed in the full test reports submitted to the FDA.
• Data Provenance: This refers to laboratory bench testing conducted to internationally recognized standards (ASTM standards). It is not clinical data, so concepts like "country of origin" or "retrospective/prospective" don't apply in the common sense.

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

• Not Applicable. The "ground truth" for the bench tests is established by the specifications of the ASTM standards and the measurements of a testing laboratory, not by expert medical opinion. For a physical device like this, performance is measured against engineering and material science standards.

4. Adjudication Method for the Test Set

• Not Applicable. As the tests are based on objective physical measurements against established standards, an adjudication method by experts is not required.

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. This is a hardware device (spine system), not an AI/software device. MRMC studies are used for evaluating diagnostic image interpretation by humans, often with AI assistance.

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

• No. This is a hardware device.

7. The Type of Ground Truth Used

• For the bench tests: Engineering specifications and material science standards as defined by the ASTM F 1717-14 and ASTM F 1798-13 standards.
• For the overall device: Substantial equivalence to a legally marketed predicate device (Trauson General Spinal System K082617) in terms of intended use, materials, function, sizes, and mechanical test results.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" in the context of this traditional hardware medical device submission. Training sets are relevant for machine learning algorithms.

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

• Not Applicable. As there is no training set, this question is not relevant.

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MySpine is intended as a thoracic and lumbar posterior guide for patients requiring spinal fusion between the levels of T1 to L5.

MySpine Screw Placement Guides are intended to be used as anatomical perforating guides specific for a single patient anatomy to assist intraoperatively in the positioning of Pedicle screws in the vertebral body. MySpine is intended for use with M.U.S.T. Pedicle Screw System and its cleared indications for use.

MySpine Low Profile screw placement guides are intended for the placement of K-wires to assist in the positioning of pedicle screws.

Use of the guides involves surgical planning software used pre-operatively to plan the surgical placement of the components on the basis of patient radiological images with identifiable placement anatomical landmarks and surgical equipment components. These components include patient-specific guides fabricated on the basis of the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan.

MySpine Screw placement guides are intended for single use only.

MySpine Pedicle Screw Placement Guides - LP are a design modification to MySpine Pedicle Screw Placement Guides (K132788). MySpine Pedicle Screw Placement Guides are patient specific surgical instruments that allow for guided K-wire placement. The MySpine software platform allows the surgeon to complete the preoperative planning in 3D based on the patient's spinal CT scans. Then, the K-wire is guided through the patient's anatomically matched MySpine LP Guides in order to provide positioning according to the surgeon's preoperative planning.

For the standard guides introduced and cleared by FDA in K132788, the holes guide the instruments used to open and prepare the pedicle to the planned entry point. After pedicle preparation, the pedicle screws will be inserted through the guiding hole into the pedicle and the vertebrae respectively. For the LP guides introduced with this 510(k), the guiding holes allow placement of the K-wire. Then, the MySpine guide is removed and the wires are used to insert cannulated implants. As an intermediate step, the surgeon can also use the cannulated awl and/or tap to better prepare the entry point in order to simplify the screw tightening.

The components of the MySpine Pedicle Screw Placement Guides - LP include a Drill Guide (PA12 Medical Grade) and Vertebral Bone Models (PA12 Medical Grade). The MySpine Pedicle Screw Placement Guides – LP are single use, external communicating devices with limited (

The provided text describes a 510(k) premarket notification for the MySpine Pedicle Screw Placement Guides - LP. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving performance against acceptance criteria for a novel device. Therefore, much of the requested information (such as specific acceptance criteria and detailed study designs for a new device's performance) is not explicitly present.

However, I can extract information related to the performance testing conducted to support the substantial equivalence claim.

Here's a breakdown of the available information and what is not provided:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not explicitly stated in the provided document. The 510(k) summary focuses on demonstrating substantial equivalence, meaning the device performs as safely and effectively as the predicate, rather than providing numerical acceptance criteria for a new device's performance. The "Performance Testing" section lists types of tests conducted (e.g., mechanical testing, cadaver testing), but not specific acceptance criteria or quantitative performance results.

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

• Sample Size for Test Set: Not explicitly stated for each test listed.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not explicitly stated. The mention of "cadaver testing" implies prospective testing on cadavers, but further details are absent.

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

This information is not provided in the document. The document refers to "surgical planning software used pre-operatively to plan the surgical placement... on the basis of patient radiological images." However, it does not detail how the ground truth for any performance testing (e.g., accuracy of screw placement) was established or by whom.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:

This information is not provided.

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/not reported. The device described is a physical pedicle screw placement guide, not an AI-driven diagnostic or interpretative system that would involve human "readers" or "AI assistance" in the context of diagnostic performance.

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

This is not applicable/not reported. The device is a surgical guide that assists a surgeon in placing K-wires; it's not a standalone algorithm. Its function inherently involves human intervention.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

Not explicitly specified in detail. For "cadaver testing," the ground truth would likely involve anatomical dissection or high-resolution imaging post-placement to assess accuracy, but the method is not described.

8. The Sample Size for the Training Set:

This information is not provided. The device uses "surgical planning software ... based on the patient's spinal CT scans" to create patient-specific guides. This implies patient-specific data for each case, but no "training set" in the machine learning sense is described for the device's development or validation.

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

This information is not provided. As mentioned above, a "training set" for an algorithm in the typical sense is not described.

Summary of available information regarding performance testing for supporting substantial equivalence (not detailed acceptance criteria for a novel device):

• Performance Testing Leveraged or Conducted:
  • Sterilization validation (in accordance with ANSI/AAMI/ISO 11137-1 and -2)
  • Packaging validation (in accordance with ANSI/AAMI/ISO 11607)
  • Biocompatibility (in accordance with ISO 10993-1)
  • Mechanical testing
  • Cadaver testing

The document asserts that "The safety and effectiveness of the MySpine Screw Placement Guides - LP are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification," but does not elaborate on the specific results or acceptance criteria for these tests. The primary objective of the 510(k) is to demonstrate that the modified device (MySpine Pedicle Screw Placement Guides - LP) is substantially equivalent to its predicate (MySpine Pedicle Screw Placement Guides, K132788), implying that it meets the same safety and performance standards.

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When used for anterior screw fixation or as a posterior, non-pedicle system of the non-cervical spine, the U.L.I.S.™ and LUMIS™ systems are indicated for:
• Degenerative disc disease (discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
• Spondylolisthesis
• Fracture
• Spinal stenosis
• Tumors
• Failed previous fusion (pseudoarthrosis)
The U.L.I.S.™ and LUMIS™ systems are pedicle screw systems indicated for skeletally mature patients who:
• have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra;
• receive fusions using autogenous bone graft only;
• have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and
• have the device removed after the development of a solid fusion.
In addition, the U.L.I.S.™ and LUMIS™ systems are pedicle screw systems 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 the thoracic, lumbar, and sacral spine (T10-S1):
• Degenerative spondylolisthesis with objective evidence of neurologic impairment
• Fracture
• Spinal tumor
• Failed previous fusion (pseudoarthrosis)

The SpineVision® Universal Lumbar Intuitive System (U.L.I.S.™ System), and Lumbar Universal Minimally Invasive System (LUMIS™ System) are composed of cannulated (LUMIS™) and non-cannulated (U.L.I.S.™) pedicle screws and fixation rods. Their components can be rigidly assembled in a variety of constructs, each corresponding to the needs and anatomy of a specific patient and are supplied non-sterile.
The purpose of this submission is to include new devices: the U.L.I.S.™ Multi-Axial Reduction Screws, additional instruments to the U.L.I.S.™ System; additional lengths for the LUMIS™ Spinal Rods; and the use of LUMIS™ Spinal Rods with U.L.I.S.™ System.

This document is a 510(k) summary for medical devices (pedicle screw fixation systems), which primarily focuses on demonstrating substantial equivalence to previously cleared devices. It does not contain information about a study proving that the device meets acceptance criteria in the context of an AI/ML powered device.

Therefore, I cannot fulfill your request for the following information based on the provided text, as it describes a traditional medical device submission, not an AI/ML product:

• A table of acceptance criteria and the reported device performance: This document does not present performance metrics or Acceptance Criteria for an AI/ML device. It discusses mechanical performance testing for the pedicle screw system, but that is not relevant to AI/ML acceptance criteria.
• Sample sized used for the test set and the data provenance: No test set for an AI/ML model is mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No experts for ground truth establishment for an AI/ML model are mentioned.
• Adjudication method for the test set: No adjudication method for an AI/ML model's test set is mentioned.
• 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 study is mentioned.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone algorithm performance is mentioned.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): No ground truth for an AI/ML model is mentioned.
• The sample size for the training set: No training set for an AI/ML model is mentioned.
• How the ground truth for the training set was established: No ground truth for an AI/ML model's training set is mentioned.

In summary, the provided text is a 510(k) submission for a pedicle screw fixation system, not a submission for an AI/ML powered medical device. Therefore, the requested information regarding AI/ML device acceptance criteria and study details is not present. The document states: "No clinical data is presented." and "No mechanical data is presented: no mechanical test is required for the added components." indicating that the submission relies on engineering analysis and validation/verification to support substantial equivalence to existing predicate devices.

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The Premier is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization of the spine as an adjunct to fusion with bone graft.

The premier consists of fixed-angle screws, fix-angle reduction screws, multi-axial screws, multi-axial reduction screws, rods, crosslink plates, set screws, planar screw, domino connector, lateral connector and hooks. It is made of Titanium Alloy (Ti6Al4V), which meets ASTM F136-13, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility. The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 10^-6 by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.

This document is a 510(k) summary for the "Premier" pedicle screw spinal system. It does not describe an AI/ML powered medical device or a study involving human readers or AI assistance. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technical characteristics.

Therefore, the requested information regarding acceptance criteria for an AI device, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from this document.

The document indicates "No clinical study is included in this submission" (Page 6). The acceptance criteria and the study that proves the device meets them are based on non-clinical tests verifying design specifications and compliance with ASTM F 1717-13 as detailed in the "Non-Clinical Test Conclusion" section (Page 6).

Here's the relevant information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance: Not applicable. This document refers to non-clinical mechanical testing, not a test set for an AI device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on the performance according to established ASTM standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This is for mechanical testing, not clinical data adjudication.

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, an MRMC study was not done. The device is not an AI/ML device.

6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done: No, this is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the mechanical tests, the "ground truth" is defined by the performance parameters and failure criteria established within the ASTM F 1717-13 standard. For material, it's compliance with ASTM F136-13. For sterilization, it's compliance with ISO 17665-1: 2006.

8. The sample size for the training set: Not applicable. There is no training set for this type of device (spinal implant).

9. How the ground truth for the training set was established: Not applicable. There is no training set.

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The Sniper® System is a non-cervical spinal fixation system intended for posterior pedicle screw fixation (11-S2/ ilium) in skeletally mature patients. The Sniper® Spine System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The Sniper® Spine System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S2/ilium), and for whom the device is intended to be removed after solid fusion is attained.

The Sniper® Spine System percutaneous instruments are intended to be used with the Sniper® System Implants. The instruments, when used with the percutaneous cannulated screws and percutaneous rods, are intended to provide the surgeon with a percutaneous approach for posterior spinal surgery for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudoarthrosis). The instruments are also intended to provide a percutaneous approach for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S2/ilium), and for whom the device is intended to be removed after solid fusion is attained.

The Sniper® Spine System consists of a selection of non-sterile, single use, titanium allov screw and connector components, and titanium allov and cobalt chrome alloy rod components that are assembled to create a rigid spinal construct. The components of the Sniper® Spine System are attached to the non-cervical spine in order to stabilize the spine during fusion of the vertebral bodies, and are intended to be removed after spinal fusion is achieved.

The provided document describes the Sniper® Spine System and its clearance by the FDA based on substantial equivalence. This type of device is a medical implant, and the approval process for such devices differs significantly from that of AI/ML-driven software as a medical device (SaMD).

Therefore, many of the requested criteria, such as "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone algorithm performance," and "ground truth for training set," are not applicable (N/A) to this specific device and the regulatory submission described. The document does not detail a study involving AI/ML performance metrics.

Instead, the submission relies on the concept of substantial equivalence to predicate devices through comparisons of technological characteristics, indications for use, materials, and mechanical performance testing.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this type of device are primarily related to safety and effectiveness demonstrated through mechanical testing and comparison to legally marketed predicate devices. The "reported device performance" refers to the mechanical testing outcomes, which are deemed acceptable if they meet established standards and are comparable to predicate devices.

"Engineering rationales determined that the proposed implants were substantially the same as the predicate devices." (Implies the testing met or was comparable to the predicate's performance) |
| Biocompatibility of materials (Titanium alloy, Cobalt chrome alloy) | The device consists of "non-sterile, single use, titanium alloy screw and connector components, and titanium alloy and cobalt chrome alloy rod components." (Implies material selection based on known biocompatible materials for spinal implants) |
| Similarity in intended use, indications for use, and technological characteristics to predicate devices. | "The substantial equivalence of the subject Sniper® Spine System to the predicates is shown by similarity in intended use, indications for use, materials and performance." (This is the overarching conclusion of the submission, indicating it meets the criteria for substantial equivalence). |

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

• Sample Size for Test Set: The document refers to "constructs representing the worst case components" for mechanical testing, but does not specify the exact number of samples (e.g., a specific N-number) tested for each type of mechanical evaluation.
• Data Provenance: The data comes from mechanical performance evaluations described as being conducted "previously." The country of origin is not specified but would typically be a testing lab, likely in the US, given the FDA submission. This is not medical data (e.g., patient data) provenance.

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

• N/A. This applies to human-interpreted medical image or diagnostic data, not to mechanical testing of physical implants. The "ground truth" here is the adherence to mechanical standards (ASTM F1717) and engineering principles for structural integrity.

4. Adjudication Method for the Test Set

• N/A. This applies to expert review and consensus on clinical data. For mechanical testing, the results are objectively measured against established standards.

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

• N/A. This type of study is relevant for AI/ML diagnostic tools that impact human reader performance. The Sniper® Spine System is a physical implant.

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

• N/A. This device is not an algorithm or software. It is a physical medical implant.

7. The Type of Ground Truth Used

• For the physical device, the "ground truth" is defined by established engineering standards (ASTM F1717) for spinal implant mechanical properties and the performance characteristics of legally marketed predicate devices. The testing aims to demonstrate that the device meets these engineering benchmarks and performs similarly to already approved devices.

8. The Sample Size for the Training Set

• N/A. This concept applies to AI/ML algorithms that learn from data. This submission is for a physical medical device.

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

• N/A. As above, this is not applicable for a physical implant device.

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The YAHUA Spinal System is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.

The spinal system consists of screws, rods, crosslink plates, set screws and hooks. It is made of Titanium Alloy (Ti6Al4VELI), which meets ASTM F136-02a, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility. The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 106 by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.

The provided document is a 510(k) summary for the YAHUA Spinal System. It describes the device's technical characteristics and compares it to a predicate device. However, it does not include information about acceptance criteria or a study proving the device meets those criteria in the context of AI/algorithm performance.

Here's why and what information is available:

• Device Type: The YAHUA Spinal System is a medical implant (pedicle screw spinal system), not an AI or algorithm-based diagnostic/therapeutic device. Its approval relies on mechanical integrity, material biocompatibility, and substantial equivalence to existing devices.
• Approval Process: A 510(k) submission primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing device specifications, materials, manufacturing processes, and performance (e.g., mechanical testing for implants) to show it's as safe and effective as the predicate.
• Lack of AI/Algorithm Information: Consequently, the document does not contain any of the requested information related to AI or algorithm performance, such as:
  • Acceptance criteria for AI performance (e.g., sensitivity, specificity, AUC)
  • Test set details (sample size, data provenance)
  • Ground truth establishment (experts, pathology)
  • Adjudication methods
  • MRMC studies
  • Standalone algorithm performance
  • Training set details

Based on the provided document, I cannot fulfill your request for information regarding acceptance criteria and studies proving an AI device's performance.

However, I can extract the relevant information regarding the mechanical performance study conducted for this implant device, which is an analogous concept to an acceptance study for an AI device.

Acceptance Criteria and Study for YAHUA Spinal System (Mechanical Performance)

1. Table of Acceptance Criteria (Implicit) and Reported Device Performance

For an implantable device like the YAHUA Spinal System, the "acceptance criteria" for mechanical performance are implicitly met by demonstrating that its performance is "similar" to a legally marketed predicate device when tested under specific industry standards. The comparison is the critical part of the substantial equivalence determination.

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

• Test Set Sample Size: Not explicitly stated in the document. Mechanical tests typically involve multiple samples to ensure statistical validity, but the exact number for each test item is not provided.
• Data Provenance: The tests were conducted by the manufacturer (or a testing facility on their behalf) as part of the 510(k) submission. The document implies these were prospective tests performed specifically for this submission, comparing the proposed device against the predicate.
• Country of Origin of the Data: Not explicitly stated, but the manufacturer is based in China: Beijing Weigao Yahua Artificial Joint Development Co. Ltd., China.

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

• This question is not applicable to this type of device and study. "Ground truth" in the context of an implant's mechanical testing refers to objective measurements against established technical standards (like ASTM F1717-14) and direct comparison to a predicate device's performance, not expert consensus on interpretations.

4. Adjudication Method for the Test Set

• This question is not applicable to this type of study. Adjudication methods are relevant for subjective interpretations (e.g., image reading) or clinical outcomes, not for objective mechanical performance testing.

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, this was not an MRMC study. This is a mechanical performance study for an implant, not a diagnostic imaging study involving human readers or AI assistance.

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

• No, this was not an algorithm performance study. It was a standalone mechanical test of the physical implant device.

7. The type of ground truth used

• Objective Mechanical Measurements and Comparison to Predicate Device Performance. The "ground truth" for demonstrating device safety and effectiveness in this context is adherence to recognized industry standards (ASTM F1717-14) and direct, quantifiable comparison of mechanical properties (static compression bending, dynamic compression bending, static torsion) between the proposed device and its established predicate.

8. The sample size for the training set

• This question is not applicable as there is no "training set" for a physical implant device's mechanical performance testing.

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

• This question is not applicable as there is no "ground truth for a training set" for this type of device and study.

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The FIREFLY™ Pedicle Screw Navigation Guide is a patient-specific system intended to guide the drilling and tapping of pilot holes for placement of pedicle screws according to surgeon-prescribed pre-operatively planned trajectories during open, posterior, instrumented spinal surgery (T1-S1/Ilium). The FIREFLY™ Pedicle Screw Navigation Guide is intended for use with the pedicle screw spinal systems specified in the instructions for use and in patients consistent with the selected system's cleared indications for use.

Use of the FIREFLY™ Pedicle Screw Navigation Guide involves surgical planning software used pre-operatively to plan the surgical placement of the pilot holes on the basis of patient CT radiological images with identifiable placement of anatomical landmarks. Only compatible OEM taps that are supplied with the pedicle screw spinal systems specified in the instructions for use may be used through the FIREFLY™ Pedicle Screw Navigation Guide to tap pilot holes. All other pedicle screw spinal system components and accessories (including non-guided taps) are to be used after removal of the FIREFLY™ Pedicle Screw Navigation Guide, as directed by the pedicle screw spinal system's instructions for use.

This device is intended for single use only.

The FIREFLY ™ Pedicle Screw Navigation Guide is a patient-specific system intended to assist in the accurate placement of pedicle screws. It consists of single-use components designed for treatment of a specific patient as well as reusable non-patient-specific components.
The FIREFLY ™ Pedicle Screw Navigation Guide uses Patient-Specific Pedicle Screw Guides that fit on the patient's anatomy to guide surgical instruments in line with trajectories chosen presurgically, by the surgeon, based on the patient's CT imaging data. Navigation guides are intended to guide instruments to create pilot holes in the pedicles for placing pedicle screws following the Approved Patient-Specific Surgical Plan.
Patient-Specific Bone Models may also be provided.

The provided text describes the FIREFLY™ Pedicle Screw Navigation Guide and its performance data. However, it does not contain specific acceptance criteria, detailed study results, sample sizes for test/training sets, or information on ground truth establishment, expert consensus, or MRMC studies. The document is a 510(k) summary for FDA clearance, which typically presents a high-level overview rather than detailed scientific study breakdowns.

Based on the available information, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The specific numerical or qualitative acceptance criteria for accuracy and sterilization stability are not detailed in this document.

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

The document mentions "Cadaveric accuracy and sterilization stability testing."

• Sample Size for Test Set: Not specified.
• Data Provenance: Cadaveric testing. (Country of origin is not specified, and it's a prospective study as it was performed for this specific device).

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

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

• MRMC Study: No, an MRMC comparative effectiveness study is not mentioned. The document describes accuracy testing, but not a comparison of human readers with and without AI assistance to measure improvement effect size.

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

The device is a "Pedicle Screw Navigation Guide," which implies it is a physical guide used by a surgeon during surgery. It is not an AI algorithm in the traditional sense that would have "standalone" performance independent of human interaction in the operating room. Therefore, the concept of "standalone algorithm performance" as typically applied to AI image analysis is not relevant here. The accuracy refers to the guide's precision in directing the surgical instruments.

7. The Type of Ground Truth Used

• Ground Truth: For accuracy, the "ground truth" would likely be the actual placement of the pilot holes or screws in the cadavers, as measured post-procedure (e.g., via CT scanning and comparison to pre-operative plans). This is implied by the term "accuracy testing," but the specific method of establishing this ground truth (e.g., using a gold-standard imaging technique and detailed measurements) is not specified.

8. The Sample Size for the Training Set

The device is a physical navigation guide, not a machine learning algorithm that requires a "training set" in the computational sense. The planning software uses patient CT images, but these are for individual patient planning, not for training a generalized model. Therefore, this question is not applicable.

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

Not applicable, as there is no "training set" in the context of an AI algorithm.

Summary of Study that Proves Device Meets Acceptance Criteria:

The document states: "Cadaveric accuracy and sterilization stability testing of the FIREFLY Pedicle Screw Navigation Guide was performed. The results demonstrated that the acceptance criteria were met and that the FIREFLY Pedicle Screw Navigation Guide performance is adequate to perform as intended."

This indicates that an experimental study was conducted using cadaveric specimens to evaluate the precision of the guide in directing surgical instruments and to confirm its sterility after processing. However, the details of these studies, including specific methodologies, data collected, statistical analyses, and the actual numerical results against defined acceptance criteria, are not provided in this 510(k) summary.

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The WASTON General Spinal System is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities deformities: (1) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, kyphosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion, (5) spinal stenosis. It is not intended for pedicle screw fixation above T8.

The WASTON General Spinal System consists of Fixed-Angle Screws, Fixed-Angle Reduction Screws, Rods, Crosslink and Set Screws. The proposed general spinal system is made of Titanium Alloy (Ti6Al4VELI), which meets ASTM F136-02a, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility. The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 10th by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.

The document provided is a 510(k) premarket notification for the WASTON General Spinal System, identifying it as a Class II medical device. The submission primarily focuses on demonstrating substantial equivalence to a predicate device (Trauson General Spinal System, K082617) through non-clinical testing.

Here's an analysis of the acceptance criteria and study information 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

• Sample Size for Test Set: The document does not specify the exact sample size for the mechanical tests conducted per ASTM F1717-14. It only states that "Non clinical tests were conducted." Typically, these tests involve multiple samples for each component or construct configuration, but the precise numbers are not disclosed in this summary.
• Data Provenance: The device manufacturer is Changzhou Waston Medical Appliance Company, Limited, located in China. Therefore, the non-clinical test data was likely generated in China, associated with the manufacturer or a contracted testing facility. The data is retrospective in the sense that the tests were completed before the 510(k) submission.

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

• This information is not applicable to this submission. The "test set" in this context refers to non-clinical, mechanical performance testing of a spinal implant system. The "ground truth" is established by adherence to a recognized standard (ASTM F1717-14) and the physical properties of the materials and device design, rather than expert interpretation of data.

4. Adjudication Method for the Test Set

• This information is not applicable to this submission. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for interpreting human-read data or clinical endpoints. For mechanical testing against a standard, the results are objectively measured and compared to the standard's pass/fail criteria, often requiring a pass for all tested samples.

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, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission." This type of study is relevant for AI-powered diagnostic or interpretive devices, which is not the case for a spinal implant system.

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

• No, a standalone algorithm performance study was not done. This device is a physical spinal implant system, not an algorithm or AI-based diagnostic tool. Therefore, a standalone algorithm performance study would not be relevant.

7. The Type of Ground Truth Used

• For the non-clinical testing, the "ground truth" is typically defined by established engineering standards and material specifications. The device's performance is compared against the requirements and methodologies outlined in:
  • ASTM F1717-14 for mechanical performance (static compression bending, dynamic compression bending, static torsion).
  • ASTM F136-02a for material composition and properties.
  • ISO 17665-1: 2006 for sterilization validation.

8. The Sample Size for the Training Set

• This information is not applicable to this submission. "Training set" refers to data used to train machine learning models. As this device is a physical spinal implant system and does not involve AI or algorithms, there is no training set in this context.

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

• This information is not applicable as there is no training set for this type of device.

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