Search Results

The Vault-C Standalone Cervical Interbody Fusion System is a standalone cervical interbody device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-T1) at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The Vault-C implants are used with two titanium alloy screws and filled with autogenous bone graft material to facilitate fusion in the cervical spine. The device is placed via an anterior approach at the C-3 to T-1 disc levels. Patients should have at least six weeks of non-operative treatment with an intervertebral fusion device.

The Vault-C consists of a spacer assembly including a PEEK cage with a titanium alloy plate and titanium bone screws for intervertebral body fusion. Screws are available in a variety of diameter-length combinations. The titanium and PEEK spacers are available in a variety of depths, widths and heights. Fixation is achieved by inserting bone screws through the openings in the spacer into the vertebral bodies of the cervical spine.

The provided text describes the Spinal USA Vault-C Standalone Cervical Interbody Fusion System, a medical device, and the testing conducted to support its 510(k) premarket notification. The study described is a non-clinical performance study, not an AI-based study or a clinical trial involving human data analysis. Therefore, many of the requested categories related to AI performance, human readers, sample sizes for training/test sets, and ground truth establishment for AI models are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria implicitly refer to performance thresholds defined within the ASTM standards (ASTM F-2077 and ASTM F-2267) which the device was tested against and found to meet. The specific quantitative values for these thresholds or the Vault-C's measured performance are not explicitly stated, but the conclusion is that the device's strength is sufficient and comparable to predicate devices.

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

• Sample Size for Test Set: Not specified in the document. Non-clinical mechanical testing standards typically involve a defined number of samples, but the exact count is not mentioned here.
• Data Provenance: The data is from non-clinical mechanical testing of the device itself. It is not patient data from a specific country, nor is it retrospective or prospective in the clinical sense.

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

Not applicable. This was a mechanical performance study of a physical device, not an AI or diagnostic study requiring expert ground truth for interpretation.

4. Adjudication method for the test set

Not applicable. This was a mechanical performance study.

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 a non-clinical mechanical performance study of a physical implant. It did not involve human readers or AI assistance.

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

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

7. The type of ground truth used

For this type of study, the "ground truth" is established by the specified ASTM standards (ASTM F-2077 and ASTM F-2267). The device's mechanical properties are measured and compared against the requirements and, implicitly, the performance of predicate devices as defined by these industry-recognized test methods.

8. The sample size for the training set

Not applicable. This is not an AI study, so there is no "training set."

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

Not applicable. There is no training set for this type of non-clinical mechanical performance study.

Ask a specific question about this device

The Spinal USA Facet Screw System is intended to stabilize the spine as an aid to fusion by transfacet fixation. The device is indicated for posterior surgical treatment with or without bone graft, at single or multiple levels, of any or all of the following spinal levels L1 to S1 (inclusive): Spondylolisthesis, Spondylolysis, Pseudoarthrosis or failed previous which are symptomatic: Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability.

The Spinal USA Facet Screw System consists of a assortment of screws. Each are made of medical grade titanium alloy conforming to such standards as ASTM F-136 and/or ISO 5832-3. The screws will be provided non-sterile.

The provided text describes a medical device, the "Spinal USA Facet Screw System," and its mechanical testing to demonstrate substantial equivalence to a predicate device. It is a 510(k) premarket notification summary.

Here's a breakdown of the requested information based on the provided text, while noting that many of the requested items are not applicable to this type of device and submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a distinct "test set" sample size for mechanical testing in the way that would apply to clinical performance studies (e.g., number of patients or images). For mechanical testing, the "sample size" would refer to the number of individual screws and/or constructs tested for each mechanical test condition (Axial Pullout, Torque to Failure, Static 3-Point Bending, Dynamic 3-Point Bending). This specific number is not provided in the summary.
• Data Provenance: The mechanical testing was "performed per ASTM F1264." This indicates it was laboratory testing conducted according to a recognized standard, not data from human subjects or clinical trials. Therefore, concepts like "country of origin" or "retrospective/prospective" are not applicable here.

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

• N/A. This information is not relevant for a mechanical testing study of a medical implant and is not provided in the document. Ground truth as typically defined in AI/clinical studies (e.g., expert consensus on medical images or patient outcomes) does not apply to this type of engineering performance evaluation.

4. Adjudication Method for the Test Set

• N/A. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert opinions, typically in clinical studies or for establishing ground truth for AI model training/testing. This is not applicable to mechanical testing data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This was not a MRMC comparative effectiveness study. This type of study involves multiple human readers evaluating cases, often with and without AI assistance, to measure diagnostic performance. The submission describes mechanical testing of a surgical implant.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

• N/A. This does not involve an algorithm or AI. It is a physical medical device (facet screw system) undergoing mechanical performance testing.

7. Type of Ground Truth Used

• The "ground truth" for this engineering study is defined by the measured mechanical properties of the device when subjected to standardized tests (ASTM F1264) and compared against pre-defined acceptance criteria, as well as against the mechanical performance of a predicate device. It's an objective measurement against engineering standards, not expert consensus, pathology, or outcomes data in a clinical sense.

8. Sample Size for the Training Set

• N/A. This device does not involve a "training set" in the context of machine learning or AI. The design and manufacturing processes are informed by engineering principles and standards, not data training.

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

• N/A. As there is no training set for an AI model, this question is not applicable.

Ask a specific question about this device

The ReForm 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, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The ReForm 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; curvatures (i.e. scoliosis; and/or lordosis) spinal tumor; pseudloarthrosis; and failed previous fusion.

The Reform System is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross-connectors, locking cap screws, and cross connectors. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All components are made from medical grade stainless steel, cobalt chromium alloys, titanium or titanium alloy described by such standards as ASTM F138, ASTM F1537, ISO 5832-12, ASTM F136 or ISO 5832-3.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ReForm Pedicle Screw System:

Based on the provided 510(k) summary, the device is a ReForm Pedicle Screw System, which is a medical device and not an AI/ML-based diagnostic or imaging device. Therefore, the questions related to AI/ML specific performance evaluation metrics, ground truth establishment for AI/ML models, and training/test set sample sizes in the context of AI/ML are not applicable.

The document describes a traditional medical device submission focusing on substantial equivalence to predicate devices, primarily through engineering analysis.

Description of Acceptance Criteria and Study:

The "acceptance criteria" for this device, in the context of a 510(k) submission, are met by demonstrating substantial equivalence to legally marketed predicate devices. The primary method used to prove this is through performance evaluation based on engineering analysis.

Essentially, the device is "accepted" if it can show that its technological characteristics and performance are comparable to (or do not represent a worst-case scenario compared to) already cleared devices with the same intended use.

1. Table of Acceptance Criteria and Reported Device Performance

Components are made from medical grade stainless steel, cobalt chromium alloys, titanium or titanium alloy described by standards such as ASTM F138, ASTM F1537, ISO 5832-12, ASTM F136 or ISO 5832-3. |
| Biocompatibility: Materials used must be biocompatible for implantation. | Materials are standard medical grade alloys (stainless steel, cobalt chromium, titanium/titanium alloy), implying accepted biocompatibility that is equivalent to predicate devices. |
| Fit and Function: New designs and sizes (specifically additional cross connectors) must integrate properly and maintain the intended function of the system. | The purpose of the submission is to make modifications by adding "an additional design and sizes of cross connectors." The engineering analysis confirms these modifications "do not substantially differ from the legally marketed predicate devices." |
| Intended Use: The device must perform effectively for its stated indications. | The intended use and technological features of the modifications/additions "do not substantially differ from the legally marketed predicate devices." The device is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for a range of spinal instabilities and deformities, consistent with the predicates. |

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 applicable in the traditional sense of a clinical or imaging study. The "test set" here refers to the specific modifications (additional design and sizes of cross connectors) and existing components that underwent engineering analysis. The number of physical units or designs tested is not specified but would typically involve a sufficient number to validate mechanical properties.
• Data Provenance: Not applicable. The "data" comes from engineering tests and material specifications, not from patient data or clinical trials.

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 is not applicable for this type of device submission. There is no "ground truth" established by medical experts for a test set in a clinical or diagnostic context. The ground truth for mechanical performance relies on established engineering principles, material science, and regulatory standards. Experts involved would be engineers and material scientists conducting the tests and analyses. Their qualifications are not specified in this document.

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

• Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or reader studies where human interpretation or diagnostic accuracy is being assessed. This submission focuses on engineering equivalence.

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/ML device, nor is it a diagnostic tool where human readers' performance with/without AI assistance would be relevant.

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

• Not applicable. This is not an algorithm or an AI/ML device.

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

• The "ground truth" in this context refers to established engineering standards, material specifications, and the mechanical performance of the predicate devices. The new device's components are evaluated against these validated benchmarks.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Not applicable. Since there is no training set, the establishment of its ground truth is irrelevant.

Ask a specific question about this device

The ReForm 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, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The ReForm Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3and 4of 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; curvatures (i.e. scoliosis, kyphosis; and/or lordosis) spinal tumor; pseudloarthrosis; and failed previous fusion.

The Reform System is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross-connectors, locking cap screws, hooks, domino connectors, and lateral offset connectors. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All components are made from medical grade stainless steel, cobalt chromium alloys, titanium or titanium alloy described by such standards as ASTM F138, ASTM F1537, ISO 5832-12, ASTM F136 or ISO 5832-3.

The provided text describes a 510(k) premarket notification for the ReForm Pedicle Screw System, specifically focusing on modifications and additions to its components. This type of submission is for medical devices, not AI/ML algorithms, and therefore the concepts of acceptance criteria, study design for performance evaluation, sample sizes, expert ground truth, adjudication methods, MRMC studies, or training sets do not apply in the way they would for a software-as-a-medical-device (SaMD) or AI-driven diagnostic tool.

The study described is a mechanical performance test for physical implant components, not a clinical or AI performance study.

Here's a breakdown of the relevant information from the provided text, adapted as much as possible to the requested format, to highlight why most of the questions are not applicable:

Acceptance Criteria and Device Performance

Study Details (Mechanical Performance Testing)

1. Sample size used for the test set and the data provenance: This refers to the number of physical components tested in dynamic axial compression. The specific number of components/constructs tested is not explicitly stated in the provided text. The data provenance is mechanical testing conducted according to ASTM F1717-12 standards, likely in a laboratory setting.

2. 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 engineering standards and measurements, not expert consensus as in diagnostic imaging.

3. Adjudication method for the test set: Not applicable. Mechanical testing involves objective 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: Not applicable. This study is for a physical orthopedic implant system, not a diagnostic AI/ML system.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.

6. The type of ground truth used: For mechanical performance, the "ground truth" is defined by the objective measurements obtained through the specified test method (dynamic axial compression) and the compliance with the ASTM F1717-12 standard, particularly its requirements for not creating a "new worst-case construct" compared to predicate devices.

7. The sample size for the training set: Not applicable. There is no concept of a "training set" for this type of mechanical device testing.

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

Conclusion from the text: The study indicates that the modified ReForm Pedicle Screw System maintains substantial equivalence to its predicate devices based on its mechanical performance. The performance data, specifically the dynamic axial compression testing per ASTM F1717-12, showed that the changes did not introduce a new worst-case construct, thus meeting the required standard for this type of device modification.

Ask a specific question about this device

The Vault ALIF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space.

The Vault ALIF System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 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 with autogenous bone graft. Patients should have at least six months of non-operative treatment prior to treatment with a lumbar intervertebral fusion device.

The Vault ALIF System is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixations.

The Vault ALIF System consists of implants with various widths, heights, lengths and bone screws to accommodate individual patient anatomy and autogenous bone graft size. All components are manufactured from medical grade polyetheretherketone (PEEK LT1).

The request asks for acceptance criteria and study details for the provided text, however, the text describes a medical device (Vault ALIF System) and its 510(k) summary, not a study evaluating an AI/ML device against acceptance criteria. Therefore, most of the requested information is not applicable.

Here's an analysis of what can be extracted and what cannot:

1. Table of acceptance criteria and reported device performance:

• Acceptance Criteria: Not explicitly stated as specific performance metrics and thresholds in the context of an AI/ML device. For this physical medical device, the acceptance criteria are inherent in demonstrating "substantial equivalence" to a predicate device, primarily through non-clinical mechanical testing.
• Reported Device Performance: The document states that the "results of this testing indicate that the Redesigned Vault ALIF System is equivalent to predicate device." Specific numerical performance metrics (e.g., stiffness values, fatigue cycles) are not provided in this summary.

• Dynamic axial compression per ASTM F2077
• Dynamic shear compression per ASTM F2077 | The Redesigned Vault ALIF System is equivalent to the predicate device in terms of dynamic axial compression and dynamic shear compression. Specific numerical results are not provided in this summary. |

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

• Not Applicable. This document describes a physical medical device (intervertebral body fusion device), not an algorithm or AI/ML device that would use a "test set" of data. The "testing" referred to is mechanical testing of the physical implant.

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

• Not Applicable. This pertains to an AI/ML medical device and ground truth establishment, which is not described in this document.

4. Adjudication method for the test set:

• Not Applicable. Pertains to an AI/ML medical device, not a physical 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:

• Not Applicable. This is relevant for AI/ML diagnostic or assistive devices, not for a physical surgical implant. The document explicitly states: "No clinical studies were performed."

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

• Not Applicable. This refers to AI/ML algorithm performance, which is not the subject of this 510(k) summary.

7. The type of ground truth used:

• Not Applicable. Pertains to an AI/ML medical device. For this physical device, the "ground truth" related to its performance is established through standardized mechanical testing (ASTM F2077) and comparison to a legally marketed predicate device.

8. The sample size for the training set:

• Not Applicable. This applies to AI/ML algorithms, not a physical medical device.

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

• Not Applicable. This applies to AI/ML algorithms, not a physical medical device.

Summary of Device and Study Information from the Text:

• Device Name: Vault ALIF System (Redesigned)
• Device Type: Intervertebral Body Fusion Device with Integrated Fixation, Lumbar (Physical implant)
• Purpose of Submission: Special 510(k) for a redesigned system.
• Substantial Equivalence to Predicate: Spinal USA Vault ALIF System - K103369
• Basis for Equivalence: Intended use, design, mechanical safety and performances, materials, packaging, and sterilization methods.
• Non-Clinical Tests Performed:
  • Dynamic axial compression per ASTM F2077
  • Dynamic shear compression per ASTM F2077
• Test Results: Indicate the Redesigned Vault ALIF System is equivalent to the predicate device.
• Clinical Tests: None performed.
• Ground Truth (for substantial equivalence): Established through non-clinical mechanical testing and comparison of results to a legally marketed predicate device, demonstrating mechanical equivalency as per FDA guidelines for intervertebral body fusion devices.

Ask a specific question about this device

The S-LOK™ PSS 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, scoliosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The S-LOK™ PSS 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; curvatures (i.e. scoliosis, kyphosis, and/or lordosis); spinal tumor; pseudoarthrosis; and failed previous fusion.

The S-LOK™ PSS System is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross links, locking cap screws and hooks. All of the components are available in a variety of sizes to match more closely the patient's anatomy.

Here's an analysis of the provided text regarding the S-LOK™ PSS Pedicle Screw System's acceptance criteria and studies:

Acceptance Criteria and Device Performance

Study Details

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

   • The document mentions a "cadaver study" but does not specify the sample size (number of cadavers or specific test subjects).
   • The provenance of the data (country of origin, retrospective/prospective) is not specified.

2. 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 provided in the document. The studies conducted are mechanical and biomechanical, not clinical studies involving expert interpretation for ground truth.

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

   • Not applicable. The studies are mechanical/biomechanical, not involving human adjudication of results.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a pedicle screw system, not an AI diagnostic tool.

5. 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. The device is a physical medical implant, not an algorithm.

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

   • For the mechanical tests (Static axial gripping, Static flexion/extension moment), the ground truth is derived from the established ASTM F1798 standard and comparison to the predicate device's performance under similar testing conditions.
   • For the cadaver study, the ground truth would be based on biomechanical measurements and observations of the system's performance within the cadaveric spine, again likely in comparison to the predicate device.

7. The sample size for the training set:

   • Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.

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

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

Ask a specific question about this device

The ReForm Pedicle Screw System is intended to provide immobilization and stabilization of spinal re relevels in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and obginonic in sittlies or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spiral tumor, and failed previous fusion (pseudarthrosis).

The ReForm 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 patiently includion 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 opine (Le to Gaeran) man reveal (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis) spinal tumor; pseudoarthrosis; and failed previous fusion.

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

The ReForm Pedicle Screw System is a medical device, and the provided text is a 510(k) summary for its clearance. Medical devices, especially implants like pedicle screw systems, typically demonstrate performance through mechanical testing rather than clinical studies or AI algorithm evaluations. Therefore, many of the requested categories related to AI performance, expert consensus, and human reader studies are not applicable to this device submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific quantitative acceptance limits (e.g., minimum load, cycles to failure) are not provided in this 510(k) summary, but the general outcome is stated as "equivalent to predicate device(s)". Equivalence implies that the ReForm Pedicle Screw System achieved performance comparable to, or better than, the predicate devices in these mechanical tests.

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

• Sample Size: Not explicitly stated. For mechanical tests, the "sample size" refers to the number of test specimens (e.g., screw constructs, rod-screw assemblies) subjected to testing. This information is typically found in the full test report, not usually in the 510(k) summary.
• Data Provenance: Not applicable in the context of geographical origin or retrospective/prospective clinical data, as this concerns mechanical testing of manufactured components. The data originates from non-clinical laboratory testing.

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

• Not applicable. This device is evaluated using objective mechanical engineering tests (ASTM F1717). There is no "ground truth" in the sense of expert medical diagnosis or interpretation required for these performance assessments. The performance is determined by physical measurements and engineering standards.

4. Adjudication Method for the Test Set

• Not applicable. As the performance is determined by objective mechanical testing against engineering standards, there is no need for an adjudication method by medical experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. The document explicitly states: "No clinical studies were performed." Therefore, no MRMC study was conducted.
• Effect Size of Human Readers with AI vs. Without AI Assistance: Not applicable, as this is a mechanical spinal fixation system, not an AI-driven diagnostic or assistive device for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• No. This is a hardware medical device, not a software algorithm. Therefore, a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used

• Engineering Standards and Predicate Device Performance. The "ground truth" for this device's performance is established by its ability to meet standardized mechanical test requirements (ASTM F1717) and demonstrate equivalence to the performance of previously cleared predicate devices.

8. Sample Size for the Training Set

• Not applicable. This device is not an AI/ML algorithm that requires a training set. Its design and materials undergo engineering validation.

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

• Not applicable. As stated above, this device does not utilize a "training set" in the context of AI/ML. The "ground truth" for its design and materials is established through engineering principles, material science, and compliance with relevant ASTM standards.

Ask a specific question about this device

The Slimplicity Solo Anterior Cervical Plate System is intended for anterior cervical fixation to the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.

The Slimplicity Solo Anterior Cervical Plate System consists of an assortment of plates and screws. Each Slimplicity Solo plate attaches to the anterior portion of the vertebral body of the cervical spine (levels C2-C7). Slimplicity Solo implants are composed of titanium alloy, as specified in ASTM F136. The components will be provided non-sterile.

The provided text describes the mechanical testing performed for the "Slimplicity Solo Anterior Cervical Plate System" to establish its substantial equivalence to predicate devices. However, it does not explicitly state "acceptance criteria" in a quantitative table format or detail a "study that proves the device meets the acceptance criteria" in the way one might expect for an AI/software device.

Instead, the document focuses on demonstrating substantial equivalence through mechanical testing and comparison to predicate devices. The "acceptance criteria" here are implied by the performance of the predicate devices and the requirements of the ASTM F1717 standard.

Here's an attempt to structure the information based on your request, interpreting the provided text and acknowledging its limitations regarding typical "acceptance criteria" for a software device:

Acceptance Criteria and Study for the Slimplicity Solo Anterior Cervical Plate System

Based on the provided text, the acceptance criteria and the study conducted are focused on demonstrating substantial equivalence to predicate devices through mechanical testing. No specific quantitative acceptance criteria or detailed study results are reported in the provided snippets, but the conclusion of meeting the criteria is stated.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the context of data for an AI/software device. Instead, it refers to mechanical testing of the physical implant device.

• Sample Size for Mechanical Testing: Not explicitly stated. Mechanical testing typically involves a certain number of samples of the physical device components (plates and screws) to ensure statistical validity of the results, but the exact number is not provided in this summary.
• Data Provenance: Not applicable in the context of data origin (e.g., country) as this is mechanical testing of a manufactured medical device.

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

This information is not applicable. The "ground truth" for mechanical testing is established by the specified standards (ASTM F1717) and engineering principles, not by expert human graders.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical data reviews (e.g., medical imaging), not for mechanical testing of physical devices.

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. An MRMC study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This document describes the mechanical testing of a physical implantable device, not an AI system.

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

This is not applicable. Standalone performance refers to the performance of an algorithm without human intervention. This document relates to a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for the mechanical testing is based on:

• Established engineering standards and methodologies outlined in ASTM F1717.
• The performance characteristics of legally marketed predicate devices to which the new device is compared for substantial equivalence.

8. The Sample Size for the Training Set

This information is not applicable. A "training set" refers to data used to train a machine learning model. This document describes the testing of a physical medical device.

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

This information is not applicable for the same reason as above.

Ask a specific question about this device

When intended to promote fusion of the cervical spine (CI-C7) in skeletally mature patients, the Sure Lok Mini Posterior Cervical/Upper Thoracic System is indicated for the following:

-DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiologic studies) -Spondylolisthesis
-Spinal Stenosis
-Fracture/dislocation
-Revision of previous cervical spine surgery
-Tumors

The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) for the purposes of anchoring the construct. Polyaxial screws are not intended to be placed in the cervical spine.

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical (C1-C7) spine.

The Sure Lok Mini Posterior Cervical/Upper Thoracic System consists of polyaxial screws, rods and hooks. The components are available in a variety of lengths in order to accommodate patient anatomy. The components are fabricated from titanium alloy. The components will be provided non-sterile.

The provided document describes a 510(k) premarket notification for the "Sure Lok Mini Posterior Cervical/Upper Thoracic System." This submission focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a study with specific acceptance criteria and performance data for a standalone device in a clinical setting.

Therefore, many of the requested details, such as specific acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert qualifications, and human-in-the-loop performance, are not applicable or not available in this type of submission.

Here's a breakdown of the information that can be extracted or inferred based on the provided text, and where the requested details are not relevant to this submission:

1. Table of acceptance criteria and reported device performance:

This device is a spinal implant for fixation. The "acceptance criteria" here relate to meeting the performance characteristics of predicate devices through mechanical testing and demonstrating substantial equivalence in design, materials, and intended use. The performance is reported in terms of passing these mechanical tests.

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

• Sample Size: Not applicable in the context of clinical data for diagnostic or AI performance. The "test set" here refers to the physical samples of the device components subjected to mechanical testing. The document does not specify the number of individual components tested but implies sufficient testing to meet ASTM F1717 standards.
• Data Provenance: Not applicable in the context of clinical data. The mechanical testing was performed in a lab setting.

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

• Not applicable. This submission does not involve clinical data requiring expert ground truth for classification or diagnosis. The "ground truth" for this device's performance is adherence to established mechanical testing standards (ASTM F1717).

4. Adjudication method for the test set:

• Not applicable. This submission does not involve clinical data requiring adjudication. Mechanical test results are objective measurements against defined standards.

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 not an AI or diagnostic device. It's a spinal implant. MRMC studies are not relevant to this type of device submission.

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

• No. This is not an AI or algorithm-based device. "Standalone" performance as a diagnostic algorithm is not applicable. The device's "standalone" performance is its mechanical integrity under various loads, which was tested.

7. The type of ground truth used:

• Mechanical Testing Standards (ASTM F1717): The "ground truth" for this device's performance relies on its ability to withstand specified mechanical forces and stresses according to a recognized standard (ASTM F1717). This standard dictates the test methods and performance metrics for spinal implant constructs.
• Substantial Equivalence: The ultimate "ground truth" for regulatory clearance is demonstrating that the device is substantially equivalent to legally marketed predicate devices in terms of intended use, indications, anatomic sites, performance, and material of manufacture.

8. The sample size for the training set:

• Not applicable. This submission does not involve an AI model or a "training set" in the context of machine learning.

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

• Not applicable. As there is no AI model or training set, this question is not relevant.

Summary of the K112025 Submission:

This 510(k) submission for the Sure Lok Mini Posterior Cervical/Upper Thoracic System focuses on demonstrating substantial equivalence to predicate devices. This is achieved by:

• Matching Intended Use and Indications: The device shares the same intended use and indications for fusion of the cervical spine as its predicates.
• Similar Design and Materials: The components (polyaxial screws, rods, hooks) are described as similar in design concept, screw thread type, size, length, locking mechanisms, torque, angulation, and dimensions to predicate systems. All components are fabricated from titanium alloy, the same material as the predicates.
• Mechanical Testing: Performance was verified through mechanical testing performed according to ASTM F1717, a recognized standard for spinal implant constructs. This testing confirmed the device's mechanical integrity under static and dynamic axial compression bending and torsion, demonstrating comparable performance to predicate devices.

The information provided does not pertain to the evaluation of a diagnostic device or an AI algorithm, but rather a physical implant device where regulatory clearance relies on established engineering principles and comparison to existing, cleared products.

Ask a specific question about this device

The Vault ALIF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space.

The Vault ALIF System is intended for use at either one level or two contiguous levels 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 with autogenuos bone graft. Patients should have at least six months of non-operative treatment prior to treatment with a lumbar intervertebral fusion device.

The Vault ALIF System is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixations.

The Vault ALIF System consists of implants with various widths, heights, lengths and bone screws to accommodate individual patient anatomy and graft material size. All components are manufactured from medical grade polyetheretherketone (Peek LTI). The products are supplied clean and "NON-STERILE".

The provided document describes the mechanical testing and substantial equivalence determination for the Vault ALIF System, an intervertebral body fusion device. It does not contain information about an AI device or a study involving human readers or ground truth for AI. Therefore, I will respond to the prompt by extracting the available information related to the device's acceptance criteria and the study (mechanical testing) demonstrating it meets these criteria, while noting the absence of AI-specific details.

Description of Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria:

The Vault ALIF System, an intervertebral body fusion device, underwent mechanical testing to demonstrate its safety and effectiveness. The acceptance criteria were primarily based on showing substantial equivalence to existing predicate devices in terms of mechanical strength and functional characteristics.

1. Table of Acceptance Criteria and the Reported Device Performance:

Mechanical Test Conclusion:

The mechanical test results concluded that the Vault system is as safe as the predicates based on its similar design, identical materials, and superior mechanical strength. It is as effective as the predicate due to the same intended use, indications for use, and equivalent bone port opening.

The following information regarding AI device testing is not applicable to the provided document, as it describes a non-AI medical device and its mechanical testing for regulatory clearance.

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 to this document, as it describes mechanical testing of a physical device, not an AI algorithm evaluated with a dataset.

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 to this document. Ground truth for mechanical testing is based on engineering standards and measurements, not expert human interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable to this document. Adjudication methods are relevant for human interpretation of data, not mechanical properties of a device.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done, as this document pertains to a physical medical device and not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable to this document. This refers to AI algorithm performance, which is not described here.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical testing, the "ground truth" would be established by the precise measurements and calculations derived from standardized test methods (e.g., ASTM F2077, F2267) and engineering principles, which define what constitutes a "passing" or "equivalent" performance. This is not comparable to expert consensus or pathology data for AI systems.

8. The sample size for the training set
Not applicable to this document, as there is no AI algorithm training described.

9. How the ground truth for the training set was established
Not applicable to this document, as there is no AI algorithm training described.

Ask a specific question about this device