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The Libra Pedicle Screw System is intended for immobilization of the posterior thoracic, lumbar and sacral/iliac spine (TI-S1/Ilium) in skeletally mature patients as an adjunct to the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

The Libra Pedicle Screw System consists of longitudinal members (rods), anchors (screws) and fasteners in a variety of sizes to accommodate differing anatomic requirements.

This document describes the FDA's clearance of the Libra Pedicle Screw System (K151770) based on substantial equivalence to predicate devices, rather than a study and acceptance criteria for a novel device's performance. Therefore, the requested information about device performance, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is not directly available in this text.

However, I can extract information related to the performance data provided for substantial equivalence and the acceptance criteria implicitly met through comparison with predicates.

Implicit Acceptance Criteria and Reported Device Performance (Table)

Since this is a 510(k) summary for a substantial equivalence determination for a medical device (pedicle screw system), the "study" is primarily focused on bench testing to demonstrate that the new device performs as safely and effectively as legally marketed predicate devices, not clinical studies with human performance metrics as one might see for AI/software devices. Therefore, many of your specific questions are not directly applicable or answerable from this document.

Here's an attempt to address your other points based on the provided text, acknowledging the nature of a 510(k) submission for a physical implantable device:

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

• Test Set Sample Size: The document does not specify the exact number of Libra Pedicle Screw System constructs tested for mechanical performance. It generally refers to "worst case Libra Pedicle Screw System constructs." For a 510(k) for a physical device, this typically involves a representative number of samples (e.g., typically 3 to 5 per test condition) to satisfy the standard (ASTM F1717). The specific number is usually detailed in the full 510(k) submission, not summarized at this level.
• Data Provenance: The data is from bench testing (mechanical testing), conducted by the manufacturer, Spinal Balance Inc., to evaluate the physical components of the device. It is not clinical data, and thus concepts like "country of origin of the data" or "retrospective/prospective" do not apply in the same way they would for clinical or AI data.

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

• Not applicable in this context. For mechanical bench testing, "ground truth" is established by the specifications and pass/fail criteria of the referenced ASTM standards (ASTM F1717). Engineers and technicians conduct the tests and determine if the results meet the criteria, comparing them against the performance of similar predicate devices. There isn't "expert adjudication" of test results in the sense of clinical image review for diagnostic accuracy.

4. Adjudication method for the test set

• Not applicable. See point 3. Testing against an industry standard (ASTM F1717) provides objective pass/fail criteria.

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 device is a physical spinal implant, not an AI software. Therefore, MRMC studies and the concept of "human readers improving with AI assistance" are irrelevant to this submission.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

• For mechanical testing, the "ground truth" is adherence to the performance standards and specifications outlined in ASTM F1717, and the comparative performance to predicate devices as demonstrated by their own cleared mechanical testing data. The goal is to show equivalent, safe, and effective mechanical properties.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not a machine learning model, so there is no training set in the AI sense.

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

• Not applicable. See point 8.

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The PSG 5.5mm Cannulated Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments 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 disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformity, or curvature (i.e., scoliosis, kyphosis, and lordosis), tumor, stenosis, pseudoarthrosis, and previous failed fusion.

The PSG 5.5mm Cannulated Pedicle Screw System is a non-cervical spinal fixation system. Pedicle screw fixation is limited to skeletally mature patients.

The PSG 5.5mm Cannulated Pedicle Screw System is a multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross-connectors, and locking cap set screws. 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 titanium alloy described by such standards as ASTM F136.

The provided document is a 510(k) premarket notification for a medical device called the "PSG 5.5mm Cannulated Pedicle Screw System." This document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and mechanical performance rather than clinical efficacy studies in the context of AI/software-as-a-medical-device (SaMD). Therefore, many of the requested details about acceptance criteria, clinical study design, and AI performance metrics are not applicable or available in this submission.

However, I can extract the information relevant to the device's mechanical performance and what the submission provides in place of clinical study details.

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices such as pedicle screw systems, "acceptance criteria" and "reported device performance" are typically defined by engineering standards to ensure mechanical integrity and safety. In this context, the device's performance is compared against these standards and to predicate devices.

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

The document does not specify the exact sample sizes (number of devices or test repetitions) used for the mechanical tests. It only states that the device "has been tested" according to the ASTM standards.

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

This is not applicable as the device is a mechanical implant, not an AI/SaMD that requires expert ground truth for image interpretation or diagnosis. The "ground truth" for mechanical testing is adherence to established engineering standards (ASTM F1717-13).

4. Adjudication method for the test set

Not applicable. Mechanical testing is objective and relies on measurements and adherence to specified test protocols, not human adjudication of results.

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 device is a pedicle screw system, not an AI/SaMD for diagnostic imaging or decision support. No MRMC study was performed.

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

Not applicable. This device is a mechanical implant, not an algorithm.

7. The type of ground truth used

The "ground truth" for this type of device is defined by engineering standards and established mechanical performance characteristics relevant to spinal implants. Specifically, the ASTM F1717-13 standard dictates the methodologies and expected performance metrics for static and dynamic mechanical integrity. Comparison to legally marketed predicate devices also serves as a benchmark for "ground truth" in terms of acceptable clinical performance and safety.

8. The sample size for the training set

Not applicable. There is no "training set" as this is a mechanical device, not a machine learning algorithm.

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

Not applicable.

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When used as a pedicle screw fixation system in the non-cervical posterior spine in skeletally mature patients, the Mahe Perfect Spine - 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 the thoracic. Iumbar and sacral spine: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), (5) tumor, and (6) failed previous fusion (i.e. pseudarthrosis). In addition, when used as a pedicle screw system placed between L3 and S1, the Mahe Perfect Spine - Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) in skeletally mature patients receiving fusion with autologous bone graft and with removal of the device after solid fusion is established.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the Mahe Perfect Spine - Pedicle Screw System is intended for use in skeletally mature patients and pediatric patients for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spondylolisthesis, (3) fracture, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) tumor resection, and/or (7) unsuccessful previous attempts at spinal fusion (pseudoarthrosis).

When intended for anterolateral fixation of the T6-L5 spine the Mahe Perfect Spine - Pedicle Screw System is indicated for: (1) degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) spondylolisthesis, (3) trauma (i.e. fracture or dislocation), (4) spinal stenosis, (5) deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis}, (6) tumor and (7) failed previous fusion.

The Mahe Perfect Spine - Pedicle Screw System consists of a variety of shapes and sizes of rods, hooks, monoaxial and polyaxial screws, cross connectors, as well as appropriate instrumentation.

The Mahe Perfect Spine - Pedicle Screw System components are fabricated from titanium alloy per ASTM F136.

The system is sold non-sterile, the products have to be sterilized prior to use.

The provided text details a 510(k) submission for the Mahe Perfect Spine - Pedicle Screw System. This is a medical device for spinal fixation, not an AI/ML powered device. As such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as it relates to AI/ML device performance (e.g., accuracy, sensitivity, specificity, F1-score) is not applicable here.

Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices based on non-clinical performance data and technological characteristics.

Here's how the information provided relates to the typical framework for medical device clearance in this context:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is not an AI/ML device, there are no "acceptance criteria" for metrics like sensitivity or accuracy. The "acceptance criteria" here are implicit in demonstrating substantial equivalence through mechanical testing, material specifications, and intended use.

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

• Test Set: The "test set" in this context refers to the samples of the device components that underwent mechanical testing. The specific number of samples for each test (static compression bending, static torsion, dynamic compression bending, etc.) is not explicitly stated in the provided text.
• Data Provenance: The data comes from non-clinical laboratory testing performed on the device itself ("the worst case construct"). There is no mention of country of origin for the data or whether it's retrospective or prospective, as it's a materials/mechanical engineering study, not a clinical trial.

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

• This question is not applicable to this type of device submission. "Ground truth" in the context of expert consensus is relevant for diagnostic AI/ML devices where experts annotate data for algorithm training and evaluation. For a spinal fixation system, the "ground truth" for its performance is derived from standardized mechanical testing against established engineering benchmarks and comparison to predicate devices, not expert human assessment of images or clinical outcomes in a test set.

4. Adjudication Method:

• Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human experts in establishing ground truth for diagnostic AI/ML systems. This is a mechanical device, not an AI/ML diagnostic.

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

• No. An MRMC study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks. This device is a surgical implant, not a diagnostic tool that assists human readers.

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

• Not applicable. This submission is for a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used:

• The "ground truth" for this device's performance is derived from objective, standardized mechanical testing results (e.g., measurements of bending strength, torsion resistance, fatigue life) compared against established performance characteristics of legally marketed predicate devices and relevant industry standards (ASTM F1717-10, ASTM F2193-02, ASTM F1798).

8. The Sample Size for the Training Set:

• Not applicable. There is no "training set" in the context of a mechanical medical device submission. Training sets are 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.

In summary: The provided document is for a traditional medical device (spinal fixation system) seeking 510(k) clearance based on substantial equivalence to predicate devices, primarily supported by non-clinical mechanical performance data and material specifications. The questions concerning AI/ML evaluation metrics, expert consensus, and ground truth establishment for algorithms are outside the scope of this submission.

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The flamenco™ is a spinal fixation system intended to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion.

When used as posterior, pedicle screw fixation, the system is intended for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients. In addition, when used as a pedicle screw fixation system in the non-cervical posterior spine (T1 to S2), the system is intended for the treatment of the following acute and chronic instabilities or deformities: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion in skeletally mature patients.

When used as a posterior, non-cervical, hook and/or sacral/iliac fixation system (i.e., nonpedicle screw), the flamenco™ is intended for the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (as conformed by patient history and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, lordosis, spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion.

The flamenco™ consists of rods, monoaxial and polyaxial pedicle screws, hooks and transverse connectors with locking set screws. The components are available in various sizes to accommodate differing patient anatomy. Rods are available in one diameter and a variety of lengths. Monoaxial and polyaxial screws are available in a variety of diameter-length combinations. Hooks are offered in a variety shapes and sizes.

The provided text describes the "flamenco™ spinal fixation system," a Class II medical device. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a comprehensive study report for standalone performance or comparative effectiveness with AI.

Based on the provided information, the following can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The acceptance criteria are implied to be achieving performance at least on par with the predicate devices under the specified ASTM F1717 mechanical tests.

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

The document reports mechanical performance data, not clinical performance data from a test set of patient cases. Therefore, information regarding "sample size used for the test set" (referring to patient data) and "data provenance" (country of origin, retrospective/prospective) is not applicable in this context. The testing was laboratory-based mechanical testing of "worst case" device constructs.

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

As this is a mechanical testing study, there were no human experts involved in establishing "ground truth" in the clinical sense. The "ground truth" for the mechanical tests would be the physical properties and performance measured by standardized mechanical testing equipment.

4. Adjudication Method for the Test Set:

Not applicable, as this was a mechanical test, not a clinical study requiring adjudication of expert interpretations.

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

No, an MRMC comparative effectiveness study was not done. This device is a spinal fixation system, not an AI diagnostic or therapeutic software that would typically be evaluated with MRMC studies comparing human readers with and without AI assistance.

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

Yes, in spirit, a standalone performance was done for the device's mechanical properties. The mechanical tests were performed on the device "constructs" themselves, independent of human interaction during the test. This is not "standalone algorithm performance" in the context of AI, but rather standalone performance of the physical device.

7. The Type of Ground Truth Used:

The "ground truth" for the mechanical performance study was physical measurements and adherence to engineering standards (ASTM F1717). The performance was compared against the measured performance of predicate devices.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical medical implant, not an AI algorithm that requires a "training set."

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

Not applicable, as there is no training set for a physical device.

Summary of Study:

The study described is a mechanical performance study conducted according to ASTM F1717. This standard specifies methods for static and dynamic testing of spinal implant constructs. The "flamenco™" system's "worst case" construct was subjected to static compression bending, torsion, and dynamic compression bending. The objective of the study was to demonstrate that the mechanical performance of the flamenco™ system is equivalent to or superior to that of legally marketed predicate devices. The study concluded that the "flamenco™ performs as well as or better than the predicate devices," thereby meeting the implied acceptance criteria for mechanical equivalence.

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When used as a pedicle screw fixation system in skeletally mature patients, the Dynesys® Spinal System is intended to provide immobilization and stabilization of spinal segments 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 neurologic impairment and failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the Dynesys system is indicated for use in patients:

• Who are receiving fusions with autogenous graft only; ●
• Who are having the device fixed or attached to the lumbar or sacral spine; .
• Who are having the device removed after the development of a solid fusion . mass.

When the Dynesys Spinal System and the OPTIMA ZS Spinal System are used on contiguous levels, they must be used with the Zimmer® DTO™ Implant, rodacord combination implant, and the U & I Corporation OPTIMA ZS Transition Screw. The indications for use for each level is as specified for each system.

The Zimmer DTO Implant is a cord-rod combination implant that is assembled intraoperatively by the final tightening of the fastening pin that secures the connection of the cord and the rod. The U & I Corporation OPTIMA ZS Transition Screw is a pedicle screw that is part of the OPTIMA ZS Spinal System. When the Dynesys Spinal System and the OPTIMA ZS Spinal System are implanted on contiguous levels the Zimmer DTO Implant and the OPTIMA ZS Transition Screw are used at the interface of these two systems. The cord portion of the Zimmer DTO Implant interfaces with the Dynesys Spinal System. The rod portion of the Zimmer DTO Implant interfaces with the OPTIMA ZS Transition Screw and with the OPTIMA ZS Spinal System.

The provided text is a 510(k) summary for the Zimmer® DTO™ Implant, a spinal fixation system. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The 510(k) summary focuses on demonstrating substantial equivalence to previously cleared devices based on design, materials, function, and intended use, rather than presenting a detailed clinical or performance study with defined acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them using the provided text. The requested information is simply not present in this regulatory submission.

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