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The S4 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for treatment of the following acute and chronic instabilities or deformities:

1 ) degenerative disc disease (defined as discogenic back pain 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,
7) pseudoarthrosis, and
8) failed previous fusion.

The S4 Spinal System consists of polyaxial screws and monoaxial screws of varying diameters and lengths, various hook styles, rods of varying lengths, fixed and adjustable cross-connectors, and various styles of rod connectors. All implant components are top loading and top tightening. The S4 Spinal System is manufactured from Titanium and Titanium alloy in accordance with ISO 5832/3 and ISO 5832/2.

The provided document describes the Aesculap® Implant Systems (AIS) S4 Spinal System Modification Lateral Offset Connectors and its premarket notification (K130291). The study proving the device meets acceptance criteria is a non-clinical performance study comparing the modified device to predicate devices.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The document mentions "non-clinical testing" was performed, which typically suggests a laboratory-based test with a specific number of samples for each test type, but the exact count is not provided.
• Data Provenance: Not applicable in the context of clinical data. This refers to laboratory-based mechanical performance testing.

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

• Not applicable. This was a non-clinical, mechanical performance study, not a study requiring expert clinical assessment for ground truth. The "ground truth" here is the physical performance data itself, measured according to industry standards.

4. Adjudication Method for the Test Set

• Not applicable. This was a non-clinical, mechanical performance study. Adjudication methods are typically associated with clinical studies involving interpretation of data or images by multiple experts.

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

• No. This document describes a non-clinical mechanical performance study, not a clinical MRMC study.

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

• Not applicable. This device is a physical spinal implant component, not an algorithm or AI system.

7. The Type of Ground Truth Used

• Mechanical performance data a per ASTM standards: The ground truth for this study was the quantifiable mechanical performance (e.g., strength, stiffness, fatigue resistance) measured according to the specified ASTM F1717-12 standards.

8. The Sample Size for the Training Set

• Not applicable. This was a mechanical performance study, not a machine learning or AI study that would typically involve a "training set."

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

• Not applicable. As above, this was a mechanical performance study, not an AI study.

Summary of the Study:

The study conducted was a non-clinical performance study on the S4 Lateral Offset Rod Connectors. It involved standardized mechanical tests (Static Axial Compression Bending, Dynamic Axial Compression Bending, and Static Torsion) as recommended by FDA Guidance for Spinal System 510(k)s and according to ASTM F1717-12. The acceptance criterion was that the modified device "meet or exceed the performance of the predicate devices" in these tests. The results demonstrated that the device successfully met this criterion, leading to a determination of substantial equivalence.

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The S4 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for treatment of the following acute and chronic instabilities or deformities:

1 ) degenerative disc disease (defined as discogenic back pain 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.
7) pseudoarthrosis, and
8) failed previous fusion.

The S4 Spinal System consists of polyaxial screws and monoaxial screws of varying diameters and lengths, staples, various hook styles, rods of varying lengths, fixed and adjustable cross-connectors, and various styles of rod connectors. All implant components are top loading and top tightening. The S4 Spinal System is manufactured from Titanium and Titanium alloy in accordance with ISO 5832/3 and ISO 5832/2.

The provided text describes a 510(k) premarket notification for the "S4 Spinal System Modification Dual Rod Extension." This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing, rather than a clinical study with acceptance criteria measuring device performance on patients or human readers.

Therefore, many of the requested sections are not applicable to the information contained within this 510(k) summary.

Here's a breakdown of what can be extracted and what information is not present:

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

Study that proves the device meets the acceptance criteria:
Non-clinical testing was performed according to FDA Guidance for Spinal System 510(k)'s. This included:

• Static Axial Compression per ASTM 1717-12
• Dynamic Axial Compression per ASTM F1717-12
• Static Torsion per ASTM 1717-12

The results of these studies showed that the subject S4 Staples "meet or exceed the performance of the predicate devices," thereby demonstrating substantial equivalence.

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

This information is not provided in the document. The testing described is non-clinical (mechanical bench testing), and typically, the sample sizes for such tests are reported as the number of devices or test specimens, not patient data. Data provenance (country of origin, retrospective/prospective) is also not applicable for non-clinical bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. The "ground truth" for non-clinical mechanical testing is typically the measured mechanical properties against established standards or predicate device performance, not expert consensus on clinical findings.

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

This is not applicable. Adjudication methods are relevant for clinical studies where subjective assessments (e.g., image interpretation) require consensus among experts. This document describes non-clinical mechanical 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

This is not applicable. This document describes a medical device (spinal implant) and its non-clinical mechanical performance. There is no mention of AI, human readers, or clinical effectiveness studies in an MRMC format.

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

This is not applicable. This document describes a medical device (spinal implant), not an algorithm or AI system.

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

The "ground truth" for this non-clinical study is the mechanical performance of the predicate devices and established ASTM standards (ASTM 1717-12). The S4 Staples' performance was compared against these benchmarks.

8. The sample size for the training set

This is not applicable. There is no "training set" mentioned or implied in the context of this non-clinical mechanical performance testing for a spinal implant. Training sets are relevant for machine learning algorithms.

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

This is not applicable as there is no training set.

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The S4 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for treatment of the following acute and chronic instabilities or deformities:

1 ) degenerative disc disease (defined as discogenic back pain 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,

7. pseudoarthrosis, and

8. failed previous fusion.

The S4 Spinal System consists of polyaxial screws and monoaxial screws of varying diameters and lengths, various hook styles, rods of varying lengths, fixed and adjustable cross-connectors, and various styles of rod connectors. All implant components are top loading and top tightening. The S4 Spinal System is manufactured from Titanium and Titanium alloy in accordance with ISO 5832/3 and ISO 5832/2.

The provided text describes a 510(k) premarket notification for the Aesculap® Implant Systems S4 Spinal System, specifically focusing on a line extension to include additional rod connectors. The evaluation largely relies on demonstrating substantial equivalence to predicate devices through non-clinical performance testing.

Here's an analysis of the acceptance criteria and study described, 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: The document does not specify a "sample size" in the context of clinical test subjects or datasets as would be common for AI/diagnostic device studies. Instead, it refers to non-clinical testing of the physical device components. The sample size for these non-clinical tests (e.g., number of rod connectors tested) is not provided.
• Data Provenance: Not applicable in the context of clinical data provenance. The "data" here comes from laboratory mechanical testing of physical devices.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable. This submission is for a physical spinal implant system, not a diagnostic or AI-driven device requiring expert consensus for ground truth establishment. The "truth" in this context is determined by adherence to ASTM standards and mechanical performance metrics compared to predicate devices.

4. Adjudication Method for the Test Set:

• Not applicable. There is no "test set" in the sense of clinical cases requiring expert adjudication. The performance is assessed through standardized mechanical testing methods per ASTM F1717-11a.

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

• Not applicable. This is a spinal implant, not a diagnostic imaging or AI-assisted interpretation device that would involve human readers.

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

• Not applicable. This submission describes a physical medical device, not an algorithm or software.

7. Type of Ground Truth Used:

• For the performance studies, the "ground truth" implicitly refers to the specified performance criteria set by ASTM standards (F1717-11a) for static axial compression bending, dynamic axial compression bending, and static torsion, as well as the performance profiles of legally marketed predicate devices. The device's performance is compared against these benchmarks rather than a clinical ground truth like pathology or outcome data.

8. Sample Size for the Training Set:

• Not applicable. This device is not an AI/machine learning model, so there is no training set in the conventional sense.

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 describes the regulatory pathway for a spinal implant system, which primarily involves demonstrating mechanical equivalence to predicate devices through standardized non-clinical testing. It does not involve AI, diagnostic algorithms, or human-in-the-loop performance studies.

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The S4 Spinal System is intended for anterior/anterolateral and posterior, non-cervical fixation in skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is intended to be used as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities:

1. degenerative disc disease (defined as discogenic back pain 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,
7. pseudoarthrosis, and
8. failed previous fusion.

The S4 Spinal System consists of polyaxial screws and monoaxial screws of varying in The SF Opinar Oystom "Oneice" or styles, rods of varying lengths, and fixed and various styles of rod connectors. All implant components are top loading and top tightening. The Styles of Four connectors: Annoufactured from Titanium alloy in accordance with 150 5832/3 and ISO 5832/2.

Acceptance Criteria and Device Performance Study for the S4 Spinal System

This document outlines the acceptance criteria and the study conducted to demonstrate the performance of the Aesculap® Implant Systems S4 Spinal System, specifically focusing on the line extension to add a new parallel rod connector.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The FDA guidance for spinal system 510(k) submissions recommends non-clinical testing to demonstrate substantial equivalence. The acceptance criteria for these tests are implicitly defined as demonstrating performance that is at least equivalent to the identified predicate devices.

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated in the provided documents. The studies likely involve a sufficient number of test samples to be statistically significant for mechanical tests as per ASTM standards, but the exact count is not given.
• Data Provenance: The studies were non-clinical mechanical tests conducted in a laboratory setting. The country of origin for the data is not specified but would typically be where these tests were performed (e.g., within Aesculap's facilities or a designated testing laboratory). This is retrospective data in the sense that it's generated for pre-market notification to compare a new device against existing standards and predicates.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable. For non-clinical mechanical performance testing of medical devices like spinal systems, "ground truth" is established through physical measurements and adherence to recognized industry standards (e.g., ASTM F1717-11a), rather than expert consensus on diagnostic images or clinical outcomes. The "experts" involved would be engineers and technicians proficient in conducting and interpreting these specific biomechanical tests.

4. Adjudication Method

• Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human interpretation of data (e.g., medical images). For mechanical testing, the results are quantitative and objective, measured directly from the physical testing.

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

• No. An MRMC study is not relevant for this type of non-clinical mechanical performance testing. MRMC studies are used to assess the impact of a diagnostic or assistive AI device on human reader performance, which doesn't apply to the S4 Spinal System's mechanical properties.

6. Standalone Performance Study

• Yes. The described performance data focuses on the "subject Aesculap S4 Parallel Rod Connector" itself, indicating a standalone evaluation of its mechanical properties. The tests (Static Axial Compression Bending, Dynamic Axial Compression Bending, Static Torsion) evaluate the device's inherent mechanical performance against established ASTM standards and in comparison to predicate devices, without human interaction as part of the performance metric.

7. Type of Ground Truth Used

• Standardized Mechanical Test Results and Predicate Device Performance Data: The ground truth for these tests is based on the quantitative results obtained from applying recognized ASTM standards (ASTM F1717-11a) to the device and comparing these results to the known performance of legally marketed predicate devices. The "truth" is whether the new connector's performance metrics meet or exceed those of the established predicate devices under the specified test conditions.

8. Sample Size for the Training Set

• Not Applicable. This is a non-clinical mechanical performance study, not an AI or algorithm-based study that requires a training set.

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

• Not Applicable. As no training set was used, this question is not applicable.

Ask a specific question about this device

The S4 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for treatment of the following acute and chronic instabilities or deformities:

1 ) degenerative disc disease (defined as discogenic back pain 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, and/or lordosis),

6. tumor.

7. pseudoarthrosis, and

8. failed previous fusion

The S4 Spinal System consists of polyaxial screws and monoaxial screws of varying diameters and lengths, various hook styles, rods of varying lengths, and fixed and adjustable rod to rod connectors. All implant components are top loading and top tightening. The S4 Spinal System is manufactured from Titanium and Titanium alloy in accordance with ISO 5832/3 and ISO 5832/2.

The provided document describes a spinal implant system (Aesculap® Implant Systems S4 Spinal System), not a device that relies on algorithms or image analysis. Therefore, many of the requested categories for acceptance criteria and study details (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details, and ground truth establishment methods) are not applicable to this type of medical device submission.

The acceptance criteria for this device are based on mechanical performance and material characteristics, and its substantial equivalence to previously cleared devices.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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 (N/A). This submission pertains to a spinal implant system, not a data-driven diagnostic or AI device. The "test set" here refers to physical components undergoing mechanical testing, not a dataset of patient information. The document does not specify the number of samples used for ASTM F1717 testing, nor the data provenance in the context of clinical data.

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 (N/A). "Ground truth" in this context would typically refer to clinical outcomes or diagnoses. For mechanical testing, the "ground truth" is established by adherence to a standardized test method (ASTM F1717). Experts are involved in developing and interpreting such standards, but not in establishing ground truth for individual test sets in the way it's done for AI models.

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

• Not applicable (N/A). Adjudication methods like 2+1 are used for resolving disagreements among multiple human readers for diagnostic tasks. Since this is a mechanical device, such methods are not relevant.

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 (N/A). MRMC studies are for evaluating diagnostic accuracy, especially with AI systems. This is a physical implant, not a diagnostic tool.

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

• Not applicable (N/A). This is a physical implant, not an algorithm.

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

• Not applicable (N/A) for clinical "ground truth." For the mechanical performance, the "ground truth" is defined by the ASTM F1717 standard and the performance of legally marketed predicate devices. The material composition "ground truth" is established by adherence to ISO 5832/3 and ISO 5832/2 standards.

8. The sample size for the training set

• Not applicable (N/A). This is a physical implant, not an AI model that requires a training set.

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

• Not applicable (N/A). As above, this is not an AI model.

Summary of the Study:

The study that proves the device meets the acceptance criteria is a mechanical performance study adhering to the ASTM F1717 standard for static and dynamic compression bending testing. The results of this testing were compared against the performance of predicate devices, and the S4 Spinal System was found to exhibit similar performance characteristics.

Additionally, the device's adherence to material standards (ISO 5832/3 and ISO 5832/2 for Titanium and Titanium alloy) and its similar design characteristics and indications for use to previously cleared predicate devices (S4 Spinal System, Blackstone Pedicle Screw System, Stryker XIA 3 Spinal System, and Depuy Expedium Spine System) form the basis of its acceptance and clearance via the 510(k) pathway for substantial equivalence. No clinical studies are referenced as part of this premarket notification.

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The S4 Spinal System, when used as a pedicle screw fixation system, is indicated for use in patients: a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 ioin: b) who are receiving fusion using autogenous graft only; c) who are having the device fixed or attached to the lumbar or sacral spin; and d) who are having the device removed after the development of a solid fusion mass may not go above the L5-S1 joint, the levels of pedicle screw fixation may span from L3 to the sacrum.

The S4 Spinal System is a pedicle screw system 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 spin: degenerative spondyloisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

When used as a hook and sacral screw system (other than pedicle screw fixation system for high grade spondylolisthesis), the S4 Spinal System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with the degeneration of the disc confirmed by a history and radiographic studies). idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture of dislocation, pseudoarthrosis, and previous failed spinal surgery/fusion. When used for this indication, screws of the S4 Spinal System are intended for sacral/illac attachment only. Hooks and transverse connectors of the system are intended for posterior throracic and/or lumbar use only. The levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.

The S4 Spinal System consists of polyaxial screws and monoaxial screws of varying diameters and lengths, various hook styles, rods of varying lengths, and fixed and adjustable rod to rod connectors. All implant components are top loading and top tightening. The S4 Spinal System is manufactured from Titanium and Titanium alloy in accordance with ISO 5832/3 and ISO 5832/2.

The provided document is a 510(k) summary for the S4 Spinal System and does not contain information about acceptance criteria for a study, nor does it describe a study proving the device meets specific acceptance criteria in the context of device performance metrics like sensitivity, specificity, or accuracy.

Instead, the document focuses on:

• Substantial Equivalence: It states that the S4 Spinal System additions are substantially equivalent to existing components of the S4 Spinal System. This is the primary claim for 510(k) submissions, not a demonstration of meeting specific performance criteria through clinical studies.
• Device Description: Details the components and materials of the S4 Spinal System.
• Indications for Use: Specifies the medical conditions and patient populations for which the device is intended.
• Technological Characteristics: Compares the new components to predicate devices, noting similar shapes, sizes, and materials.
• Performance Data: This section broadly states: "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable. In addition, testing per the 'Spinal System 510(k)s' was completed where applicable."

This statement on "Performance Data" refers to non-clinical (e.g., mechanical, biocompatibility) testing required by guidance documents for orthopedic devices, not clinical studies assessing diagnostic accuracy or performance against specific acceptance criteria for AI or diagnostic devices. There is no mention of:

• A table of acceptance criteria and reported device performance (in terms of clinical metrics).
• Sample sizes for test sets, data provenance, or ground truth.
• Numbers or qualifications of experts.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance.
• Training set details.

Therefore, I cannot fulfill the request as the essential information related to acceptance criteria and a study proving device performance (in the context implied by the questions, i.e., clinical or AI performance) is absent from the provided text. The document is for a spinal implant system, and the "performance data" mentioned would typically refer to mechanical and material safety, not diagnostic or AI performance.

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The S4 Spinal System, when used as a pedicle screw fixation system, is indicated for use in patients: a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 ioin: b) who are receiving fusion using autogenous graft only; c) who are having the device fixed or attached to the lumbar or sacral spine; and d) who are having the device removed after the development of a solid fusion mass may not go above the L5-S1 joint, the levels of pedicle screw fixation may span from L3 to the sacrum.

The S4 Spinal System is a pedicle screw system 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 spin: degenerative spondyloisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

When used as a hook and sacral screw system (other than pedicle screw fixation system for high grade spondylolisthesis), the S4 Spinal System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with the degeneration of the disc confirmed by a history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture of dislocation, pseudoarthrosis, and previous failed spinal surgery/fusion. When used for this indication, screws of the S4 Spinal System are intended for sacral/iliac attachment only. Hooks and transverse connectors of the system are intended for posterior throracic and/or lumbar use only. The levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.

The S4 Spinal System consists of polyaxial screws and monoaxial screws of varying diameters and lengths, various hook styles, rods of varying lengths, and fixed and adjustable rod to rod connectors. All implant components are top loading and top tightening. The S4 Spinal System is manufactured from Titanium and Titanium alloy in accordance with ISO 5832/3 and ISO 5832/2.

Here's an analysis of the provided text regarding the S4 Spinal System, focusing on information typically found in acceptance criteria and study designs for medical devices.

Important Note: The provided document is a 510(k) summary and an FDA clearance letter for a line extension of an existing spinal system. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and mechanical testing. It does not describe a study involving human or animal subjects to assess clinical performance or comparative effectiveness with human readers using AI. Therefore, many of the requested fields related to clinical studies, human readers, and ground truth establishment will be marked as "Not Applicable" or "Not Provided" based on the content.

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative "acceptance criteria" in the format of specific performance metrics that the device had to achieve for clinical efficacy (e.g., success rates, complication rates). Instead, the acceptance is based on demonstrating substantial equivalence to existing, legally marketed predicate devices through technological similarities and mechanical performance testing.

Table of Acceptance Criteria and Reported Device Performance

Study Details (Based on Provided Text)

Given the nature of a 510(k) submission for a line extension of an orthopedic implant, the "study" referred to is almost entirely mechanical and material testing, not a clinical study involving human patients or AI algorithms.

1. 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 specified for individual tests. The "test set" refers to the physical device components subjected to mechanical tests. The number of components tested for each specific mechanical evaluation (e.g., fatigue, static bending) is not provided in this summary.
   • Data Provenance: Not applicable in the context of geographical origin for mechanical testing. The testing was conducted internally or by accredited labs as part of the manufacturer's due diligence for regulatory submission. It is inherently prospective in the sense that the new components were manufactured and then tested to demonstrate performance.

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):

   • Not Applicable. The "ground truth" for mechanical testing is established by engineering standards and specifications (e.g., ISO standards, FDA guidance documents for spinal systems), not by human expert consensus or clinical interpretation.

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

   • None. Adjudication methods like 2+1 or 3+1 refer to resolving discrepancies among human expert reviewers in clinical studies. This is not relevant for mechanical testing. Mechanical test results are objective measurements against defined pass/fail criteria.

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, an MRMC comparative effectiveness study was not done. This is a mechanical device, not an AI-assisted diagnostic tool.

5. 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 does not involve any AI algorithms.

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

   • Engineering Standards and Specifications. The "ground truth" for the performance of this device in a 510(k) context consists of meeting predefined mechanical performance limits and material specifications outlined in national and international standards (e.g., ISO 5832 series for materials, and relevant FDA guidance documents for spinal implants concerning fatigue, static strength, and construct integrity).

7. The sample size for the training set:

   • Not Applicable. There is no "training set" in the context of a mechanical device.

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

   • Not Applicable. There is no "training set" for this type of device.

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When intended to promote fusion of the cervical spine and the thoracic spine (C1 - T3), the S4 Spinal System is intended for the following;

• DDD (Neck pain pf discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
• Spondylolisthesis
• Spinal stenosis
• Fracture/dislocation
• Failed previous fusion
• Tumors

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1 – T3) spine.

The use of the polyaxial screws is limited to placement in T1 - T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.

The S4 Spinal System consists of 3.5mm rods in 6 lengths, thin and thick lamina hooks, 3.5 and 4.0mm polyaxial screws of various lengths and a cross connector. The S4 Spinal System is manufactured from Titanium forged alloy Ti6Al4V.

This is a medical device submission, specifically a 510(k) premarket notification for a spinal system. These submissions do not typically include information about AI/ML algorithms, performance metrics like sensitivity/specificity, or human reader studies. Instead, they focus on demonstrating substantial equivalence to a predicate device through engineering and biocompatibility testing.

Therefore, for the input provided, there is no information about:

• Acceptance criteria in terms of AI/ML performance metrics.
• A study proving the device meets AI/ML acceptance criteria.
• Sample sizes for test sets or data provenance in the context of AI/ML.
• Number of experts for ground truth or their qualifications.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone AI algorithm performance.
• Type of ground truth (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

The document states the following regarding performance data:

"All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable. In addition, testing per the 'Spinal System 510(k)s' was completed where applicable."

This indicates that standard engineering and biocompatibility testing was performed to demonstrate the safety and effectiveness of the modified components (cross connector and smooth shank screws) and their substantial equivalence to the predicate device. However, specifics of these tests (e.g., fatigue testing, pull-out strength, etc.) and their acceptance criteria are not detailed in this summary.

In summary, the provided document does not contain the type of information requested about AI/ML device performance. It is a regulatory submission for a physical medical device (spinal implant) that relies on demonstrating substantial equivalence through standard device testing, not AI/ML performance evaluation.

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The S4 Spinal System, when used as a pedicle screw fixation system, is indicated for use in patients: a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 join; b) who are receiving fusion using autogenous graft only; c) who are having the device fixed or attached to the lumbar or sacral spin; and d) who are having the device removed after the development of a solid fusion mass may not go above the L5-S1 joint, the levels of pedicle screw fixation may span from L3 to the sacrum.

The S4 Spinal System is a pedicle screw system 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 spin: degenerative spondyloisthesis with objective evidence of neurological impairment, fracture, dislocation, scollosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

When used as a hook and sacral screw system (other than pedicle screw fixation system for high grade spondylolisthesis), the S4 Spinal System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with the degeneration of the disc confirmed by a history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture of dislocation, pseudoarthrosis, and previous failed spinal surgery/fusion. When used for this indication, screws of the S4 Spinal System are intended for sacral/iliac attachment only. Hooks and transverse connectors of the system are intended for posterior throracic and/or iumbar use only. The levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.

The S4 Spinal System consists of polyaxial screws and monoaxial screws of varying diameters and lengths, various hook styles, rods of varying lengths, and fixed and adjustable rod to rod connectors. All implant components are top loading and top tightening. The S4 Spinal System is manufactured from Titanium and Titanium alloy in accordance with ISO 5832/3 and ISO 5832/2.

The provided text describes a medical device, the S4 Spinal System, and its 510(k) premarket notification. However, it does not contain any information about acceptance criteria or a study proving the device meets particular acceptance criteria for software or AI-enabled functionalities.

The document discusses:

• Device Description: Components, materials.
• Indications for Use: Specific patient conditions and spinal applications.
• Technological Characteristics: Comparison to predicate devices (similar shapes, sizes, materials).
• Performance Data: Mentions that "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable. In addition, testing per the 'Spinal System 510(k)s' was completed where applicable."

This statement about performance data refers to standard regulatory requirements for mechanical and material testing of spinal implants to ensure their safety and effectiveness (e.g., fatigue testing, static strength testing). It does not pertain to the performance of an AI algorithm or software.

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document predates the widespread regulatory submission of AI/ML-enabled medical devices, which typically require such performance evaluation details. The S4 Spinal System is a mechanical implant, not a software or AI device.

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When intended to promote fusion of the cervical spine and the thoracic spine (C1 - T3), the S4 Spinal System is intended for the following;

• DDD (Neck pain pf discogenic origin with degeneration of the disc as confirmed . by patient history and radiographic studies)
• Spondylolisthesis .
• Spinal stenosis .
• Fracture/dislocation .
• Failed previous fusion .
• Tumors .

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1 - T3) spine.

The use of the polyaxial screws is limited to placement in T1 – T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.

The S4 Spinal System consists of 3.5mm rods in 6 lengths, thin and thick lamina hooks, 3.5 and 4.0mm polyaxial screws of various lengths and a cross connector. The S4 Spinal System is manufactured from Titanium forged alloy Ti6Al4V.

The provided text describes a 510(k) summary for the S4 Spinal System and indicates that the device has undergone performance testing. However, it does not contain details about specific acceptance criteria, study methodologies, sample sizes, or ground truth establishment typically found in a clinical study report.

Instead, it states:

"All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable. In addition, testing per the 'Spinal System 510(k)s' was completed where applicable."

This implies that the device met the general requirements outlined in the FDA's guidance documents for spinal systems, which typically include mechanical and biocompatibility testing. It does not provide the specific "acceptance criteria" or the "reported device performance" in a quantitative manner as requested. It also lacks information on clinical study aspects like ground truth, expert opinions, or MRMC studies.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide information on sample sizes, ground truth establishment, or clinical study details based on the provided text. The document is a regulatory submission summary rather than a detailed performance study report.

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