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The LAKI device is intended to be used for fixation of bone fractures of long bones in fingers. The LAKI device is a semi-invasive device intended to be attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

This 510(k) consists on the submission of an evolution of an external fixation device. The LAKI Hand Fixation System provides opportunity to patients to develop solid bone re-growth in cases of fractures, pseudo-arthrosis, and limb lengthening by use of modular elements, rods, and nuts. The LAKI utilizes a threaded rod bound to two semi modular elements with nuts which allows the former to be locked in the most suitable position for each specific case. Kirschner wires are also used for stabilization. All invasive components of the LAKI Hand Fixation System are made of 316L stainless steel. External locking connector components are all made of Ti6AL4V titanium alloy.

The provided text is a 510(k) summary for the LAKI Hand Fixation System. It describes the device, its indications for use, and claims substantial equivalence to a predicate device (LIMA SEM Modular External Stabilizer, K880282). Crucially, the document states under "V. Performance Data": "Please see 510(k) submission for the SEM Modular External Stabilizer, K880282."

This means that a separate document (K880282) would contain the performance data, acceptance criteria, and details of any studies proving the device meets those criteria. The current document (K082679) does not include this information directly.

Therefore, I cannot provide the requested table and study details based solely on the provided text. The document explicitly defers to the predicate device's 510(k) for performance data.

Based on the provided text for K082679, I can only state the following:

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

• Not available in the provided text. The document directs to K880282 for performance data.

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

• Not available in the provided text. The document directs to K880282 for performance 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 available in the provided text. The document directs to K880282 for performance data.

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

• Not available in the provided text. The document directs to K880282 for performance data.

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 a hardware medical device (fixation system), not an AI-assisted diagnostic device that would involve human readers.

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

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

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

• Not available in the provided text. The document directs to K880282 for performance data.

8. The sample size for the training set:

• Not applicable. This is a hardware medical device, not a machine learning algorithm that requires a training set.

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

• Not applicable. This is a hardware medical device, not a machine learning algorithm.

To answer your request comprehensively, one would need to access and review the 510(k) submission for the LIMA SEM Modular External Stabilizer (K880282).

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The Posterior Lumber System Multi-Axial Screw DESCO is a posterior, nonpedicle screw system of the noncervical spine indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, tumor, pseudoarthrosis, and failed previous fusion.

The Posterior Lumbar 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 spine: degenerative spondylothesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Posterior Lumbar System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to Sacrum) with removal of the implants after the attainment of a solid fusion.

As a special 510(k) submission, the predicate device to which we are claiming equivalence is our own product, Sintea Biotech's Posterior Lumbar System (K020085). This 510(k) submission represents a modification to the predicate, in which the locking cap threads are modified and additional size diameter screws are added to the already cleared Posterior Lumbar System.

This document is a 510(k) premarket notification for a medical device called the "Posterior Lumbar System Multi-Axial Screws - DESCO" by Sintea Biotech, Inc. It's a review by the FDA determining substantial equivalence to predicate devices, rather than a study proving acceptance criteria for a new AI/software device.

Therefore, the provided document does not contain any of the requested information regarding acceptance criteria or a study proving a device meets acceptance criteria for an AI/software product. The document pertains to a traditional medical device (pedicle screws) and its regulatory clearance process, where "substantial equivalence" is the key determination, not performance against specific acceptance criteria in the context of an AI study.

Specifically, there is no information on:

1. A table of acceptance criteria and reported device performance for an AI/software.
2. Sample sizes or data provenance for a test set.
3. Number of experts, their qualifications, or adjudication methods for ground truth.
4. Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
5. Standalone algorithm performance.
6. Type of ground truth used (e.g., pathology, outcomes data) in the context of an AI study.
7. Sample size for a training set.
8. How ground truth for a training set was established.

The document primarily focuses on the device's indications for use and its substantial equivalence to previously cleared devices (K020085 and K043355), with a modification to locking cap threads and the addition of new screw sizes. The "Performance Data" section explicitly states to "Please see 510(k) submission for the Sintea Biotech's Multi-Axial Screws System, K043355," indicating that any relevant performance testing would be documented in that predicate device's submission, and would likely involve mechanical or biocompatibility testing for a physical implant, not software performance.

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The SPIDER™ is intended to be used as a system for the creation of a cavity in cancellous bone in the spine, in order to treat pathological compression fractures that may result from osteoporosis, benign lesions, and/or malignant lesions. This system is to be used with an already FDA cleared PMMA bone cement.

The Sintea Biotech's SPIDER™ expandable tamp is designed to compress cancellous bone as it expands. The SPIDER™ consist of a controlled expanding tamp at the distal end, a cannulated gauge, an awl, guided wires, and a reamer. The product has the same intended use as the predicate. The expandable tamp is made out of biocompatible Nitinol metal.

The provided text is a 510(k) summary for the Sintea Biotech Spider Spinal System. It does not describe a study that proves the device meets acceptance criteria, nor does it provide a table of acceptance criteria and reported device performance. The document focuses on regulatory submission for market clearance rather than detailed performance study results against specific criteria.

Therefore, most of the requested information cannot be extracted from this document because it outlines a regulatory submission rather than a clinical or performance study.

Here's what can be gathered based on the available text:

General Information from the Document:

• Device Name: SPIDER™ Spinal System
• Intended Use: To be used as a system for the creation of a cavity in cancellous bone in the spine, in order to treat pathological compression fractures that may result from osteoporosis, benign lesions, and/or malignant lesions. This system is to be used with an already FDA cleared PMMA bone cement.

Given that the document does not contain a detailed study proving the device meets acceptance criteria, the following points will be answered based on the absence of information in the provided text.

Acceptance Criteria and Device Performance:

1. A table of acceptance criteria and the reported device performance:
   • Acceptance Criteria: Information not provided. The document states "There is no set standard of testing for this type of device."
   • Reported Device Performance: Information not explicitly detailed in quantifiable acceptance criteria format. The document generically states that "Sintea Biotech has performed mechanical tests to verify the device meets the functional and performance specifications it was designed for. Please see section 18 of this 510(k) submission for detailed test and results." However, Section 18 is not included in the provided text.

Study Details (Based on absence of information):

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 as no performance study details are provided in this summary. The document mentions "mechanical tests" but does not detail their methodology, sample size, or data provenance.

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. No ground truth for a test set is discussed.

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

   • Not applicable. No test set adjudication is discussed.

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 surgical instrument, not an AI-assisted diagnostic tool, so an MRMC study is not relevant here.

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

   • Not applicable. This device is a surgical instrument, not an algorithm.

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

   • Not applicable. No ground truth for a study is discussed. The "performance data" mentioned refers to mechanical tests validating engineering specifications, not clinical outcomes or diagnostic accuracy against a ground truth.

8. The sample size for the training set:

   • Not applicable. No training set for an algorithm is mentioned.

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

   • Not applicable. No training set is mentioned.

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The DSC/ALF Spinal System is a vertebral body replacement system intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The DSC/ALF Spinal System is to be used with supplemental fixation. Specifically, the DSC/ALF system is to be used with the anterior lateral plate that is included in the system, and may also be used with the Sintea Biotech PLS Spinal System. Additionally, the use of bone grafting material with the DSC/ALF System is optional.

The Sintea Biotech DSC/ALF system is a dorsolumbar somatic vertebral body replacement device with its own supplemental fixation. The DSC/ALF Spinal System provides two basic components: A VBR (DSC) and an anterior lateral fixation plate (ALF). The DSC has a hollow internal module that can slide in relation to an external tightening module, which enables the former to be locked in the most suitable position by means of two screws for each individual case. A safety screw is also provided. Both modules can be completed with extremity covers that optimise the contact with the vertebral bodies between which the device is inserted, thus ensuring better primary stability. The ALF is composed of two plates that connect to the anterior side of a vertebra by two screws. The two plates are connected by a rod that ranges from 32mm to 92mm in length. All components of the DSC/ALF Spinal System are made of medical grade titanium alloy (Ti-6Al-4V) as described by ASTM Standard F136.

The provided 510(k) summary for the DSC/ALF Spinal System describes a medical device, not an AI/ML powered device. Therefore, the requested information pertaining to acceptance criteria and performance studies in the context of AI/ML, such as sample sizes for test/training sets, expert consensus for ground truth, adjudication methods, or MRMC studies, is not applicable to this document.

The performance data included in the summary is related to mechanical testing of the device to demonstrate substantial equivalence to a predicate device, as per FDA guidance for spinal systems.

Here's an overview of the "performance data" as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance: Not applicable (not an AI/ML study). Mechanical testing would involve a certain number of device samples, but this is not detailed for the 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable (not an AI/ML study).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable (not an AI/ML 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: Not applicable (this is a physical medical device, not an AI-powered diagnostic/interpretive tool).

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical testing, the "ground truth" or reference standard would be the established engineering specifications and performance requirements outlined in the referenced FDA guidance and ASTM standards for spinal implants.

8. The sample size for the training set: Not applicable (not an AI/ML study).

9. How the ground truth for the training set was established: Not applicable (not an AI/ML study).

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The Sintea Posterior Lumbar System is a posterior, nonpedicle screw system of the noncervical spine indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, tumor, pseudoarthrosis, and failed previous fusion.

The Sintea Biotech Posterior Lumbar 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 spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Sintea Biotech Posterior Lumbar System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-SI 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.

The PLS Sunflower II screws are available with the same material, shape, fillet, diameters and length of PLS Sunflower screws (K043355). They have the same characteristics as PLS Sunflower Multi-axial screws with the exception that the Sunflower II holds both 5mm and 5.5mm diameter rods instead of only 5mm rods, both sizes fall under an already FDA cleared range.

The locking mechanism of the PLS Sunflower II is the same as the PLS Sunflower Multiaxial screw (K043355) with the exception of the external ring in the locking cap. The external ring in the SUNFLOWER locking cap did not contribute to the mechanical stability of the system, therefore, its absence in the Sunflower II Screw will make the system easier to use intraoperatively.

The PLS Multi-axial Sunflower II screws are made of the same material as the PLS Multi-axial Sunflower screws. The somatic thread is the same as the thread of the PLS standard screws. The lengths and diameters of the multi-axial screws are the same as the lengths and diameters of the PLS standard screws. The design of this screw allows for up to 25 degrees of angulation in any direction to accommodate different anatomic conditions.

The provided text describes a 510(k) submission for a medical device, the Sintea Biotech Posterior Lumbar System Sunflower II Multi-axial Screw. Such submissions focus on demonstrating substantial equivalence to a predicate device rather than conducting new clinical studies to establish acceptance criteria and device performance in the same way a PMA (Pre-Market Approval) would.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them, in the typical sense of a clinical trial with performance metrics. Instead, it relies on demonstrating equivalence through design modifications and biomechanical testing, as well as adherence to standards.

Here's a breakdown of why the requested information is not present and what is available:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not found: The document refers to "Biomechanical studies" but does not provide specific acceptance criteria or quantitative performance results in a table. It only states that these studies "demonstrate that the device system is safe, effective, and suitable for use as a spinal fixation device system."
• The 510(k) process for this type of device typically relies on mechanical testing to ensure the modified device meets the same performance standards as the predicate, not on clinical performance metrics like sensitivity, specificity, or surgical outcomes with specific acceptance thresholds.

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

• Not found: No clinical test set or data provenance (country of origin, retrospective/prospective) is mentioned, as this is not a clinical study report. The "test set" in this context would implicitly refer to the specimens used in biomechanical testing, but details are not provided.

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

• Not applicable/Not found: This pertains to clinical studies involving human interpretation or pathology. Since this is a hardware modification submission, such expert ground truth for a test set is not relevant.

4. Adjudication Method for the Test Set:

• Not applicable/Not found: See point 3.

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

• Not applicable/Not found: This type of study evaluates human reader performance, often with AI assistance. This document is about a mechanical implant, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance:

• Not applicable/Not found: This concerns AI algorithms. The device is a physical implant.

7. Type of Ground Truth Used:

• Not applicable/Not found: For a medical implant, the "ground truth" related to its performance is typically established through a combination of engineering design principles, material testing, and biomechanical studies, rather than expert consensus, pathology, or outcomes data in a clinical trial setting for a 510(k) submission.

8. Sample Size for the Training Set:

• Not applicable/Not found: This is relevant for machine learning models. The device is a mechanical implant.

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

• Not applicable/Not found: See point 8.

What the document does provide in relation to proof of meeting criteria:

• Predicate Device Equivalence: The primary "proof" is the demonstration of substantial equivalence to a legally marketed predicate device (Sintea Biotech's own Posterior Lumbar System Multi-axial Screw).
• Modification Justification: The modification (holding 5mm and 5.5mm rods, and removal of an external ring) is described as being within the scope of already cleared sizes and not affecting mechanical stability.
• Biomechanical Studies: The document explicitly states: "Biomechanical studies conducted on the Sintea Biotech Posterior Lumbar System Sunflower II multi-axial screw implant construct demonstrate that the device system is safe, effective, and suitable for use as a spinal fixation device system." However, no specific results, methods, or acceptance criteria from these studies are detailed in the provided text.
• Compliance with Standards: The company "intends to comply with all voluntary Performance Standards applicable to the Sintea Biotech Posterior Lumbar System. At the present time, various performance standards such as ASTM, ISO, QSR/GMP and in-house SOP standards are used." This implies that the biomechanical studies would be designed to meet the requirements of these standards.
• Special Controls: The device must comply with specific special controls, including:
  • Compliance with material standards
  • Compliance with mechanical testing standard
  • Compliance with biocompatibility standard
  • Specific labeling requirements

In summary, for K060513, the "acceptance criteria" are primarily established by demonstrating substantial equivalence to a predicate device and adherence to recognized industry standards and FDA special controls, supported by internal biomechanical testing (for which details are not provided in this excerpt). It's crucial to understand that a 510(k) notification, especially a "special" one for modifications, doesn't require the same depth of clinical evidence and acceptance criteria reporting as a PMA.

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The Sintea Posterior Lumbar System is a posterior, nonpedicle screw system of the noncervical spine indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, tumor, pseudarthrosis, and failed previous fusion.

The Sintea Biotech Posterior Lumbar 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 spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Sintea Biotech Posterior Lumbar System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-SI 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.

PLS recovery screws and screws for ring are available with the same material, shape, fillet, diameters and length of PLS standard screws. They have the same characteristics as PLS standard screws with the exception of a locking ring adopted in place of a locking cap.

The PLS Multi-axial screws are made of the same material as the PLS standard (monoaxial) screws. The somatic thread is the same as the thread of the PLS standard screws. The lengths and diameters of the multi-axial screws are the lengths and diameters of the PLS standard screws. The design of this screw allows for up to 25 degrees of angulation in any direction to accommodate different anatomic conditions.

The provided document is a 510(k) summary for a medical device (Sintea Biotech Posterior Lumbar System Multi-axial Screw and Recovery Screw with Ring). It focuses on demonstrating substantial equivalence to a predicate device through mechanical testing and comparison of design, materials, and intended use.

Therefore, it does not describe a clinical study in the traditional sense that would involve patient data, ground truth established by experts, or human reader performance. The "acceptance criteria" here refer to the performance of the device in biomechanical tests compared to a predicate device, as required for 510(k) clearance rather than clinical efficacy/diagnostic accuracy.

However, based on the information provided, I can infer and extrapolate the relevant parts that would correspond to your requested sections, focusing on the device performance within a biomechanical study context.

Here's a breakdown of the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not explicitly stated, as this was a biomechanical (material/engineering) study, not a clinical study involving patients. "Test set" in this context would refer to the number of device constructs tested. This detail is typically found in the full biomechanical report, not the 510(k) summary.
• Data Provenance: Not applicable in the context of geographical origin or retrospective/prospective for a biomechanical study. The studies were "conducted on the Sintea Biotech Posterior Lumbar System multi-axial screw, recovery screw, screw for ring and ring implant constructs," implying testing in a lab setting.

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

• This is not applicable to this type of submission. "Ground truth" established by experts (e.g., radiologists) is relevant for diagnostic devices or those involving interpretation of medical images/patient data. For a biomechanical study, the "ground truth" would be established by validated engineering test standards and measurements, interpreted by engineers or scientists.

4. Adjudication Method for the Test Set

• Not applicable for this type of biomechanical study. Adjudication typically refers to resolving discrepancies between human readers or experts, which is not relevant here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC study was not done. This is a submission for a spinal implant, not an AI/diagnostic device.

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

• No, this is not applicable. This is a hardware device (spinal implant), not an algorithm or software.

7. The Type of Ground Truth Used

• For the biomechanical studies, the "ground truth" would be the physical measurements and performance under established mechanical testing standards (e.g., ASTM, ISO standards mentioned, though specific test numbers are not listed in the summary). This would be based on empirically measured properties and engineering specifications.

8. The Sample Size for the Training Set

• Not applicable. This submission describes a physical medical device, not a machine learning model, so there is no "training set."

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

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

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The Sintea Biotech Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C3 to C7).

The device is intended for single use only and is packaged non-sterile with sterilization required prior to use.

WARNING: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

The Sintea Biotech Anterior Cervical Plate System is indicated for use in the cervical spine (levels C3 to C7) in the following conditions:

• Degenerative disc disease (defined as neck pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies)
• Spondylolisthesis
• Trauma (fracture or dislocation)
• Spinal stenosis
• Deformities or curvature (scoliosis, kyphosis, lordosis)
• Tumor
• Pseudarthrosis
• Failed previous fusion

The Sintea Biotech Anterior Cervical Plate System is a family of anterior cervical spine locking plates, screws and associated instruments, providing an anterior buttress. opstruct for use following Corpectomy or discectomy. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. It is indicated for traumatic, degenerative, and tumor pathologies.

All system components are made of biocompatible Ti6A14V ELI titanium alloy, which minimizes the possibility of allergic reaction and enhances post-operative MRJ/CT analyses as described by ASTM F136. Do not use any of the Sintea Biotech Anterior Cervical Plate System components with components from any other system or manufacturer.

The provided text describes a medical device called the Sintea Biotech Anterior Cervical Plate System. It details its intended use, indications, and how its substantial equivalence to a predicate device was established. However, this document does not contain any information regarding clinical studies with acceptance criteria or device performance data as typically found for AI/ML-driven devices or diagnostic tools.

Instead, the document focuses on regulatory compliance, mechanical testing, and comparison to a predicate device to demonstrate safety and effectiveness for a conventional orthopedic implant.

Therefore, I cannot fulfill the request for information regarding acceptance criteria and performance studies because this information is not present in the provided text.

Here's a breakdown of why this information is missing based on your request:

• Acceptance Criteria and Reported Device Performance (Table): The document provides "Performance Standards" but these are general regulatory and voluntary standards (ASTM, ISO, QSR/cGMP, in-house SOPs) for manufacturing and materials, not specific clinical performance metrics with acceptance thresholds and reported device results from a study. The "Summary of Biomechanical Testing" mentions overcoming static and fatigue tests according to ASTM F1717 without microscopic or macroscopic failures, but these are engineering/mechanical tests, not clinical performance acceptance criteria.
• Sample Size (Test Set) and Data Provenance: Not applicable, as no clinical test set is described. The "testing" refers to mechanical/biomechanical tests on constructs, not clinical data sets.
• Number of Experts & Qualifications: Not applicable, as no ground truth establishment for a clinical test set is described.
• Adjudication Method: Not applicable.
• Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not mentioned. No human readers or AI assistance are discussed.
• Standalone Performance: Not applicable, as this is a physical medical implant, not a software algorithm.
• Type of Ground Truth: Not applicable, as no ground truth for clinical performance is mentioned. The ground truth for mechanical testing would be the ASTM F1717 standard.
• Sample Size (Training Set): Not applicable, as no training set for an AI/ML model is mentioned.
• Ground Truth for Training Set: Not applicable.

In summary, the provided document is a 510(k) summary for a spinal implant, which relies on demonstrating substantial equivalence to a predicate device through mechanical testing and material compatibility, rather than clinical efficacy studies with specific performance metrics and acceptance criteria for a diagnostic or AI-based device.

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The Intended Use of the Sintea Biotech Traumafix (TFX) System is to obtain a safe, nonrigid fixation, to stimulate bone re-growth. The function of the Schanz Screw is to transfer axial forces between the bones and the rings of TFX system, in a mono-lateral construct. The Sintea Biotech external fixation screw is indicated for use in the external fixation of bone.

Schanz's screws are components of the Sintea Traumafix (TFX) system and were developed for external fixation according to Ilizarov's principle to treat severe articular fractures, pseudo-arthrosis and limb lengthening. The purpose of the TFX system is to obtain a safe, non-rigid fixation, to stimulate bone re-growth. The function of the Schanz's screws is to transfer axial forces between the bones and the rings of TFX system, in a mono-lateral construct. The Schanz's screws are available in three different diameters (4.0, 5.0, 6.0 mm) and three different lengths (120, 150, 180 mm). They consist of round bars having a thread at one end and a square tang at the other end to allow for easy screwing. Furthermore, the threaded length may be interrupted to allow bi-cortical fixation. The special shape of the threaded extremity makes the screws self-tapping.

Here's an analysis of the provided text regarding the Sintea Biotech Traumafix System with Schanz Screw, focusing on acceptance criteria and supporting studies:

This document is a 510(k) premarket notification for a medical device (Sintea Biotech Traumafix System with Schanz Screw). For such submissions, the acceptance criteria and study data typically revolve around demonstrating substantial equivalence to a previously legally marketed predicate device, rather than proving novel clinical effectiveness through extensive human trials. Therefore, the information provided is structured differently than what one might expect for a new drug or a high-risk novel device requiring de novo authorization or a PMA.

Based on the provided text, the device's acceptance criteria and the "study" that proves it meets them are primarily focused on mechanical testing and comparison to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states "Mechanical tests" were performed, but it does not specify the sample size for these tests. It also does not specify the data provenance (e.g., country of origin, retrospective/prospective). This is typical for 510(k) submissions focusing on bench testing rather than clinical data.

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

This information is not applicable to this type of submission. The "ground truth" for demonstrating substantial equivalence here is primarily established through direct comparison of materials, design, and performance in mechanical tests against a predicate device, not through expert review of clinical cases or images.

4. Adjudication Method for the Test Set

This information is not applicable as there is no expert review or human-in-the-loop performance measurement described in the document.

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 subject to a 510(k) clearance, which primarily relies on demonstrating substantial equivalence through bench testing and comparison to a predicate, not clinical efficacy studies involving human readers or AI assistance.

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

No, this product is a physical medical device (bone fixation system) and does not involve any algorithms or software that would have standalone performance.

7. The Type of Ground Truth Used

For this 510(k) submission, the "ground truth" is primarily based on:

• Engineering specifications and material standards: Ensuring the device meets predefined criteria for strength, durability, and biocompatibility.
• Direct comparison to a predicate device's established characteristics: The predicate device (Howmedica Osteonics Corp.'s Apex Fixation Pins) serves as the benchmark against which the new device is found "substantially equivalent" in design, materials, and intended function.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

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

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• The Sintea Posterior Lumbar System is a posterior, nonpedicle screw system of the noncervical spine indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, tumor, pseudoarthrosis, and failed previous fusion.

• The Sintea Biotech Posterior Lumbar 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 spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

• The Sintea Biotech Posterior Lumbar System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

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The provided document describes a medical device, the "Sintea Biotech Posterior Lumbar System," and its clearance process through a 510(k) premarket notification. This process assesses substantial equivalence to legally marketed predicate devices, rather than a clinical trial demonstrating new performance claims against acceptance criteria in the way a novel AI device might.

Therefore, many of the typical acceptance criteria and study elements you've requested (like AI performance, ground truth establishment for training sets, expert consensus, MRMC studies, etc.) are not applicable to this type of medical device submission.

However, I can extract information related to the device's design verification and validation, which serves as its "acceptance criteria" in this context, and the study (biomechanical testing) that proves it meets these criteria.

Here's a breakdown based on the provided text:

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

For this device, the "acceptance criteria" are compliance with established standards and demonstrated equivalence to predicate devices, focusing on safety and mechanical performance.

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

• Sample Size for Test Set: Not explicitly stated as a number of devices/constructs, but the description refers to "constructs made of titanium." The testing was likely performed on a sufficient number of samples to meet ASTM testing requirements and provide statistically significant results for mechanical strength. For mechanical testing, samples are typically physical specimens of the device or its components.
• Data Provenance: The testing was conducted by Sintea Biotech Inc. as part of their submission. It is internal testing performed by the manufacturer to demonstrate compliance with standards. It is prospective in the sense that the tests were designed and conducted specifically to support this regulatory submission. It is not patient data; it's laboratory testing data.

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

• Not Applicable. This device submission does not involve clinical data or "ground truth" derived from expert interpretation of medical images or patient outcomes in the way an AI diagnostic device would. The "ground truth" here is adherence to engineering standards and comparison to established predicate devices. The "experts" involved would be mechanical engineers and regulatory specialists ensuring compliance with the testing protocols and standards.

4. Adjudication Method for the Test Set

• Not Applicable. There is no "adjudication" in the clinical sense for this type of mechanical testing. The results are quantitative measurements against predefined ASTM standards (e.g., number of cycles survived, load at failure). The outcome is determined by whether the measurements meet the numerical thresholds set by the standard.

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

• No. An MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical data, often with or without AI assistance. The Sintea Biotech Posterior Lumbar System is an implantable surgical device, not a diagnostic tool requiring human interpretation of medical images for its primary function.

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

• Not Applicable. This device is a passive, implantable medical device, not an algorithm or AI system. Therefore, standalone performance in that context is irrelevant.

7. Type of Ground Truth Used

• The "ground truth" for this device's performance validation is compliance with established mechanical testing standards (ASTM) and demonstrated similarity to legally marketed predicate devices in terms of material, design, and intended use. This is primarily engineering and regulatory compliance ground truth, not clinical or pathological ground truth in the patient sense.

8. Sample Size for the Training Set

• Not Applicable. This device is not an AI algorithm; therefore, there is no "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 algorithm or training set, this question is not relevant.

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The Sintea Biotech Traumafix System is indicated for use in the following conditions: - Fracture . - Limb lengthening . - Reconstruction . - . Traction

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Here's an analysis of the provided text regarding the Sintea Biotech Traumafix System, structured to address your specific questions.

Based on the provided text, the Sintea Biotech Traumafix System received 510(k) clearance due to its substantial equivalence to a predicate device, the Lima-Lto External Circular Stabilizer (ECS). The documentation does not describe a study that proves the device meets specific acceptance criteria in the manner one might expect for a novel AI device or a new clinical claim. Instead, the acceptance is based on demonstrating equivalence to an already legally marketed device. Therefore, many of your specific questions regarding acceptance criteria and study details (like sample sizes, expert ground truth, MRMC studies, standalone performance, training sets) are not applicable or cannot be answered from this type of regulatory submission.

Acceptance Criteria and Device Performance

Explanation: The "acceptance criteria" here are effectively the criteria for establishing substantial equivalence to the predicate device. The “reported device performance” is the assertion by the manufacturer that their device meets these equivalence criteria.

Study Details and Ground Truth

Given that this is a 510(k) submission based on substantial equivalence to a predicate device, a traditional study to "prove the device meets acceptance criteria" in the sense of a new clinical investigation with detailed performance metrics was not performed for this specific device. Instead, the argument is that because it is essentially the "same device" as the predicate (Lima-Lto External Circular Stabilizer), its safety and effectiveness are established.

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

   • Not applicable for a distinct test set used for clinical performance validation of this specific device. The submission relies on mechanical tests and the established clinical performance of the predicate device. The text does not provide details of any specific clinical test set for the Sintea Biotech Traumafix System.

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. There is no mention of an expert panel establishing ground truth for a test set in the provided summary. Ground truth, in this context, is implicitly derived from the established safety and effectiveness of the predicate device as a legally marketed product.

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

   • Not applicable. No such adjudication method is described as there isn't a described clinical test set requiring such expert review.

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 device is a mechanical bone fixation system, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies and "human reader improvement with AI" are not relevant.

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

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

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

   • The "ground truth" for demonstrating safety and effectiveness is primarily the established clinical performance and safety record of the predicate device (Lima-Lto External Circular Stabilizer), combined with mechanical test data on the substantial equivalence of the Sintea Biotech Traumafix System's materials and design to the predicate. No new clinical outcomes data for the Sintea Biotech Traumafix System are presented in this summary.

7. The sample size for the training set:

   • Not applicable. As this is a mechanical device, there is no "training set" in the context of machine learning or AI.

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

   • Not applicable. See point 7.

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