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The SYNMESH™ Spacer is a vertebral body replacement device in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The SYNMESH Spacer is intended to be used with Synthes supplemental internal fixation of the SYNMESH Spacer can be packed with bone graft.

The SYNMESH™ System is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

The SYNMESH System spacer is a titanium vertebral body replacement device used in conjunction with supplemental internal fixation to provide structural stability in skeletally mature individuals following corpectomy/vertebrectomy. Different cross section sizes and heights are available to suit the individual pathology and anatomical conditions.

The SYNMESH System spacer consists of a cylindrical round or oblong mesh, end rings, standard rings and screws. The round mesh is used in pairs and is available in various diameters and heights. The oblong mesh is used individually and is also available in various cross-section sizes and heights.

The provided text is a 510(k) summary from the FDA for a medical device called the "SYNMESH™ System." It describes the device, its intended use, and claims substantial equivalence to a predicate device based on material and non-clinical performance testing.

However, the document DOES NOT contain information regarding the acceptance criteria or study details for an AI/algorithm-driven device.

Specifically, the device described is a spinal implant (vertebral body replacement device), which is a physical product, not a software or AI-driven diagnostic/treatment tool. As such, the concept of "acceptance criteria" related to AI performance metrics (like sensitivity, specificity, AUC) and studies involving expert readers, ground truth establishment, training/test sets, or MRMC studies are not applicable to this particular 510(k) submission.

The "performance data" mentioned (static/dynamic torsion, compression, expulsion, subsidence) refers to mechanical testing of the physical implant, not the performance of an AI algorithm.

Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and study proving an AI device meets them, as the provided document describes a physical medical implant.

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The T-PAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The T-PAL Spacer should be packed with autogenous bone graft (i.e. autograft).

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. These patients should be skeletally mature and have had six months of nonoperative treatment.

The T-PAL Spacer is intended to be used with DePuy Synthes supplemental fixation.

The T-PAL Spacer System is an interbody fusion device used in conjunction with supplemental internal fixation to provide structural stability in skeletally mature individuals following intervertebral discectomy. The T-PAL Applicator is used to insert the T-PAL Spacer into the disc space. The T-PAL Applicator is composed of an inner shaft and handle (outer shaft). The scope of this submission is to develop an additional T-PAL Applicator option for surgeons to facilitate insertion of the T-PAL Spacer and final positioning in the interbody disc space.

Here's an analysis of the provided text regarding the DePuy Synthes T-PAL Spacer System, focusing on the acceptance criteria and study information:

Based on the provided text, the device in question is the T-PAL Advanced Applicator which is a minor modification to the already cleared T-PAL Applicator. This submission (K181231) is for the modified applicator, not the T-PAL Spacer System itself, though the applicator is used with the spacer system.

The submission is a 510(k) for substantial equivalence. This means the device is being compared to a legally marketed predicate device (T-PAL Spacer System K100089 and DePuy Synthes T-PAL Ti Spacer System K151276) to demonstrate that it is as safe and effective.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated. The text mentions "mechanical testing simulated the insertion of the implant," but does not provide details on the number of tests, specific loads, cycles, or other parameters of the mechanical testing.
• Data Provenance: Not explicitly stated, but it is implied to be from internal lab testing conducted by the manufacturer, DePuy Synthes. There is no mention of country of origin for the data or whether it was retrospective or prospective. Given it's a 510(k) for a modified component, it's highly likely to be internal, prospective, laboratory-based testing.

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

• This information is not applicable and not provided in the document. The study described is mechanical testing, not a clinical study involving human assessment or expert review of images/data to establish ground truth.

4. Adjudication method for the test set

• This information is not applicable and not provided in the document. The study described is mechanical testing, which does not involve human adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• This information is not applicable and not provided in the document. The device is a surgical applicator (mechanical device), not an AI/software device that assists human readers in interpreting medical images or data.

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

• This information is not applicable and not provided in the document. The device is a mechanical surgical applicator, not an algorithm or AI.

7. The type of ground truth used

• The "ground truth" for the mechanical testing would be the engineering specifications and performance metrics defined by the manufacturer and relevant industry standards for surgical instruments. The device's performance was evaluated against these predefined mechanical acceptance criteria.

8. The sample size for the training set

• This information is not applicable and not provided in the document. As this is mechanical testing for a physical device, there is no "training set" in the context of machine learning or AI.

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

• This information is not applicable and not provided in the document. There is no training set mentioned or implied.

Summary of Device Performance Study and Conclusion:

The study performed was mechanical testing that simulated the insertion of the implant into an intervertebral body using the subject T-PAL Advanced Applicator. The purpose was to demonstrate that modifications to the applicator did not negatively impact its mechanical performance.

Conclusion: "The performance acceptance criteria was met." and "The insertion testing further demonstrates that the modifications to the design do not introduce any new questions of safety and effectiveness." The submission concludes that the T-PAL Advanced Applicator is substantially equivalent to the predicate devices.

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The VEPTR/VEPTR II device is indicated for skeletally immature patients with severe, progressive spinal deformities and/or three dimensional deformity of the thorax associated with or at risk of Thoracic Insufficiency Syndrome (TIS). TIS is defined as the inability of the thorax to support normal respiration or lung growth. This would include patients with progressive congenital, neuromuscular, idiopathic, or syndromic scoliosis.

In children with or at risk of developing Thoracic Insufficiency Syndrome, the natural course of lung development is arrested due to constriction by the thorax. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow.

The VEPTR devices are attached perpendicularly to the subject's natural ribs and lumbar vertebra or pelvis. This mechanically stabilizes the chest wall and enlarges the thorax to improve respiration and lung growth. Once the VEPTR/VEPTR II device is in place, its design allows for expansion, anatomic distraction, and replacement of component parts through less invasive surgery.

The VEPTR/VEPTR II devices allow assembly in a number of different configurations. All of these configurations are required to accommodate the wide variety of anatomical deformities encountered by the clinician in treating patients with or at risk of developing Thoracic Insufficiency Syndrome.

This document is a 510(k) Premarket Notification for the DePuy Synthes Spine Vertical Expandable Prosthetic Titanium Rib (VEPTR/VEPTR II) device. It is a medical device submission, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance in the way a diagnostic AI/ML device submission would.

Therefore, the requested information elements related to AI/ML device performance, ground truth, expert adjudication, sample sizes for training/test sets, and MRMC studies are not applicable to this document. This submission relates to a physical orthopedic implant, not a diagnostic algorithm.

Here's a breakdown of the applicable information:

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

Since this is a submission for a physical implant demonstrating substantial equivalence, "acceptance criteria" are not defined as specific performance metrics like sensitivity/specificity for an AI/ML diagnostic. Instead, the submission relies on comparison to predicate devices and mechanical testing standards.

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

• Test Set (for clinical evaluation of safety and effectiveness): The submission references the results of the HDE (H030009) post-market follow-up. The specific sample size for this HDE is not provided in this document summary.
• Data Provenance: The HDE (H030009) is a Humanitarian Device Exemption, typically involving devices for rare conditions. This indicates a clinical study with human subjects, likely multi-center, but the specific country of origin and retrospective/prospective nature are not detailed in this summary. HDEs are inherently prospective post-market follow-ups to gather data on probable benefit and safety.

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. This is not an AI/ML device where "ground truth" is established by experts for diagnostic performance. Clinical outcomes and safety were evaluated in the HDE study.

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

Not applicable. This is not an AI/ML device with a human-labeled test set requiring adjudication. Clinical trial data typically has pre-defined endpoints and evaluation criteria.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a physical orthopedic implant.

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

Not applicable. This is a physical orthopedic implant, not an algorithm.

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

The closest equivalent to "ground truth" here would be clinical outcomes data from the HDE post-market follow-up, which would involve patient data reflecting safety and probable benefit in treating Thoracic Insufficiency Syndrome.

8. The sample size for the training set:

Not applicable. This is a physical orthopedic implant, not an AI/ML model.

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

Not applicable. This is a physical orthopedic implant, not an AI/ML model.

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The Synthes Navigable Pedicle Preparation Instruments are intended to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or a vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. These procedures include but are not limited to spinal fusion.

The Navigable Pedicle Preparation Instruments are manual surgical instruments which are designed to interface with already-cleared surgical navigation systems. Instruments in this system may be pre-calibrated to already-cleared surgical navigation systems, or may be manually calibrated to already-cleared surgical navigation systems using manufacturers' instructions. These instruments are intended to be used in spine applications to perform general manual functions within the orthopaedic surgical environment.

This is a 510(k) summary for a set of surgical instruments, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study data, expert involvement, and ground truth for an AI device is not applicable and cannot be extracted from the provided text.

The document describes the Synthes Navigable Pedicle Preparation Instruments, which are manual surgical instruments designed to interface with existing surgical navigation systems.

Here's a breakdown of the relevant information provided:

1. Acceptance Criteria and Reported Device Performance (Non-AI/ML):

2. Sample size used for the test set and data provenance (Not applicable for AI/ML):

The document mentions "usability testing" as a validation activity in the "Performance Data" section. However, it does not specify sample sizes for test sets, data provenance (e.g., country of origin), or whether the data was retrospective or prospective, as these details are typically associated with clinical studies or AI/ML performance evaluations, not characterization of manual surgical instruments.

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

This information is not provided because the validation involved usability testing of manual instruments, not the establishment of ground truth for an AI/ML algorithm.

4. Adjudication method (Not applicable for AI/ML):

This concept is not relevant to the validation described.

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 for AI/ML):

No MRMC study was conducted as this device is not an AI/ML system or a reading assistance tool.

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

This is not applicable as the device is a set of manual surgical instruments.

7. The type of ground truth used (Not applicable for AI/ML):

Ground truth as it relates to AI/ML performance is not relevant here. The validation focused on the functional performance and usability of the physical instruments.

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

There is no "training set" in the context of manual surgical instrument validation, as this is a concept associated with AI/ML model development.

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

This is not applicable for the reasons stated above.

In summary: The provided 510(k) summary focuses on demonstrating the substantial equivalence of manual surgical instruments through non-clinical performance testing (usability testing). It does not contain the detailed information related to AI/ML device validation, such as specific acceptance criteria for algorithm performance, sample sizes for test/training sets, expert involvement in ground truth establishment, or comparative effectiveness studies of AI assistance. The document explicitly states: "Clinical data was not needed for the Navigable Pedicle Preparation Instruments."

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The Synthes USS are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis).

When treating patients with Degenerative Disc Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct.

When used with the 3.5 mm/6.0mm parallel connectors, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5mm Systems. In addition, when used with 3.5 mm/5.0mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5mm Systems. When used with the 5.0 mm/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0 mm rod systems. When used with the 5.5 mm/6.0mm parallel or extension connectors, Synthes USS 5.5 mm rod systems can be linked to the Synthes USS 6.0 mm rod systems. 5.5 mm/5.5mm parallel or extension connectors can be used to link all Synthes USS 5.5 mm rod systems to one another. 6.0 mm/6.0mm parallel or extension connectors can be used to link all Synthes USS 6.0 mm rod systems to one another.

Rod-to-rod connectors can be used to link all Synthes USS 5.5 mm rod systems to one another.

When used with the 3.5 mm/6.0mm and 4.0 mm/6.0mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 3.5 mm/5.5mm and 4.0 mm/5.5 mm tapered rods, Synthes USS 5.5 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 5.5 mm/6.0mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to Synthes USS 5.5 mm rod systems.

In addition, Synthes USS 6.0 mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors except Synthes 6.0 mm cobalt-chromium-molybdenum alloy and titanium grade 3 rods, which can only be used with Pangea. Synthes USS 5.5 mm rod systems can be interchanged with all USS 5.5 mm rods and transconnectors.

This is an addition to Synthes' existing non-cervical spinal fixation devices intended for are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). The current system is comprised of monoaxial and polyaxial screws, rods, locking caps, transverse bars and connectors. The additional locking cap in this submission is manufactured of cobalt chrome (Cobalt- 28Chromium - 6Molybdenum per ASTM F1537 - 08).

The provided text describes a 510(k) Summary for a medical device called the "Synthes Matrix System," which is an addition to an existing line of non-cervical spinal fixation devices. The document explicitly states that clinical data and conclusions were NOT needed for this device. This means that the information requested regarding acceptance criteria, study design, sample sizes, expert ground truth, MRMC studies, standalone performance, and training sets is not available in this document because a clinical study was not performed or deemed necessary for this 510(k) submission.

The acceptance criteria and proof of meeting them are based on non-clinical performance data (bench testing), which demonstrated equivalence or superiority to predicate devices.

Here's a breakdown of the available information:

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

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

• Sample Size for Test Set: Not specified. (Refers to mechanical testing specimens, not human subjects or a data set for an AI model).
• Data Provenance: Not applicable in the context of human data. The data comes from bench testing of the device components.

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

• Experts: Not applicable. Ground truth for mechanical testing is established by engineering specifications and direct measurement, not expert consensus on medical images or diagnoses.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. This is mechanical bench testing, not a clinical study requiring adjudication of diagnostic outcomes.

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

• MRMC Study: No. This device is a spinal implant, not an AI or diagnostic imaging device. No human reader studies were performed or relevant.

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

• Standalone Performance: Not applicable. This is a physical medical device (spinal implant), not an algorithm or AI.

7. The type of ground truth used

• Ground Truth: For mechanical testing, the ground truth is based on the physical properties and performance characteristics defined by engineering standards (e.g., ASTM F1717-11a) and compared against the performance of legally marketed predicate devices.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. There is no AI model or learning algorithm mentioned or relevant to this device.

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

• Ground Truth for Training Set: Not applicable. There is no AI model or learning algorithm mentioned or relevant to this device.

In summary, this 510(k) submission relied on non-clinical (bench) testing to demonstrate substantial equivalence to predicate devices, and explicitly stated that clinical data was not required. Therefore, all questions pertaining to clinical study design, human data, expert review, and AI model specifics are not addressed by the provided document.

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The Synthes Zero-P VA is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the spacer component of the Synthes Zero-P VA should be packed with autogenous bone graft and implanted via an anterior approach.

The Synthes Zero-P VA is a radiolucent and radiopaque intervertebral body fusion device. The Synthes Zero-P VA is composed of a spacer made from Invibio® PEEK-Optima® LT-1 (ASTM F2026) with a single posterior titanium alloy (Ti-6Al-4V ELI; TAV; ASTM F136-2a) radiopaque marker. The marker allows accurate intra-operative radiographic assessment of the position of the implant. The spacer component is preassembled with a mating titanium alloy (Ti-6Al-7Nb: TAN; ASTM F1295) interbody plate. The device is implanted anteriorly by inserting two screws (TAN) through the plate, one screw per vertebral body. The interbody plate incorporates a lock-catch mechanism in each screw hole comprised of a TAV lock-screw and catch, as well as an Elgiloy (ASTM F1058) spring. The screws offered with the Zero-P VA system are 3.7mm in diameter and are currently offered non-sterile. This line extension covers the addition of sterile-packed screws.

The provided document is a 510(k) summary for the Synthes Zero-P VA device, specifically for an extension covering sterile-packed screws. It describes the device, its intended use, and its equivalence to predicate devices. However, this document states that "Non-clinical performance data and conclusions were not needed for this device" and "Clinical data and conclusions were not needed for this device."

Therefore, the information required to answer the specific questions about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not present in this document. This 510(k) relies on demonstrating substantial equivalence to previously cleared predicate devices without requiring new performance studies for this specific modification (sterile-packed screws).

To fully answer your questions, one would need to refer to the performance data and studies conducted for the original Synthes Zero-P VA device (K112068) and its earlier versions (K093762, K112459), or if such studies were performed for those previous clearances. This document explicitly states that no new performance data was needed for this particular 510(k) submission.

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The Scout Vessel Guard System is indicated as a cover for vessels during anterior vertebral surgery.

The Synthes Scout Tack Fixation is a method of fixation of the Scout Vessel Guard to bone. The single-use Scout Tack implant is made of a titanium alloy (TAN, per ASTM F1295-05, "Standard Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)," January 1, 2005). It has a low profile head. The tack is inserted by light impaction through the Scout Vessel Guard into lumbar vertebral bone. The Scout Tack implant can be used as an alternative to, or a complement to, suturing the Scout Vessel Guard in place.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample sizes for each test (pullout, dynamic mechanical, dynamic biomechanical, and usability). However, it implies that the tests involved sufficient samples to draw conclusions about equivalence or superiority.

The data provenance is not explicitly stated as "country of origin," but the testing was conducted by Synthes, an American company. The tests are described as "non-clinical," and the phrase "cadaver lab testing" suggests a controlled, pre-clinical environment. The study is retrospective in the sense that it evaluates the device's performance against established predicate devices and methods.

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

The document does not mention the number of experts used or their specific qualifications for establishing ground truth in the non-clinical tests. For usability testing in cadaver labs, it is implied that surgeons or trained professionals evaluated the device, but their number and specific qualifications (e.g., years of experience, specialty) are not provided.

4. Adjudication Method for the Test Set:

The document does not describe a formal adjudication method. The evaluation of test results (e.g., pullout strength measurements, mechanical properties) would typically involve engineering analysis and comparison against pre-defined thresholds or predicate device performance. For usability, it's likely a qualitative assessment by the testing personnel.

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

No, an MRMC comparative effectiveness study was not done. The tests described are non-clinical, mechanical, and biomechanical evaluations, along with cadaver lab usability, not studies involving multiple human readers interpreting cases.

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

Not applicable. This device is a physical medical device (tack fixation) and not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used:

The ground truth used for these non-clinical tests was based on direct measurements of mechanical properties (e.g., pullout strength, dynamic response) and observations of usability in a cadaver model, compared against the performance of established predicate devices and traditional fixation methods (suturing). There is no "pathology" or "outcomes data" ground truth as this is a pre-clinical evaluation.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not a machine learning algorithm, 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 for this type of device.

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The Synthes USS are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (TI-S2/ilium), posterior hook fixation (TI-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis).

When treating patients with Degenerative Disc Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct.

When used with the 3.5 mm/6.0mm parallel connectors, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5mm Systems. In addition, when used with 3.5 mm/5.0mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5mm Systems. When used with the 5.0 mm/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0 mm rod systems. When used with the 5.5 mm/6.0mm parallel or extension connectors, Synthes USS 5.5 mm rod systems can be linked to the Synthes USS 6.0 mm rod systems. 5.5 mm/5.5mm parallel or extension connectors can be used to link all Synthes USS 5.5 mm rod systems to one another. 6.0 mm/6.0mm parallel or extension connectors can be used to link all Synthes USS 6.0 mm rod systems to one another.

When used with the 3.5 mm/6.0mm and 4.0 mm/6.0mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 3.5 mm/5.5mm and 4.0 mm/5.5 mm tapered rods, Synthes USS 5.5 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 5.5 mm/6.0mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to Synthes USS 5.5 mm rod systems.

In addition, Synthes USS 6.0 mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors except Synthes 6.0 mm cobalt-chromium-molybdenum alloy and titanium grade 3 rods, which can only be used with Pangea. Synthes USS 5.5 mm rod systems can be interchanged with all USS 5.5 mm rods and transconnectors.

Synthes USS
6.0 mm Rod Systems: USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, USS Iliosacral, ClampFix
5.5 mm Rod System: Matrix, MIRS
5.0 mm Rod System: USS Small Stature

CerviFix
3.5 mm Rod Systems: CerviFix, Axon, Synapse
4.0 mm Rod System: Synapse

This is an addition to Synthes' existing non-cervical spinal fixation devices intended for posterior pedicle screw fixation (TI-S2/ilium). posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). The current system is comprised of monoaxial and polyaxial screws, rods, locking caps, transverse bars and connectors. The new sagittal screw that is the subject of this submission is similar to the already-cleared polyaxial screw and is manufactured of TAN (Titanium-6 Aluminum-7 Niobium Alloy per ASTM F1295 - 05 ). These screws restrict head angulation to the direction parallel to the rod slot (typically the cranial/caudal direction).

The provided text describes a 510(k) summary for the Synthes Matrix System, a medical device for spinal fixation, and its substantial equivalence to predicate devices, rather than a study proving the device meets specific performance criteria.

Therefore, many of the requested categories for AI/algorithm performance and study design are not applicable as this document pertains to a medical device submission, not an AI or software study.

However, I can extract the relevant information regarding performance data and acceptance criteria based on the provided text.

Here's a breakdown of the requested information based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as numerical thresholds for specific performance metrics in the context of an AI study. Instead, it refers to the device demonstrating "equivalently or superiorly" to predicate devices.

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

Not Applicable (N/A) - This document describes non-clinical bench testing for a physical medical device (spinal fixation system), not a study with a test set of data (images, clinical records, etc.) for an AI algorithm. The performance data is from mechanical bench testing, not a clinical data set.

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

N/A - Ground truth as defined for an AI study (e.g., expert consensus on image interpretation) is not applicable here. The "ground truth" for mechanical testing would be the physical properties and performance metrics measured using established engineering standards.

4. Adjudication method for the test set

N/A - This concept is relevant for studies involving human judgment or interpretation (like image reading). For mechanical bench testing, data is typically collected directly from instruments and analyzed against engineering standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

N/A - This is an AI-specific study type. The document describes a physical medical device and its mechanical testing.

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

N/A - This refers to AI algorithm performance. The Synthes Matrix System is a physical implantable device.

7. The type of ground truth used

For the non-clinical performance data, the "ground truth" (or reference standard) inherently comes from established engineering standards and physical measurements obtained during mechanical bench testing. Specifically, it adheres to ASTM F1717-11a, an American Society for Testing and Materials standard for spinal implant constructs.

8. The sample size for the training set

N/A - This document does not describe the development or testing of an AI algorithm, and therefore there is no "training set."

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

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

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The Synthes USS are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), turnor, stenosis, and failed previous fusion (pseudoarthrosis).

When treating patients with Degenerative Disc Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct.

When used with the 3.5 mm/6.0mm parallel connectors, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5mm Systems. In addition, when used with 3.5 mm/5.0mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5mm Systems. When used with the 5.0 mm/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0 mm rod systems. When used with the 5.5 mm/6.0mm parallel or extension connectors, Synthes USS 5.5 mm rod systems can be linked to the Synthes USS 6.0 mm rod systems. 5.5 mm/5.5mm parallel or extension connectors can be used to link all Synthes USS 5.5 mm rod systems to one another. 6.0 mm/6.0mm parallel or extension connectors can be used to link all Synthes USS 6.0 mm rod systems to one another.

Rod-to-rod connectors can be used to link all Synthes USS 5.5 mm rod systems to one another.

When used with the 3.5 mm/6.0mm and 4.0 mm/6.0mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 3.5 mm/5.5mm and 4.0 mm/5.5mm tapered rods, the Synthes USS 5.5 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 5.5 mm/6.0mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to the Synthes USS 5.5 mm rod systems.

In addition, Synthes USS 6.0 mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors except Synthes 6.0 mm cobalt-chromium-molybdenum alloy and titanium grade 3 rods, which can only be used with Pangea. Synthes USS 5.5 mm rod systems can be interchanged with all USS 5.5 mm rods and transconnectors.

The Synthes USS Connector is an addition to Synthes' existing non-cervical spinal fixation devices intended for posterior pedicle screw fixation (TI-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). These components are rod-to-rod connectors which can connect spinal rods of 5.5mm diameter. The rod-to-rod connectors are comprised of TAN (Titanium-6 Aluminum-7 Niobium, per ASTM F1295-05).

This document describes the 510(k) summary for the Synthes USS Connector, a spinal fixation device. It details the device's intended use, indications for use, and performance data.

Here's an analysis of the provided information, framed as acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

Study used to prove device meets acceptance criteria:

The study proving the device meets the acceptance criteria is described as non-clinical testing conducted according to ASTM F1717-10. This standard covers "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model."

2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size for the non-clinical testing (e.g., number of connectors tested). It only mentions "non-clinical testing."

Data Provenance: Not applicable, as this was non-clinical (mechanical) testing, not human-subject or clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for mechanical testing is established by engineering standards and measurements, not by expert consensus.

4. Adjudication method for the test set
Not applicable. Adjudication methods are typically used for subjective assessments (e.g., image interpretation) or clinical outcomes, not for objective 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
No MRMC comparative effectiveness study was done. This document describes a spinal implant, not an AI-powered diagnostic or assistive device.

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, not an algorithm.

7. The type of ground truth used
The ground truth used for mechanical performance testing is the specifications and requirements outlined in ASTM F1717-10. The acceptance criterion for mechanical performance is that the device demonstrates mechanical characteristics (strength, fatigue resistance) that are "substantially equivalent" to predicate devices, as measured against the forces described in the ASTM standard.

8. The sample size for the training set
Not applicable. There is no concept of a "training set" for the mechanical testing of a physical medical device. This is not an AI/ML product.

9. How the ground truth for the training set was established
Not applicable, as there is no training set.

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The Synthes USS are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis).

When treating patients with Degenerative Disc Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct.

When used with the 3.5/6.0mm parallel connectors, the Synthes USS 6.0mm rod systems can be linked to the CerviFix 3.5mm Systems. In addition, when used with 3.5/5.0mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5mm Systems. When used with the 5.0/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0mm rod systems. When used with the 5.5/6.0mm extension connectors, Matrix can be linked to the Synthes USS 6.0mm rod systems. 6.0/6.0mm extension connectors can be used to link all Synthes USS 6.0mm rod systems to one another.

When used with the 3.5/6.0mm and 4.0/6.0mm tapered rods, the Synthes USS 6.0mm rod systems can be linked to the CerviFix 3.5mm and 4.0mm Systems, respectively. When used with the 3.5/5.5mm and 4.0/5.5 mm tapered rods, Matrix can be linked to the CerviFix 3.5mm and 4.0mm Systems, respectively. When used with the 5.5/6.0mm tapered rods, the Synthes USS 6.0mm rod systems can be linked to the Matrix System.

In addition, Synthes USS 6.0mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors except Synthes 6.0mm cobalt-chromium-molybdenum alloy and titanium grade 3 rods, which can only be used with Pangea.

The Synthes USS Line Extension is an addition to Synthes' existing non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). These components are in-line extension connectors which can connect spinal rods of the same or different diameters. The in-line extension connectors are comprised of TAN (Titanium-6 Aluminum-7 Niobium, per ASTM F1295-05).

The document describes the K113149 510(k) submission for the Synthes USS Line Extension (connectors), which are non-cervical spinal fixation devices.

Here's an analysis of the provided text with respect to your questions:

1. Table of acceptance criteria and the reported device performance

Explanation: The acceptance criteria are implicitly met if the "non-clinical testing according to ASTM F1717-10 - static compression bending, static torsion, and dynamic compression bending - to determine that the Synthes USS Connector is substantially equivalent to the predicate devices identified" was successful. The document states that the testing was conducted "to determine" this, and the FDA's clearance implies the substantial equivalence was demonstrated.

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

The document does not explicitly state the specific sample sizes (number of devices tested) for the non-clinical tests. It refers to "non-clinical testing according to ASTM F1717-10". ASTM F1717-10 is a standard for testing spinal implant constructs, and it would specify the required number of samples for each test type. The data provenance is non-clinical, meaning it's from laboratory testing rather than human subjects. The country of origin for the data is not specified, but the firm (Synthes Spine) is located in West Chester, PA, USA.

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

This question is not applicable to this type of device and study. The "ground truth" for mechanical testing is based on the physical properties and performance measured against a standard (ASTM F1717-10), not on expert consensus or human interpretation.

4. Adjudication method for the test set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies involving expert review of medical images or patient outcomes, not for mechanical bench 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 question is not applicable. MRMC studies are relevant for AI-powered diagnostic or interpretive devices that assist human readers (e.g., radiologists). This submission concerns a physical medical device (spinal connectors), not a diagnostic algorithm.

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

This question is not applicable. This is not an algorithm or AI device.

7. The type of ground truth used

The ground truth used for these non-clinical tests is the performance metrics defined by the ASTM F1717-10 standard and the performance characteristics of the identified predicate devices. The new device's performance is compared against these established benchmarks to demonstrate substantial equivalence.

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of mechanical bench testing for spinal implants. Training sets are relevant for machine learning or AI models.

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

This question is not applicable for the same reason as #8.

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