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The CastleLoc-S Posterior Cervical Fixation System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fosion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine (TI-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The CastleLoc-S Posterior Cervical Fixation System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The CastleLoc-S Posterior Cervical Fixation System can be linked to the LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System and AccelFix Spinal Fixation System via rod to rod connector and transitional rod.

The CastleLoc-S Posterior Cervical Fixation System is a top-loading, multiple components, posterior (cervical-thoracic) spinal fixation system which consists of poly screw, Reduction poly screw, partially screw, semi-reduction partially screw, straight rod, set screw, hooks and accessories that can be used via an open surgical approach. The devices are manufactured from titanium alloy per ASTM F136 and cobalt chromium per ASTM F1537.

This document is a 510(k) Premarket Notification from L&K Biomed Co., Ltd. for their CastleLoc-S Posterior Cervical Fixation System. It asserts substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria or provide new device performance data. Instead, it relies on the assertion of identicality and substantial equivalence to predicate devices. The "performance" is implicitly deemed acceptable because the device is stated to be identical to already cleared devices that met the necessary performance standards.

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

No new test set was used for this submission to establish substantial equivalence based on performance. The document states: "The CastleLoc-S Posterior Cervical Fixation System is identical to the predicates; mechanical testing is not required to establish substantial equivalence."

A risk assessment, including ASTM F1717 testing for static compression bending and static torsion mechanical testing, was conducted "to confirm that the additional components do not introduce new issues of safety or effectiveness." However, this testing was performed on predicate devices, and the data from those previous clearances (K103414, K120879, K143278, K162136, K200793) was leveraged.

Therefore, there is no distinct "test set" and no new data provenance for the CastleLoc-S system's performance.

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

Not applicable. No new studies requiring expert-established ground truth were performed for this submission, as the device's performance is asserted through substantial equivalence to predicate devices.

4. Adjudication Method for the Test Set:

Not applicable. No new studies requiring adjudication were performed.

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

No MRMC comparative effectiveness study was done. This type of study is typically associated with AI/software devices and would measure the improvement of human readers with AI assistance. The CastleLoc-S system is a physical medical device (spinal fixation system), not an AI diagnostic tool.

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

Not applicable. The CastleLoc-S system is a physical medical device, not an algorithm or software.

7. Type of Ground Truth Used:

Not applicable, as no new performance studies for the CastleLoc-S system were conducted for this submission. The "ground truth" for the predicate devices' performance would have been established through mechanical testing standards (e.g., ASTM F1717 for static compression bending and static torsion) which define acceptable physical properties and performance characteristics for spinal fixation systems.

8. Sample Size for the Training Set:

Not applicable. The CastleLoc-S system is a physical medical device. It does not employ a "training set" in the context of machine learning or AI models.

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

Not applicable. As above, there is no "training set" for this physical device.

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The CastleLoc-P Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization of the spine as an adjunct to fusions in patients with:

• · degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
• · spondylolisthesis,
• · trauma (i.e. fractures or dislocations),
• · tumors,
• · deformity (defined as kyphosis, lordosis, or scoliosis),
• · pseudoarthrosis.
• · failed previous fusion,
• · spinal stenosis.

The AccelFix Lumbar Plate System is indicated for use via the anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels as an adjunct to fusion. This system is indicated in the treatment of lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, scoliosis, spondylolisthesis, lordotic deformities of the spinal stenosis, or a failed previous spine surgery.

The CastleLoc-P Anterior Cervical Plate System is composed of plates, screws and lockers which are made from titanium alloy per ASTM F136. These plates attach to the anterior cervical spine with a minimum of four screws per plate. The plates are offered in one-level, two-level, four-level fusion configurations (13~97mm). The plate screws are 3.5mm and 4.0mm diameter head screws. They are self-tapping and self-drilling threaded. This device can be provided both as non-sterile.

The AccelFix Lumbar Plate System's implants are Lumbar Plate System intended for use as an aid in spinal fixation. They are made from titanium alloy per ASTM F136. The AccelFix Lumbar Plate System consists of a variety of shapes and sizes of plates and screws. The plate has been designed to include spikes for added stability and alignment during screw insertion. The plates feature a curvature for anatomic fit. The diameter of screw is available from 5.5 to 6.0 mm and the length from 20 to 55 mm.

This document is a 510(k) Pre-Market Notification from the FDA, which declares substantial equivalence for medical devices to legally marketed predicate devices. It typically does not contain acceptance criteria or study results demonstrating performance in the way a clinical trial or AI device validation would.

Instead, the FDA 510(k) process focuses on demonstrating substantial equivalence to a predicate device. This means showing that the new device is as safe and effective as a legally marketed device that is not subject to pre-market approval (PMA).

Based on the provided text, here's what can be extracted and inferred regarding "acceptance criteria" and "study":

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

This document does not contain a table of acceptance criteria or reported device performance in the context of diagnostic accuracy or clinical outcomes for the CastleLoc-P Anterior Cervical Plate System or the AccelFix Lumbar Plate System. The submission is a 510(k) for spinal intervertebral body fixation orthoses, which are mechanical implants, not AI/diagnostic devices.

The "performance testing" section, specifically for the CastleLoc-P Anterior Cervical Plate System and AccelFix Lumbar Plate System, states:

"The additional components to be added through this submission do not require additional mechanical testing. None of the additional components is the worst case of the CastleLoc-P Posterior Anterior Cervical Plate System."
"Therefore, we substitute mechanical test data of CastleLoc-P Anterior Cervical Plate System (predicate devices K113509, K143279, K190425) and AccelFix Lumbar Plate System (predicate device K 192481) for additional components with the predicate device data."

This indicates that instead of new performance tests for the new components, the company relied on the existing mechanical test data of the predicate devices. Therefore, the "acceptance criteria" implied are that the new components perform no worse than the predicate devices' mechanical properties. However, these specific mechanical properties (e.g., fatigue strength, torsional rigidity) and their quantitative acceptance limits are not detailed in this document.

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

Not applicable. As explained above, no new performance study with a test set of data (e.g., patient cases) was conducted for these devices as part of this 510(k). The evaluation relies on the substantial equivalence to predicate devices, including their prior mechanical testing.

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

Not applicable. This is not a study involving ground truth established by experts for a diagnostic or AI device.

4. Adjudication method for the test set:

Not applicable. No such test set or adjudication process is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

Not applicable. This is not a diagnostic device for which an MRMC study would typically be performed.

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

Not applicable. This is a spinal implant, not an algorithm or AI device.

7. The type of ground truth used:

Not applicable. "Ground truth" in the context of diagnostic or AI studies is not relevant here. The evaluation instead relies on conformity to material specifications (ASTM F136) and the mechanical performance previously established for the predicate devices.

8. The sample size for the training set:

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

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

Not applicable. There is no "training set" or corresponding ground truth establishment process described.

In summary:

This 510(k) submission for the CastleLoc-P Anterior Cervical Plate System and AccelFix Lumbar Plate System focuses on demonstrating substantial equivalence to existing predicate devices. The "study" mentioned for performance is the reliance on prior mechanical test data of the predicate devices. The document does not provide details on specific acceptance criteria and detailed performance data from new studies in the manner typically expected for AI/diagnostic software.

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The PathLoc SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The PATHLOC SI Joint Fusion System consists of different diameter bone screws in various lengths and thread configurations to accommodate variations in patient anatomy. The devices are manufactured from titanium alloy per ASTM F136.

• Arch Screw will be implanted in patient's bone then autograft will be inserted.
• Locking Screw can be used with washer or can be used on its own
• Self-tapping flute centers screw for easy insertion

This document is a 510(k) summary for the PathLoc SI Joint Fusion System, a Class II medical device. It's important to understand that a 510(k) submission primarily demonstrates "substantial equivalence" to existing legally marketed devices, rather than proving novel effectiveness or safety through extensive clinical trials.

The provided text focuses on the device's design, materials, and substantial equivalence to predicate devices, but does not contain information regarding studies that prove the device meets specific acceptance criteria based on performance metrics such as accuracy, sensitivity, or specificity, which would typically be found for AI/ML-driven devices or diagnostics.

Therefore, I cannot provide a response filling the requested sections as the document describes a traditional mechanical medical device, not one with performance characteristics that would be evaluated with the type of study design you're asking about (e.g., AI/ML performance, diagnostic accuracy etc.).

The document explicitly states:

• "A risk assessment, including FE analysis, was conducted to confirm that the additional components do not introduce new issues of safety or effectiveness. And the results of the risk assessment were confirmed, and that there were no problems with safety and effectiveness. None of the additional components is the worst case of the PathLoc SI Joint Fusion System and the additional components to be added through this submission do not require additional mechanical testing."
• "Therefore, we substitute mechanical test data of PathLoc SI Joint Fusion System for additional components with the predicate device data (K153656/K181600)."

This indicates that the "performance testing" was primarily a risk assessment and Finite Element (FE) analysis, comparing the new components to previously cleared predicate devices based on mechanical properties and safety, not a clinical study evaluating diagnostic or therapeutic accuracy against a ground truth.

To directly answer your prompt, the information about acceptance criteria and study proving device performance as you've outlined (e.g., sample size, expert ground truth, MRMC study, standalone performance, training set details) is not present in this 510(k) summary because it's not relevant for this type of device submission. This is a mechanical implant, not an AI or diagnostic device that would require such performance evaluations.

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The ASK System is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, primary and secondary traumatic arthritis, avascular necrosis of the femoral condyle, posttraumatic loss of joint configuration. Moderate valgus, varus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. This device may also be indicated in correction of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure. The ASK System is designed for cemented use only.

The ASK System is of the fixed bearing type with a posterior stabilized design and cruciate retained design. It is a patellofemorotibial, polymer/metal/ polymer, semi-constrained, cemented knee prosthesis that consists of a femoral component, tibial insert, tibial tray, and patellar component. The femoral component articulates with the tibial insert component. The underside of the tibial insert component is flat and "snaps" into the tibial baseplate component. The design and sizing of the femoral components correspond to the natural femoral anatomy, enhancing stress distribution and restoring original femoral dimensions and normal rotation, extension and flexion. Each femoral component has the same intercondylar distance and radius of curvature. Each tibial insert component is complimentarily shaped to conform to the femoral component. The dome shape of each UHMWPE patellar component provides excellent contact with the femoral component and evenly distributes stresses. The dome shape of each patellar component also simplifies implantation by eliminating the need for rotational orientation.

This document does not contain information about an AI/ML medical device. The submitted text is a 510(k) premarket notification for "The ASK System," which is a knee joint prosthesis. As such, it describes the physical and mechanical testing of the prosthesis, not the performance of an AI/ML algorithm.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device, as the provided text pertains to a traditional medical device (knee implant).

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VENUS Lumbar Intervertebral body Fusion Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bone graft. VENUS Lumbar Intervertebral body Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.

The VENUS Lumbar Intervertebral body Fusion Cage System is intended to help provide support in the intervertebral body space during fusion of vertebral bodies in the lumbar spine. This system is intended to be used with supplemental fixation. The VENUS Lumbar Intervertebral body Fusion Cage System consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The Implants are made of PEEK-OPTIMA® LTI body with the titanium marker pins made of Titanium alloy (Ti-6Al-4V ELI). The purpose of this submission is to add the size of the devices.

Here's an analysis of the provided text regarding the VENUS Lumbar Intervertebral body Fusion Cage System, focusing on acceptance criteria and supporting studies:

Acceptance Criteria and Device Performance Study for VENUS Lumbar Intervertebral body Fusion Cage System (K121096)

Based on the provided 510(k) summary, this submission is a Special 510(K) for a line extension, specifically to add additional device sizes to an already cleared intervertebral body fusion cage system. This type of submission relies heavily on substantial equivalence to previously cleared devices rather than new, extensive clinical or non-clinical performance studies to establish acceptance criteria for a novel device.

Therefore, the "acceptance criteria" here are primarily met through demonstrating that the proposed size additions do not introduce new safety or effectiveness concerns, and that the device, with its new sizes, remains substantially equivalent to its predicates.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. This submission is for a line extension based on substantial equivalence to predicate devices, not a new device requiring a separate "test set" in the context of clinical or performance data generation. The "test" here is the comparison of the design characteristics of the newly sized devices against the previously cleared predicate devices.
• Data Provenance: Not applicable in the context of generating new clinical or performance data. The "data" used is the existing regulatory clearances and technical specifications of the predicate devices.

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

• Not applicable. Ground truth, in the sense of clinical outcome or diagnostic accuracy, is not being established for a new device here. The regulatory review process involves FDA experts to assess substantial equivalence.

4. Adjudication Method for the Test Set

• Not applicable. There is no "test set" in the sense of evaluating diagnostic performance or clinical outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• No, a MRMC comparative effectiveness study was not done. This type of study is typically for evaluating the diagnostic performance of AI or imaging devices with human readers, which is not relevant to a spinal implant line extension applying for 510(k) clearance based on substantial equivalence.

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

• No, a standalone performance study was not done. This is not an AI or algorithm-based device.

7. The Type of Ground Truth Used

• The "ground truth" for this submission is the established safety and effectiveness of the identified predicate devices through their prior FDA clearances (K110783, K120063, K100516, K083661, K090816, K093704, K092162, K043405, K052210, K071795, K081611, K081888, K101720, K100175, K112405, K113528). The submission's "truth" is that the new sizes do not alter this established safety and effectiveness.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" as this is not an AI/ML device or a study involving data modeling.

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

• Not applicable. There is no "training set" for this device.

Summary Rationale for K121096 (Line Extension):

This 510(k) submission for the VENUS Lumbar Intervertebral body Fusion Cage System is a "Special 510(k)" specifically for a line extension to add more device sizes. In this context, the primary "study" is the non-clinical comparison to predicate devices to demonstrate substantial equivalence.

The core argument is that the expanded sizes do not introduce new questions of safety or effectiveness because:

• The fundamental design remains the same.
• The materials are identical.
• The intended use and indications for use are unchanged.
• The added sizes are within the expected physiological range and manufacturing capabilities already established for the predicate devices, thus not constituting a "new worst case."

Therefore, the "acceptance criteria" are met by successfully demonstrating this robust substantial equivalence to already cleared devices through non-clinical reasoning and comparison, rather than through new human clinical trials or extensive novel performance testing.

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The LEXUS Cervical Fixation System is indicated for the following:

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

The implants are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following the reduction of fractures/dislocations or trauma in the spine.

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

The pedicle screws are limited to placement in T1 -T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.

The purpose of this 510(k) submission is to add reduction polyaxial screws and curved rods. The LEXUS Cervical Spinal Fixation System is a top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system which consists of polyaxial screws, reduction poly screws, straight rods, curved rods, set screws, and hooks.

Materials: All products are made of titanium alloy (Ti-6A1-4V ELI/ in conformance with ASTM F136) approved for medical use.

Here's an analysis of the provided text regarding the acceptance criteria and study for the LEXUS Cervical Fixation System:

This device (LEXUS Cervical Fixation System) is a Spinal Fixation System, and its "performance" is evaluated based on mechanical testing, not on parameters usually associated with AI/software devices (like sensitivity, specificity, or accuracy in diagnosing conditions). Therefore, many of the typical questions for AI medical devices (like expert adjudication, MRMC studies, training set details, etc.) are not applicable to this type of medical device submission.

The acceptance criteria here relate to the structural integrity and mechanical properties of the implants.

Acceptance Criteria and Reported Device Performance

Explanation: The "acceptance criteria" for this physical device are the standards set by ASTM F1717 for spinal fixation systems. The "reported device performance" indicates that the device was tested against and found to meet these established standards. The submission asserts that because it meets these recognized consensus standards, it is substantially equivalent in safety and effectiveness to predicate devices.

Study Details

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

   • Test Set Sample Size: Not explicitly stated in terms of a number of physical implants, but mechanical testing typically involves a sufficient number of samples to ensure statistical validity for the specific tests outlined in ASTM F1717.
   • Data Provenance: The testing was conducted in the context of the manufacturer's submission for regulatory approval. The country of origin for the device manufacturer is South Korea. The study is prospective in the sense that the sponsor conducted the tests specifically for this submission.

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

   • Not Applicable. For a mechanical device, ground truth in terms of clinical diagnosis or interpretation by experts is not relevant. The "ground truth" for mechanical testing is established by the specifications and methodologies defined in the ASTM F1717 standard itself. The results are physical measurements, not expert interpretations.

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

   • Not Applicable. Adjudication methods are used for expert disagreements on qualitative assessments (e.g., image interpretation). This is a mechanical performance test.

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 is not an AI/software device and does not involve human readers interpreting data.

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

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

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

   • The "ground truth" is adherence to the mechanical performance standards and methodologies specified by ASTM F1717. This includes physical properties like strength, stiffness, and resistance to fatigue under various loads, which are measured objectively.

7. The sample size for the training set:

   • Not Applicable. This is a hardware medical device, not a machine learning model; therefore, there is no "training set."

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

   • Not Applicable.

Summary of Device Performance Claim:

The L&K BIOMED LEXUS Cervical Fixation System's performance and safety are demonstrated by its compliance with internationally recognized mechanical testing standards (ASTM F1717). This standard evaluates static and dynamic axial compression, static tension, and static torsion. By meeting these benchmarks, the manufacturer asserts substantial equivalence to predicate devices, implying its safety and effectiveness for its intended use as a spinal fixation system.

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The FOCUS Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. And the FOCUS Spinal System can be used in an open approach and a percutaneous approach with MIS instrumentation.

The FOCUS Spinal System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and for lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.

When used in a percutaneous approach with MIS Instrumentation, the FOCUS Spinal Systems are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and for lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

FOCUS Spinal System consists of cannulated polyscrews, straight rods, curved rods, crosslinks and set screw components that can be used via percutaneous surgical approach. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy and are fabricated from titanium alloy (ASTM F136). The implants will be provided non-sterile.

The provided text describes a medical device, the FOCUS Spinal System, and its performance data relative to predicate devices. However, the document does not contain information about "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the context of an AI/ML device, as requested by the prompt.

The "Performance Data" section explicitly states:

"Static compression bending, tension, torsion and dynamic compression bending were performed according to ASTM F1717 on a worst-case, screw construct. The mechanical test results demonstrated that the FOCUS Spinal System performs as well as the predicate device."

This indicates a mechanical performance study for a physical spinal implant, assessed against a recognized industry standard (ASTM F1717) to show substantial equivalence to predicate devices.

Therefore, I cannot extract the following information because it is not present in the provided document:

1. A table of acceptance criteria and the reported device performance: No such criteria or performance metrics (e.g., sensitivity, specificity, AUC) are mentioned for an AI/ML device.
2. Sample size used for the test set and the data provenance: Not applicable to a mechanical test.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
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: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document pertains to the 510(k) summary for a physical medical device (spinal system) focusing on its mechanical equivalence to existing products, not an AI/ML device.

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VENUS Lumbar Intervertebral body Fusion Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolistesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bone graft. VENUS Lumbar Intervertebral body Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The VENUS Lumbar Intervertebral body Fusion Cage devices intended for use as an aid in spinal fixation. The VENUS Lumbar Intervertebral body Fusion Cage System consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The Implants are made of PEEK-OPTIMA® LTI body with the titanium marker pins made of Titanium alloy (Ti-6Al-4V ELI).

The provided 510(k) summary (K110783) for the VENUS Lumbar Intervertebral Body Fusion Cage System details the device's substantial equivalence to previously marketed devices based on performance data derived from established ASTM standards. However, it does not describe a study involving human subjects or AI algorithms with human-in-the-loop performance.

Here's an analysis based on the information provided, highlighting the mechanical testing rather than clinical or AI-related studies:

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

Note: The document states that the device was "tested according to the ASTM F 2077" and "per ASTM F 2267." This implies that the device met the requirements of these standards, which are the acceptance criteria for mechanical performance of intervertebral body fusion devices. Specific quantitative results (e.g., actual load values, fatigue cycles) are not provided in this summary. Instead, the summary asserts that these tests demonstrate the device's functional equivalence to predicates.

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

This information is not provided in the document. The performance data refers to mechanical testing of the device itself, not a clinical test set with patient 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)

This information is not applicable as the study described is a mechanical performance study, not a study evaluating human interpretation or diagnosistic accuracy.

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

This information is not applicable as the study described is a mechanical performance study.

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

There is no mention of an MRMC comparative effectiveness study in this 510(k) summary. The device is a physical intervertebral body fusion cage, not an AI software or diagnostic aid.

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

There is no mention of a standalone algorithm performance study as the device is a physical medical implant.

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

For the mechanical performance testing, the "ground truth" (or standard against which performance is measured) is the established requirements and methodologies outlined in the ASTM F 2077 and ASTM F 2267 standards. These standards define how an intervertebral body fusion device should perform under various mechanical loads to be considered safe and effective for its intended use.

8. The sample size for the training set

This information is not applicable as there is no "training set" for physical implant device testing.

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

This information is not applicable as there is no "training set" for physical implant device testing.

In summary:

The 510(k) summary describes a mechanical performance study demonstrating that the VENUS Lumbar Intervertebral Body Fusion Cage System meets the acceptance criteria set forth in ASTM F 2077 and ASTM F 2267 standards. It is a traditional 510(k) submission for a physical medical device and therefore does not involve clinical studies with human readers, AI algorithms, or the associated concepts of test sets, training sets, expert ground truth, or adjudication methods typically seen in AI/diagnostic device submissions. The "study" proving the device meets acceptance criteria is the successful completion of these defined mechanical tests, thereby supporting its substantial equivalence claim.

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The VENUS BASIC Spinal Fixation System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 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.

In addition, the VENUS BASIC Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

The VENUS BASIC Spinal Fixation System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, nuts, and a transverse (cross) linking mechanism.

The VENUS BASIC Spinal Fixation System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. VENUS BASIC Spinal Fixation System implant components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the VENUS BASIC Spinal Fixation System

Here's a breakdown of the acceptance criteria and study information for the VENUS BASIC Spinal Fixation System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document primarily focuses on demonstrating substantive equivalence through mechanical testing, rather than setting specific numerical performance thresholds for the device itself. The acceptance criteria are implicitly met by demonstrating that its mechanical properties are comparable to legally marketed predicate devices.

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

The document does not specify a "test set" in the context of clinical data or human evaluations. The performance data presented refers to mechanical testing.

• Sample Size for Mechanical Testing: Not explicitly stated in terms of number of devices or components. It's generally understood that mechanical tests adhering to ASTM standards involve a sufficient number of samples to ensure statistically sound results, but the exact count is not provided.
• Data Provenance: The mechanical testing was conducted in accordance with ASTM F1717-04. This is a recognized international standard for spinal implant testing. The tests would likely have been performed in a laboratory setting, presumably by or for the manufacturer (Implanova Co.,Ltd. / L&K BIOMED Co., Ltd. in Republic of Korea). The data is generated prospectively for the purpose of regulatory submission.

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

This information is not applicable to this 510(k) submission. The "ground truth" here is established through physical mechanical testing according to an engineering standard (ASTM F1717-04), not through expert clinical interpretation or consensus.

4. Adjudication Method for the Test Set

This information is not applicable as the "test set" refers to mechanical testing, not a clinical study involving human readers/evaluations.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for a medical device (spinal fixation system) and relies on mechanical testing to demonstrate substantial equivalence, not clinical effectiveness studies with human readers interpreting results.

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

This question is not applicable. The device is a physical pedicle screw spinal fixation system, not an algorithm or AI software. Therefore, there is no "standalone performance" of an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating the device's performance is based on objective measurements derived from mechanical testing protocols (ASTM F1717-04). This standard sets forth the methods for evaluating static and fatigue properties of spinal implant constructs, and the reported equivalence to predicate devices serves as the truth for regulatory purposes.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of this device, as it is a physical implant and not an AI/ML model.

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

This information is not applicable for the same reasons as #8.

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The Laparo-Tenser is intended for use as a laparoscopic retractor in gasless laparoscopic procedures. the Laparo-Tenser creates a gasless cavity to permit direct viewing of the organs within the peritoneal cavity for the purpose of performing diagnostic and surgical procedures.

Laparo-Tenser Laparoscopic Abdominal Retractor

This document is a 510(k) clearance letter from the FDA for a medical device called the "Laparo-Tenser Laparoscopic Abdominal Retractor." It is a regulatory approval document, not a study report or clinical trial summary.

Therefore, the input document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria. The document only confirms that the device is substantially equivalent to a predicate device already on the market, allowing it to be marketed.

Specifically, it lacks:

• A table of acceptance criteria and reported device performance.
• Details about a study, sample sizes, data provenance, expert qualifications, or adjudication methods.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.
• Details about ground truth establishment or training set sample sizes.

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