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Found 19 results
510(k) Data Aggregation
(37 days)
Catamaran SI Joint Fusion System
The Tenon Medical Catamaran SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including:
- Sacroiliac joint disruptions and degenerative sacroiliitis
- To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
The Catamaran SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The Catamaran SI Joint Fusion System was developed as a less invasive alternative to traditional open posterior surgical SI Joint fusion. The system consists of the Catamaran SI Joint Fixation Implant (Ti6A1-4V ELI Titanium alloy / ASTM F136) included in a reusable System Tray containing: Access, Drill and Delivery, Bone Graft Packing, and Extraction Instruments. The Catamaran SI Joint Fixation Implants are designed in various widths and lengths, and allow autologous bone graft material placement in the barrels of the implant to support SI Joint fixation and fusion. The Instrument Set includes Class II single use and reusable surgical instruments designed to facilitate placement of the implant within the sacroiliac joint using an inferior-posterior surgical approach. The implants and associated instruments are provided clean and non-sterile and are designed for steam sterilization prior to use.
This document is a 510(k) Premarket Notification from the FDA regarding the Tenon Medical CATAMARAN™ SI Joint Fusion System. Based on the provided text, the submission does not include any study data relating to the performance of an AI/ML medical device.
The central point of this 510(k) submission is a change in the Indications for Use for an already cleared device. The text explicitly states:
- "The sole purpose of this submission is to modify the indications for use." ([Page 5])
- "No clinical or non-clinical performance testing was necessary to support the change in indications for use proposed." ([Page 5])
Therefore, I cannot extract the information required by your request about acceptance criteria and a study proving a device meets them, as this document concerns a change to an existing device's labeling and did not involve new performance testing.
If you have a document related to an AI/ML device approval that includes performance study data, please provide that.
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(14 days)
TiLink-P SI Joint Fusion System
The TiLink-P Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The TiLink-P SI Joint Fusion System contains various orthopedic instruments to assist the user in implanting a titanium sacroiliac implant into the sacroiliac joint. The SurGenTec TiLink-P SI Joint Fixation System includes TiLink Implants and associated Instruments (sterile or non-sterile). The TiLink-P SI Joint Fusion System may be used via lateral or posterior oblique. Bone graft material is used with the TiLink-P SI Joint Fusion System to facilitate bone growth.
This document is a 510(k) premarket notification decision letter from the FDA to SurGenTec LLC for their TiLink-P SI Joint Fusion System. It states that the device has been determined to be substantially equivalent to legally marketed predicate devices.
Based on the provided text, the device discussed is NOT an AI/ML medical device. The document describes a physical medical device (components of a sacroiliac joint fusion system) and its mechanical, material, and biological performance testing.
Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML performance (e.g., sensitivity, specificity, MRMC studies, ground truth establishment with experts) is not applicable to this submission.
The document discusses performance testing relevant to a physical implantable device, such as:
- Axial Pullout Testing per ASTM F543: This likely measures the force required to pull the implant out of bone, assessing its fixation strength.
- Static and Dynamic Cantilever Test per ASTM F3574: This assesses the implant's resistance to bending under various loading conditions, relevant for its structural integrity.
- Sterilization, Packaging, and Shelf-Life Validations: These ensure the device remains sterile and functional over time.
- Biocompatibility Assessment per ISO 10993: This confirms the materials used in the device are safe for contact with human tissue.
The "acceptance criteria" for these tests would be specific parameters and thresholds (e.g., minimum pullout force, maximum deflection under load) defined by the manufacturer and often guided by relevant ASTM/ISO standards. The "study" proving it meets these criteria would be the results of the physical tests.
Since the prompt specifically asks for details relevant to an AI/ML device, and this document does not pertain to AI/ML, I cannot provide the requested information in that context.
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(30 days)
TiLink-P SI Joint Fusion System
The TiLink-P SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The purpose of this Special 510(k) is to introduce the TiLink-P with Window variant to the TiLink-P SI Joint Fusion System. The Window feature is designed to promote osteointegration.
The TiLink-P SI Joint Fusion System contains various orthopedic instruments to assist the user in implanting a titanium sacroiliac implant into the sacroiliac joint to transfix the joint. The SurGenTec TiLink-P SI Joint Fixation System includes TiLink Implants and associated Instruments. The TiLink-P implants may be used standalone. The TiLink-P SI Joint Fusion System fixates the sacroiliac joint by transfixing the cortices of the ilium and cortices of the sacrum.
The TiLink-P Compression Anchor is positioned so that it spans the cortices of ilium and cortices of sacrum, the TiLink-P Locking Screw is inserted through the TiLink-P Compression Anchor and along the SI Joint via a posterior approach, in order to compress the joint. Bone graft material is used with the TiLink-P SI Joint Fusion System to facilitate bone growth.
The FDA letter provided is a clearance letter for a medical device (TiLink-P SI Joint Fusion System), not an AI/ML device. Therefore, the document does not contain information about acceptance criteria or studies pertaining to AI/ML device performance. The information requested regarding sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training data is not applicable to the content of this document.
The document discusses the substantial equivalence of the "TiLink-P SI Joint Fusion System" to a predicate device (TiLink-P Joint Fusion System K240720) through mechanical strength tests.
Here is the information that is available in the document:
1. A table of acceptance criteria and the reported device performance
The document states that performance testing was conducted according to specific ASTM standards to demonstrate substantial equivalence to the predicate device. However, it does not provide a table of acceptance criteria (e.g., specific thresholds for pullout strength or shear strength) nor the reported numerical performance data. It only lists the types of tests performed.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document (Implied: To be substantially equivalent to predicate device as measured by ASTM F543 and ASTM F3574) | "demonstrates substantial equivalence to the predicate device." |
| Axial Pullout per ASTM F543 | Testing performed |
| Static and Dynamic Vertical Shear per ASTM F3574 | Testing performed |
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. The "test set" here refers to physical devices for mechanical testing, not a dataset for an AI/ML model. The document does not specify the number of devices tested. Data provenance such as country of origin or retrospective/prospective is not relevant for this type of device clearance.
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. Ground truth as typically understood in AI/ML (e.g., expert labels on images) is not relevant for this type of mechanical device testing. The "ground truth" for mechanical testing is derived from established engineering principles and ASTM standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used for resolving disagreements among human experts in labeling datasets, which is not relevant for 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
Not applicable. This is a clearance for a physical medical implant, not an AI/ML diagnostic or assistive device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For mechanical testing, the "ground truth" is provided by the established ASTM standards and the physical properties and performance of the predicate device.
8. The sample size for the training set
Not applicable. There is no AI/ML model, and therefore no training set.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML model, and therefore no training set or ground truth for a training set.
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(276 days)
BowTie SI Joint Fusion System
The BowTie™ SI Joint Fusion System is indicated for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. When the Bow Tie SI Fusion System is implanted, both the Iliac and Transfix Screw components must be used.
The BowTie™ SI Joint Fusion System is intended to provide stabilization of the sacroiliac joint until fusion occurs. The device consists of an implant and a set of ancillary instruments. The implant is comprised of an interarticular component, an iliac screw, and a transfix screw. All implant components are titanium and available in various sizes to accommodate varying patient anatomy. The implant components are provided gamma sterilized and individually packaged. The ancillary instruments are provided non-sterile and will be sterilized by the end user.
This is a medical device, not an AI/ML powered device, so many of the requested fields are not applicable.
Here's a breakdown of the requested information based on the provided text, with "N/A" where the information is not present or not relevant to this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
For this medical device (BowTie™ SI Joint Fusion System), "acceptance criteria" and "reported device performance" are typically demonstrated through biomechanical testing and comparison to predicate devices, rather than accuracy metrics seen in AI/ML solutions. The document states that testing was performed to demonstrate substantial equivalence and that there are no new risks.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biomechanical performance equivalent to predicate devices | Bench Testing Performed and Results (Summary): |
- Cadaveric Biomechanical Evaluation of SAIL Implant Construct
- Implant Static Torsion per ASTM F3574
- Fatigue Vertical Shear Testing per ASTM F3574
- Porous Coating Characterization per ASTM F1854
- Implant Fatigue Torsion Testing per ASTM F3574
- Static Vertical Shear Testing per ASTM F3574
- Bone Screw Mechanical Testing – Torsion Strength per ASTM F543
- Bone Screw Mechanical Testing – Insertion Torque per ASTM F543
- Bone Screw Mechanical Testing – Pull-Out per ASTM F543
- Bone Screw Mechanical Testing – Static Cantilever Bending Testing per ASTM F2193
- Bone Screw Mechanical Testing – Fatigue Cantilever Bending Testing per ASTM F2193
Conclusion: "rationales and mechanical testing of the BowTie™ SI Joint Fusion System indicated there are no new risks and demonstrated substantial equivalence in performance compared to a legally marketed predicate." |
| Materials meet specified ASTM standards and are biocompatible | Interarticular component: Ti-6Al-4V ELI per ASTM F3001
Screws: Ti-6Al-4V ELI per ASTM F136 |
| Device design is consistent with its intended use | "The BowTie™ SI Joint Fusion System implant components are made from similar materials and have equivalent design philosophy, sizing, configurations, fixation methods, sterilization and packaging, and surgical approach to the predicate device." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated for each test, but standard biomechanical tests involve a discreet number of samples. For the cadaveric study, the number of cadavers used is not specified.
- Data Provenance: N/A for this type of device submission. Biomechanical testing is conducted in a lab environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: N/A. Ground truth is established through physical and mechanical testing according to recognized standards (e.g., ASTM).
- Qualifications of Experts: N/A.
4. Adjudication method for the test set
- Adjudication Method: N/A. Results are typically determined by direct measurement or observation during standardized 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
- MRMC Study: No. This is not an AI-assisted diagnostic device.
- Effect Size: N/A.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No. This is a physical implant device, not an algorithm.
7. The type of ground truth used
- Type of Ground Truth: Established through adherence to recognized industry standards (e.g., ASTM for material properties and mechanical performance) and comparison to a legally marketed predicate device. The cadaveric study provides real-world simulation for biomechanical evaluation.
8. The sample size for the training set
- Sample Size for Training Set: N/A. There is no "training set" in the context of this physical medical device. Device design and development involve engineering principles, material science, and iterative testing, not machine learning training.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: N/A. See above.
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(27 days)
TiLink-P SI Joint Fusion System
The TiLink-P SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The TiLink-P SI Joint Fusion System contains various orthopedic instruments to assist the user in implanting a titanium sacroiliac implant into the sacroiliac joint to transfix the joint.
The SurGenTec TiLink-P SI Joint Fixation System includes TiLink Implants and associated Instruments. The TiLink Implant may be used standalone. The TiLink Implants are manufactured from titanium alloy and include the TiLink Locking Screw and the TiLink Compression Anchor. The TiLink Compression Anchor is designed to transfix the ilium and sacrum while compressing the SI joint. The TiLink Compression Anchor includes an opening to insert the TiLink Locking Screw. During the Procedure, the TiLink Compression Anchor is positioned so that it spans the ilium and sacrum, the TiLink Locking Screw is inserted through the TiLink Compression Anchor via a posterior approach. Bone graft material is placed within the TiLink implant to facilitate bone growth.
The SurGenTec TiLink-P SI Joint System may be provided sterile single-use or non-sterile.
This document describes an FDA 510(k) clearance for a medical device, the "TiLink-P SI Joint Fusion System." The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process typically involves performance testing to show the new device meets the same safety and effectiveness standards as the predicate.
However, the provided text does not contain any information about an AI/ML-based device or a study involving AI assistance for human readers. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to the mechanical, material, and biological properties of the physical implant device (TiLink-P SI Joint Fusion System), not the performance of an AI algorithm or its impact on human readers.
Therefore, I cannot fulfill the request to describe the acceptance criteria and study for an AI device. The text focuses on:
- Device Name: TiLink-P SI Joint Fusion System
- Intended Use: Sacroiliac joint fusion
- Materials: Titanium alloy
- Performance Testing:
- Dynamic vertical shear testing (ASTM F3574)
- Foam block pullout testing (ASTM F543)
- Biocompatibility (ISO 10993)
- Sterilization Validation
The closest thing to "acceptance criteria" in this context is that the device "met the pre-determined acceptance criteria for the verification activities" for these specific mechanical, biological, and sterilization tests. The "study" mentioned is the "Performance Testing" which consists of these engineering and and biocompatibility evaluations.
There is no information in the provided document about:
- A table of acceptance criteria and reported device performance (in the context of AI metrics like sensitivity, specificity, etc.)
- Sample sizes for AI test sets
- Data provenance for AI data
- Number of experts for AI ground truth
- Adjudication methods for AI ground truth
- MRMC comparative effectiveness study
- Standalone AI performance
- Type of ground truth for AI (expert consensus, pathology, etc.)
- Sample size for AI training set
- How AI training set ground truth was established
In summary, the provided document is for a physical medical implant device, not an AI/ML diagnostic or assistive tool. Thus, the specific criteria and study details requested for an AI device are not applicable to the information given.
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(29 days)
PathLoc SI Joint Fusion System
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. This submission adds an additional screw option to the system.
This document is an FDA 510(k) clearance letter for a medical device called the "PathLoc SI Joint Fusion System." It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria related to AI or algorithm performance.
The content of the provided text focuses on:
- The FDA's determination of substantial equivalence to a predicate device.
- Regulatory requirements and classifications.
- Description of the device and its intended use (sacroiliac joint fusion).
- Material composition.
- A brief mention of "performance testing" through engineering analysis, stating that added components do not introduce a "new worst case" and don't require additional mechanical testing. This refers to mechanical integrity and safety of the implant itself, not AI performance.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study that proves the device meets those criteria, as the provided text does not contain this information. The device in question is a physical implant (bone screws), not a software or AI-driven diagnostic or therapeutic device.
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(180 days)
TiLink-P SI Joint Fusion System
The TiLink-P SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The TiLink-P SI Joint Fusion System contains various orthopedic instruments to assist the user in implanting a titanium sacroiliac implant into the sacroiliac joint to transfix the joint.
The SurGenTec TiLink-P SI Joint Fixation System includes TiLink Implants and associated Instruments. The TiLink implant may be used standalone. The TiLink Implants are manufactured from titanium alloy and include the TiLink Locking Screw and the TiLink Compression Anchor. The TiLink Compression Anchor is designed to transfix the ilium and sacrum while compressing the SI joint. The TiLink Compression Anchor includes an opening to insert the TiLink Locking Screw. During the Procedure, the TiLink Compression Anchor is positioned so that it spans the ilium and sacrum, the TiLink Locking Screw is inserted through the TiLink Compression Anchor and along the SI Joint via a posterior approach. Bone graft material is placed within the TiLink implant to facilitate bone growth.
The provided text does not contain information about acceptance criteria and a study proving a device meets them in the context of an AI/ML medical device. The document is an FDA 510(k) clearance letter for a TiLink-P SI Joint Fusion System, which is a physical implant for sacroiliac joint fusion, not an AI/ML device.
Therefore, I cannot provide the requested information, including:
- Table of acceptance criteria and reported device performance.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth.
- Sample size for the training set.
- How ground truth for the training set was established.
Instead, the document details the regulatory clearance for a medical implant and lists non-clinical performance data for mechanical testing, biocompatibility, sterilization validation, and a side-by-side cadaver study to demonstrate substantial equivalence to predicate devices.
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(55 days)
CATAMARAN SI Joint Fusion System
The Tenon Medical CATAMARAN™ SI Joint Fusion System is intended for sacroillac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis.
The CATAMARAN SI Joint Fusion System is intended for sacroillac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis. The CATAMARAN SI Joint Fusion System was developed as a less invasive alternative to traditional open posterior surgical SI Joint fusion. The system consists of the CATAMARAN SI Joint Fixation Implant (Ti6A1-4V ELI Titanium alloy / ASTM F136) included in a reusable System Tray containing: Access, Drill and Delivery, Bone Graft Packing, and Extraction Instruments. The CATAMARAN SI Joint Fixation Implants are designed in various widths and lengths, and allow autologous bone graft material placement in the barrels of the implant to support SI Joint fixation and fusion. The Instrument Set includes Class II single use and reusable surgical instruments designed to facilitate placement of the implant within the sacroillac joint using an inferiorposterior surgical approach. The implants and associated instruments are provided clean and non-sterile and are designed for steam sterilization prior to use.
The provided text is a 510(k) summary for a medical device (CATAMARAN™ SI Joint Fusion System) and does not contain information about studies evaluating an AI/ML-driven device, particularly regarding acceptance criteria, sample sizes for test/training sets, expert involvement, or MRMC studies.
Therefore, it is impossible to describe "the acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML performance from the provided document. The document primarily focuses on demonstrating substantial equivalence to a predicate device, and the "study" mentioned pertains to MR compatibility testing, not clinical performance or AI/ML algorithm validation.
The "Design Verification Standards Testing" section (page 5) lists ASTM standards for MR compatibility assessment. This is a crucial part of the device's validation but doesn't involve the kind of performance metrics or expert reviews associated with AI/ML diagnostic or prognostic tools.
The prompt's request for information on "acceptance criteria and the study that proves the device meets the acceptance criteria" (specifically for an AI/ML device), along with details like "sample size used for the test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," "ground truth type," and "training set details," cannot be addressed using the provided text.
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(22 days)
PathLoc SI Joint Fusion System
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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(106 days)
TiLink-L SI Joint Fusion System
The TiLink-L Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroillac joint disruptions and degenerative sacroiliitis.
The TiLink-L Joint Fusion System contains various orthopedic instruments to assist the user in implanting a titanium sacroiliac implant into the sacroiliac joint to fixate the joint. There are various sacroiliac implant sizes available for implanting to accommodate a range of sacroiliac joint sizes and geometries.
This document is a 510(k) premarket notification for a medical device called the "TiLink-L SI Joint Fusion System." It establishes the substantial equivalence of this new device to previously cleared predicate devices. Therefore, the information provided focuses on demonstrating this equivalence rather than presenting an original study with acceptance criteria and device performance in the typical sense of a diagnostic or algorithmic device.
Here's an analysis based on your requested points, highlighting that this document is for a mechanical implant and not an AI or diagnostic device:
1. A table of acceptance criteria and the reported device performance:
This document does not present acceptance criteria or reported device performance in the manner expected for a device like an AI algorithm with metrics like sensitivity, specificity, or accuracy. Instead, the "performance data" listed are primarily related to general device safety and mechanical integrity, demonstrating that the new device performs comparably to the predicate devices in these aspects. The acceptance criteria implicitly refer to meeting established standards for medical implants.
| Acceptance Criteria (Implied from testing types) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility (per ISO 10993-1:2018) | Compliant with standard (essential for substantial equivalence) |
| Sterilization Validation (per ISO 17665-1:2006/(R) 2013) | Compliant with standard (essential for substantial equivalence) |
| Mechanical Static Testing (per ASTM F543) | Substantially equivalent to predicate (demonstrated through testing) |
| Mechanical Dynamic Testing (per ASTM F1264) | Substantially equivalent to predicate (demonstrated through testing) |
| V/V Mechanical and Safety Testing | Conforms to Mechanical and Safety requirements (essential for substantial equivalence) |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of this submission. The "test set" here refers to the physical samples of the TiLink-L device that underwent engineering and biological testing, not a dataset of patient cases. The number of physical units tested for each mechanical or biocompatibility standard would be part of the detailed test reports (which are not included in this summary).
- Data Provenance: Not applicable in the context of this submission. The tests are laboratory-based engineering and biological assessments of the device itself, not analyses of patient 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" in this context is irrelevant as the tests are for physical and biological properties against established standards, not for diagnostic accuracy or clinical outcomes assessed by experts.
4. Adjudication method for the test set:
Not applicable. This concept applies to human interpretation of data where consensus is needed. For mechanical and biological testing, the outcome is determined by adherence to predefined standards and measurement against those 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:
Not applicable. This is for a physical implant, not an AI or diagnostic device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a standalone physical implant, not an algorithm.
7. The type of ground truth used:
Not applicable in the AI/diagnostic sense. The "ground truth" for the performance data in this submission would be the established scientific and engineering standards (e.g., ISO 10993-1, ISO 17665-1, ASTM F543, ASTM F1264) that the device must meet or demonstrate equivalence against.
8. The sample size for the training set:
Not applicable. This device is not an AI model, so there is no training set in the machine learning sense.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set.
Summary for this specific document:
This 510(k) submission successfully demonstrates substantial equivalence for a physical medical implant (TiLink-L SI Joint Fusion System) by showing that its technological characteristics and performance (biocompatibility, sterilization, mechanical properties) are comparable to legally marketed predicate devices. The "study" here refers to the non-clinical performance data and engineering tests conducted on the device components themselves, which align with established standards for medical implants. It is crucial to understand that the requested questions about acceptance criteria, sample sizes, experts for ground truth, and MRMC studies are primarily relevant for diagnostic devices, especially those incorporating AI, and not for mechanical implants like the one described in this document.
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