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510(k) Data Aggregation
(89 days)
The XTREME-LOOP is used for fixation of tendons and ligaments during orthopaedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction.
The XTREME-LOOP fixation device consists of a Ultra High Molecular Weight Polyethylene (UHMWPE) continuous loop captured on a titanium alloy button sits on the exit to a bone tunnel on the cortex, suspending the continuous loop inside the tunnel to provide secure, strong fixation for ligament reconstruction. The XTREME-LOOP fixation device is supplied with sutures that are used to pull the graft assembly into place and then flip the button allowing ligament reconstruction to be performed arthroscopically.
The XTREME-LOOP device is a soft tissue fastener used for fixation of tendons and ligaments during orthopedic reconstruction procedures, such as Anterior Cruciate Ligament (ACL) reconstruction. The device was deemed substantially equivalent to the predicate device, SECURE-LOOP (K151601), based on performance testing. The reported information focuses on the device's physical properties and biological safety rather than clinical performance metrics in the context of diagnostic accuracy or clinical outcomes often seen in AI/ML device submissions.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Performance Measure) | Reported Device Performance (XTREME-LOOP) |
|---|---|
| Strength | Substantially equivalent to SECURE-LOOP. |
| Stiffness | Substantially equivalent to SECURE-LOOP. |
| Strength after fatigue | Substantially equivalent to SECURE-LOOP. |
| Extension at predicate Ultimate Tensile Strength (UTS) | Substantially equivalent to SECURE-LOOP. |
| Cyclic fatigue testing | Substantially equivalent to SECURE-LOOP. |
| Functional testing | Substantially equivalent to SECURE-LOOP. |
| Pyrogenicity (Endotoxin) | ). |
2. Sample size used for the test set and the data provenance:
The provided document does not specify a "test set" in the context of patient data or image datasets, as this device is a physical implant. The testing described is pre-clinical engineering and biological safety testing. Therefore, information on sample size and data provenance like country of origin or retrospective/prospective nature is not applicable in the way it would be for AI/ML device studies. The sample sizes would pertain to the number of devices or test samples evaluated in the mechanical and biological tests. These specific numbers are not detailed in the summary.
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. Ground truth, in the context of expert consensus, refers to a human interpretation of data (e.g., medical images). For a physical medical device like the XTREME-LOOP, the "ground truth" for performance is established through standardized laboratory testing and material characterization, not expert human interpretation.
4. Adjudication method for the test set:
This information is not applicable for the same reasons as point 3.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. The XTREME-LOOP is a physical device, not an AI/ML diagnostic or therapeutic aid that would involve human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. The XTREME-LOOP is a physical device, not an algorithm.
7. The type of ground truth used:
The ground truth for the device's performance was established through:
- Mechanical Testing: Standardized engineering tests (strength, stiffness, fatigue, functional testing) comparing the XTREME-LOOP to the predicate device, SECURE-LOOP.
- Biological Safety Testing: Adherence to established standards for pyrogenicity, specifically:
- Turbidimetric Limulus Amoebocyte Lysate (LAL) method in line with ANSI/AAMI ST72:2011 for endotoxins.
- Rabbit pyrogenicity test per USP, General Chapter .
8. The sample size for the training set:
This is not applicable. The XTREME-LOOP is a physical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established:
This is not applicable for the same reasons as point 8.
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(84 days)
The Smith & Nephew EndoButton Direct Fixation Device is used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) or Posterior Cruciate Ligament (PCL) Reconstruction.
The EndoButton Direct is a machined titanium implant designed to provide cortical fixation in the repair of tendons and ligaments. The design of the EndoButton Direct allows for the device to be endoscopically delivered from a single access point. The device is available in 5-10mm lengths to accommodate different graft sizes.
The provided text is a 510(k) summary for the Smith & Nephew EndoButton Direct, a fixation device for tendons and ligaments. It establishes substantial equivalence to a predicate device, but it does not contain any information about specific acceptance criteria or performance data beyond a general statement of equivalency. Therefore, I cannot construct a table of acceptance criteria or describe a study that proves the device meets them from this document.
The document states:
- "The performance testing conducted demonstrates substantial equivalence to the Smith & Nephew EndoButton CL, cleared in K980155. The testing also demonstrates that the differences in the new device and the predicate device do not raise any new issues of safety and efficacy."
This indicates that performance testing was done, but the details of that testing, including acceptance criteria, results, sample sizes, ground truth establishment, or expert involvement, are not provided in this 510(k) summary.
Therefore, I cannot answer the specific questions regarding acceptance criteria, study details, sample sizes, ground truth, experts, adjudication, or MRMC studies based solely on the provided text.
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(25 days)
The Smith & Nephew Continuous Loop Fixation Device is used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) or Posterior Cruciate Ligament (PCL) Reconstruction.
The Smith & Nephew Continuous Loop Fixation Device is a suture loop manufactured from polyester suture. The Continuous loop is used in the same way as surgical suture with the benefit of pre-measured lengths and no need for knot tying. The device is available in 20, 40 & 60 mm.
The provided text contains minimal information about acceptance criteria or specific performance data for the Smith & Nephew Continuous Loop Fixation Device, other than general statements of substantial equivalence. Therefore, some sections of your request will be left blank or noted as "Not specified in the provided text."
Acceptance Criteria and Reported Device Performance
The submission relies on claims of substantial equivalence to a predicate device (Smith & Nephew Endobutton CL, K980155) rather than detailing specific non-inferiority or superiority criteria against established thresholds.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as numerical performance metrics. The core acceptance criterion is likely demonstrating substantial equivalence to the predicate device in terms of design, materials, function, and intended use, and ensuring no new safety or efficacy issues are raised by the differences in the new device. | The performance testing conducted "demonstrates substantial equivalence to the Smith & Nephew Endobutton CL, cleared in K980155." It also "demonstrates that the differences in the new device and the predicate device do not raise any new issues of safety and efficacy." |
Study Information
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Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified in the provided text.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not specified. This type of device (suture loop) typically undergoes mechanical testing rather than requiring expert-established ground truth on clinical images or diagnoses.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable or not specified.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a medical implant, not an AI-assisted diagnostic tool.
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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.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this type of device, ground truth would typically be established through mechanical performance testing (e.g., tensile strength, fatigue testing, knot security) to ensure it meets performance standards comparable to or exceeding those of the predicate device, or relevant ASTM/ISO standards for surgical sutures. The document refers to "performance testing" but does not detail the nature of this testing or the "ground truth" (i.e., expected performance outcomes) against which it was measured.
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The sample size for the training set: Not applicable. This is a physical medical device, not an AI model that requires a training set.
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How the ground truth for the training set was established: Not applicable. This is a physical medical device, not an AI model.
Summary of Information Gaps:
The provided 510(k) summary is typical for a predicate-based clearance of a physical device. It focuses on demonstrating substantial equivalence through comparison of characteristics and general statements about performance testing. It does not provide the detailed study protocols, specific quantitative acceptance criteria, or raw performance data that would be found in a more comprehensive clinical or engineering report. Therefore, detailed information about sample sizes for testing, ground truth methodology (beyond general mechanical testing implied), or expert involvement (as would be relevant for diagnostic AI) is not present.
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(65 days)
Fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.
The Titanium Toggle Buttons are a toggle bar designed with one or two eyelets through which multiple loops of suture are threaded. There are two types of Toggle Buttons, the standard toggle button with two eyelets and the NS toggle button with one larger eyelet only. The suture loops provide a means to attach the soft tissue grafts to the toggle buttons. The loops are attached to the toggle button by putting the loops through the eyelet(s). This device is used to anchor the suture loops to bone.
The provided text describes a 510(k) premarket notification for a medical device called "Titanium Toggle Button(s)". This submission is for a physical medical device, not a software algorithm or an AI-powered diagnostic tool. Therefore, the questions related to acceptance criteria for algorithmic performance, sample sizes for test/training sets in AI, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable to this document.
The document primarily focuses on demonstrating substantial equivalence to predicate devices through material similarity, intended use, size comparisons, and non-clinical mechanical testing.
Here's a breakdown of the relevant information from the provided text:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Pull-out strength at least equivalent to predicate devices | The Titanium Toggle Button(s) has a greater pull-out strength than that of the predicate devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified for the mechanical testing.
- Data Provenance: Not specified (implied to be internal laboratory testing).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. Ground truth for mechanical testing is based on physical measurements and engineering standards, not expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Mechanical testing data is objective.
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. This is a physical device, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the mechanical testing, the "ground truth" would be the objective measurements of pull-out strength according to established engineering standards or test protocols.
8. The sample size for the training set:
- Not applicable. This is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable.
Additional Information from the Document:
- Clinical Testing: None provided as a basis for substantial equivalence. The submission relies solely on non-clinical (mechanical) testing and comparison to predicate devices.
- Summary of Technologies: "The titanium Toggle Buttons are similar to or identical to predicate devices in terms of material, intended use, and size."
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