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The Knotilus™ Anchor System is intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Specific indications are: foot, ankle, knee, hip, hand, wrist, elbow and shoulder.

The Knotilus Anchor System consists of:
• Knotilus Anchor - an implantable anchor preloaded on a disposable inserter to aid with anchor insertion into the bone. The Knotilus Anchor will be offered in outer diameters ranging from 3.5 mm to 6.0 mm and length ranging from 10 mm to 20 mm.
• Knotilus Implant Loop - A non-absorbable UHMWPE (Dyneema) loop designed for fixation of soft tissue without the need of knot tying. The Knotilus Implant Loop will be offered with a total length of 470 mm and distal loop sizes of 22 mm, 25 mm and 28 mm.
The Knotilus Anchor and Knotilus Implant Loop will be provided separately, sterile for single use only.

The provided text describes a 510(k) summary for the Knotilus Anchor System, which is a medical device for soft tissue to bone fixation. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive performance studies with specific statistical acceptance criteria.

Based on the provided text, there is no information available regarding specific acceptance criteria, a study proving the device meets those criteria, or details such as sample size, data provenance, expert qualifications, or MRMC studies.

Instead, the submission focuses on:

• Comparison of Technological Characteristics: The document states, "With respect to its indication for use, the Knotilus Anchor System is substantially equivalent to its predicate devices. With respect to technology, the design is similar, as confirmed by comparison, and the performance is the same as verified by design verification."
• Design Verification: This phrase indicates that internal testing was conducted to ensure the device performs as intended and is similar to the predicate. However, no specifics of these "design verification" tests (e.g., test methods, acceptance criteria, results) are provided in this summary.

Therefore, I cannot populate the requested tables and information as the details are not present in this 510(k) summary. The summary focuses on demonstrating equivalence rather than the detailed performance study of the device against specific performance metrics for acceptance criteria that would be found in a clinical trial or a more extensive engineering report.

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The Lateral Button™ is intended to protect the suture / bone during transosseous fixation procedures.

The Lateral Button™ consists of an implanted Button preloaded on a disposable inserter necessary for its insertion into the bone tunnel, the inserter is removed upon completion of the procedure. The implant is made of implantable grade PEEK (polyether - etherketone). The inserter is made of Polycarbonate. The Lateral Button and its inserter will be supplied sterile for single use. The implant has an O.D. of 3.1 mm, overall length of 10 mm and an I.D. of 1.8 mm. In use, the suture is threaded through the implant, which helps to distribute the pressure created by the suture and assists in the prevention of suture migration and damage to suture and/or bone. The implant will be supplied either as a stand alone device or as part of a kit i.e. with other devices already cleared for transosseous fixation procedures.

The provided text is a 510(k) Summary for the "Lateral Button™" device, which is a smooth or threaded metallic bone fixation fastener. The summary focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific performance acceptance criteria.

Therefore, many of the requested details about acceptance criteria, specific study designs, sample sizes, expert involvement, and ground truth establishment cannot be fully extracted from the provided document. The document primarily describes the device, its intended use, and comparisons to a predicate device based on technological characteristics and design verification (static and dynamic testing).

Here's an attempt to answer the questions based on the available information:

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

The document does not explicitly state numerical acceptance criteria for performance, nor does it provide specific quantitative results of the "static and dynamic testing" beyond a general statement of "substantial equivalence."

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

The document mentions "static and dynamic testing" as part of design verification, but does not specify the sample size used for these tests. The data provenance (country of origin, retrospective/prospective) is also not provided.

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 type of information is not applicable and not provided in the document, as the study described is a device performance test (static and dynamic) rather than a clinical study requiring expert assessment of outcomes or images.

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

This is not applicable and not provided for the type of device performance testing described.

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

This is not applicable. The device is a bone fixation fastener, not an AI-powered diagnostic tool, so an MRMC study is not relevant.

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

This is not applicable. The device is a physical implant, not an algorithm. The "standalone" mentioned in the document refers to the implant being supplied as a standalone device or as part of a kit.

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

For the "static and dynamic testing," the "ground truth" would likely be engineering specifications, material properties, and established biomechanical testing standards for bone fixation devices. The document does not explicitly detail these "ground truth" sources, but it implies comparison to predicate device performance.

8. The sample size for the training set

This is not applicable. The device is a physical implant and does not involve a "training set" in the context of machine learning.

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

This is not applicable for the reasons stated in point 8.

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The Latarjet Cortical Screw Set is intended to provide the orthopedic surgeon a means of bone fixation and to assist in the management of fractures and reconstructive surgeries.

The Latarjet Cortical Screw Set consists of an implantable fixation screw which is used for fixation of bone grafts or bone fragments to cortical bone in shoulder surgeries. The fixation screws are offered in the following overall range of length: 20mm - 48mm. (features- other than the overall length- are identical on all). The set also includes a threaded bushing which attaches to the proximal end of the fixation screw. Its purpose is to position the screw firmly and safely during the fixation procedure. The bushing is provided in one size. The fixation screw and bushing are supplied in either in Titanium alloy or Stainless Steel. The Latarjet Cortical Screw Set is supplied nonsterile, for single patient use.

The provided text is related to a 510(k) submission for a medical device called the "Latarjet Cortical Screw Set." This document focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for low-to-moderate risk medical devices.

The information you are requesting about "acceptance criteria and the study that proves the device meets the acceptance criteria" (specifically for AI/algorithm performance) is not applicable to this submission.

Here's why, based on the provided text:

• Device Type: The Latarjet Cortical Screw Set is a physical implantable device (bone fixation screw) used in orthopedic surgery. It is not an AI/algorithm-based diagnostic or treatment device.
• Regulatory Pathway: The submission is a 510(k) Pre-market Notification, which focuses on demonstrating "substantial equivalence" to a legally marketed predicate device. This typically involves comparing design, materials, intended use, and performance (e.g., mechanical testing, biocompatibility) to show it's as safe and effective as existing devices. It does not involve clinical studies to demonstrate the performance of an AI algorithm against specific acceptance criteria for diagnostic accuracy, sensitivity, or specificity.
• Lack of AI/Algorithm Information: There is no mention of any AI component, software, diagnostic algorithm, or any form of "AI assistance" in the entire document. The device is purely mechanical.

Therefore, I cannot extract the information requested as it pertains to AI/algorithm performance studies, as such studies were not conducted or described for this specific device.

The study referenced in the document is a "validation" to verify that the device's "performance is the same" as the predicate device based on its technological characteristics. This would typically involve engineering tests (e.g., mechanical strength, fatigue, torque, biocompatibility) rather than clinical performance metrics in humans or AI performance metrics.

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