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The Artemis Lap Cannula has applications in abdominal, thoracic, and gynecologic minimally invasive procedures to establish a path of entry for minimally invasive instruments. Artemis Lap Cannula may be used for primary and secondary insertions.

Artemis Lap Cannula system is a radiolucent, reusable, bladeless laparoscopic trocar, consisting of a cannula, an obturator, a depth limiter, and a disposable standalone seal pack. The trocar is available in two diameters: Ø5mm and Ø12mm, each consists of 4 different length variants. Depth limiter component is available in two diameters and fits either the Ø5mm or Ø12mm cannula regardless of the length. Depth limiter can be used to prevent over penetration during surgical procedures. Artemis Lap Cannula may be used in abdominal, thoracic, or gynecological procedures.

The provided text describes a 510(k) premarket notification for a medical device called the "Bladeless Trocar - Artemis Lap Cannula" (K231400) and references a previous clearance (K230058) as a primary predicate. This document is a regulatory submission, not a study report, and thus focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone clinical or analytical performance study with acceptance criteria and detailed outcomes in the same way one might describe an AI/ML device study.

Therefore, the information requested regarding acceptance criteria and a study proving the device meets those criteria, particularly aspects like sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable or available in this type of regulatory document for this specific device.

This device (Bladeless Trocar - Artemis Lap Cannula) is a physical surgical instrument, not an AI/ML diagnostic or prognostic system. The performance claims for such devices typically revolve around mechanical properties, biocompatibility, and sterility, which are verified through non-clinical testing and comparison to legally marketed predicate devices.

However, I can extract information regarding the non-clinical testing performed and the conclusion drawn from it, which serves as a form of "proof" of meeting the regulatory requirements for substantial equivalence.

Non-Clinical Testing and Performance for Bladeless Trocar - Artemis Lap Cannula (K231400)

1. Table of Acceptance Criteria and Reported Device Performance (Derived from Regulatory Review)

Explanation of "Acceptance Criteria" for this type of device:
For a physical surgical instrument like a trocar, "acceptance criteria" are typically defined by recognized consensus standards (e.g., ISO standards for medical devices, biomechanical testing standards) and comparison to predicate devices. The primary goal is to demonstrate that the new device is as safe and effective as a legally marketed device.

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

• Sample Size: Not specified in the provided text. Non-clinical testing typically involves a statistically relevant number of units for mechanical or material tests, but the exact count is not detailed here.
• Data Provenance: The testing was "Nonclinical Testing" conducted to support the 510(k) submission. This is laboratory-based testing, not human or patient data. The country of origin of the data is implicitly the country where the manufacturer (T.A.G. Medical Products Corporation, Ltd, Israel) conducted or commissioned the tests.

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

• Not applicable. This information pertains to studies involving expert review for setting ground truth (e.g., for AI/ML algorithms). This device and its associated testing do not involve establishing ground truth from expert clinical review. The "ground truth" for non-clinical testing is typically defined by the test protocol, measurement standards, and device specifications.

4. Adjudication Method for the Test Set:

• Not applicable. This concept relates to reconciling disagreements among experts in setting ground truth for data. Non-clinical physical testing results are usually objective measurements, not subject to expert adjudication in the same manner.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. An MRMC study is relevant for comparing the performance of human readers, often with and without AI assistance, on diagnostic cases. This device is a surgical instrument, not a diagnostic tool requiring such a study.

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

• Not applicable. This refers to the performance of an AI algorithm in isolation. This device is a physical instrument, not an algorithm.

7. The Type of Ground Truth Used:

• For the non-clinical tests (leak testing, ISO 80369-7 compliance), the "ground truth" is defined by:
  • Established Test Standards: Adherence to the specified mechanical and performance characteristics outlined in the relevant ISO standard (ISO 80369-7).
  • Predicate Device Performance: Comparison to the performance characteristics of the legally marketed predicate device (K230058) for specific attributes like leak resistance.
  • Device Specifications: Meeting the manufacturer's own design specifications for the device.

8. The Sample Size for the Training Set:

• Not applicable. There is no "training set" in the context of a physical medical device like a trocar. This concept applies to AI/ML algorithms that learn from data.

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

• Not applicable. As there is no training set, this question is not relevant.

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The Artemis Lap Cannula has applications in abdominal, thoracic, and gynecologic minimally invasive procedures to establish a path of entry for minimally invasive instruments. Artemis Lap Cannula may be used for primary and secondary insertions.

Artemis Lap Cannula system is a radiolucent, reusable, bladeless laparoscopic trocar, consisting of a cannula, an obturator, a depth limiter, and a disposable standalone seal pack. The trocar is available in two diameters: Ø5mm and Ø12mm, each consists of 4 different length variants. Depth limiter component is available in two diameters and fits either the Ø5mm or Ø12mm cannula regardless of the length. Depth limiter can be used to prevent over penetration during surgical procedures. Artemis Lap Cannula may be used in abdominal, thoracic, or gynecological procedures.

This document describes a 510(k) premarket notification for the "Bladeless Trocar - Artemis Lap Cannula." The submission seeks to prove substantial equivalence to a legally marketed predicate device (K032676, the ENDOPATH III Trocar System).

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria for performance metrics in a table format, nor does it provide detailed quantitative performance data for the Artemis Lap Cannula. Instead, the document focuses on demonstrating substantial equivalence through a comparison of technological characteristics and nonclinical testing.

Here's a summary of the stated performance and comparisons:

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

The document does not explicitly state sample sizes for specific tests (e.g., biocompatibility testing might involve various samples for different analyses, and leak testing would have its own sample size).

• Test Set Sample Size: Not explicitly stated for each test.
• Data Provenance: Not explicitly stated whether retrospective or prospective. Given the nature of pre-market testing for medical devices (biocompatibility, reprocessing, performance testing), it is typically prospective testing conducted specifically for the submission. The country of origin of the data is not specified beyond the applicant's location (Israel).

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

This information is not provided in the document. The tests described (biocompatibility, reprocessing, ISO standard testing, leak testing) are primarily objective engineering/scientific tests, not typically reliant on expert interpretation for "ground truth" in the same way clinical imaging or diagnostic studies might be.

4. Adjudication Method for the Test Set

Not applicable for the types of nonclinical tests described. Adjudication methods are typically relevant for studies involving human interpretation or clinical outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices, which the "Bladeless Trocar - Artemis Lap Cannula" is not. It is a surgical instrument.

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

A standalone performance study (algorithm only) was not done. This is not an AI/algorithm-based device.

7. The Type of Ground Truth Used

The "ground truth" for the nonclinical tests (biocompatibility, reprocessing, ISO standards, leak testing) typically refers to established scientific methodologies, validated test methods, and pre-defined acceptance criteria based on industry standards and regulatory requirements. For example:

• Biocompatibility: Established ISO standards (e.g., ISO 10993 series) define the ground truth for evaluating biological response.
• Reprocessing: Ground truth is established by validated protocols demonstrating the device can be consistently cleaned and sterilized to meet sterility assurance levels.
• ISO 80369-7: Ground truth is the successful meeting of the dimensional and performance requirements defined in the standard.
• Leak Testing: Ground truth is the quantitative measurement of leakage and its statistical equivalence to the predicate, demonstrating it meets performance expectations for sealing.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that uses a "training set."

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

Not applicable. This is not an AI/machine learning device.

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The FiberStitch™ Implant is intended for use as a suture retention device to facilitate endoscopic soft tissue procedures. The FiberStitch™ Implant Device is indicated for use in rotator cuff and meniscal repair procedures.

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The provided text is a 510(k) Summary for a medical device called "FiberStitch™ Implant". This document details the device's classification, indications for use, and a comparison to predicate devices, including nonclinical testing performed to support its safety and effectiveness.

However, the 510(k) Summary does not contain information about a study proving the device meets specific acceptance criteria based on AI performance, human reader improvement with AI assistance, or standalone algorithm performance. The testing discussed is biomechanical tensile strength testing and cadaveric evaluation to assess the device's usability and functionality for its intended surgical uses.

Therefore, I cannot provide a response filling in the requested table and study details as they pertain to AI/algorithm performance. The document focuses on the physical and functional characteristics of a surgical implant, not a diagnostic or AI-driven medical device.

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The Betta Link™ Knotless 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 Betta Link™ Knotless Anchor System consists of an inserter and PEEK (Polyether-ether-ketone) non-absorbable anchor. The device is a manual surgical device and is comprised of a handle and PEEK anchor on a proximal (to user) edge of the inserter shaft.
The inserter shaft ends with a dedicated "fork" tip which holds the anchor. The handle is designed for hammering the inserter into the pilot hole to deploy the anchor. When the anchor is inserted into bone and the inserter is removed the fixation is achieved.

This is a 510(k) premarket notification for a medical device called the Betta Link™ Knotless Anchor System. This document does not pertain to an AI/ML device, therefore the requested information for acceptance criteria and study proving device meets the criteria is not applicable in the context of AI/ML performance.

The provided document describes a traditional medical device submission for a knotless anchor system used in soft tissue to bone fixation. The document focuses on demonstrating substantial equivalence to a predicate device through nonclinical testing (biocompatibility, sterilization, and various mechanical/functional tests) rather than AI/ML performance metrics.

Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria, study details, sample sizes, ground truth, or MRMC studies, as these aspects are not present in the provided text.

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The VersaLoop™ 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 VersaLoop™ Anchor System consists of an inserter and Ultra High Molecular Weight Polyethylene (UHMWPE) non-absorbable loop suture anchor and threaded sutures.
The inserter shaft ends with a "fork" tip which holds the suture anchor. There are 3 narrow slots on the handle which holds the suture, which can be press-locked and released. The handle is designed for hammering the inserter into the pilot hole to deploy the anchor.
When the suture anchor is inserted into bone and the inserter is removed, the main sutures are pulled, and the all-suture anchor (loop) creates a "bunching" effect using targeted compression zones within the implant sheath for optimal fixation.

This is a 510(k) premarket notification for a medical device called the VersaLoop™ Anchor System. The document does not describe a study involving an AI/ML device. Therefore, it is unable to provide information on acceptance criteria and a study proving the device meets them in the context of an AI/ML model.

This document describes a medical device, specifically a suture anchor system used for soft tissue to bone fixation. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and nonclinical testing, rather than reporting on a clinical effectiveness study or AI/ML performance.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, adjudication methods, or MRMC studies is not applicable or present in this document. The document confirms that nonclinical testing was performed to demonstrate that the VersaLoop™ Anchor System meets established performance characteristics and design requirements.

Summary of available information related to performance:

• Nonclinical test discussion: Nonclinical testing was completed to demonstrate that the VersaLoop™ Anchor System devices meet the established performance characteristics and to verify that design requirements are satisfied.
• Types of testing: Biocompatibility evaluation (per ISO 10993-1), ethylene oxide sterilization validation, Bacterial Endotoxin (BET), dimensional, mechanical (fatigue testing, pullout testing, torque testing, applied forces testing), and functional testing.
• Conclusion from nonclinical tests: "It was concluded from the nonclinical tests that the device is as safe, as effective, and performs as well as or better than the legally marketed device predicate (21 CFR 807.92(b)(3))."
• FDA Guidance used: "Bone Anchors - Premarket Notification (510(k)) Submissions Guidance for Industry and Food and Drug Administration Staff."

The acceptance criteria and device performance would be specific to each of these nonclinical tests (e.g., specific tensile strength limits for pullout testing, sterility assurance levels for sterilization validation) but are not explicitly detailed in this summary.

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The FiberStitch™ Meniscal Repair Device is intended for use as a suture retention device to facilitate endoscopic soft tissue procedures.
The FiberStitch™M Meniscal Repair Device is indicated for use in meniscal repair procedures.

The FiberStitch™ devices are an all-inside meniscal repair device. The devices include two non-absorbable polyester implants, pre-tied with #2-0 non-absorbable sutures and preloaded into a needle delivery system. The adjustable depth penetration limiter is preset to approximately 18mm from the tip of the needle. It can be adjusted down in 2 (mm) increments to approximately 10mm.

I am sorry, but the provided text describes a medical device called "FiberStitch™ Implant" and its 510(k) summary for FDA clearance. This document outlines the device's indications for use, comparison to predicate devices, and nonclinical testing that was performed.

However, the text does not contain information about the acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML-driven medical device, which would typically involve performance metrics like sensitivity, specificity, AUC, etc., derived from a test set with established ground truth.

Therefore, I cannot provide the requested information in the format you specified. The information about sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not present in this regulatory document for this type of medical device.

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The T.A.G. Dental Implant System is intended to replace single or multiple teeth in the fully or partially edentulous mandibular or maxillary alveolar process. The implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The T.A.G.'s Dental Implant System is composed of three sub-families:
(1) Massif - A self-tapping cylindrical screw type implant Available in lengths: 8 - 16 mm and diameters: 3.75 - 6.0 mm Note: length 6 mm not available for diameters below 4.2 mm.
(2) Axis - A self-tapping conical implant. Available in lengths: 8 - 16 mm and diameters: 3.75 - 6.0 mm Note: length 8 mm not available for diameters below 3.75 mm, length 16 mm not available for diameters above 4.2
(3) Crestone - A one piece implant Available in Lengths of 10 - 16 mm and Diameters 3.0 - 3.5 mm.
The implants are provided sterilize for single patient use. Each implant is provided with cover screw inside the sterile package. All implants are made of titanium alloy grade 23 (Ti-6AI-4V-ELI).
Provided are accessories which are used in dental implantation procedures. They are: Superstructures which are Healing Caps & Abutments made from Titanium Alloy TI 6AL 4V ELI, Stainless Steel, and/or PEEK. The superstructures are single patient use to be supplied non-sterile.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the T.A.G. Dental Implant System.

It's important to note that the provided document is a 510(k) summary for a dental implant system, which is a medical device, not a software or AI-driven diagnostic device. Therefore, the concepts of "test set," "training set," "ground truth experts," "adjudication," and "MRMC studies" are typically not applicable in the context of hardware medical devices like dental implants. The "performance" here refers to mechanical and material performance, not diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the typical sense of a diagnostic device with metrics like sensitivity, specificity, or AUC. Instead, it refers to compliance with established standards for mechanical performance.

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

• Sample Size for Test Set: The document does not specify the exact sample size for the mechanical testing. For ISO 14801, standard practice involves testing multiple samples per device configuration (e.g., different lengths, diameters) to establish statistical significance. The document states "testing, which was submitted."
• Data Provenance: The testing was "performed at an accredited independent laboratory." The country of origin of the data is not explicitly stated, but the manufacturer (T.A.G. Medical Products) is located in Kibbutz Gaaton, Israel. The testing would, therefore, likely originate from a lab commissioned by the manufacturer, possibly in Israel or an international lab accredited to perform such tests. The study is prospective in the sense that the implants were manufactured and then tested.

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

This concept is not applicable to this type of device and study. "Ground truth" for mechanical testing is established by the physical testing results themselves and their compliance with engineering specifications, not by expert consensus or interpretation of images. An independent accredited laboratory performing the tests serves as the "expert" in terms of confirming the test methodology and results.

4. Adjudication Method for the Test Set

This concept is not applicable to this type of device and study. Adjudication typically refers to resolving discrepancies in human interpretation, which is not relevant for mechanical performance testing.

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 type of study is specifically designed for diagnostic devices where human readers interpret medical images or data, and its goal is to assess the impact of a device (often AI-assisted) on human performance. Since the T.A.G. Dental Implant System is a physical implant, such a study is irrelevant.

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

This concept is not applicable. The device is a physical dental implant, not an algorithm. The performance testing described (mechanical loading) is inherently "standalone" in the sense that it assesses the device's physical properties directly, without human interpretation of results needing to be factored into the device's intrinsic function.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing of the dental implant system is the physical measurement and observation of the implant's behavior under controlled mechanical stress, as defined by the ISO 14801 standard. This standard specifies how dental implants should be subjected to static and dynamic (cycling) loading to evaluate their fatigue strength and resistance to fracture. The "truth" is whether the implant withstands the specified forces and cycles without failure, thus meeting the criteria of the standard.

8. The Sample Size for the Training Set

This concept is not applicable. Dental implants are hardware devices. There is no "training set" in the machine learning sense. The design and manufacturing process are informed by engineering principles, material science, and previous experience, but not through an iterative learning process with a "training set" of data like an AI algorithm.

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

This concept is not applicable as there is no training set for a hardware medical device. The "ground truth" for the device's design and manufacturing is derived from established engineering principles, material specifications (e.g., Ti-6Al-4V-ELI), regulatory requirements (e.g., FDA guidance, ISO standards), and clinical experience with similar devices.

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The G-Lok® and G-Lok® XL Extender are intended to provide suspension fixation for soft tissue to bone in the repair of the natural ligament or tendon disruption or assist in reconstruction surgeries and to assist in the management of reconstructive surgeries.

The G-Lok® suspension fixation device is a single-use, titanium implant used for fixation of soft tissue to bone. The G-Lok® has two configurations: One has a Continuous Loop, made of ultra high molecular weight polyethylene, offered in several sizes to accommodate various bone tunnel lengths. The second configuration does not have a loop, and enables custom loop lengths to be tied using an appropriate material (not included). Both of these configurations have a Lead Suture and an optional Flipping Suture. The G-Lok® XL Extender is a single-use, titanium implant used for providing additional button width and length to the G-Lok®.

This document is a 510(k) premarket notification for the G-Lok® and G-Lok® XL Extender, which are metallic bone fixation fasteners. The purpose of this 510(k) is to demonstrate substantial equivalence to a predicate device (K101616 - GrappLR™ and GrappLR™ Extender).

The information provided does not describe clinical acceptance criteria or a study that proves the device meets such criteria in the way typically expected for an AI/CADe device. This document is for a medical implant (a bone fixation fastener), and the evaluation focuses on mechanical performance and substantial equivalence to a predicate device, not on diagnostic accuracy metrics like sensitivity or specificity.

Therefore, many of the requested points are not applicable to the information contained in this document. However, I will answer the applicable questions based on the provided text.

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

The document explicitly states: "The purpose of this 510(k) was to add an optional Flipping Suture. With respect to technology, the design is similar as confirmed by comparison, and the performance is the same as verified by validation. Based upon this, T.A.G. Medical Products Corporation, Ltd. believes that its device is safe and effective because it performs the same function in the same manner."

The "performance" referred to here is largely mechanical and functional equivalency to the predicate device. The Acceptance Criteria are implicitly that the modified device's mechanical performance is equivalent to or better than the predicate device.

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

The document mentions "performance testing indicated equivalency to the predicate device," but it does not specify the sample size, data provenance, or whether the testing involved human subjects or was purely mechanical/bench testing. Given the nature of a bone fixation fastener, it's highly likely this refers to bench testing rather than clinical data from patients.

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 is not applicable. The "ground truth" for a mechanical device like this would be its physical and mechanical properties, not expert-labeled clinical data.

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

This is not applicable as there is no "test set" in the context of diagnostic performance requiring adjudication.

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. This is not an AI/CADe device.

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

This is not applicable. This is not an AI/CADe device.

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

Given the context of a 510(k) for a medical implant, the "ground truth" would be related to material properties, mechanical strength, biocompatibility, and functional performance as determined by engineering tests and regulatory standards. The document doesn't explicitly state the type of ground truth, but it would be based on validated scientific and engineering principles for mechanical functionality and safety.

8. The sample size for the training set

This is not applicable. There is no mention of a training set as this is not an AI/CADe device.

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

This is not applicable. There is no mention of a training set.

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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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