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The Opus MiniMagnum™ bone anchor with inserter is indicated for use in fixation of soft tissue to bone. Examples of such procedures include: Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis, and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, and midfoot reconstruction Foot: Hallux valgus reconstruction Elbow: Tennis elbow repair, biceps tendon reattachment Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions

The Opus MiniMagnum™ Anchor with Inserter is substantially equivalent to the existing Opus Magnum™ Anchor with Inserter and the Mitek Bioknotless Anchor cleared by the Food and Drug Administration. Additionally, the intended use of the Opus MiniMagnum™ Anchor with Inserter is identical and therefore substantially equivalent to the intended use of the existing Mitek BioKnotless Anchor, for fixation of soft tissue to bone. The purpose of this 510(K) is to notify the FDA of the clearance of a new Opus product, the Opus MiniMagnum™ Bone Anchor. The Opus MiniMagnum™ is substantially equivalent to Opus Magnum™ originally cleared under 510(k) 012125, but is smaller in size. The intended use and indications for use are the same as the predicate device, the Mitek BioKnotless Bone Anchor. The fundamental technology of the Opus MiniMagnum™ Bone Anchor System is substantially equivalent to the Opus Magnum™ Bone Anchor.

The provided text is a 510(k) premarket notification for a medical device (Opus MiniMagnum™ Bone Anchor with Inserter). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies with defined acceptance criteria and performance metrics. Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment for a new clinical trial.

Instead, the document asserts substantial equivalence based on:

• Identical intended use and indications for use to the predicate devices (Opus Magnum™ Anchor with Inserter and Mitek BioKnotless Anchor).
• Similar fundamental technology to the Opus Magnum™ Bone Anchor.
• The MiniMagnum™ is described as being "smaller in size" than its predicate.

To directly answer your specific questions in the context of this 510(k) submission, the following would be the response:

1. Table of acceptance criteria and the reported device performance:

This 510(k) submission does not include a table of acceptance criteria and reported device performance based on a new clinical study. The device's performance is implicit in its substantial equivalence to predicate devices, meaning it is expected to perform similarly to devices already on the market for the same intended use.

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

No test set sample size or data provenance is reported, as a new clinical study demonstrating specific performance metrics was not conducted. The submission relies on the established safety and effectiveness of its predicate devices.

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

Not applicable. No ground truth establishment by experts for a test set is mentioned, as no new clinical study was performed.

4. Adjudication method for the test set:

Not applicable. Since there was no test set or expert ground truth establishment, no adjudication method is 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:

Not applicable. This device is a bone anchor, not an AI-assisted diagnostic tool. Therefore, an MRMC study involving human readers improving with AI assistance is not relevant and was not conducted.

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

Not applicable. This device is a physical bone anchor, not a software algorithm. Standalone algorithm performance is not relevant.

7. The type of ground truth used:

Not applicable. Given that no new clinical study with performance metrics was conducted, there is no mention of ground truth derived from expert consensus, pathology, or outcomes data. The "ground truth" for this submission is implicitly the established safety and effectiveness of the legally marketed predicate devices.

8. The sample size for the training set:

Not applicable. No training set is mentioned as this is a physical medical device seeking substantial equivalence, not an AI/ML device requiring a training set for algorithm development.

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

Not applicable. As there is no training set for an algorithm, the method of establishing ground truth for it is not discussed.

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The Opus Magnum™ bone anchor with inserter is indicated for use in fixation of soft tissue to bone for rotator cuff repair.

Opus Magnum™ Anchor with Inserter

The provided text is a 510(k) premarket notification for a medical device called the "Opus Magnum™ Bone Anchor with Inserter." This document establishes substantial equivalence to an existing device rather than presenting a study to prove acceptance criteria for a novel device. Therefore, the information typically found in such a study (like detailed performance metrics, sample sizes for test and training sets, expert qualifications, or adjudication methods) is not present in the provided text.

The core of this 510(k) is a claim of substantial equivalence to a previously cleared device. This means the manufacturer is asserting that the modified device is as safe and effective as the predicate device, not that it has independently met specific performance criteria through a new clinical or laboratory study in the way a novel device might.

Here's a breakdown of what can be extracted and what information is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The document does not describe acceptance criteria for a new device's performance, nor does it report specific performance metrics from a study designed to meet those criteria. The submission is based on substantial equivalence.

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

Not applicable. No "test set" in the context of device performance evaluation (e.g., a cohort of patients or a set of images) is mentioned because this is a substantial equivalence submission, not a de novo study.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. No ground truth establishment by experts is described as there is no performance study presented.

4. Adjudication Method

Not applicable. No adjudication method is described.

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

Not applicable. No MRMC study is mentioned. The device is a bone anchor, not an AI or imaging device that would typically undergo an MRMC study.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The device is a physical bone anchor and inserter, not an algorithm.

7. Type of Ground Truth Used

Not applicable. No ground truth is described.

8. Sample Size for the Training Set

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

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

Not applicable. There is no training set or ground truth established for training.

Summary of Provided Information Relevant to Substantial Equivalence:

• Device Name: Opus Magnum™ Bone Anchor with Inserter
• Manufacturer: Opus Medical, Inc.
• Predicate Device: Opus Magnum™ Anchor with Inserter (cleared under 510(k) K012125)
• Reason for 510(k): Proposed modification to the Magnum™ Bone Anchor.
• Claim of Equivalence: The modified Opus Magnum™ is substantially equivalent to the original, with the same intended use, indications for use, and technology.
• Indications for Use: Fixation of soft tissue to bone for rotator cuff repair.

In essence, this 510(k) notification is a regulatory submission for a minor modification to an already approved device, asserting that the change does not alter its safety or effectiveness compared to the previous version. It does not contain the kind of detailed performance study data you would request for a novel device.

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Is indicated for use for in placement of suture through soft tissue in endoscopic and other limited access procedures.

The Opus Medical SpeedStitch™ Suture Device is intended for use in endoscopic procodures as well as other limited access open procedures for the purpose of suturing soft tissues. The wen us oner minned docess open preedStitch™ is based on a hand held, manually powered suture punch for the dclivery of a suture needle through soft tissue. The device delivers a simple stitch using USP #2 braided suture.

The provided text is a 510(k) premarket notification for the Opus SpeedStitch™ Suture Device. It outlines the device's intended use and claims substantial equivalence to an existing device. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone studies, ground truth types, or training set details. This type of detailed study information is typically found in the "Performance Data" or "Clinical Data" sections of a 510(k) submission, which are not present in the provided snippets.

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The Opus Magnum® implant is indicated for use for rotator cuff repair in the shoulder.

The purpose of this 510(k) is to notify the FDA of a modification to the Opus Magnum® Implant System wherein a new suture, MagnumWire™, will be added as an option to provide convenience to the user. MagnumWire™ is substantially equivalent to FiberWire® USP braided polyester suture size #2 originally cleared under 510(k) 031083. The intended use and indications for use are the same as the predicate device. The addition of the use of MagnumWire™ with the Opus Magnum® Implant System does not alter the fundamental technology of the Opus Magnum® Implant System.

This document is a 510(k) summary for the Opus Magnum® Anchor with Inserter, focusing on a modification to include a new suture, MagnumWire™. The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) is primarily concerned with demonstrating substantial equivalence to a predicate device (the existing Opus Magnum® Implant Set with FiberWire® suture) for the purpose of regulatory clearance, not with presenting performance studies against predefined acceptance criteria for a new AI/software device.

Therefore, I cannot provide the requested information, as it is not present in the provided text.

The document details:

• Manufacturer, contact, and date prepared.
• Device information: Trade Name, Common Name, Classification Name, Classification, and Product Code.
• Substantial Equivalence claim: States the new device (with MagnumWire™) is substantially equivalent to the previously cleared Opus Magnum® Implant Set (with FiberWire®).
• Indications For Use: Rotator cuff repair in the shoulder.
• Reason for 510(k) Notification: To add MagnumWire™ as an option, stating it is substantially equivalent to the previously cleared FiberWire®.
• FDA Clearance Letter: Confirms the device's substantial equivalence and clearance for marketing.

To answer your specific questions, information about acceptance criteria, performance studies, sample sizes, ground truth establishment, expert involvement, or MRMC studies would need to be present in a different section of the 510(k) submission, typically a more detailed performance data section, which is not included in the provided summary.

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The Opus SmartStitch M-Connector is indicated for use for placement of Braided Polyester Suture through soft tissue in endoscopic and other limited access procedures.
The Opus SmartStitch Needle Cassette is indicated for use for placement of Braided Polyester Suture through soft tissue in endoscopic and other limited access procedures.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to Opus Medical, Inc. regarding their Reuseable SmartStitch M-Connector and SmartStitch Needle Cassette. This document confirms the substantial equivalence of the device to legally marketed predicate devices and outlines general regulatory requirements.

However, the document DOES NOT contain information regarding: acceptance criteria, device performance, details of any studies (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods), or multi-reader multi-case studies.

Therefore, I cannot provide the requested information from the given input.

To answer your request, I would need a document that describes the design verification and validation testing performed for the device, including acceptance criteria and study results.

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The Opus SmartStitch M-Connector is indicated for use with a OM-8000 Actuation Handle for placement of #2 Braided Polyester Suture through soft tissue in endoscopic and other limited access procedures.

The Opus SmartStitch Actuation Handle is indicated for use with a OM-8007 M-Connector for placement of USP size #2 braided polyester suture (not supplied) through soft tissue in endoscopic and other limited access procedures.

Reusable SmartStitch® Suture Device

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving a device meets them. The document is an FDA 510(k) clearance letter for the Reusable SmartStitch Suture Device, indicating that it has been determined substantially equivalent to a predicate device.

While it mentions the device name, intended use, and regulatory classification, it does not include any information about:

• Acceptance criteria
• Device performance data
• Details of any studies conducted (sample size, data provenance, ground truth, experts, adjudication methods, MRMC studies, standalone performance, training set details).

Therefore, I cannot generate the table or provide the requested information based on this text.

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The Opus Magnum Implant is intended for fixation of tendon to bone using a "silky" II Polydek® non-absorbable braided polyester or FiberWire® braided polyblend USP size #2 suture for the indications listed below. The Magnum system consists of a fixation device pre-loaded with suture snares in an inserter handle. The Magnum Implant is a knotless fixation device whereby surgical knots are not necessary for fixation. Bone stock must be adequate to allow proper placement.

Indications:

(1) Shoulder 1) Rotator Cuff Repair

The Magnum system consists of a fixation device pre-loaded with suture snares in an inserter handle. The Magnum Implant is a knotless fixation device whereby surgical knots are not necessary for fixation.

This document is a 510(k) clearance letter from the FDA for the Opus Magnum™ Implant System. It does not contain any information about acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, or study methodologies (like MRMC or standalone performance studies).

The letter explicitly states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance. There is no performance data, clinical study information, or details of a study proving the device meets acceptance criteria provided in this document.

Therefore, I cannot fulfill your request for information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods from the provided text.

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The Device is indicated for hair removal and permanent hair reduction in dermatology and plastic surgery procedures.

The F1 Diode Laser System delivers a pulsed infrared laser light at a wavelength of 810 nanometers. The laser consists of several interconnected sections: The cabinet which houses the laser diode, the power supply, the PC-104, and the microcontroller, the umbilical which houses the fiber optics delivery system, and the handpiece and the external TE chiller.

This submission is a 510(k) premarket notification for the F1 Diode Laser System. The provided documents establish substantial equivalence to predicate devices based on intended use and technological characteristics. However, they do not contain information about specific acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any details related to AI or MRMC studies.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or details about the studies as such information is not present in the provided text.

The closest information available is the claim that:

• "The device, as designed, is as safe and effective as the predicate devices, and the device is substantially equivalent to the referenced predicate devices."
• "The differences between the F1 Diode Laser System and the predicate devices cited do not raise any different questions regarding safety and effectiveness."

This indicates a qualitative assessment of equivalence rather than a quantitative study with defined acceptance criteria and performance metrics.

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SmartStitch Suture Device:

The Opus SmartStitch M-Connector (Model #OM-8005) is indicated for use with a Actuation Handle (Model #OM-8500) and Suture Cartridges (Models #OM-8051, -8052, -8053) for placement of #2 Braided Polyester Suture through soft tissue in endoscopic and other limited access procedures.

SmartStitch Sutures:

The Opus Polyester Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic, orthopedic, and neurological procedures.

Not Found

The provided documentation is a 510(k) summary for the Opus SmartStitch® Suture Device. This type of document is intended to demonstrate substantial equivalence to a predicate device and therefore does not typically contain information about specific performance acceptance criteria or detailed study results of the kind requested for AI/ML-driven devices.

The document discusses the regulatory classification, indications for use, and a general statement of substantial equivalence. It does not include the type of detailed study information (acceptance criteria, sample sizes, expert qualifications, ground truth establishment, MRMC studies, standalone performance, or training data details) that would be present for a modern AI/ML device approval.

Therefore, I cannot extract the requested information from the provided text. The document itself is a regulatory clearance letter, not a performance study report.

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The Opus SmartStitch Suture Device is indicated for use for placement of #2 Braided Polyester Suture (such as Genzyme Polydek®) through soft tissue in endoscopic and other limited access procedures.

SmartStitch® Suture Device

I am sorry, but the provided text is a 510(k) clearance letter for the SmartStitch® Suture Device. It primarily focuses on regulatory approval and does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Information on experts used to establish ground truth.
• Adjudication methods.
• Results from multi-reader multi-case comparative effectiveness studies or standalone algorithm performance.
• Details about the type of ground truth used.
• Information regarding the training set size or how its ground truth was established.

The letter confirms that the device is "substantially equivalent" to a legally marketed predicate device, but it does not provide the technical performance study details that would typically be found in a 510(k) summary or an extensive clinical study report.

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