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The ADHOC® CLAW is an implant used for rotator cuff repair in shoulder surgery.

The ADHOC® CLAW is an implant used for rotator cuff repair in shoulder surgery. The ADHOC® CLAW is made of 316L stainless steel.

The provided text is a 510(k) summary for the ADHOC® CLAW soft tissue fixator. It does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

The document primarily focuses on establishing substantial equivalence to predicate devices (MITEK GII and ACUFEX MICROSURGICAL) based on similar intended use and design, rather than on performance metrics or clinical study results demonstrating new acceptance criteria.

Therefore, I cannot provide the requested information. The sections below indicate why each point cannot be addressed from the given text:

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

• Not applicable. The document does not define any specific acceptance criteria for performance (e.g., tensile strength, fixation force, biocompatibility thresholds) nor does it report device performance against such criteria. The basis for clearance is substantial equivalence to legally marketed predicate devices, not meeting novel performance benchmarks.

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

• Not applicable. No test set or study data are mentioned explicitly in the provided summary.

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. No ground truth establishment or expert involvement in a test set is described.

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

• Not applicable. No test set or adjudication method is mentioned.

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 medical implant (soft tissue fixator), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.

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

• Not applicable. As stated above, this is an implant, not an algorithm, so standalone performance in that context is not relevant.

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

• Not applicable. No ground truth for performance evaluation is mentioned. The "ground truth" for clearance in this context is the safety and effectiveness of the predicate devices.

8. The sample size for the training set

• Not applicable. No training set is mentioned as this is not an AI/ML device.

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

• Not applicable. No training set or ground truth for it is mentioned.

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To provide interference fixation of soft tissue graft and bone-tendon-bone patellar graft during cruciate ligament repair through arthroscopy or arthrotomy.

The titanium cannulated interference screw is tapered and has a smooth threaded design, which provides interference fixation of soft tissue grafts and bone-tendon-bone patellar grafts during cruciate ligament repair through arthroscopy or arthrotomy. The screw comes in lengths between 20 and 50 mm and diameters between 7mm and 12mm, resulting in a screw adapted to the morphology of the graft and patient.

The provided text is a 510(k) summary for a medical device called the "Titanium cannulated interference screw." This document primarily focuses on demonstrating substantial equivalence to a predicate device and outlines the intended use and design, rather than detailing a study with acceptance criteria and performance metrics typically found in AI/software device submissions.

Therefore, many of the requested categories for a study proving device performance (acceptance criteria, sample sizes, expert involvement, ground truth, MRMC study, standalone performance) cannot be answered directly from this 510(k) summary. These types of studies are not typically required for a mechanical device like an interference screw seeking substantial equivalence.

Here's what can be extracted based on the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The 510(k) summary for this mechanical device does not present specific acceptance criteria or quantitative performance metrics in the way a software or AI device submission would. The acceptance is based on demonstrating substantial equivalence to a legally marketed predicate device.

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

Not applicable. There is no mention of a "test set" in the context of evaluating performance against specific criteria, as this is a mechanical interference screw, not a diagnostic or AI device. The comparison is primarily dimensional and functional equivalence to a predicate.

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

Not applicable. There is no mention of experts establishing a "ground truth" for a test set.

4. Adjudication Method for the Test Set

Not applicable. No test set or adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

Not applicable. An MRMC study is relevant to diagnostic interpretation by human readers, often with AI assistance. This device is a surgical implant, not an imaging or diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is a mechanical device, not an algorithm.

7. The Type of Ground Truth Used

Not applicable. "Ground truth" as understood in AI/diagnostic studies is not relevant here. The "truth" in this context is the established safety and efficacy of the predicate device for its intended use.

8. The Sample Size for the Training Set

Not applicable. No "training set" exists for a mechanical device like this in the context of a 510(k) submission focused on substantial equivalence.

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

Not applicable.

Summary of Device and its Equivalence (from the 510(k) summary):

• Device Name: Titanium cannulated interference screw
• Intended Use: To provide interference fixation of soft tissue grafts and bone-tendon-bone patellar grafts during cruciate ligament repair through arthroscopy or arthrotomy.
• Predicate Device: K010595: Alaron Technologies, LLC.
• Basis for Substantial Equivalence: The submission states, "The titanium cannulated interference screw and the predicate device have the same overall design. In addition, the small differences in design do not affect the use, safety and effectiveness, between the device and the predicate device."
• Design Details: Tapered, smooth threaded design, comes in lengths between 20-50mm and diameters between 7-12mm.

This 510(k) relies on demonstrating that the new device is sufficiently similar to a previously cleared device that no new questions of safety or effectiveness are raised, rather than providing new performance data from a clinical or analytical study with defined acceptance criteria.

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The ENDO FMS® UROLOGY is a fluid management system used to maintain adequate irrigation pressure and flow in endoscopic Urology procedures, including all endoscopic procedures in the Kidney, Ureter/Urethra , Bladder and Prostate.

ENDO FMS® UROLOGY is a fluid management system.

This is a premarket notification (510(k)) letter from the FDA regarding the ENDO FMS® UROLOGY (Fluid Management System). This document is an approval letter and does not contain detailed information about acceptance criteria or study results. A 510(k) submission typically demonstrates substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through extensive clinical studies like those required for Pre-Market Approval (PMA).

Therefore, based solely on the provided text, I cannot provide the requested information. The document primarily focuses on the FDA's decision regarding the substantial equivalence of the device.

To address your request, I would need to review the actual 510(k) submission (K980808) which would detail the technical specifications, performance testing, and comparison to the predicate device.

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