(69 days)
Intended Use: The DePuy FRS-Screw is intended to be implanted for the fixation of bone fractures, fusion of a joint or bone reconstructions.
Indications for Use: The FRS®-Screw is indicated for fixation of bone fractures, fusion of a joint, or bone reconstruction (osteotomy) of the mid-foot bones, metatarsal and phalanges of the foot or the phalanges, metacarpals, and carpals of the hand. Examples include: Hallux Valgus correction, Akin Osteotomies, MTP arthrodesis, Interphalangeal arthrodesis
The DePuy FRS-Screw is a cannulated thread-head screw made of a Titanium alloy and is available in lengths of 10-34mm in 2mm increments.
The provided text is for a 510(k) premarket notification for a medical device called the "FRS® Screw." This document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study proving the device meets specific acceptance criteria in terms of performance metrics like sensitivity or specificity.
Therefore, many of the requested categories for a study proving device performance (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) are not applicable to this type of regulatory submission.
The 510(k) summary primarily addresses:
- Device Description: What the device is.
- Intended Use and Indications: What the device is for.
- Basis of Substantial Equivalence: How it is similar to already approved devices.
Here's how to address your request based on the provided text:
Acceptance Criteria and Device Performance Study Analysis
The provided document describes a 510(k) premarket notification for the FRS® Screw. The primary goal of a 510(k) submission is to demonstrate substantial equivalence to a previously legally marketed device (predicate device), not to prove performance against specific clinical acceptance criteria through a dedicated study with metrics like sensitivity, specificity, or reader improvement.
Therefore, the input document does not contain information on quantitative acceptance criteria for device performance (e.g., diagnostic accuracy metrics) nor a study designed to explicitly prove the device meets such criteria through a performance evaluation study. Instead, the "study" referred to in the context of a 510(k) is the demonstration of substantial equivalence based on similarities in intended use, indications for use, materials, and design, which relies on the predicate device's established safety and effectiveness.
Information from the Document:
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Table of acceptance criteria and the reported device performance:
- Not Applicable. The document does not specify quantitative performance acceptance criteria or report performance metrics like sensitivity, specificity, accuracy, etc. The "performance" demonstrated is that the device is substantially equivalent to predicate devices, implying similar safety and effectiveness.
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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 clinical "test set" or data directly evaluating the FRS® Screw's performance is described in this submission in the way you might find for a diagnostic or AI device. The demonstration of substantial equivalence is based on engineering principles, material properties, and comparison to existing devices.
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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. Ground truth, in the context of clinical performance evaluation often established by experts, is not relevant to this 510(k) submission.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable.
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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 is a bone fixation screw, not an AI-powered diagnostic device. An MRMC study is not relevant.
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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 (bone screw), not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable.
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The sample size for the training set:
- Not Applicable. This device does not involve a "training set" in the context of AI or machine learning.
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How the ground truth for the training set was established:
- Not Applicable.
Summary of Substantial Equivalence Basis:
The basis for the 510(k) clearance is substantial equivalence to predicate devices. This means the FRS® Screw is considered as safe and effective as the predicate devices because of the following similarities:
- Intended Use: Fixation of bone fractures, fusion of a joint, or bone reconstructions.
- Indications for Use: Specifically, for mid-foot bones, metatarsals, phalanges of the foot, phalanges, metacarpals, and carpals of the hand (e.g., Hallux Valgus correction, Akin Osteotomies, MTP arthrodesis, Interphalangeal arthrodesis).
- Materials: Titanium alloy.
- Design: Cannulated thread-head screw, available in specific lengths.
Predicate Devices Referenced:
The FDA reviewed this comparison and determined that the FRS® Screw is substantially equivalent to these devices, allowing it to be marketed.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.