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The APTUS® Titanium Fixation System is intended for use in hand and forearm fractures, osteotomies and arthrodeses.

APTUS® Hand group:

• Management of the fractures of the distal, middle and proximal phalanges . and metacarpals
• Management of all types of transversal fractures, spiral fractures, fractures near joints with or without joint involvement, shaft factures, comminuted fractures, dislocation fractures, avulsion fractures
• DIP and PIP arthrodoses t

APTUS® Radius 2.5 group:

• Management via radio volar approach of extra-articular extension and . flexion fractures, articular extension and flexion fractures, correction osteotomies for badly healed radius fractures
• Management via dorsal approach of rare extension fractures that cannot be . adequately reduced via volar approach, procedures for which the soft tissue conditions make a volar approach very difficult or impossible, correction osteotomies requiring stabilization from the dorsal side, carporadial fusions.

The APTUS® Titanium Fixation System consists of implant plates and implant screws and is used for internal fixation of small bones.

APTUS Plates
Implant Modules are provided in sizes Hand 1.2, Hand 1.5, Hand 2.0, Hand 2.3 for miplant Modules are pro rised in oristius reconstruction plate system is used for fixation valious iniger segmonts. The distal for corrective osteotomies of the distal radius with of fractures or the under laccess. Variations of plate shapes include H frame, straight, T and L shaped.

APTUS Screws
Locking screws for the Radius and Hand 2.0 Lock product lines, designated TriLock™, utilize a spherical three point wedge locking design and are used with locking plates. Conventional bone screws have a double thread design and precisely cut sharp thread profile, tapering core diameter and atraumatic tip. The shorter screws have a small pitch in order to maintain optimal purchase in the bone, while the longer screws have a larger pitch in order to minimize the number of revolutions.

This 510(k) summary for the APTUS® Titanium Fixation System does not contain information about acceptance criteria, device performance testing, or clinical studies of the nature you've requested (e.g., sample sizes for test sets, expert ground truth, MRMC studies, standalone performance).

The document is a premarket notification (510(k)) submission to the FDA, which typically focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than presenting a full clinical trial or performance validation of the type you've outlined.

Here's how the provided information relates to your request:

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

• Not provided. This document highlights the "intended use" and "device description" but does not specify quantitative acceptance criteria for performance (e.g., strength, biocompatibility thresholds) or report specific performance metrics against such criteria. The basis for clearance is substantial equivalence to predicate devices, implying similar performance characteristics.

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

• Not provided. No performance test set or associated data provenance is mentioned.

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/Not provided. This type of information is typically for diagnostic or AI-driven devices where ground truth relies on expert interpretations. This document is for a medical implant (fixation system).

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

• Not applicable/Not provided.

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. MRMC studies are relevant for diagnostic devices involving human interpretation, often with AI assistance. This device is a bone fixation system, not a diagnostic tool with an AI component.

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

• Not applicable. This device does not have an algorithm component.

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

• Not applicable/Not provided in the context of device performance. For a fixation system, "ground truth" often refers to clinical success (e.g., fracture healing, absence of complications) which would be assessed in clinical studies, but such studies are not detailed here for this 510(k). The focus is on material properties and mechanical design mirroring predicates.

8. The sample size for the training set:

• Not applicable/Not provided. There is no "training set" as this device does not involve a machine learning algorithm.

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

• Not applicable/Not provided.

Summary of available information relevant to regulatory submission principles:

The 510(k) summary describes the APTUS® Titanium Fixation System as implants (plates and screws) for internal fixation of small bones in hand and forearm fractures, osteotomies, and arthrodeses.

The primary "proof" that the device meets regulatory requirements for marketing is its substantial equivalence to already legally marketed predicate devices. The document lists the following predicate devices:

• Profyle™ Titanium Hand and Small Fragment System (K961497) from Howmedica (Stryker)
• Stryker® Leibinger Universal Distal Radius System (K040022) from Stryker Leibinger
• Distal Radius Fracture Repair System (K002775, K023007, K030198) from Hand Innovations
• Fragment Plate System (K041081) from Hand Innovations

The equivalence is asserted "in indications and design principles." This implies that the materials, mechanical properties (even if not explicitly quantified in this summary), sterilization, and general design features are considered similar enough to the predicate devices that no new safety or effectiveness concerns are raised, negating the need for extensive new clinical studies for this specific clearance.

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The HALLU® -PLATES are intended to be implanted for fixation of fractures, osteotomies or arthrodesis of the first metatarso-phalangeal joint. Examples include:
-Hallux rigidus
-Severe hallux valgus (IM angle > 20° and HV angle > 40°)
-Deformity from rheumatoid arthritis
-Failed previous surgical procedure
-Traumatic arthritis
-Neuromuscular instability.

The HALLU® -PLATES are available in two different designs :

• the HALLU®-C PLATE -
• the HALLU®-S PLATE -
  The HALLU®-C PLATE and the HALLU® -S PLATE are low profile Titanium plates dedicated to first metatarso-phalangeal arthrodesis. Those implants are pre-bent for optimal anatomical adaptation (10° valgus and 10°dorsiflexion). Their fixation is provided by Titanium SNAP-OFF® screws available in a two diameters: 3.0 and 2.7 mm. They exist in different colors for size identification. The bone contact surface is sand blasted in order to maximize plate stability. The range of HALLU -C PLATE and HALLUS S PLATE include 6 sizes ( 31eft/3right) for optimal anatomic fit. Moreover, the HALLU®-S PLATE has an anatomical design providing optimal bone coverage.

The provided text describes a medical device, the HALLU®-PLATES, and its regulatory clearance based on substantial equivalence to predicate devices, rather than a study proving performance against specific acceptance criteria for a new AI/software device. Therefore, much of the requested information regarding AI/software device studies (e.g., sample sizes for test/training sets, expert adjudication methods, MRMC studies, standalone performance, ground truth for training) is not applicable.

However, I can extract the information related to the device's testing and the standards it met.

1. Table of Acceptance Criteria and Reported Device Performance

Detailed Breakdown of Applicable Information:

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

• Sample Size: Not explicitly stated as this was a physical device test, not a data-driven software evaluation. The document mentions "Test 1" and "Test 2," implying multiple samples of the plate were tested for bending and fatigue.
• Data Provenance: The tests were conducted to comply with French Standard ISO 9585 and ASTM Standard F-382-99. This implies the tests were performed in a controlled laboratory setting, likely in the country of origin of the sponsor (France) or a qualified testing facility. The study type is experimental/bench testing, not retrospective or prospective human data.

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

• This question is not applicable as the "ground truth" for a physical device test like this is defined by established engineering standards (ISO 9585 and ASTM F-382-99) and the physical properties of the materials and design, not by expert human interpretation.

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

• This question is not applicable for a physical device test. The compliance is determined by measurements against predefined standard thresholds.

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:

• No, a MRMC comparative effectiveness study was not done. This is a physical bone plate, not an AI or imaging device that would involve human readers.

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

• Yes, a standalone test was done. The device's performance (bending strength, stiffness, fatigue strength) was evaluated independently against established physical standards. This is analogous to a "standalone" test for a physical product.

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

• The ground truth was based on established engineering standards for bone plates: French Standard ISO 9585 and ASTM Standard F-382-99.

8. The sample size for the training set:

• Not applicable. This device underwent physical bench testing, not a machine learning training process.

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

• Not applicable. As above, there was no training set for a machine learning model.

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The washers are intended to be used to provide additional surface area contact between the screw head and bone surface, when used in combination with bone screws between the occord froution of the mandible, hand, foot and the midfacial skeleton where there exists a condition of a thin cortex or osteoporotic bone.

The Howmedica® and Howmedica® Leibinger Bone Screw Washers consist of sizes ranging from .8 mm internal diameter to 3.5 mm internal diameter. The washers are used in conjunction with screws, of like or similar material, currently available in Luhr® and Leibinger®-Luhr® plating systems, which were cleared under various 510(k) notifications (K761228, K854886, K862482, K862534, K882454, K901941, K913355, K923861, K935448, K950595, K951415, K961485, K961497, K963739, K963740, K970912,) and any future styles of Howmedica® and Howmedica Leibinger® screws found substantially equivalent.

This document is a 510(k) summary for medical devices, specifically bone screw washers. It details the device's intended use, materials, and establishes substantial equivalence to previously cleared devices. However, it does not contain the kind of performance study data, acceptance criteria, ground truth establishment, or sample size details that would typically be found in a clinical study report or a more detailed technical submission for a diagnostic AI/ML device.

Therefore, many of the requested points cannot be answered from the provided text.

Here is what can be inferred or explicitly stated from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy). The acceptance for this type of device (bone screw washers) is based on substantial equivalence to predicate devices in terms of intended use, materials, design, and operational principles.
• Reported Device Performance: Not applicable in the context of diagnostic performance metrics. The document asserts that the device is substantially equivalent to predicate devices.

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

• Sample Size (Test Set): Not applicable. There was no "test set" in the sense of a dataset of patient cases used to evaluate diagnostic performance. The substantial equivalence argument relies on a comparison of device characteristics rather than a performance study on a test set.
• Data Provenance: Not applicable for a performance study. The "data" here refers to the specifications and characteristics of the bone screw washers and their predicate devices.

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

• Not applicable. There was no test set requiring ground truth establishment by experts for diagnostic performance.

4. Adjudication method for the test set:

• Not applicable.

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 is not an AI/ML diagnostic device, and no MRMC study was conducted.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• The "ground truth" in this context is the safety and effectiveness of the predicate devices. The device is deemed safe and effective because it is substantially equivalent to devices already cleared for market. This isn't "ground truth" in the diagnostic sense, but rather regulatory precedent.

8. The sample size for the training set:

• Not applicable, as this is not an AI/ML device requiring a training set.

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

• Not applicable.

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