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The Medline UNITE® Snap-Off Screws are indicated for use in bone reconstruction, osteotomies, joint fusion, fracture repair, and fracture fixation of bones appropriate for the device. Screws are intended for single use only.

The Medline UNITE® Snap-Off Screws are manufactured from titanium alloy. The screws include a groove between the head and the drive mechanism that is intended to snap off the drive mechanism below the surface of the head of the screw. The screws are offered in various diameters, lengths, and thread lengths.

The provided documents describe a 510(k) premarket notification for the Medline UNITE® Snap-Off Screws. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria through the kind of studies you've outlined.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria, specifically concerning:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for a test set or data provenance.
3. Number of experts used or their qualifications for ground truth.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study or effect size.
6. Standalone algorithm performance.
7. Type of ground truth used (expert consensus, pathology, outcomes).
8. Sample size for the training set.
9. How ground truth for the training set was established.

Instead, the submission utilizes non-clinical testing to demonstrate that the new device does not present a new worst-case scenario compared to the predicate device in terms of torsional or pullout strength. It explicitly states, "Summary of Clinical Testing: Not applicable."

The core of this 510(k) submission is to demonstrate:

• Same Intended Use: Both the predicate and subject device are indicated for use in bone reconstruction, osteotomies, joint fusion, fracture repair, and fracture fixation.
• Same Indications for Use.
• Same Materials: Both are manufactured from titanium alloy (Ti-6AL-4V).
• Similar Design Features: Although the subject device introduces a snap-off mechanism and a three-pronged external drive, the overall function as a bone fixation fastener is similar to the predicate cannulated screws.
• Non-clinical Testing: The critical aspect highlighted is that "The subject screw does not present a new worst-case when compared to the predicate screw in torsional or pullout strength." This is the primary "proof" of equivalence for mechanical properties.

In summary, this document supports the substantial equivalence of a medical device by comparing its characteristics and performance to an already legally marketed predicate device, primarily through engineering and material compatibility, and demonstrating no new worst-case performance in relevant mechanical tests, rather than establishing and meeting specific performance acceptance criteria through clinical or AI-specific validation studies as described in your request.

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Indications for use include fixation of fractures. For specific screw indications please see below.

MetaFixTM LS Locking Screws

• · For adult and pediatric patients
• · In combination with Merete Locking Plates
• · Fixation of fractures, osteotomies, non unions of the clavicle, scapula, olecranon, radius, ulna, fibula, metacarpals, metatarsals
• · Hallux Valgus osteotomy correction, middle hand and middle foot bones and particular in osteopenic bone

Merete® Cannulated PCS

• · For adult and pediatric patients
• · Fixation of fresh fractures
• · Revision procedures
• · Joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes

Merete® CS Cortical Screws

• · For adult and pediatric patients
• · Fixation of fresh fractures
• · Revision procedures
• · Joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes

Merete® Cannulated HCS

• · Fixation of fractures and reconstruction of various bones
• · Osteotomies in the foot (as Hallux Valgus) or hand
• · Athrodesis in hand, foot or ankle surgery
• · Fixation of bone fragments in long bones or small bone fractures

DuoThread™ Scarf Screws

• · Small bone fracture fixation
• · Fixation and stabilization of bones of the feet
• · Osteotomies (Scarf-Osteotomy, Chevron-Austin Osteotomy, Closing Wedge Osteotomy)
• · Fusion (MPG-Athrodesis)
• · Fixation of almost all common osteotomies of the first metatarsal

TwistCut™ Snap-Off Screws

• · Fixation of fractures and reconstruction of bones
• · Fixation of small bone fragments
• · Mono cortical fixation
• · Osteotomies (Weil-Osteotomy)
• · Fracture fixation in the foot and hand

MetaFix™ LS Locking Screws: The screws are fully threaded and self-tapping with a threaded head to lock into Merete Locking plates. Locking screws/plates incorporate a screw-to-plate locking feature which creates a locked, fixed angle construction to hold fracture or osteotomy reduction. The screws are made of titanium (ASTM F-136) and are available in the lengths from 12 mm (Ø3.0 mm), 12 mm to 48 mm (Ø3.5 mm) and 10 mm to 48 mm (Ø3.8 mm).

Merete® Cannulated PCS: The Merete® Cannulated PCS screw is a partly threaded, self-tapping, self-drilling and cannulated compression screw. The screws are made of titanium (ASTM-F136) and are available in the lengths from 12 mm to 48 mm (Ø3.0 mm). The wrench type of the screw is a torx socket.

Merete® CS Cortical Screws: The Merete® CS Cortical Screw is fully or partly threaded and self-tapping. The screws are made of titanium (ASTM-F136) and are available in the lengths from 10 mm (Ø3.0 mm or Ø3.5 mm). The wrench type of the screw is a torx socket.

Merete® Cannulated HCS: The Merete® Cannulated HCS screw is a partly threaded, self-tapping, self-drilling and cannulated headless compression screw. The screw is featured with a sinkable threaded head. The thread pitch of the shaft and the head are different to achieve a better compression. The screws are made of titanium (ASTM F-136) and are available in the lengths from 12 mm to 40 mm (Ø3.0 mm to 60 mm (Ø4.3 mm). The wrench type of the screw is a torx socket.

DuoThread™ Scarf Screws: The DuoThread™ Scarf screw is a partly or fully threaded, cannulated compression screw. The compression is obtained through a different thread pitch at the head of the screw. The screws are made of titanium (ASTM-F136) and are available in the lengths from 10 mm to 34 mm (Ø3.0 mm). The wrench type of the screw is a torx socket.

TwistCut™ Snap-Off Screws: The TwistCut™ Snap-Off screw is self-tapping and self-drilling. The screw has a shank to chuck it into a K-Wire pistol, which is cut off when the screw head hits the cortex. The screws are made of titanium (ASTM-F136) and are available in the lengths from 11 mm to 14 mm (Ø2.0 mm).

This document is a 510(k) Premarket Notification from the FDA regarding Merete Medical Incorporated's bone fixation fasteners. It does not provide information about a study proving the device meets specific acceptance criteria in the context of an AI/ML device, as it describes physical medical devices (screws) rather than a software or AI-driven system.

Therefore, most of the requested information (acceptance criteria, device performance, sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth) is not applicable to this document.

However, I can extract the following relevant information based on the document's content:

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

2. Sample size used for the test set and the data provenance: Not applicable. This document refers to physical device testing (mechanical, sterilization, packaging) not a software test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context would refer to material and mechanical engineering standards, not expert clinical interpretation.

4. Adjudication method for the test set: Not applicable. Testing was based on engineering standards (ASTM F543).

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 document is about physical bone fixation screws, not an AI system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.

7. The type of ground truth used: For mechanical performance, the ground truth is established by engineering standards, specifically ASTM F543. For sterilization and packaging, the ground truth is established by validated protocols and current standards.

8. The sample size for the training set: Not applicable. There is no concept of a "training set" for physical device testing in this context.

9. How the ground truth for the training set was established: Not applicable.

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The Nexis® osteosynthesis compressive screws are single use devices indicated for the fixing and stabilizing the elective osteotomies of the mid foot bones and the metatarsal and phalanges of the foot only.

Nexis® osteosynthesis snap-off screws are single-use bone fixation devices intended to be permanently implanted. Nexis® osteosynthesis snap-off screws are non canulated snap-off screws made of Titanium (Alloy Ti-6Al-4V ELI). Nexis® osteosynthesis snap-off screws are non canulated snap-off bone screws which allow a permanent compression, thus supporting a secure osseous restoration.

The document describes a 510(k) premarket notification for the "Nexis® osteosynthesis snap-off screws" device, comparing it to a predicate device, the "Memometal Fixos screws." This type of submission relies on demonstrating substantial equivalence to a legally marketed device rather than conducting extensive new clinical trials. Therefore, the information provided does not align with the typical structure of acceptance criteria and a study proving a device meets them in the context of an AI/ML medical device.

However, I can extract and structure the available information regarding the "performance data" that NOVASTEP provided to demonstrate substantial equivalence, framing it in terms of "acceptance criteria" and "reported device performance" as much as possible for this specific type of device (an orthopedic screw).

Acceptance Criteria and Reported Device Performance for Nexis® osteosynthesis snap-off screws

1. Table of Acceptance Criteria and the Reported Device Performance

• Driving and removal torque
• Pull-out strength
• Torsional resistance |
  | Biocompatibility | Evaluation conducted in accordance with Blue Book Memorandum #G95-1 (Use of International Standard ISO-10993) and International Standard ISO 10993-1 (Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process) as recognized by FDA. |
  | Design Characteristics | Similar design characteristics to the predicate device. Nexis® screws are described as non-cannulated snap-off screws designed for permanent compression and secure osseous restoration. |
  | Intended Use & Indications for Use | Identical intended use: fixing and stabilizing elective osteotomies of the mid foot bones and the metatarsal and phalanges of the foot only. |

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

• Sample Size: Not explicitly stated. The performance data for mechanical testing and biocompatibility study typically involves a certain number of samples for each test, but the specific quantities are not detailed in this summary.
• Data Provenance: Not explicitly stated. These tests are usually conducted in specialized labs.
• Retrospective or Prospective: Not applicable in the context of comparing a new device's material and mechanical properties to a predicate and recognized standards.

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

• Not applicable. This is not a study involving expert assessment of data like in AI/ML performance evaluation. The "ground truth" here related to engineering standards and material properties.

4. Adjudication method (e.g. 2+1, 3+1, none) 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 device.

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

• Not applicable. This is not an AI/ML device.

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

• The "ground truth" in this context refers to established engineering standards (e.g., ISO 5832-3 for material, ASTM F543-13 for mechanical tests, ISO 10993 for biocompatibility) and the known characteristics of the legally marketed predicate device (Memometal Fixos screws). The testing confirms the new device's properties align with these standards and the predicate.

8. The sample size for the training set

• Not applicable. No training set is used for this type of device submission.

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

• Not applicable. No training set is used for this type of device submission.

Summary Explanation:

The "study" demonstrating the device meets the acceptance criteria is detailed under "Performance data" in the 510(k) summary. It states that NOVASTEP's Nexis® osteosynthesis snap-off screws have been evaluated for biocompatibility according to FDA-recognized ISO 10993 standards and for mechanical characteristics (driving and removal torque, pull-out strength, torsional resistance) to demonstrate similarity with the predicate device, Memometal Fixos screws. The material (Titanium Alloy Ti-6Al-4V ELI) is also stated to be in accordance with ISO 5832-3 and similar to the predicate.

Crucially, the document explicitly states: "Clinical studies were not required for this submission" and "Animal Studies were not required for this submission." This is typical for 510(k) submissions where substantial equivalence is primarily demonstrated through comparison to a predicate device's design, materials, and mechanical performance, and adherence to recognized standards, rather than new human clinical efficacy trials. The "acceptance criteria" are effectively the established standards and the characteristics of the predicate device that the new device must match or be equivalent to.

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