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The MIS Z-Pedicle Screw System is intended to provide immobilization and stabilization of the spinal segments for posterior, non-cervical pedicle fixation in skeletally mature patients as an adjunct to fusion for the following indications: · degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies): · spondy lolisthesis (grades 3 and 4) at L5-S1 - · trauma (i.e., fracture or dislocation) - · spinal stenosis - · curvatures (i.e.,scoliosis, kyphosis, and/or lordosis) - · tumor - · pseudoarthrosis - · failed previous fusion.

The MIS Z - Pedicle Screw System consists of a variety of Pedicle screws and rods in different sizes. The devices are intended to provide immobilization of the spinal segments for posterior, noncervical pedicle fixation in skeletally mature patients as an adjunct to fusion. The safety and effectiveness of this device has not been established when used in conjunction with bone cement or for use in patients with poor bone quality (e.g. osteoporosis, osteopenia). This device is intended only to be used with saline or radiopaque dye. Z-Pedicle Screws: Material: ASTM F136 (Ti-6Al-4V ELI) Length: 35mm to 55 mm Diameter: 5, 6, 7, 8 mm Z- Rods: Material: ASTM F136 (Ti-6Al-4V ELI) Length: 35mm to 300mm Diameter: 5,5 mm

I am sorry, but I cannot provide information on the acceptance criteria and study details for the device, as the provided text does not contain any details regarding acceptance criteria, device performance, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC comparative effectiveness studies, standalone performance, training set sample size, or how ground truth was established for the training set.

The document is a 510(k) premarket notification clearance letter from the FDA for a medical device (MIS Z-Pedicle Screw System). It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices based on indications for use, material, technology, design, and mechanical bench testing. While it mentions some testing performed (biocompatibility, sterilization, packaging/shelf life, and mechanical bench testing), it does not provide the specific performance metrics or acceptance criteria that would be relevant to the questions you've asked, particularly in the context of an AI-powered device or a study involving human readers.

The mechanical testing section (Item 6.4) states that "the results of the testing exceed the values we defined in our rational for the worst case scenario based on literature," but it doesn't quantify these values or specific acceptance criteria.

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The Z-Medical SnapOff screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:

• Fixation of small bone fragments
• Weil osteotomy
• Mono-cortical fixation
• Osteotomies and fractures fixation in the foot and hand

The Z-Medical double thread compression screws are indicated for fixation of bone fractures or bone reconstruction. Examples included:

• Fixation of bone fragments or small bone fractures
• Fracture management in the foot and hand
• Arthrodesis in hand, foot or ankle surgery
• Mono or Bi-cortical osteotomies in the foot and hand

The Z-Medical's guide wires are intended to perform as fixation and stabilization unit of bone fractures or as guidance at insertion of implants into the skeletal system.

The Z-Medical Staples are indicated for fixation of bone fractures, bone reconstruction, ligament, soft tissue and tendon. Examples included:

• Fixation of bone fragments or small bones fractures
• Fracture management in the foot and hand

Z-Snap Off Screw: Main application is forefoot surgery. Intended to connect bones or bone fragments. Material: ASTM F136 (Ti-6AI-4V ELI), Length: 11 mm to 14 mm, Diameter: 2 mm.

Z-Double Thread Compression Screw: Mainly used in forefoot surgery. Most common use is in the "Scart"-osteotomy. Cannulated to work with a guide wire and drilled in manually. Material: ASTM F136 (Ti-6Al-4V ELI), Length: 10 mm to 36 mm, Diameter: 3 and 4 mm.

Z-Guide Wire: Used in all fields of surgery. Main applications are: determine the correct position for e.g. screws or drills, or fixation of bones, fragments. Usually put in by machine. Also used to drill holes, e.g. to apply staples. Material: ASTM F 138 (1.4441), Length: 80 mm to 380 mm, Diameter: 0.7 mm to 6.35 mm, End Styles: Trocar, Type: Smooth.

Z-Staple: Implants for fixing bones or fragments. Use the SnapOff-technology. The distal end can be used as drilling gauge as well as grip to put in the staple. After reaching the final position, the grip can be snapped off by moving sideways. Material: ASTM F136 (Ti-6Al-4V ELI), Size: 8 mm to 25 mm, Method of insertion: Staple inserter and SnapOff technique.

The acceptance criteria and study details for the Z-Medical GmbH & Co. KG bone fixation devices (Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-Staple) are described below.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document provided is a 510(k) summary for medical devices where the primary goal is to demonstrate substantial equivalence to legally marketed predicate devices. As such, the acceptance criteria are generally framed in terms of meeting relevant standards (e.g., ASTM) and showing performance comparable to the predicate devices, rather than specific numerical thresholds presented in this summary. The "reported device performance" is a general statement indicating compliance.

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

The document does not specify the exact sample sizes used for each test. The studies mentioned appear to be mechanical/bench tests, not clinical studies involving human patients. Therefore, information regarding "country of origin of the data" and "retrospective or prospective" is not applicable in the context of clinical data. The tests are laboratory-based.

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

Not applicable. The tests performed are mechanical/bench tests to assess the physical properties and performance of the devices. They do not involve expert interpretation or human ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable, as the tests are mechanical/bench tests and do not require adjudication of human assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document describes bench testing for device characteristics, not studies on human reader performance with or without AI assistance.

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

Not applicable. The devices are physical implants (screws, wires, staples), not algorithms or AI-driven systems.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims is based on engineering standards and mechanical testing results. The devices were tested against established industry standards (such as ASTM F564-10 for Z-Staple, and implied similar standards for other components) and internal specifications designed to demonstrate equivalence to the predicate devices.

8. The Sample Size for the Training Set

Not applicable. The devices are physical implants, not AI/machine learning models that require a training set.

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

Not applicable. There is no training set for these conventional medical devices.

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