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The CHARLOTTE™ 7.0 MUC Screw and Washer are indicated for fixation of bone fractures or for bone reconstruction. Examples include:

• Fixation of bone fragments, in long bones or small bones fractures
• Fracture management in the foot or hand
• Arthrodesis in hand, foot or ankle surgery
• Mono or Bi-cortical osteotomies in the foot or hand or in long bones
• Treatment of inferior tibio fibular diastasis
• Hindfoot arthrodesis

The CHARLOTTE™ 7.0 MUC Screw and Washer are manufactured from Stainless Steel conforming to ASTM F138. The Screws are offered in varying overall lengths and thread lengths to accommodate variability among patients and the Washer are offered for straight or oblique screw placement.

The provided document describes a 510(k) premarket notification for a medical device, the CHARLOTTE™ 7.0 MUC Screw and Washer. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical studies or detailed performance metrics against acceptance criteria typical for AI/software devices.

Therefore, many of the requested categories (e.g., sample sizes, expert qualifications, MRMC studies, standalone performance) are not applicable to this type of traditional medical device submission.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not applicable/provided. The submission relies on demonstrating substantial equivalence to predicate devices through material and mechanical testing, not a clinical test set with patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable/provided. Ground truth, in the context of AI/software, refers to verified clinical diagnoses or outcomes. For this bone screw, "ground truth" would relate to the physical properties and performance against engineering standards.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods are typically used in clinical studies to resolve discrepancies among expert readers.

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

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices to assess changes in human reader performance.

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

No, a standalone performance evaluation was not done. This concept is specific to AI algorithms.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by engineering standards and specifications:

• ASTM F138: For material composition of the stainless steel.
• ASTM F543-02: For mechanical performance testing of metallic bone screws.
• Comparison to predicate devices: The "ground truth" for its clinical utility and safety is its substantial equivalence to previously cleared devices which have an established record of safe and effective use.

8. The Sample Size for the Training Set

This information is not applicable/provided. "Training set" refers to data used to train AI algorithms, which is not relevant for this traditional medical device.

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

This information is not applicable/provided, as there is no AI training set.

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The Multi-Use Compression Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:

-Mono or Bi-Cortical osteotomies in the foot or hand

-Distal or Proximal metatarsal or metacarpal osteotomies

-Weil osteotomy

-Fusion of the first metatarsophalangeal joint and interphalangeal joint

-Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)

-Akin type osteotomy

-Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus

-Calcaneus/ cuboid arthrodesis

-talar/ navicular arthrodesis

The design features of the Multi-Use Compression Screw are summarized below:

• Manufactured from Stainless Steel .
• Offered in two diameters: 3.0mm and 4.3mm .
• Offered in lengths ranging from 10mm-60mm .
• Offered in two thread lengths: short and long .
• Self drilling and self tapping features on both distal and proximal . threads
• Proximal threaded head is fully recessed into bone to allow for a zero . profile once fully inserted

The provided text describes the 510(k) summary for the Multi-Use Compression Screw, which is a medical device for bone fixation. Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based only on the provided text.

The document does not describe an AI/ML device, a study with human readers, or a ground truth established by experts/pathology for image analysis. Instead, it describes a mechanical bone fixation screw and its substantial equivalence to previously cleared predicate devices through direct comparison and mechanical testing. Therefore, many of the requested fields are not applicable.

Acceptance Criteria and Device Performance

The acceptance criteria for the Multi-Use Compression Screw are implicitly derived from demonstrating substantial equivalence to existing legally marketed predicate devices, specifically the Newdeal BOLD® Compression Screw and the Newdeal I.CO.S.® Screw. The performance is measured by conformance to an ASTM standard, which assesses mechanical properties relevant to its intended use.

Table 1: Acceptance Criteria and Reported Device Performance

Study Details (Based on available information)

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

   • The document does not specify a "test set" in the context of an algorithm's performance on human data (e.g., images). Instead, it refers to mechanical testing.
   • The sample size for the mechanical testing (conforming to ASTM 543-02) is not explicitly stated. ASTM standards themselves often specify minimum sample sizes for different tests, but this specific number is not provided in the 510(k) summary.
   • Data Provenance: The "data" refers to the results of mechanical tests performed on the Multi-Use Compression Screw. The document does not specify a "country of origin" for this data, but the submission is from Wright Medical Technology, Inc., located in Arlington, Tennessee, USA. The testing would have been conducted by or for the manufacturer. It is a prospective test in the sense that the new device was manufactured and then tested to the ASTM standard.

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

   • Not Applicable. This is a mechanical device, not an AI/ML device requiring expert-labeled ground truth from data like images. The "ground truth" for a mechanical screw's performance is established by objective engineering standards and physical measurements as per ASTM 543-02.

3. Adjudication method for the test set:

   • Not Applicable. No human adjudication of data for ground truth was performed or required as this is a mechanical device with performance evaluated against a standard.

4. 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, and no human reader study was conducted.

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

   • Not Applicable. This is not an algorithm. Standalone performance for a mechanical screw relates to its intrinsic physical and mechanical properties, which were assessed via the ASTM standard.

6. The type of ground truth used:

   • For a mechanical device like this, the "ground truth" is defined by established engineering standards and physical measurements. Specifically, the device's mechanical properties (e.g., strength, torque, fatigue resistance) are compared against the requirements specified in ASTM 543-02. The successful compliance with this standard serves as the "ground truth" for its mechanical performance and substantial equivalence.

7. The sample size for the training set:

   • Not Applicable. This is not an AI/ML device; therefore, there is no "training set."

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

   • Not Applicable. As there is no training set for an AI/ML model, there is no ground truth to establish in this context.

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