(73 days)
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
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Composition Equivalence: Manufactured from materials equivalent to predicate devices. | Manufactured from Stainless Steel. The document states: "The design features, material, and indications for use of the Multi-use Compression Screw are substantially equivalent to the previously cleared Newdeal BOLD® Compression Screw and the Newdeal I.CO.S.® Screw." This implies the material meets equivalence. |
| Design Feature Equivalence: Similar design features (diameters, lengths, thread types, self-drilling/tapping, recessed head) to predicate devices. | "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." These features are presented as being substantially equivalent to the predicate devices. |
| Intended Use Equivalence: Indications for use are the same as predicate devices. | The Indications for Use section lists specific bone fracture and reconstruction procedures, which are stated as substantially equivalent to the predicate devices. |
| Mechanical Performance: Confirms to relevant performance standards for bone fixation screws. | Confirmed by testing conforming to ASTM 543-02. The document states: "The safety and effectiveness of the Multi-use Compression Screw is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification." |
Study Details (Based on available information)
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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.
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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. 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.
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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.
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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 not an AI/ML device, and no human reader study was conducted.
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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.
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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.
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The sample size for the training set:
- Not Applicable. This is not an AI/ML device; therefore, there is no "training set."
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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.
§ 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.