(124 days)
indicated for single use to stabilize intracapsular, certain cervical and subcapital fractures of the femur; fractures of the distal femur and proximal tible: pelvis and acetabular fractures and certain fractures of the shoulder and elbow. They are contraindicated for attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, lumbar spine.
The EZ-Fix™ Cannulated Screws are fabricated from titanium allov (Ti-BAL-4V ELI). They are tested per ASTM standards and have a thread diameter and length of 7.3 mm and 20 mm respectively and a shaft diameter of 5.3 mm. They accept a 3.2 mm guide pin through the 3.45 mm cannulation. They are self reaming and tapping and have reverse cutting flutes. The EZ-Fix™ Cannulated Screws are available in 35 mm to 125 mm lengths are supplied non-sterile.
The EZ-Fix™ Cannulated Screw System is a medical device, and its acceptance criteria as well as the study proving its compliance are primarily focused on demonstrating substantial equivalence to predicate devices. This type of regulatory submission (510(k)) relies on showing that the new device is as safe and effective as a legally marketed predicate device.
Here's an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission like this, acceptance criteria typically revolve around demonstrating similarity to predicate devices across various attributes. The "Comparison Table" provided in the document serves as the primary evidence for meeting these criteria. The "SE" column (Substantial Equivalence) indicates whether the EZ-Fix™ Cannulated Screw is considered equivalent to the predicate for that specific characteristic.
| Acceptance Criteria (Characteristic) | Reported Device Performance (EZ-Fix™ Cannulated Screw) | Outcome (vs. Predicates) |
|---|---|---|
| Materials | Titanium Alloy | Equivalent to Alphatec, Ace (some predicates use Stainless Steel) |
| MRI Compatible | Yes | Equivalent to Alphatec, Ace (some predicates are not) |
| Cannulated | Yes | Equivalent to all predicates |
| Thread Diameter | 7.3 MM | Varies across predicates (e.g., 6.5 MM, 7.0 MM, 8.0 MM) - declared equivalent |
| Guide Pin Diameter | 3.2 MM | Equivalent to Alphatec, Ace, Howmedica (some predicates 2.4 MM) - declared equivalent |
| Screw Lengths | 35 - 125 MM | Equivalent to Alphatec (varies for others) - declared equivalent |
| Thread Lengths | 20 MM | Equivalent to Alphatec, Ace, Howmedica (some predicates 16 MM) - declared equivalent |
| Intended Use | Single Use | Equivalent to all predicates |
| Indications | Intracapsular, certain cervical and subcapital fractures of the femur; Distal femur and proximal tibia fractures; Pelvis and acetabular fractures; Certain fractures of the shoulder and elbow. | Equivalent to all predicates |
| Contraindications | Attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine | Equivalent to all predicates |
| Performance Standards | ASTM F117 | Equivalent to all predicates |
| Self Reaming | Yes | Equivalent to Alphatec, Ace, Howmedica (some predicates are not) - declared equivalent |
| Self Tapping | Yes | Equivalent to all predicates |
| Reverse Cutting | Yes | Equivalent to Alphatec, Richards, Howmedica (Ace is not) - declared equivalent |
| Sterile | Non-Sterile | Equivalent to all predicates |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a specific test set in the traditional sense of a clinical trial or a large-scale performance study. This is typical for a Class II device submitted under a 510(k) based on substantial equivalence. Instead, the "testing" mentioned refers to:
- Compliance with ASTM standards: "They are tested per ASTM standards." This implies manufacturing and material testing, not necessarily a clinical outcomes study with a "test set" of patients.
- Pyrogenicity testing: "Pyrogenicity testing of the EZ-Fix™ to determine level of endotoxin performed using LAL (Limulus Amebocyte Lysate) method." This is a laboratory test on device samples, not a clinical test set.
- Equivalence to referenced equivalent: "These test values are identical to those obtained on the referenced equivalent." This suggests comparative engineering or material testing against the predicate devices' specifications, not human subject data.
Therefore, there is no explicit sample size for a test set of patient data, nor is information provided on data provenance (country, retrospective/prospective).
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)
Given that there isn't a traditional "test set" of patient data in this submission focused on clinical outcomes, there are no experts mentioned for establishing ground truth in the context of clinical interpretation or diagnosis. The "ground truth" here is compliance with engineering standards and similarity to predicate devices as determined by the manufacturer's testing and comparison.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Since there is no "test set" in the context of clinical image interpretation or patient outcomes, there is no adjudication method described.
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 MRMC study was done or described. This device is a bone fixation screw, not an AI-powered diagnostic tool, so such a study would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No standalone performance study for an algorithm was done. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this submission is established through:
- Manufacturer specifications and design parameters: For characteristics like material, thread diameter, screw lengths.
- ASTM standards: For performance (e.g., ASTM F117 for material properties or mechanical strength).
- Laboratory testing: For pyrogenicity (LAL method).
- Comparison to predicate devices: The core of a 510(k) is demonstrating that the new device's characteristics and performance are "substantially equivalent" to legally marketed devices. So, the established characteristics and performance of the predicate devices implicitly serve as a form of "ground truth" for comparison.
8. The sample size for the training set
No training set is described or applicable as this is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable as there is no training set.
§ 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.