(53 days)
The Pioneer SilCoat Sternal Cable System is intended for use in closure of the sternum after sternotomy or fracture of the sternum stabilizing the sternum to promote fusion.
The Pioneer SilCoat Sternal Cable System consists of cables and associated crimps. Each cable; has a central portion coated with silver, a monofilament wire is welded to one end of the cable with an attached needle. The cables will be offered with various types of needles, and in several cable lengths. A cylindrical crimp supplied with each cable is used to crimp the cable. The crimp and cable are made of similar biocompatible materials. The system will be double barrier sterile packaged in various quantities.
The provided text describes a Special 510(k) Device Modification for the "Pioneer SilCoat Sternal Cable," which is a modification of the previously cleared "Songer™ Sternal Cable System." The submission aims to demonstrate substantial equivalence of the modified device.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Metric | Study Acceptance Criteria | Reported Device Performance (Pioneer SilCoat Sternal Cable) |
|---|---|---|---|
| Mechanical Performance (Static) | Yield Load Comparison | No specific numerical acceptance criteria explicitly stated, but the goal is "no difference" compared to the predicate device. | ANOVA of the yield load with an α=0.01, P-value=0.017 shows no difference. |
| Mechanical Performance (Fatigue) | Fatigue Life | No specific numerical acceptance criteria explicitly stated, but the goal is "equivalent" to the predicate device. | Fatigue life curves show the SilCoat cable to be equivalent to the non-coated cable construct. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The text only mentions "static tests" and "fatigue life curves" without specifying the number of cables or tests performed.
- Data Provenance: The studies were conducted by "Pioneer Surgical Technology" as part of their 510(k) submission. These are likely prospective bench tests performed in a controlled laboratory environment. The country of origin is not explicitly stated, but Pioneer Surgical Technology is based in Marquette, Michigan, USA, suggesting the tests were likely conducted in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This study involves bench testing of mechanical properties of a medical device (cables), not interpretation of medical images or clinical data by experts. Therefore, there is no "ground truth" to be established by medical experts in the context of this performance data. The "ground truth" here is the physical measurement of the mechanical properties.
4. Adjudication Method for the Test Set
- Not Applicable. As this is a bench test of mechanical properties, there is no need for an adjudication method as would be used for subjective assessments or ambiguous clinical data. The results are quantitative measurements.
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. This is a submission for a modified medical device (sternal cable), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm. Standalone performance studies typically refer to the performance of an AI algorithm without human input, which is not relevant here.
7. The Type of Ground Truth Used
- The "ground truth" for this performance study is established by objective, quantitative mechanical measurements of the physical properties (yield load, fatigue life) of the sternal cables. This is based on standard engineering and materials science principles and testing methodologies.
- For yield load, the ground truth is the measured force at which the cable begins to deform plastically.
- For fatigue life, the ground truth is the measured number of cycles a cable can withstand before failure under specified load conditions.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" in the context of this device modification. Training sets are typically associated with machine learning or AI algorithm development, which is not relevant for demonstrating substantial equivalence of a physical medical device through bench testing.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set, this question is not applicable.
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.