(170 days)
The CyclaPlex Correction System is intended for the following surgical indications: to assist in the correction of Hallux Valgus deformity by providing reduction of the 1st intermetatarsal angle.
The CyclaPlex Correction Systemis comprised of the Implant, Accessories and Instrument Set. The Implant device pulls the 1ª metatars al inward to wards 2ª metatars al and reduces the internetatarsal angle to medically accepted values. The implant is comprised of two metallic bone screws with internal polymeric housing connected by UHMW polyethylene multiple sutures cord. The cord is looped at Anchor 2 and secured to Anchor 1 by multiple surgical knots. Tw implants (paired) are implanted to reduce local loads on the bone and reduce loads on the device as well.
The provided text describes a 510(k) premarket notification for the CyclaPlex Correction System, a medical device intended to assist in the correction of Hallux Valgus deformity.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state numerical acceptance criteria in a table format. Instead, it uses qualitative statements to demonstrate equivalence to the predicate device. The performance is consistently stated as "at least as good as the predicate device" or "same as the predicate device."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical static resistance to biomechanical forces | Can withstand biomechanical forces at least as well as the predicate device |
| Mechanical fatigue resistance to biomechanical forces | Can withstand biomechanical forces at least as well as the predicate device |
| Device performance in preclinical animal models | At least as good as predicate device in minipig animals |
| Surgical instrument safety and usability | Provides safe use at least as good as the predicate device |
| Suitability of implant structure, surgery procedure, and instruments for implantation | Demonstrated suitable for intended implantation in cadaver tests |
| Biological compatibility of materials post-manufacturing and cleaning | Meets ISO 10993-1 requirements |
| Biological safety assessment (further) | Demonstrated through animal testing |
| Device implantation procedure and surgical instrument usability | Demonstrated through animal testing |
| Packaging validation conformance | Met requirements |
| Sterilization validation conformance | Met requirements |
| Cleaning validation conformance | Met requirements |
| MR compatibility (Magnetic field interactions, MR artifacts, MR heating) | Demonstrated to be "MR conditional" (per ASTM F2119-07, F2052-15, F2182-11a, F2213-06) |
| Raises no new safety or effectiveness questions compared to predicate | A detailed analysis and testing demonstrated this |
2. Sample size used for the test set and the data provenance:
- Mechanical Testing: Not explicitly stated. The document mentions "The mechanical static and fatigue testing were performed."
- Preclinical Animal Tests: Not explicitly stated. The document mentions "Preclinical animal tests showed that CyclaPlex device performance in minipig animals..."
- Cadaver Tests: Not explicitly stated. The document mentions "Cadaver tests further demonstrated..."
- Biological Evaluation: Not explicitly stated for tests demonstrating ISO 10993-1 compliance. "Animal testing further extended the biological safety assessment."
- MR Testing: Not explicitly stated.
Data Provenance: The studies are described as "Preclinical animal tests" and "Cadaver tests," suggesting they were conducted specifically for this device submission. The location of these studies (country of origin) is not specified, but the applicant's address is Israel. This would be considered prospective data for the device's evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This type of information is generally not applicable to the non-clinical (mechanical, animal, cadaver, biological, MR) testing performed for this device. The "ground truth" here is objective physical or biological performance measurements, not expert interpretation of images or patient outcomes.
For the Surgical instrument human factor analysis, the document states "Analysis had demonstrated that instruments provide safe use at least as good as the predicate device." It does not specify the number or qualifications of experts involved in this human factors analysis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to independent review of clinical data (e.g., imaging studies) by multiple experts to establish a consensus ground truth. The studies described are non-clinical, objective tests.
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. An MRMC study is a clinical study design used to evaluate the diagnostic performance of a system (often AI-assisted) by multiple human readers across multiple cases. This submission describes a mechanical, biological, and animal testing evaluation of a surgical implant, not an AI-based diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No. This device is a physical surgical implant, not an algorithm or AI. Therefore, the concept of standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the various tests appears to be based on:
- Mechanical Testing: Established engineering standards and measurements of force, displacement, and material properties. The comparison is against the predicate device's measured performance.
- Biological Evaluation: Adherence to international standards (ISO 10993-1) for biocompatibility, and observed biological responses in animal models.
- Animal & Cadaver Studies: Direct observation of device performance, surgical procedure compatibility, and lack of adverse events or structural failure under simulated surgical conditions.
- MR Testing: Compliance with specific ASTM standards.
8. The sample size for the training set:
Not applicable. This device is a physical product and not an AI/machine learning algorithm, so there is no "training set."
9. How the ground truth for the training set was established:
Not applicable. As there is no training set for a physical implant, there is no ground truth to be established for it.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.