(126 days)
The Stryker QuikFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fixation of non load-bearing bony areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher).
The Stryker QuikFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fixation of non-load-bearing bony areas subsequent to craniectomy, craniectomy and cranial fractures. The device can be used in both adults and adolescents (age 12 and higher). Six different procedure packs of Stryker QuikFlap Sterile Procedure Pack will be offered. They consist of different combinations and number of plates and screws. The overview of these combinations is provided in Table 1. All implants which are part of the Stryker QuikFlap Sterile Procedure Pack are also part of the Universal Neuro 3 system. The instruments of the Universal Neuro 3 system are therefore used with the Stryker QuikFlap Sterile Procedure Packs. Universal Neuro 2 products are not contained in the Stryker QuikFlap Sterile Procedure Pack sold in the US.
The Stryker QuikFlap Sterile Procedure Pack is an easy to use implant carrier providing sterile plates, burr hole covers and screws in different groups to allow the use in OR. For a list of the diverse implants groups provided in Stryker QuikFlap Sterile Procedure Pack please refer to (Table 1).
The provided text describes a 510(k) premarket notification for the Stryker QuikFlap Sterile Procedure Pack. This is a medical device submission seeking regulatory clearance based on substantial equivalence to a predicate device, not a study designed to prove the device meets acceptance criteria for a new, independent performance measure.
Therefore, many of the requested categories for acceptance criteria and a study proving device performance are not directly applicable or explicitly stated in this document. The submission focuses on demonstrating that the new device is essentially the same as a previously cleared device.
However, I can extract information related to how its safety and effectiveness were established in relation to its predicate.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of quantitative acceptance criteria typical of a performance study for a novel device (e.g., sensitivity, specificity, accuracy). Instead, it establishes "acceptance" by demonstrating substantial equivalence to a predicate device (Stryker Universal Neuro 3 system - K112557). The performance criteria are implicitly met if the new device is shown to be as safe and effective as the predicate.
The key reported performance is the identical design, material, physical properties, and manufacturing process of the implants within the QuikFlap pack to those in the Universal Neuro 3 system.
| Acceptance Criterion (Implicit through Substantial Equivalence to Predicate) | Reported Device Performance (Stryker QuikFlap Sterile Procedure Pack) |
|---|---|
| Implant Design (Plates, Burr Hole Covers, Screws) | Identical in design to Universal Neuro 3 system implants. |
| Material Composition (for implants) | Made of commercially pure titanium or Ti6AI4V alloy (acc. to ASTM F67, ASTM F136/ISO 5832-3), identical to Universal Neuro 3 system implants. |
| Physical Properties (for implants) | Identical to Universal Neuro 3 system implants. |
| Manufacturing Process (for implants) | Identical to Universal Neuro 3 system implants. |
| Biocompatibility (for implants) | Proven according to ISO 10993-1, identical to Universal Neuro 3 system implants. |
| Corrosion Resistance (for implants) | Demonstrated, identical to Universal Neuro 3 system implants. |
| Mechanical Safety/Stability (for implants) | Sufficient stability of plates and screws according to ASTM F 382-99 and ASTM F 543, identical to Universal Neuro 3 system implants. |
| Cleanliness and Sterilization (for implants) | Possible to clean and sterilize within the Universal Neuro 3 module and container; also, the QuikFlap pack itself is double-sealed and sterile. |
| Biocompatibility (for implant carrier) | Proven including cytotoxicity and GC/MS Fingerprint tests. |
| Handling Performance (for implant carrier) | Determined to be safe and effective. |
| Transport Safety (for implant carrier and packaging) | Determined for blister, pouch, and outer box; passed transport safety tests. |
| Blister Safety (Blister-Tyvek sterile barrier) | Successfully tested after conditioning of samples in a transport test; known blister type with proven sealed seam safety. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes a regulatory submission based on demonstrating equivalence, not a clinical trial or performance study with a distinct "test set" of patient data in the typical sense. The "sample" for evaluating the new aspects (packaging, implant carrier) relates to engineering tests, not patient data sets.
- Sample Size: Not specified in terms of patient numbers or specific product quantities for performance testing. The text mentions "conditioning of the samples" for blister testing.
- Data Provenance: Not applicable in the context of clinical patient data. The engineering and material characterization tests would typically be performed by the manufacturer, Stryker, which is headquartered in the USA (Portage, MI).
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)
Not applicable. This is not a study involving expert annotation or determination of ground truth from images or patient outcomes. The "ground truth" for the implants is their established safety and effectiveness as part of the predicate Universal Neuro 3 system.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a clinical study requiring adjudication of expert interpretations.
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
Not applicable. This device is a surgical implant/procedure pack and not an AI-powered diagnostic or assistive tool for human readers.
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.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" or basis for acceptance relies on the prior regulatory clearance and proven safety/effectiveness of the predicate device's implants and engineering test results for the new packaging components.
- For the implants: The "ground truth" is their established performance and safety based on the predicate K112557.
- For the new components (implant carrier, packaging): Ground truth is established through standard material compatibility, sterility, and physical integrity tests (biocompatibility, transport safety, seal strength).
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device does not use a training set.
§ 882.5320 Preformed alterable cranioplasty plate.
(a)
Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).