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510(k) Data Aggregation
(58 days)
The ROKI Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The ROKI Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided non-sterile.
Model: L and M, white color, and Level 3 barrier level per ASTM F2100-19.
The subject device is white color, and flat pleated type mask, utilizing ear loops' way for wearing, and has nose fitter design for fitting the facemask around the nose.
The subject device is consisted of three layers, the inner and outer layers are made with spun-bond polypropylene, and the middle laver is made with melt blown polypropylene.
The subject device is held in place over the user's mouth and nose by two elastic ear loops welded to the mask. The elastic ear loops are made with polyester and polyurethane. The nose fitter contained in the subject device is in the layers of the mask to allow the user to fit the mask around their nose, which is made of malleable aluminum wire.
There are two models of the subject device, Model M. They differ only in the width. Model L is wider than Model M. However, the material formulation, chemical composition, and material 's processing methods are the same. The subject device is a single-use, disposable device, provided non-sterile.
The performance of the subject device meets Level 3 requirements per ASTM F2100-19.
The provided text describes the acceptance criteria and performance data for the ROKI Surgical Mask, demonstrating its substantial equivalence to a predicate device (Qiqihar Hengxin Medical Supplies, Ltd. Single-Use Surgical Mask, K201924). The device's performance was evaluated against ASTM F2100-19 Level 3 requirements.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (ASTM F2100-19 Level 3) | Reported Device Performance (Model L) | Reported Device Performance (Model M) |
|---|---|---|---|
| Fluid Resistance Performance (ASTM F1862) | 160 mmHg | 160 mmHg (96/96 no penetration) | 160 mmHg (96/96 no penetration) |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | ≥ 98.09% | ≥ 98.07% |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | ≥ 98.1% | ≥ 98.1% |
| Differential Pressure (Delta-P) (EN14683) | < 6.0 mmH2O/cm² | ≤ 4.4 mmH2O/cm² | ≤ 3.7 mmH2O/cm² |
| Flammability (16 CFR Part 1610) | Class 1 (≥3.5 sec) | Class 1 (96/96 no ignition) | Class 1 (96/96 no ignition) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: For performance testing (Fluid Resistance, PFE, BFE, Differential Pressure, Flammability), a total of 96 samples per model (L and M) were used. This was determined according to a 4% acceptance quality limit (AQL) on the production lot size, with samples drawn from three non-consecutive lots (32 samples per lot, per model).
- Data Provenance: The document does not explicitly state the country of origin for the data collection. However, the manufacturer is ROKI Co., Ltd. from Japan. The testing was conducted according to international standards (ASTM, EN, ISO). The study is non-clinical performance testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- This information is not applicable as the evaluation involved physical and chemical performance testing against codified standards (ASTM, EN) for a medical device (surgical mask), not diagnostic or interpretative tasks requiring human expert ground truth.
4. Adjudication Method for the Test Set:
- This information is not applicable for the same reason as point 3. Testing results are quantitative measurements against defined thresholds.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
- No, a MRMC comparative effectiveness study was not conducted. This type of study is for evaluating human performance with and without AI assistance, which is outside the scope of testing for a surgical mask.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- This question is not directly applicable as this device does not involve an algorithm. The "device performance" reported is the standalone physical and chemical performance of the surgical mask itself.
7. The Type of Ground Truth Used:
- The "ground truth" used for this device's evaluation is defined by codified performance standards (e.g., ASTM F2100-19 Level 3, ASTM F1862, ASTM F2299, ASTM F2101, EN14683, 16 CFR 1610) and biocompatibility standards (ISO 10993 series). These standards specify the acceptable thresholds for various physical and biological properties.
8. The Sample Size for the Training Set:
- This question is not applicable as this device is a physical product (surgical mask) and does not involve AI algorithms that require a training set.
9. How the Ground Truth for the Training Set Was Established:
- This question is not applicable as there is no training set for this type of device.
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(77 days)
High density restorative for cavity preparation in posterior teeth. May be used as an indirect restorative for inlays and onlays.
Not Found
This document is a 510(k) clearance letter from the FDA for a dental device called "ROK." It primarily confirms the device's substantial equivalence to a legally marketed predicate device and does not contain information about the acceptance criteria or a study proving the device meets specific performance criteria.
Therefore, I cannot provide the requested information based on the input text. The document focuses on regulatory approval based on equivalence, not on a detailed performance study with acceptance criteria.
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