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510(k) Data Aggregation
(206 days)
The Single-use Medical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
The Single-use Medical Face Mask is designed and manufactured by Conod Medical Co., Limited. It is non-sterile and for single use. The Single-use Medical Face Mask has two models, Earloop and Tie Coverall. It is made of three-layer nonwovens, ear loops (for Earloop model)/ tie tapes (for Tie Coverall model) and nose piece. Inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops/ tie tapes are held in place over the users' mouth and nose by two elastic ear loops/ tie tapes welded to the mask. The ear loops are made of polyester, and the tie tapes are made of spun-bond polypropylene. The nose piece in the layers of mask is to allow the user to fit the mask around their nose, which is made of malleable aluminum wire. It is a self-inhalation filter mask, which works by filtering the air containing harmful substances through the filter material of the mask before being inhaled or exhaled. The product is level 2 according to ASTM F2100-19.
This is a 510(k) premarket notification for a medical device (Single-use Medical Face Mask), not an AI/ML-enabled device. Therefore, many of the requested categories for AI/ML study design and performance evaluation are not applicable.
However, I can extract the acceptance criteria and performance data for the medical face mask as presented in the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Acceptance Criteria (Level 2 ASTM F2100) | Reported Device Performance (Average for 3 lots) |
|---|---|---|
| Bacterial Filtration Efficiency (BFE) | ≥ 98% | 99.77% |
| Sub-Micron Particle Filtration Efficiency | ≥ 98% | 99.80% |
| Differential Pressure, mm H2O/cm² |
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(59 days)
CONOD Enteral Feeding Sets are intended to dispense liquid nutrition (feeding solutions) at a user controlled rate. These enteral feeding sets interface with a patient's feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The enteral feeding sets include a bag to contain the feeding solution and/or a piercing spike to connect to a pre-filled container. The device is used for infants, children, adolescents and adults.
The CONOD Enteral Feeding Sets have three models, CONOD safety spike plus pump set, CONOD gravity feeding set and CONOD feeding pump set. The CONOD Feeding Pump Set (1200ml) and gravity feeding set both have a structure of a 1200ml formula bag with 100ml graduations and a protective closure cap. The difference is the former is droved by pump and the latter is droved by gravity. CONOD Safety spike plus Pump Set features a piercing spike used to connect the set to a prefilled container of enteral feeding solution. It is a single-use, non-sterile device.
I am sorry, but based on the provided text, there is no information about acceptance criteria and a study proving a device meets those criteria in the context of AI/ML performance.
The document is a 510(k) premarket notification for "CONOD Enteral Feeding Sets," which is a medical device for dispensing liquid nutrition. The provided sections detail:
- Submission Information: Company, contact, device name, regulation, product code.
- Device Description: Models (pump set, gravity set, safety spike plus pump set), single-use, non-sterile.
- Indications for Use: Dispensing liquid nutrition at a user-controlled rate, interfacing with a feeding tube, for infants, children, adolescents, and adults.
- Comparison to Predicate Device (K150286, Medline Enteral Feeding Sets): Highlights similarities in intended use, product code, classification, design features (non-DEHP material, ISO 80369-3:2016 connector), materials, prescription use, disposability, intended use time (no longer than 24 hours), non-sterility, shelf-life, and available tube lengths.
- Performance Data: This section describes biocompatibility testing (cytotoxicity, sensitization, skin irritation, 10993-1, 10993-5, 10993-10 standards) and performance testing (fluid leakage, stress cracking, resistance to separation (axial load, unscrewing), resistance to overriding, disconnection by unscrewing, tensile properties, liquid leakage, flow rate, bioburden, usability), all conducted according to various ISO/EN/IEC standards.
- Animal Study/Clinical Study: States that neither was required.
- Conclusion: The device is substantially equivalent to the predicate based on non-clinical data and performance testing.
The "performance data" discussed refers to engineering and material safety tests for the medical equipment itself, not the performance of an AI/ML algorithm. Therefore, I cannot extract the information requested about AI/ML acceptance criteria, study details, sample sizes, expert involvement, or ground truth for an AI/ML device.
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