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510(k) Data Aggregation
(119 days)
For use with pulmonary function testing. To filter air between the patients's exhaled air and the testing equipment. Single patient use, single session, disposable.
The PFT Filter is filter for use with PFT equipment and testing. It is intended to interface between the equipment and the patient during the test. It has a lightweight, compact housing with electrostatic filter media.
The provided text describes a 510(k) summary for "The PFT Filter," a device intended for use with pulmonary function testing equipment to filter air between the patient and the equipment.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Attribute | Acceptance Criteria (Predicate Device) | Reported Device Performance (The PFT Filter) |
|---|---|---|
| Indications for Use | For use with pulmonary function testing. To filter air between the patients's exhaled air and the testing equipment. | For use with pulmonary function testing. To filter air between the patients's exhaled air and the testing equipment. |
| Environments of use | Hospital, Sub-acute Institutions, Doctor's offices, Laboratories | Hospital, Sub-acute Institutions, Doctor's offices, Laboratories |
| Single patient use, single session, disposable | Yes | Yes |
| May be used on different PFT testing machines | Yes - not specified (for predicate EMS - PFT - K013123) | Yes |
| Filter media type | Electrostatic | Electrostatic |
| Internal volume | 50 ml (for predicate PDS KoKo – K934475) | 51 ml |
| Resistance to flow @ 60 Lpm | 0.5 cm H2O | 0.5 cm H2O |
| Resistance to flow @ 720 Lpm | 0.7 cm H2O | 0.7 cm H2O |
| Bubble test per ASTM F316-03 | 1.2 cm H2O @ 0.26 Lpm (Reference only) | 1.0 cm H2O @ .26 Lpm |
| Bacterial Filtration Efficiency (BFE) | 99.99+% | 99.9+% |
| Viral Filtration Efficiency (VFE) | 99.99+% (for predicate PDS - KoKo-K934475) | 99.9+% |
| Weight | 41 gm (for predicate PDS-KoKo – K934475) | 46 gm |
| Duration of use | <24 hours or not specified | < 24 hours |
| Materials | Housing – polystyrene; Media - spun polypropylene (Identical to EMS – Filter– K013122, AM Systems – K063526) | Housing – polystyrene; Media - spun polypropylene |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a distinct "test set" in the context of clinical data for performance evaluation in the way one might expect for an AI/CADe device. Instead, the performance claims are based on bench testing and comparison to predicate devices.
- Sample Size: Not explicitly stated as a number of patient cases. The evaluation appears to involve measurements taken on device prototypes or production samples during specific tests. For example, "Resistance to flow" and "Bubble test" refer to physical measurements. Bacterial and Viral Filtration Efficiency would be tested on filter material samples.
- Data Provenance: Not applicable in the sense of patient data. The data originates from laboratory and bench testing of the filter device. There is no information regarding country of origin or whether it's retrospective or prospective patient data, as it's not a clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This section is not applicable to this submission. The device is a physical filter, and its performance criteria (e.g., filtration efficiency, resistance to flow) are established through objective laboratory measurements and engineering standards, not through expert consensus on medical images or patient diagnoses.
4. Adjudication Method for the Test Set:
This is not applicable. There is no "test set" of cases requiring adjudication by medical experts, as the evaluation is based on objective physical and microbiological performance metrics.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret results, sometimes with AI assistance. The PFT Filter is a physical accessory, and its performance is evaluated through bench testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This concept is not applicable. "Standalone performance" refers to the performance of an algorithm without human intervention, which is relevant for AI/CADe devices. The PFT Filter is a passive mechanical device; it does not involve algorithms or human-in-the-loop performance in its primary function. Its "standalone performance" refers to its physical filtration capabilities without a human directly influencing its filtering action during a pulmonary function test.
7. The Type of Ground Truth Used:
The "ground truth" for the PFT Filter's performance metrics is based on objective laboratory measurements and established engineering standards (e.g., ASTM F316-03 for bubble test), as well as microbiological testing protocols (e.g., Nelson Labs per MIL-M-36954-1975 for filtration efficiency). The comparison is often made against the performance of legally marketed predicate devices which have already been deemed safe and effective.
8. The Sample Size for the Training Set:
This is not applicable. The PFT Filter is not an AI/ML device that requires a "training set" of data. Its design and performance are based on engineering principles and materials science, not on learning from data.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable for the same reasons as point 8.
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