(86 days)
The Instrumentation Industries, Inc. Negative Inspiratory Force (NIF) Meters are devices used to measure and monitor patient inspiratory effort. During use the NIF Meter is attached to the patient airway at a point that provides optimal readings of patient respiratory effort. Federal law restricts these devices to sale by or on the order of a physician.
The NS Series NIF Meters are intended to measure inspiratory airway pressures of up to 30, 60 or 120 cm H2O , dependent upon the specific model used.
This document is a 510(k) summary for the NS Series NIF (Negative Inspiratory Force) Meters, which are inspiratory airway pressure meters. It does not contain information about a study that proves the device meets specific acceptance criteria in the way described in the prompt.
The document focuses on demonstrating substantial equivalence to predicate devices (Instrumentation Industries, Inc. - BE 149 and Smiths Medical - NIF Kit) based on similar technological characteristics and intended use. The "acceptance criteria" discussed are implicit in the comparison of the new device's function, anticipated usage, and operation to the predicate devices.
Therefore, most of the requested information regarding detailed acceptance criteria and a study to prove them is not present in this 510(k) summary. I can only provide the information that is explicitly or implicitly present.
Here's an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of acceptance criteria with reported device performance metrics in the sense of a clinical or performance study. Instead, the acceptance criteria are implied by the "Technological Characteristics" section, which highlights similarities and differences with predicate devices.
| Acceptance Criteria (Implied by Predicate Comparison) | Reported NS Series NIF Meters Performance (from "Device Description" / "Technological Characteristics") |
|---|---|
| Functionality: To measure inspiratory pressure. (Similar to predicate devices) | Functionality: "NS Series NIF Meters are intended to measure inspiratory airway pressures..." and "The function of the NS Series NIF Meters... are the same. All are analog-faced manometers used to measure inspiratory pressure." |
| Anticipated Usage: Similar to predicate devices, including a memory indicator pointer (MIP) for maximum pressure. | Anticipated Usage: "The anticipated usage of all of the devices is the same. All versions of the NS NIF meters... include a memory indicator pointer (MIP) that records the maximum pressure reached during inspiration. The pointer can be re-set and the exercise repeated." |
| Operation: Analog manometer with a diaphragm that activates pressure and MIP via a spring when exposed to inhaled breath. (Technologically the same) | Operation: "The operation of the NIF meters is technologically the same: All have a diaphragm which, when exposed to a patient's inhaled breath, activates the pressure and MIP via a spring." |
| Measurement Range: Compatible with clinical needs for NIF measurement. | Measurement Range: The NS Series offers three pressure ranges: 0-30, 0-60, 0-120 cm H2O. (This is a difference from predicates which typically have 0-60 cm H2O, but is presented as an enhancement rather than a failure to meet criteria). The specific models are for "up to 30, 60 or 120 cm H2O." |
| Attachment Points: Provide suitable means for patient connection. | Attachment Points: The III NIF meters have three: ¼” NPT bottom fitting, ¼” NPT rear fitting, and a small-bore tubing fitting. (This is a difference from Smiths Medical NIF meter which has one type, but is presented as an enhancement). |
| Sold as: Device sold alone. (Different from Smiths Medical NIF kit) | Sold as: The NS Series NIF meters are sold alone; adapters and tubing are not included. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The 510(k) summary does not describe a test set, sample size, or data provenance from a specific study to evaluate the device's performance against detailed acceptance criteria.
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)
This information is not provided in the document. No test set or ground truth establishment process by experts is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. No adjudication method for a test set is described.
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
This information is not applicable / not provided. This device is a manual inspiratory airway pressure meter, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable / not provided. This device is a manual, analog medical instrument. It does not involve algorithms or AI, so "standalone" algorithm performance is not relevant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not provided in the document. No specific ground truth methodology is described, as the submission focuses on substantial equivalence to existing predicate devices based on design and intended use, rather than a clinical performance study with an established ground truth.
8. The sample size for the training set
This information is not provided in the document. No training set is mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This information is not provided in the document. No ground truth for a training set is mentioned.
§ 868.1780 Inspiratory airway pressure meter.
(a)
Identification. An inspiratory airway pressure meter is a device used to measure the amount of pressure produced in a patient's airway during maximal inspiration.(b)
Classification. Class II (performance standards).