(265 days)
The Hudson RCI Voldyne Volumetric Exerciser is intended as an inspiratory deep breathing positive exerciser for adult and pediatric (above 5 yrs) patients. It is a single patient, multi-use device used in hospital or home care setting.
The Hudson RCI® Voldyne® Volumetric Exerciser ("Voldyne") is a volumetric incentive spirometer. It is a single patient multi-use device. The primary interface of the user with the device is through a mouthpiece. The device contains two chambers; one for the flow chip, and one for the piston. The piston chamber is marked with a graduation from 500 ml to 4,000 ml (for the Voldyne 4000) or 250 ml to 2,500 ml (for the Voldyne 2500 and Voldyne Pediatric) on the front and the back of the main housing. The flow chip chamber for the device is marked with a happy face symbol with arrows pointing to the optimum position of the Voldyne Pediatric version includes a sticker sheet with clouds and trees graphics, which can be placed onto the device. When the patient inhales the flow chip and piston rise due to the negative pressure created; this indicates breathing volume and flow, while the device provides an exercise incentive to patients who require sustained maximal inspiration (SMI).
This document describes the premarket notification (510(k)) for the Teleflex Medical, Inc. Hudson RCI® Voldyne® Volumetric Exerciser (K182847). The 510(k) submission seeks to demonstrate substantial equivalence to a predicate device, the Besmed Volumetric Incentive Spirometer (K141355).
Based on the provided text, the device is an incentive spirometer, a medical device used for inspiratory deep breathing exercises. The information provided heavily focuses on justifying substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a clinical study with an "AI" component. Therefore, much of the requested information regarding AI device performance, expert review, MRMC studies, and ground truth definitions for AI models is not present in the provided 510(k) summary, as this is a traditional medical device, not an AI/ML software as a medical device (SaMD).
Here's an analysis of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results in the format typically seen for AI/ML device evaluations against specific metrics like sensitivity, specificity, or AUC. Instead, it relies on demonstrating equivalence to the predicate device and meeting applicable standards and internal performance specifications for a mechanical device.
The closest to "acceptance criteria" and "reported performance" for an incentive spirometer device, as presented in this document, are:
| Acceptance Criterion (implicitly by comparison to predicate/standards) | Reported Device Performance (Hudson RCI® Voldyne® Volumetric Exerciser) |
|---|---|
| Classification Name: Spirometer, Therapeutic (Incentive) | Matches predicate |
| Product Code: BWF | Matches predicate |
| Class: II | Matches predicate |
| Regulation Number: 868.5690 | Matches predicate |
| Single Patient Use: Yes | Matches predicate |
| Usability: Multi-use | Matches predicate |
| Patient Population: Adults and Pediatric patients (above 5 years) | Similar to predicate (patients requiring inspiratory exercise, though specific age for predicate not detailed beyond "Pediatric above 5 yrs") |
| Prescription Only: Yes | Matches predicate |
| Environments of Use: Home care settings and hospitals | Matches predicate |
| Sterile: No | Matches predicate |
| Indication for Use: Inspiratory deep breathing positive exerciser for adult and pediatric (above 5 yrs) patients; single patient, multi-use; hospital or home care setting. | Substantially equivalent to predicate, which also describes an inspiratory deep breathing positive exerciser for single-patient, multi-use in hospital or home care setting. |
| Contraindications: None | Matches predicate |
| Basic Components: Housing, 1 ball/piston, Tubing, Mouthpiece | Matches predicate |
| Patient Interface: Mouthpiece | Matches predicate |
| Materials Evaluation (Biocompatibility): Per ISO 10993-1:2009 | Materials evaluated per ISO 10993-1:2009, 10993-5:2009, 10993-10:2010, 10993-11:2017. Results demonstrated biocompatibility. |
| Shelf-life: Not explicitly specified for predicate, but generally expected. | 1 Year |
| Accuracy: ± 15% (for predicate) | Equivalent (implies meets or is comparable to predicate's ± 15%) |
| Performance Testing: (Age, Mouthpiece/Tubing Engagement, Leakage, Volume Accuracy, Flow Chip/Piston Operation, Slide Operation) | Performed: Age testing (Pre and Post Aging), Mouthpiece and Tubing Engagement Test, Tubing and Housing Engagement Test, Collapsible Tubing Leakage Test, Volume Accuracy Test, Flow Chip and Piston Operation, Slide Operation. Also tested to ISO 5356-1:2015. |
| Volume: 2500 and 4000 cc | Compared to predicate's 2500 and 5000 cc; similar volumes offered. |
2. Sample size 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 as it pertains to a clinical study dataset for an AI/ML device. The performance data refers to device engineering tests (e.g., shelf life, cleaning validation, biocompatibility, mechanical performance tests like volume accuracy and leakage). Details on specific sample sizes for these engineering tests are not provided in this summary, nor is data provenance in the sense of patient data.
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 is not applicable as this is not an AI/ML device requiring expert ground truth for classification or diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as this is not an AI/ML device requiring expert adjudication for ground truth.
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
A MRMC study comparing human performance with and without AI assistance was not done. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone algorithm performance study was not done. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" as it relates to AI/ML models is not applicable here. For this physical medical device, the "ground truth" for its performance is derived from:
- Physical measurements: Accuracy of volume, leakage tests, engagement tests.
- Compliance with standards: ISO 10993 (biocompatibility), ISO 5356-1 (conical connectors).
- Bench testing: Age testing (pre and post aging).
8. The sample size for the training set
This information is not applicable as this is a traditional medical device, not an AI/ML device that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable as this is a traditional medical device, not an AI/ML device that requires a "training set" with established ground truth.
In summary:
The provided document is a 510(k) summary for a traditional medical device (incentive spirometer). It focuses on demonstrating substantial equivalence to an existing predicate device through comparative feature analysis and engineering performance testing (e.g., biocompatibility, mechanical performance). It does not involve any Artificial Intelligence (AI) or Machine Learning (ML) components, and therefore, many of the questions related to AI acceptance criteria, clinical study designs for AI, expert reviews, and ground truth for AI models are not addressed in this document. The "study that proves the device meets the acceptance criteria" refers to the engineering and biocompatibility tests conducted, not a clinical trial or AI performance study.
§ 868.5690 Incentive spirometer.
(a)
Identification. An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.(b)
Classification. Class II (performance standards).