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510(k) Data Aggregation
(168 days)
VISTA PLUS
Recorder :
Vista Plus is intended to record one, two or three channels surface ECG data from ambulatory patients (Holter) for period up to 11 days on one channel, 6 days on two channels, 4 days on three channels. Recorded data are intended to be analysed by holterSoft Ultima analysis on the ECG data.
Software :
HolterSoft Ultima is intended to read data acquired by the Vista Plus, analyze, edit, review, report and store these data. The system is intended to be used by trained operators under the direct supervision of a licensed Health Care practitioner in a hospital or a clinic environment.
The VISTA PLUS holter recorder is a miniature ambulatory ECG recorder (ECG holter) which can continuously record one, two or three channels for a period up to several days ( 1 1 days on 1 channel, 6 days on 2 channels, 4 days on 3 channels).
The entire ECG is stored on a removable memory (compact falsh card) and can be read directly by HolterSoft Ultima software installed in a computer.
The VISTA PLUS has a microphone allowing the recording of voice messages from the physician or the patient (patient diary) during monitoring.
This ECG holter recorder does not perform any analysis on the ECG data.
The VISTA PLUS recorder weighs about 100gr. including flash card and batteries and is connected to the patient with a single multilead cable connected to the ECG electrodes.
The VISTA PLUS is supplied in a case containing a 128 MB compact flash memory card, one standard ECG cable 180cm, two neck protective pouches, one protective pouch for belt, one shoulder strap, two 1,5V AAA batterics, and a CD-Rom which contains multilingual user's manual.
The provided text is a 510(k) summary for the NOVACOR VISTA PLUS Holter Recorder and HolterSoft Ultima software. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a dedicated study.
Therefore, many of the requested elements (acceptance criteria table, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training) are not available in the provided document. The document describes the device's technical specifications and intended use, and then compares these to predicate devices to establish equivalence.
However, I can extract the following information:
1. A table of (implied) acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" but instead provides a comparative table of specifications between the Vista Plus and its predicate devices. The implicit acceptance criterion is that the Vista Plus's specifications should be comparable to or better than the predicate devices to demonstrate substantial equivalence.
| Specification | Vista Plus Performance (Novacor) | Implied "Acceptance Criterion" (Based on Predicate Devices) |
|---|---|---|
| Recorder: | ||
| Type | Digital | Digital (matched) |
| Number of channels | 1, 2, 3 | Comparable (Predicate: 2,3,5,9; 2,3,12; 2,3) |
| Recording duration | Up to: 264 h | Comparable or better (Predicate: Up to 96 h; Up to 48 h; Up to 120 h) |
| Sampling rate | 200 Hz | Comparable (Predicate: 200 Hz; 1024 Hz; 175 Hz) |
| Resolution | 10 bits | Comparable (Predicate: 15 bits; 12 bits; 10 bits) |
| Dynamic range | +/- 6 mV | Comparable (Predicate: +/- 16 mV; +/- 6, +/-3 or +/- 1,5 mV; +/- 6 mV) |
| Bit resolution | 12 μV | Comparable (Predicate: 10 μV; 1,465 μV) - Note: Direct comparison difficult without more context. |
| Compression | No | Flexible (Predicate: Yes; No; No) |
| Analogue Bandwidth | (Not specified directly, implied comparable) | Comparable (Predicate: 0,05-25 Hz/0,05-80 Hz; 0,05-75 Hz; 0,05-60Hz) |
| Pacemaker spike detect. & report | Yes | Yes (matched) |
| Open lead detection | Yes | Yes (matched) |
| Impedance test | Yes | Yes (matched) |
| Storage capacity | Up to 512 MB | Comparable or better (Predicate: Up to 64 MB; Up to 512 MB) |
| Memory type | CF card | Comparable (Predicate: MMC or SD flash card; CF card; Internal Flash memory) |
| LCD | Yes | Yes (matched) |
| Keyboard | Yes | Yes (matched) |
| Size | 86x54x19 | Comparable (Predicate: 97x54x23 mm; 108x79x22 mm; 85x65x20 mm) |
| Weight | 100g | Comparable (Predicate: 110g; 145g; 100g) |
| Cables | 5 wires | Comparable (Predicate: 3,5,7 wires; 5,7 wires; 5 wires) |
| Accessories | Belt, shoulder strap, pouch, neck pouch | Comparable (Predicate: Belt + pouch) |
| Batteries | 2 AAA (1,5 V) | Comparable (Predicate: 1 AA (1,5V), 1 or 2 AA (1,5V), 1 AA (1,5 V)º) |
| Rechargeable batteries | Accepted | Accepted (matched) |
| Patient ID record | Vocal message | Comparable (Predicate: With the display + keyboard) |
| ECG display | At any time (programmable) | Comparable (Predicate: Preview only) |
| Real-time built-in analysis | Yes, for real-time HR calculation | Comparable (Predicate: No; No; No) - Distinguishing feature, but not a mismatch for equivalence |
| Event marker | Yes (event key + vocal message) | Yes (matched) |
| Display during recording | Time programmable, HR programmable, HR curve programmable | Comparable (Predicate: Yes (during hook up only); Yes (during hook up inly); Yes) |
| ECG analysis | Analysis software on PC | Analysis software on PC (matched) |
| Replay and analysis system | HolterSoft Ultima | Syneview/Synescope; Holter for Windows; Philips 1810 series or 2010 software |
| Software: | ||
| Type | Software | Software/Workstation (matched) |
| PC based | Yes | Yes (matched) |
| OS compatibility | Windows 98,NT,2000, XP | Comparable (Predicate: Windows 98/NT/2000/XP) |
| Input data | Digital (CF card from Vista series recorders) | Comparable |
| Graphic User Interface | Yes | Yes (matched) |
| Templates (shapes) edition | Yes | Yes (matched) |
| Events list display | Yes | Yes (matched) |
| Arrhythmia detection | Yes | Yes (matched) |
| Conduction abnormalities detect. | Yes | Yes (matched) |
| ST segment | multichannel | multichannel (matched) |
| Superimposition | Yes | Yes (matched) |
| PM patient analysis | Yes | Yes (matched) |
| Report customisation | Yes | Yes (matched) |
| Report edition | Yes | Yes (matched) |
| ECG strip edition and printing | Yes | Yes (matched) |
| Archiving | Yes | Yes (matched) |
| Report Export | Yes | Comparable (Predicate: No; No; No) - Advantage, but not a mismatch |
| AFib | Yes | Comparable (Predicate: No; No; No) - Advantage, but not a mismatch |
| Events | Yes | Yes (matched) |
| Histograms/trends (RR histrogram) | Yes | Yes (matched) |
| Editing/Printing full disclosure | Yes | Yes (matched) |
| Editing tools for QRS ins./supp. | Yes | Yes (matched) |
| Time domain HRV | Yes | Yes (matched) |
| Frequency Domain HRV | Yes | Yes (matched) |
| QT | Yes | Comparable (Predicate: Yes (but not commercially available in the US); Yes; Yes) |
| OSAS | Yes | Comparable (Predicate: No; No; No) - Advantage, but not a mismatch |
| Networking | Yes | Yes (matched) |
| Patient Diary | Voice Messages | Comparable (Predicate: No; No; Text Input) |
AFib Module: The document also compares the HolterSoft Ultima AF module to a predicate device for Atrial Fibrillation.
| Specification | HolterSoft Ultima AF module Performance | Implied "Acceptance Criterion" (Based on Predicate) |
|---|---|---|
| Type of data recorded | Continuous ECG | ECG strips (Comparable, different approach) |
| Sampling rate | 200 Hz | 218 Hz (Comparable) |
| Bit resolution | 10 μV | 15,6 μV (Comparable, higher resolution often beneficial) |
| Monitoring duration | 264 hours | 7 days (Comparable, 264 hours = 11 days, so better) |
| Recording duration | 264 hours | 10 minutes (Comparable, much longer duration so better) |
| Maximum number of events | No limit | 60 (Comparable, "No limit" is better) |
| Maximum event length | 264 hours | 10 minutes (Comparable, much longer duration so better) |
| Number of channels used for analys | 1 to 3 | 1 (Comparable, more channels for Novacor) |
2. Sample sized used for the test set and the data provenance: Not available in the provided text. The submission is a 510(k) summary focusing on substantial equivalence to predicate devices based on technical specifications rather than a new clinical study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in the provided text. No specific test set or ground truth establishment process is described beyond the device's functional specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available in the provided text.
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: Not available in the provided text. The device is an ECG recorder and analysis software without explicit AI assistance described, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available in the provided text. The software performs analysis, but the submission doesn't detail standalone performance metrics in a study. The "Intended Use" states the system is "intended to be used by trained operators under the direct supervision of a licensed Health Care practitioner."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not available in the provided text. The submission focuses on comparing technical specifications with predicate devices to establish substantial equivalence, not on validating performance against a "ground truth" derived from patient data.
8. The sample size for the training set: Not available in the provided text. The document does not describe the development of an algorithm that would typically require a training set.
9. How the ground truth for the training set was established: Not available in the provided text.
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