(142 days)
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No
The provided text contains no mention of AI, ML, image processing, or any other indicators of AI/ML technology. The only relevant information is the intended user (therapist) and a statement about performance studies that does not suggest AI/ML.
No
The summary of performance studies states, "Penny and Giles Biometrics makes no claims for the effectiveness of this equipment," which indicates it is not a therapeutic device.
No
The "Summary of Performance Studies" explicitly states, "Penny and Giles Biometrics makes no claims for the effectiveness of this equipment," which is inconsistent with a diagnostic device that would typically make claims about its ability to diagnose. Additionally, information typically present in diagnostic device descriptions (like Intended Use, Indications for Use, Device Description) is "Not Found".
Unknown
The provided 510(k) summary is incomplete and lacks crucial information about the device description and intended use, making it impossible to determine if it is a software-only medical device. The mention of "equipment" and "Verification and Validation section" could potentially refer to hardware components, but without a device description, this is speculative.
Based on the provided information, it is highly unlikely that this device is an IVD (In Vitro Diagnostic). Here's why:
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Lack of Key IVD Information: The document is missing crucial information typically found in descriptions of IVD devices, such as:
- Intended Use/Indications for Use: This is fundamental for an IVD, as it defines what the device is used to measure or detect in a biological sample.
- Device Description: IVDs usually involve reagents, instruments, or kits designed to analyze biological samples. The description is "Not Found".
- Input Imaging Modality: While not all IVDs use imaging, many do (e.g., microscopy). This is "Not Found".
- Anatomical Site: IVDs analyze samples taken from the body, and the source of the sample is often relevant. This is "Not Found".
- Key Metrics (Sensitivity, Specificity, etc.): Performance metrics like sensitivity and specificity are essential for evaluating the accuracy of an IVD in detecting a condition or substance. These are "Not Found".
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Intended User: The intended user is listed as "therapist". While therapists might use some diagnostic tools, the primary users of IVDs are typically laboratory personnel, physicians, or other healthcare professionals involved in analyzing biological samples.
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Performance Study Description: The statement "Penny and Giles Biometrics makes no claims for the effectiveness of this equipment, but wishes to direct the attention of the examiners to the reports included as the Verification and Validation section of this document" is unusual for an IVD. IVD manufacturers are required to demonstrate the performance and effectiveness of their devices through rigorous studies.
In summary, the absence of information related to biological sample analysis, diagnostic claims, and typical IVD performance metrics, combined with the intended user being a "therapist," strongly suggests that this device is not an In Vitro Diagnostic. It is more likely a device used in a therapeutic setting, possibly for monitoring or assessment during therapy, but not for diagnosing a condition by analyzing biological samples.
N/A
Intended Use / Indications for Use
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Product codes (comma separated list FDA assigned to the subject device)
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Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 890.5360 Measuring exercise equipment.
(a)
Identification. Measuring exercise equipment consist of manual devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. These devices also include instrumentation, such as the pulse rate monitor, that provide information used for physical evaluation and physical planning purposes., Examples include a therapeutic exercise bicycle with measuring instrumentation, a manually propelled treadmill with measuring instrumentation, and a rowing machine with measuring instrumentation.(b)
Classification. Class II (special controls). The device, when it is a measuring exerciser or an interactive rehabilitation exercise device for prescription use only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
0
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION CONTAINED IN THIS SUBMISSION
- Passive Safety -1.
1962855 DEC 1 1 1996
- a. At all times the extent and duration of activity is determined by the therapist. (Appendix 1)
- b. The equipment provides an aid to the rehabilitation or training of the patient, but does not force the patient to undertake any activity. (Appendix 1)
- c. There is no energy exchange between exercise device and patient; (Appendix 1)
- d. The patient is not attached to the equipment in any way other than by the patients' grip. (Appendix 1)
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- Electrical Safety
- a) Opto isolation of data outputs to 4Kv (Appendix 6)
- b) Isolation of low voltage DC power supply to 4Kv (Appendix 6)
- c) Primary insulation in addition to A and B (Appendix 5)
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- Effectiveness -
Penny and Giles Biometrics makes no claims for the effectiveness of this equipment, but wishes to direct the attention of the examiners to the reports included as the Verification and Validation section of this document.