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510(k) Data Aggregation
(196 days)
The Legacy Medical Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure measuring devices to measure systolic and diastolic blood pressures and heart rate. It is non-sterile and may be used with neonatal, pediatric and adult patients. The cuff is not designed, sold or intended for use except as indicated: Prescription Use, Part 21 CFR 801 Subpart D
Per CFR 870.1120, a blood pressure cuff is a device that has an inflatable bladder within, or integral to, an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with an appropriate measuring device to determine a subject's blood pressure. The Legacy Medical Blood Pressure Cuff comprises a soft inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and
The provided document describes the Legacy Medical Blood Pressure Cuff, which is intended for use with non-invasive blood pressure measuring devices. The document highlights the regulatory submission (510(k) summary) and the performance testing conducted to demonstrate substantial equivalence to predicate devices.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard) | Reported Device Performance (Compliance) |
|---|---|
| ANSI/AAMI SP10 (2002+A1:2003+A2:2006+(R)2008) for manual, electronic, or automated sphygmomanometers | Tested according to the standard. Non-clinical tests showed substantial equivalence in functional and operational performance characteristics including compression, pressure control, and leakage when connected to inflation and measurement equipment. |
| ISO 10993-5 (1999) Biological evaluation of medical devices, Part 5: Tests for In Vitro cytotoxicity | Tested according to the standard. (No specific performance data beyond "tested according to" provided in this document segment for this standard). |
| ISO 10993-12 (Date not specified) Biological Evaluation of Medical Devices, Part 12: Sample Preparation and Reference Materials | Tested according to the standard. (No specific performance data beyond "tested according to" provided in this document segment for this standard). |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes "comparative bench testing" as the method used to assess and prove similarity of function between the Legacy Medical Blood Pressure Cuff and predicate devices.
- Sample Size: The document does not specify the sample size used for the test set. It only mentions "non-clinical tests."
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's "bench testing," it's likely conducted in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
The document describes "non-clinical tests" and "comparative bench testing" for functional and operational performance. This type of testing typically relies on standardized measurement equipment and protocols rather than human expert opinion to establish ground truth for performance parameters like compression, pressure control, and leakage.
Therefore, this section is not applicable as expert consensus is not the method for establishing ground truth for these types of mechanical and functional performance tests.
4. Adjudication Method for the Test Set:
As mentioned above, the testing involved "comparative bench testing" against predicate devices using objective measurements. This typically does not involve an adjudication method in the context of human interpretation or review. Therefore, this section is not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The document explicitly states "Non-clinical tests - comparative bench testing was utilized to assess and prove similarity of function." This type of study focuses on mechanical and functional performance, not human reader interpretation of images or data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This section is not applicable. The device is a physical blood pressure cuff, not an algorithm or AI system. The testing described is for the physical and functional aspects of the cuff.
7. The Type of Ground Truth Used:
The ground truth for the "comparative bench testing" appears to be based on objective measurements performed in accordance with established engineering and medical device standards (ANSI/AAMI SP10, ISO 10993). The performance of the Legacy Medical Blood Pressure Cuff was compared against these standards and against the performance of predicate devices.
8. The Sample Size for the Training Set:
This section is not applicable. The device is a physical medical device (blood pressure cuff), not a machine learning or AI model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
This section is not applicable for the same reason as point 8.
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(91 days)
The Hygia Health Services Reprocessed Blood Pressure Cuff is intended to be used in conjunction with non-invasive blood pressure monitoring systems by personnel properly trained in the use of manual or automatic sphygmomanometers as appropriate. The device is non-sterile and is intended as a single patient use device. It is available in neonatal through large adult size.
The Hygia Health Services Reprocessed Blood Pressure Cuff is an accessory used by trained personnel in conjunction with non-invasive blood pressure measurement systems, primarily in a clinical setting.
Per CFR 870.1120, a Blood Pressure Cuff is a device that has an inflatable bladder within, or integral to, an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with an appropriate measuring device to determine a subject's blood pressure.
The Hygia Health Services Reprocessed Blood Pressure Cuff comprises tubing attached to a soft inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device tubing is connected to an appropriate non-invasive blood pressure measurement system. The blood pressure cuffs contain no latex. Sizes include neonatal through large adult. Each cuff is packed in a sealed polyethylene (non-sterile) bag and each cuff is marked with the effective size range of limbs on which it may be used.
The provided document is a 510(k) Pre-market Notification for a reprocessed blood pressure cuff. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device. Therefore, a direct table of acceptance criteria and reported device performance, and details about a study designed to meet specific performance criteria using AI, are not present.
However, based on the information provided, here's a breakdown of what can be extracted and inferred regarding performance and testing:
1. A table of acceptance criteria and the reported device performance:
Since this is a reprocessed device seeking substantial equivalence, the "acceptance criteria" are implicitly the performance characteristics of the predicate devices. The performance reported centers on demonstrating that the reprocessed device matches these characteristics.
| Acceptance Criterion (Implicitly, from predicate devices) | Reported Device Performance (Hygia Reprocessed BP Cuff) |
|---|---|
| Functional and operational performance characteristics (compression, pressure control, leakage) | "functional and operational performance characteristics including compression, pressure control, leakage... were substantially equivalent." |
| Safety parameters | "safety and operational parameters used when connected to inflation and measurement equipment were substantially equivalent." |
| Operational parameters when connected to inflation and measurement equipment | "safety and operational parameters used when connected to inflation and measurement equipment were substantially equivalent." |
| Design, materials, energy source, mode of operation | "The technological characteristics... are identical to the originally manufactured Blood Pressure Cuff in design, materials, energy source, mode of operation, and performance characteristics." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "Comparative bench testing," but does not provide details on the number of cuffs or tests performed.
- Data Provenance: Not explicitly stated. The testing was "Non-clinical Tests" and conducted by Hygia Health Services, Inc. within the USA. It appears to be prospective testing specifically for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. The ground truth for this device's performance is not established by expert consensus on clinical findings. Instead, it's established by comparing physical and functional characteristics to new, predicate devices.
- Qualifications of Experts: N/A.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable in the context of expert review. The "adjudication" was a comparison of physical and functional test results against established specifications or performance of predicate devices.
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:
- MRMC Study: No.
- Effect Size: Not applicable. This document is for a physical medical device (blood pressure cuff), not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Study: Not applicable. This device is a blood pressure cuff and does not involve an algorithm or AI.
7. The type of ground truth used:
- Ground Truth: The "ground truth" for this reprocessed device is effectively the published specifications and demonstrated functional performance of the new, un-reprocessed predicate blood pressure cuffs. The study aimed to show that the reprocessed cuff performs identically or substantially equivalently. The "test conclusions" explicitly state: "Non-clinical test results...indicated substantial equivalence in the measured characteristics to the predicate devices, the as originally manufactured blood pressure cuffs."
8. The sample size for the training set:
- Training Set Sample Size: Not applicable. This device does not use machine learning or AI algorithms, and therefore, there is no "training set."
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as there is no training set.
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(201 days)
The CRITIKON Soft Blood Pressure Cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The device is non-sterile and semidisposable (may be single-patient use or optional limited reuse). It is available in neonatal, pediatric and adult sizes. The device is not designed, sold, or intended for use except as indicated.
The device comprises tubing attached to a soft inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device tubing is connected to a noninvasive blood pressure measurement system.
The device is available in the following configurations:
- five neonatal and eight pediatric and adult sizes t
- single and dual cuff tubing, connectors, adapters and bulb/valve . assemblies available for use with a variety of manual and automated sphygmomanometers
The provided text describes the 510(k) summary for the CRITIKON Soft Blood Pressure Cuff, focusing on its substantial equivalence to previously marketed devices. The document details the device's description, technological characteristics, and performance testing, but it does not contain specific acceptance criteria or an explicit study proving the device meets those criteria in the format requested.
The information primarily focuses on demonstrating substantial equivalence to predicate devices, which is a different regulatory pathway than proving performance against specific acceptance criteria for a novel device.
However, based on the provided text, here's an attempt to extract and infer information relevant to your request, acknowledging that explicit "acceptance criteria" and a detailed "study" demonstrating adherence to those criteria are not fully present for areas like accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from testing) | Reported Device Performance |
|---|---|
| Biocompatibility: Device materials are safe for patient contact. | Bench and laboratory testing was conducted to demonstrate performance. (Specific results not detailed, but testing implies meeting safety standards.) |
| Reprocessing Validation: Instructions for reprocessing ensure the device remains safe and effective for limited reuse. | Validated according to a formal protocol (052496), comprising sound scientific principles and laboratory procedure. Conceptually based on AAMI TIR No. 12-1994. |
| Repeated Inflations: Device maintains integrity and function over repeated inflation cycles (for limited reuse). | Bench and laboratory testing was conducted to demonstrate performance. (Specific number of inflations or failure rate not detailed, but implies meeting durability standards.) |
| Blood Pressure Measurement Accuracy: (Inferred from device function, but not explicitly stated as an acceptance criterion for the cuff itself) | The cuff is an accessory used in conjunction with non-invasive blood pressure measurement systems. The document does not provide data on the accuracy of blood pressure readings using this cuff, as that is typically evaluated for the measurement system as a whole. The substantial equivalence argument implies it performs similarly to predicate cuffs. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Bench and laboratory testing" but does not specify sample sizes for these tests (e.g., number of cuffs tested for biocompatibility, reprocessing, or repeated inflations). It also does not discuss data provenance in terms of country of origin or whether it was retrospective or prospective, as these tests are product performance evaluations rather than clinical data collection.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The tests performed are engineering/laboratory tests (biocompatibility, reprocessing validation, repeated inflations) rather than clinical studies requiring expert ground truth for interpretation.
4. Adjudication Method for the Test Set
This is not applicable and not provided. The tests described are objective, laboratory-based performance tests, not clinical studies requiring expert adjudication methods like 2+1 or 3+1.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not conducted or described for this device. This type of study is typically used for diagnostic devices where human readers interpret images or data, and AI assistance might improve their performance. The CRITIKON Soft Blood Pressure Cuff is a physical medical accessory.
6. Standalone (Algorithm Only) Performance
A standalone performance study was not conducted or described. This device is a physical accessory and does not involve an algorithm.
7. Type of Ground Truth Used
For the described tests:
- Biocompatibility: Ground truth is established by recognized standards and laboratory protocols for material safety.
- Reprocessing Validation: Ground truth is established by adherence to a formal protocol (052496) conceptually based on AAMI TIR No. 12-1994, which details acceptable microbiological and material integrity outcomes after reprocessing cycles.
- Repeated Inflations: Ground truth is established by engineering specifications for durability and functional performance over a specified number of inflation cycles (though specific details are not provided).
8. Sample Size for the Training Set
This is not applicable and not provided. The CRITIKON Soft Blood Pressure Cuff is a hardware medical device and does not involve a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This is not applicable and not provided. As mentioned, there is no training set for this type of device.
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