(121 days)
Compression Garments (Large and X-Large Sizes)
The Reprocessed Compression Garments are intended to be used with an intermittent pneumatic device to increase venous blood flow in at-risk patients, including bariatric and morbidly obese patients, in order to help prevent deep vein thrombosis and pulmonary embolism.
Compression Garments (Small and Medium Sizes)
The Reprocessed Compression Garments are intended to be used with an intermittent pneumatic device to increase venous blood flow in at-risk patients in order to help prevent deep vein thrombosis and pulmonary embolism.
The Reprocessed Compression Garment is the sleeve component of the pneumatic compression system intended to apply circumferential pressure to a patient's leg. This pressure will aid in the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE).
The Reprocessed Compression Garment is compatible with the OEM pneumatic compression controller. The controller generates air pressure which is transferred through tubinq to individual bladders within the garment. The controller's software delivers and monitors the pressure within the bladders. Once predetermined time and pressure criteria are met, the pressure is released by venting air through a valve system.
The modified reprocessed compressible garment is for single-patient-use and is available in knee length and thigh length confiqurations.
This is a 510(k) summary for a reprocessed medical device (compression garments), not an AI/ML device. Therefore, the questions about acceptance criteria, study design, expert involvement, and training/test sets for an AI/ML device are not directly applicable.
However, I can extract the relevant information regarding the performance data and the conclusion for this reprocessed device:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or a detailed table of reported device performance in the manner expected for an AI/ML device. Instead, it indicates:
| Acceptance Criteria Type | Reported Device Performance |
|---|---|
| Functional Characteristics | Demonstrated appropriate functional characteristics through bench top verification. |
| Manufacturing Process | Includes visual and functional testing of all reprocessed products prior to release. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document mentions "Representative samples of the Reprocessed Compression Garments were tested." It does not specify the exact number of samples.
- Data Provenance: Not applicable/not specified. The testing is bench-top verification of reprocessed physical devices.
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)
Not applicable. This is for a physical reprocessed medical device, not an AI/ML device requiring expert ground truth for output evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is for a physical reprocessed medical device.
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 applicable. This is for a physical reprocessed medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is for a physical reprocessed medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" here is the expected functional performance of the original (non-reprocessed) compression garment and the established quality standards for medical devices. The performance is assessed via "bench top verification" and "visual and functional testing."
8. The sample size for the training set
Not applicable. This is for a physical reprocessed medical device, not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is for a physical reprocessed medical device.
Study Proving Device Meets Acceptance Criteria:
The study described is bench-top verification and functional testing of "Representative samples of the Reprocessed Compression Garments." The purpose of this testing was to demonstrate that the reprocessed garments possess "appropriate functional characteristics" and that the manufacturing process ensures quality through "visual and functional testing of all reprocessed products prior to release."
Conclusion:
Based on this functional testing, Covidien concluded that the modified Reprocessed Compression Garment is substantially equivalent to the existing Reprocessed Compression Garment (K140813). This substantial equivalence implies that the reprocessed device meets the necessary performance and safety standards without requiring the extensive clinical trial data that might be associated with a new or significantly different device.
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).