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510(k) Data Aggregation
(87 days)
MEDICAL DEVICE SERVICES
Sequential compression sleeves are intended to increase venous comment contrallym in por as a prophylaxis for the formation of deep vein thrombosis or pulmonary embolism in non ambulatory patients. Sequential compression sleeves are single patient use devices only
Reprocessed Used Disposable Sequential Compression Sleeves
The provided text does not contain information about the acceptance criteria or a study proving the device meets those criteria.
The document is a 510(k) "substantially equivalent" letter from the FDA to a medical device manufacturer. It primarily discusses:
- Device Identification: Reprocessed Used Disposable Sequential Compression Sleeves (K022753).
- Regulatory Classification: Class II, Product Code JOW.
- FDA Determination: The device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
- Regulatory Requirements: General controls, good manufacturing practices, labeling, advertising, and other compliance aspects.
- Intended Use Statement: "Sequential compression sleeves are intended to increase venous comment contrallym in por as a prophylaxis for the formation of deep vein thrombosis or pulmonary embolism in non ambulatory patients. Sequential compression sleeves are single patient use devices only."
The letter explicitly states that "FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies." Substantial equivalence is determined by comparing the device to a predicate device, not necessarily by requiring the submission of new clinical or performance study data with specific acceptance criteria.
Therefore, I cannot provide the requested information as it is not present in the given text.
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(77 days)
MEDICAL DEVICE SERVICES
Cold biopsy forceps are intended to be used through an endoscope to remove polyps and/or tissue specimens throughout the alimentary tract
Hot Biopsy Forceps are intended to be used through an endoscope to cauterize and remove polyps and/or tissue specimens throughout the alimentary tract.
MDS reprocessed biopsy forceps are disposable unless reprocessed again by MDS.
MDS intends to market Reprocessed Used Disposable Biopsy Forceps. Reprocessing Biopsy Forceps is performed by MDS to MDS protocol Number 40003.
"Reprocessed," means all operations performed to render a contaminated single-use device patient ready (Enforcement Priorities for Single-Use Devices Reprocessed by Third Party Reprocessors and Hospitals). MDS is a "third party reprocessor" and reprocesses used, single-use medical devices.
MDS believes that Used Disposable Biopsy Forceps can be considered "reusable - by MDS" as defined in the Food and Drug Administration Compliance Policy Guide #7124.16: they are able to withstand the necessary cleaning and sterilization process, the physical characteristics or quality of the device will not be adversely effected, and the device remains safe and effective for its intended use.
Biopsy forceps are long instruments with a small jaw type mechanism on one end and a handle mechanism on the other. Forceps are designed to collect tissue samples.
The provided text is a 510(k) summary and FDA clearance letter for a reprocessed medical device (biopsy forceps). It does not contain information about studies related to AI/algorithm performance. Therefore, I cannot generate an answer that includes details about acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance for AI-based devices.
The document discusses the substantial equivalence of the reprocessed physical device to legally marketed predicate devices, focusing on the ability of the physical device to withstand reprocessing and remain safe and effective for its intended use. There is no mention of any AI or algorithmic component in the reprocessed biopsy forceps.
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(51 days)
MEDICAL DEVICE SERVICES
Reprocessed trocars are designed to provide a pathway for entry of minimally invasive instruments to a body organ or cavity during general, abdominal, thoracic, gynecologic or other minimally invasive surgical procedures. Reprocessed trocars are single patient use devices.
Reprocessed Disposable Trocars
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study details, or ground truth establishment. The document is a 510(k) clearance letter from the FDA for "Reprocessed Disposable Trocars," which indicates that the device has been found substantially equivalent to a legally marketed predicate device.
The letter does not include:
- A table of acceptance criteria or reported device performance.
- Details about any studies, including sample sizes, data provenance, or the number/qualifications of experts.
- Information on adjudication methods.
- Mention of multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used or how it was established for training or testing sets.
The document primarily focuses on regulatory clearance, device classification, and general controls provisions.
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(51 days)
MEDICAL DEVICE SERVICES
Endoscopic scissors and graspers are instruments that have a 5 to 10 mm diameter insulated shaft designed for use through surgical trocars. Endoscopic scissors and graspers, in conjunction with trocars, are used in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissections and transection of tissue.
Endoscopic Surgical Scissors and Graspers are hand-manipulated devices, with and without electrocautery capability; and with and without rotation capability. They are designed for use during minimally invasive surgical procedures and are equipped with elongated shafts to fit through the surgical trocar cannula.
The provided document is a 510(k) summary for Adven Medical, Inc.'s reprocessed used disposable endoscopic scissors and graspers. It describes the device, its intended use, and its substantial equivalence to a legally marketed predicate device.
However, this document does not contain information regarding objective acceptance criteria, a detailed study proving the device meets said criteria, or specific performance metrics. It is a regulatory submission outlining the device's classification and substantial equivalence for market clearance, rather than a scientific study report with detailed performance data.
Therefore, I cannot extract the requested information such as acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, or MRMC study details from this document. The document focuses on regulatory compliance and substantial equivalence, not on a detailed performance study with specific quantitative acceptance criteria and results.
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(30 days)
MEDICAL DEVICE SERVICES
Arthroscopic blades and burs are indicated for resection of tissue within joint spaces under arthroscopic control.
Reprocessed Used Disposable Arthroscopic Blades and Burs are single use surgical devices used for resection of tissue within joint spaces under arthroscopic control. MDS Reprocessed Stryker and Dyonics Disposable Arthroscopic Blades Burs are composed of the same materials as currently marketed hand-manipulated Stryker and Dyonics Disposable Arthroscopic Blades/Burs sold new.
The provided text is a 510(k) summary for the reprocessing of used, disposable arthroscopic blades and burs. It focuses on establishing substantial equivalence to a predicate device and does not contain information about specific acceptance criteria, performance studies, or data related to AI or ground truth establishment.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, or information about MRMC, standalone, or AI studies based on the provided document. The document is about a reprocessed medical device, not an AI/ML-driven device, and does not describe any such studies.
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(245 days)
MEDICAL DEVICE SERVICES, INC.
The sequential compression sleeve is designed to increase venous blood flow in the non-ambulatory patient in order to help prevent deep vein thrombosis and pulmonary embolism.
The compressible sleeve is a garment used for compressing patient's lower limbs by inflation with air to aid the blood flow back towards the heart to prevent deep vein thrombosis (DVT) in patients at risk. The inflatable sleeve consists of inflatable air bladders and tubing, and are connected to the OEM equipment using specific connector(s). The MDS reprocessed sleeve pair is cleaned, inspected and sterilized in sealed individual pouches and returned to the originating hospital.
The provided text describes a 510(k) premarket notification for a reprocessed compressible limb sleeve. The submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study with specific acceptance criteria and detailed performance data often seen for novel devices or software.
Here's an analysis based on the provided information, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Functional and Safety Characteristics | No significant difference in functional and safety characteristics between new and reprocessed devices. | Data indicates no significant difference in functional and safety characteristics between new and reprocessed devices. | This is the overarching acceptance criteria for demonstrating substantial equivalence. Specific metrics for "functional and safety characteristics" are not detailed in this summary. |
| Technological Characteristics | Substantially equivalent in materials, design, and intended use to the sleeves as originally distributed. | The reprocessed sleeves are substantially equivalent (in materials, design, and intended use) to the sleeves as originally distributed. | This is a declaration of equivalence rather than a specific performance metric. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The document mentions "Comparative bench testing," which implies a sample was used, but the size of this sample is not provided.
- Data Provenance: The study was "conducted at Medical Device Services, Inc." It appears to be a bench test conducted by the manufacturer, rather than a clinical study with patient data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" are not directly applicable in the way they would be for patient-centric studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This submission describes bench testing for a physical medical device (a reprocessed limb sleeve), not a diagnostic algorithm that requires expert interpretation for ground truth. The "ground truth" here would relate to the functional and safety specifications of the device itself, likely assessed through engineering tests and measurements.
4. Adjudication Method for the Test Set
- Not Applicable. As this is bench testing and not an expert-based ground truth establishment, adjudication methods like 2+1 or 3+1 are not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No. This is not an AI-powered diagnostic device, and therefore, an MRMC study is not applicable. The device is a reprocessed compressible limb sleeve.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. This is not an algorithm, so standalone performance is not relevant.
7. The Type of Ground Truth Used
- The "ground truth" for this comparative bench testing would be the functional and safety specifications of the original new device (Kendall Model 6325 SCD Sequential Compression System). The reprocessed devices were tested against how the original, new devices are expected to perform. This likely involved quantitative measurements of parameters like inflation pressure, cycle times, air leakage, material integrity, and biocompatibility (though the latter isn't explicitly detailed in the summary).
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for an AI/ML algorithm.
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