(79 days)
The S-SCORT® Model 2500 is a portable suction pump to be used by professional personnel for constant suctioning. It can be used in hospital crash cart suction; patient transport; surgi-center back-up suction; emergency medical service; and home health care/nursing homes.
The S-SCORT® Model 2500 is a portable suction pump to be used by professional personnel for constant suctioning. The unit comes equipped with a pump, regulator, battery, canister, suction tubing, suction tip with vent control, and carrying case.
This document is a 510(k) summary for a medical device (S-SCORT® Model 2500 Portable Suction Pump), not a study demonstrating device performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics cannot be extracted from the provided text.
Here's an attempt to address the points based on what can be inferred from the document:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not available in the provided 510(k) summary. The summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific performance criteria and the results of a study against those criteria.
2. Sample size used for the test set and the data provenance
This information is not available. The document doesn't describe a performance 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
This information is not available. No ground truth establishment for a test set is mentioned.
4. Adjudication method for the test set
This information is not available. No test set or adjudication is mentioned.
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
This information is not available. An MRMC study is not mentioned, and the device is a portable suction pump, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not available. The device is a physical pump, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not available. No ground truth is established for device performance in the context of this 510(k) summary.
8. The sample size for the training set
This information is not available. The document does not describe a training set as it pertains to an AI/algorithm.
9. How the ground truth for the training set was established
This information is not available.
Summary of what can be extracted from the document:
The provided 510(k) Notification is a regulatory submission focused on demonstrating "substantial equivalence" of the S-SCORT® Model 2500 Portable Suction Pump to an existing predicate device (SSCOR S-SCORT® Jr. Model 90024B). It asserts that the new device is "technologically similar in design and operation" to the predicate, specifically mentioning pump, battery, regulator, electrical input & output, airflow, negative pressure, and positive pressure as comparable characteristics.
The purpose of this type of submission is to show that a new device is as safe and effective as a legally marketed predicate device, not to present a detailed performance study with acceptance criteria and a test set against a specific "ground truth." Therefore, the requested information about acceptance criteria, study methodology, sample sizes, expert ground truth establishment, and AI performance metrics is not present in this document.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.