(286 days)
MIDSLEEVE, Calibration Tube for Sleeve Gastrectomy is indicated for use in the bariatric procedure known as Longitudinal Sleeve Gastrectomy (LSG), to drain and remove gastric fluid and to provide a calibration of the gastric pouch.
MIDSLEEVE™ Calibration tube for Sleeve Gastrectomy is a sterile, single use medical device which consists of a 900 mm long, silicone tube of 37.5 French diameter, with a PVC valve at the proximal end of the tube. The tube has several holes and a rounded end, distal from the valve and an asymmetric balloon which can be filled through the valve. Reference markings are provided on the tube, from the distal end to 70 cm to locate the tube position.
The provided text is a 510(k) summary for the MIDSLEEVE™ Calibration Tube for Sleeve Gastrectomy. It discusses the device's indications for use, comparison to predicate devices, and performance testing, but it does not contain detailed acceptance criteria and a study demonstrating how the device meets that criteria in the format requested.
Specifically, the document lists "Intended performance" goals but these are qualitative statements rather than specific acceptance criteria with numerical targets. The "Performance testing" section mentions conforming to various ISO and ASTM standards and internal engineering specifications, but it does not provide the results of these tests, what specific acceptance criteria were used for each test, or how the device's performance measured against those criteria.
Therefore, for your required output, I can only extract what is mentioned in the document and note where information is missing.
Here's the breakdown of the information available in the document:
Acceptance Criteria and Study for MIDSLEEVE™ Calibration Tube for Sleeve Gastrectomy
The provided document describes "Intended performance" goals and lists various performance tests conducted. However, it does not explicitly define quantifiable acceptance criteria in a table format with corresponding reported device performance values. The document asserts that the device conforms to various standards and engineering specifications, implying successful completion of tests, but does not provide the specific data from these tests or the numerical acceptance thresholds.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated as "Intended Performance" or implied by standards) | Reported Device Performance (As stated or implied in the document) |
|---|---|
| Allows intubation through the patient's mouth and down towards the stomach. | (Implied: Device design allows for this, no specific test data provided) |
| Allows simpler calibration of the gastric pouch during sleeve gastrectomy compared to typical method (nasogastric tube). | (Implied: Device design with balloon aims to achieve this, no specific comparative study data provided) |
| Dimension of preserved gastric pouch optimizes sleeve gastrectomy effectiveness (weight loss and quality of life). | (Implied: Device design aims for optimizing. No specific outcome data on weight loss or quality of life provided for this device.) |
| Allows combination with a suction system to drain gastric fluids and/or perform a leak test. | (Implied: Device includes features for this, e.g., "distal side holes for suction". No specific test data provided.) |
| Conformance to ISO 11607-01:2009 (Packaging - Part 1) | Conforms to standard. (No specific test data provided.) |
| Conformance to ISO 11607-01:2009 (Packaging - Part 2) | Conforms to standard. (No specific test data provided.) |
| Conformance to ASTM F88-09:2009 (Seal Strength) | Conforms to standard. (No specific test data provided.) |
| Conformance to ASTM F1980-07:2011 (Accelerated Aging) | Conforms to standard. (No specific test data provided.) |
| Conformance to NF EN ISO 10993-1:2010 (Biocompatibility - Part 1) | Conforms to standard; biocompatibility assessed. (No specific test data provided.) |
| Conformance to ASTM F1140/F1140M-13 (Internal Pressurization Failure) | Conforms to standard. (No specific test data provided.) |
| Conformance to NF EN ISO 10993-5:2010 (Cytotoxicity) | Conforms to standard. (No specific test data provided.) |
| Conformance to NF EN ISO 10993-10: 2010 (Irritation and Skin Sensitization) | Conforms to standard. (No specific test data provided.) |
| Dimensional Analysis (Engineering specification) | Tested; conforms to specifications. (No specific test data provided.) |
| Reliability and Safety of the Distal Balloon Inflation and Proximal Valve (Engineering specification) | Tested; conforms to specifications. (No specific test data provided.) |
| Burst Volume Testing on the Inflated Balloon (Engineering specification) | Tested; conforms to specifications. (No specific test data provided.) |
| Distal End piece Gluing Reliability (Engineering specification) | Tested; conforms to specifications. (No specific test data provided.) |
| Valve to Tube Joint Strength Test (Engineering specification) | Tested; conforms to specifications. (No specific test data provided.) |
| Sterile Packaging Integrity (Engineering specification) | Tested; conforms to specifications. (No specific test data provided.) |
| Biocompatibility of materials (Implied by NF EN ISO 10993 standards) | Materials' biocompatibility assessed; no safety concern. (No specific test data provided.) |
| Device supplied EO-sterilized; limits additional risk of residual ethylene oxide intoxication. | Validation of aeration method (Implied successful). (No specific test details provided.) |
| Differences in dimensions (Length, Outer Diameter) from predicates do not impair safety or performance. | (Implied conclusion from testing, no specific comparative study data provided for new dimensions.) |
| Presence of a balloon and its position does not impact calibration function compared to predicate. | (Implied conclusion from testing, no specific comparative study data provided.) |
2. Sample size used for the test set and the data provenance
- The document does not specify the sample size used for the performance tests mentioned (e.g., dimensional analysis, reliability, burst volume, gluing, joint strength, packaging integrity).
- The data provenance (e.g., country of origin, retrospective or prospective) for these tests is not mentioned. These appear to be bench or lab tests rather than clinical studies on human subjects. For biocompatibility, it refers to standards, but no origin of direct test data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable as the provided document details bench testing and conformance to standards, not a clinical study requiring expert ground truth for interpretation of images or patient data.
4. Adjudication method for the test set
- This information is not applicable for the same reasons as point 3.
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
- No MRMC comparative effectiveness study was done. This device is a physical medical instrument, not an AI or imaging diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable. The device is a physical tool, not an algorithm.
7. The type of ground truth used
- The "ground truth" for the performance criteria appears to be adherence to established international and national standards (e.g., ISO, ASTM, NF EN ISO) and internal engineering specifications for parameters like dimensions, material properties, and functional reliability. There is no mention of expert consensus, pathology, or outcomes data as "ground truth" for these tests.
8. The sample size for the training set
- This information is not applicable. The device is a physical product, not a machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
- This information is not applicable for the same reasons as point 8.
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.