(137 days)
The PneumoLiner device is intended for use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue, considered benign, resected during single-port or multi- site laparoscopic surgery during power morcellation and removal. When used in women with fibroids, the PneumoLiner is for women who are pre-menopausal and under age 50. The PneumoLiner is compatible with bipolar or electromechanical laparoscopic power morcellators that are between 15mm and 18mm in shaft outer diameter and 135mm and 180mm in shaft working length and which have an external component that allows for the proper orientation of the laparoscope to perform a contained morcellation.
The ASC PneumoLiner is an inflated morcellation containment system that allows for containment of gynecological tissue, cells and fluids during power morcellation and removal. It is a sterile single use device and requires the surgeon to successfully complete a validated training program before use. The ASC PneumoLiner is for clinical use in a hospital or surgical center operating room. The device consists of the following components: the Retractor Introducer, Boot Assembly, the PneumoLiner Introducer and the PneumoLiner. The first three components (Retractor, Retractor Introducer and Boot Assembly) are used to retract an incision in the abdominal wall and to allow for the introduction of laparoscopic instruments and the PneumoLiner Bag while under pneumoperitoneum and with vision from a laparoscope. The PneumoLiner Bag is introduced via the PneumoLiner introducer and the large valve on the Boot Assembly. The PneumoLiner is intended for use in gynecological power morcellation. It is intended to form a complete containment barrier from the spillage of liquids, cells and tissue from the time the tissue or organ is excised and encapsulated in the PneumoLiner bag, throughout the morcellation procedure and withdrawal of the containment bag with accompanying liquids and debris.
Based on the provided text, the device in question (PneumoLiner) is a medical device for contained morcellation, not an AI/ML powered device. Therefore, the information requested about acceptance criteria and studies proving the device meets them, especially those pertaining to AI/ML device performance (like MRMC studies, standalone algorithm performance, number of experts for ground truth, training set size and ground truth establishment), is largely not applicable to this document.
The document describes a 510(k) submission for a revision to the labeling (indications for use and contraindications) of an existing device, and some non-clinical performance testing related to packaging and shelf-life. There are no mentions of AI/ML or a "study that proves the device meets the acceptance criteria" in terms of an AI/ML algorithm's clinical performance.
However, I can extract the relevant information regarding the changes made and the supporting information for those specific changes, which are primarily based on clinical literature reviews rather than a new clinical study of the device itself.
Since the request is about acceptance criteria and a study proving the device meets them, and this document describes a labeling change for a physical medical device, I will reframe the answer based on the information available:
Acceptance Criteria and Study for PneumoLiner (K192898 Labeling Revision)
The provided document (K192898 510(k) clearance letter) describes a submission primarily for a revision to the Indications for Use and contraindications of an existing medical device, the PneumoLiner. It also includes updated non-clinical performance data for shelf-life and packaging. It does not describe a clinical study of the device's efficacy or safety as an AI/ML system.
Therefore, many of the requested points related to AI/ML device performance are not applicable. I will address the relevant points based on the information provided in the document.
1. Table of Acceptance Criteria and Reported Device Performance
For this specific 510(k), the "acceptance criteria" appear to be related to the justification of the labeling changes and the non-clinical performance of packaging and shelf-life. The "performance" is demonstrated through literature review for the labeling changes and specific testing for packaging/shelf-life.
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from document) | Reported Device Performance / Supporting Information |
|---|---|---|
| Labeling Changes (Indications for Use / Contraindications) | Justification for modifying patient population definition (pre-menopausal, under 50 for fibroids) based on risk stratification. | Supported by "published clinical literature," specifically: |
- JMIG Special Article, "Morcellation during Uterine Tissue Extraction: An Update by the Tissue Extraction Task Force Members" (2018).
- FDA Updated Assessment of the Use of Laparoscopic Power Morcellators to Treat Uterine Fibroids (December 2017).
- Seidhoff et al. (2017) meta-analysis.
These sources stratify the risk of occult leiomyosarcoma (LMS) by age. |
| Non-Clinical Performance (Shelf-Life & Packaging) | Sterilization validity. | Sterilization validated to ISO 11137-1:2006 and ISO 11137-2:2013. |
| | Shelf-life validity (updated from 1 year to 3 years). | Tested on samples accelerated aged which underwent simulated shipping, including: - Sterile Barrier Integrity testing
- Visual inspection per ASTM F1996:2009 (2013)
- Bubble leak testing per ASTM F2096:2011
- Seal strength per ASTM F88:2009.
- Device functionality (leak testing, bond/material strength testing). |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable for a clinical performance test of an AI/ML algorithm. The "test set" for the labeling changes was the existing body of clinical literature. The provenance is explicitly cited as published academic journals and FDA assessments.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable as an AI/ML algorithm was not being evaluated. The "ground truth" for the labeling changes was derived from peer-reviewed clinical literature and FDA assessments, which represent the consensus or findings of multiple medical experts and researchers in the field. The specific number of individual experts directly involved in "establishing ground truth" for this submission is not quantified in the document, as it relied on previously established and published data.
4. Adjudication Method for the Test Set
This is not applicable as an AI/ML algorithm was not being evaluated. The "adjudication" for the literature review was implicitly handled through the peer-review process of the cited publications and the FDA's own assessment methodologies.
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, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI assistance on human performance, which is not the subject of this 510(k) submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This submission is not for an AI-powered device.
7. The Type of Ground Truth Used
For the labeling changes, the "ground truth" was derived from published clinical literature, meta-analyses, and FDA assessments regarding the risk stratification of occult leiomyosarcoma (LMS) by age in women with presumed fibroids. This effectively represents:
- Expert Consensus (via peer-reviewed publications): The conclusions drawn in the cited articles reflect the collaborative findings and consensus (or significant findings) of experts in gynecology and oncology.
- Outcomes Data (clinical studies summarized in literature): The literature reviewed is based on real-world clinical outcomes and patient data that informed the risk stratification.
8. The Sample Size for the Training Set
This is not applicable as there was no AI/ML algorithm to train.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there was no AI/ML algorithm to train.
In summary, the provided document describes a regulatory submission for a physical medical device (PneumoLiner) that involves labeling revisions and non-clinical performance testing for shelf-life and packaging. It is crucial to note that this is not an AI/ML-powered device and therefore, most of the questions related to AI/ML study methodologies are not relevant to this specific 510(k) clearance letter. The justification for labeling changes was based on existing clinical literature and expert-driven assessments.
§ 884.4050 Gynecologic laparoscopic power morcellation containment system.
(a)
Identification. A gynecologic laparoscopic power morcellation containment system is a prescription device consisting of an instrument port and tissue containment method that creates a working space allowing for direct visualization during a power morcellation procedure following a laparoscopic procedure for the excision of benign gynecologic tissue that is not suspected to contain malignancy.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible;
(2) Device components that are labeled sterile must be validated to a sterility assurance level of 10
−6 ;(3) Performance data must support shelf life by demonstrating continued sterility of the device or the sterile components, package integrity, and device functionality over the intended shelf life;
(4) Non-clinical performance data must demonstrate that the device meets all design specifications and performance requirements. The following performance characteristics must be tested:
(i) Demonstration of the device impermeability to tissue, cells, and fluids;
(ii) Demonstration that the device allows for the insertion and withdrawal of laparoscopic instruments while maintaining pneumoperitoneum;
(iii) Demonstration that the containment system provides adequate space to perform morcellation and adequate visualization of the laparoscopic instruments and tissue specimen relative to the external viscera;
(iv) Demonstration that intended laparoscopic instruments and morcellators do not compromise the integrity of the containment system; and
(v) Demonstration that intended users can adequately deploy the device, morcellate a specimen without compromising the integrity of the device, and remove the device without spillage of contents;
(5) Training must be developed and validated to ensure users can follow the instructions for use; and
(6) Labeling must include the following:
(i) A contraindication for use in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy;
(ii) Unless clinical performance data demonstrates that it can be removed or modified, a contraindication for removal of uterine tissue containing suspected fibroids in patients who are: Peri- or postmenopausal, or candidates for en bloc tissue removal, for example, through the vagina or via a mini-laparotomy incision;
(iii) The following boxed warning: “Warning: Information regarding the potential risks of a procedure with this device should be shared with patients. Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer. The use of this containment system has not been clinically demonstrated to reduce this risk.”
(iv) A statement limiting use of device to physicians who have completed the training program; and
(v) An expiration date or shelf life.