(114 days)
The EndoSign® Cell collection device is to be used for the collection of cells from the surface of the oesophagus for molecular, cytological and histological analyses.
The EndoSign® Cell collection device is to be used for the collection of cells from the surface of the oesophagus for molecular, cytological and histological analyses. It is a non-sterile low risk, transient use, minimally invasive, single use, oesophageal cell collection device designed for use by trained and qualified medical professionals. The device is composed of a clear, size 00 capsule made from vegetable-derived material. The capsule houses a 30mm compressed spherical sponge and is connected to a non-absorbable silicone-coated braided polyester thread, secured to a clear polycarbonate applicator. The patient swallows the capsule along with the bundled thread, and as it travels through the oesophagus, the capsule dissolves allowing the sponge to expand and release. The thread is then gently pulled to retrieve the sponge, which collects cells from the lining of the oesophagus as it is removed. The device is used to collect cell samples which are further analyzed for identification of disease biomarkers. The results of the test will be used to assess patients suspected of oesophageal pathologies such as Barrett's oesophageal cancer, eosinophilic esophagitis, and other abnormalities.
The provided FDA 510(k) summary for the EndoSign® Cell collection device (K233142) does not contain specific acceptance criteria, detailed study results, or information typically found in a clinical study report for device performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Cytosponge™ Cell Collection Device, K181020) through bench functional testing and general performance and safety validation.
Therefore, I cannot provide the detailed information requested in the prompt based solely on the provided text. The document states:
"Performance testing for the EndoSign® Cell collection device consisted of bench functional testing, performance and safety validation, and shelf life. Functional testing included dissolution, tensile strength, biocompatibility, manufacturing accuracy, dimensional reproducibility, sampling sufficiency, and usability/human factors testing. Results of performance testing demonstrate performance equivalence for the EndoSign® Cell collection device when evaluated against the predicate device."
This is a general statement about the types of tests conducted, but it does not provide the acceptance criteria (e.g., minimum tensile strength), the reported performance metrics (e.g., actual tensile strength measured), or the methodologies (e.g., sample size, ground truth establishment) for any of these tests.
If this were a typical AI/ML medical device submission, the acceptance criteria and study details would be much more explicit, particularly regarding diagnostic performance metrics. However, this is a physical device submission where the focus is on the collection mechanism's equivalence and safety.
Based on the provided text, here is what can be inferred and what cannot be provided:
1. A table of acceptance criteria and the reported device performance
- Cannot provide. The document lists categories of functional testing (dissolution, tensile strength, biocompatibility, manufacturing accuracy, dimensional reproducibility, sampling sufficiency, usability/human factors testing) but does not provide specific numerical acceptance criteria or the measured performance values for these tests. It only states that the "Results of performance testing demonstrate performance equivalence."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot provide. The document mentions "performance testing" but does not specify sample sizes or data provenance (e.g., number of devices tested for tensile strength, origin of samples for biocompatibility). Given its focus on demonstrating equivalence for a physical device, these tests are likely lab-based bench tests rather than clinical studies with patient data.
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)
- Cannot provide. This type of information is typically relevant for diagnostic devices that rely on expert interpretation of images or data. For a cell collection device, "ground truth" would likely relate to objective measurements of physical properties (e.g., cell yield, integrity) rather than expert consensus on a diagnosis. The document does not describe such expert involvement for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot provide. Adjudication methods are specific to studies involving human readers or evaluators, often in cases where subjective interpretation needs to be standardized. This is not applicable to the functional bench tests described for this physical 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
- Cannot provide. An MRMC study is relevant for AI/ML diagnostic tools where the impact of AI on human reader performance is assessed. The EndoSign® is a physical cell collection device, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot provide. Standalone performance is relevant for AI/ML algorithms. The EndoSign® is a physical device, so this concept does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot clearly provide. For the functional tests mentioned (dissolution, tensile strength, biocompatibility, etc.), the ground truth would be objective physical measurements against engineering specifications or established standards. For "sampling sufficiency," it would likely be laboratory analysis of collected cells (e.g., cell count, viability, presence of specific markers), but the document does not specify the method or "ground truth" criteria for this.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
In summary, the provided document describes a 510(k) submission for a physical medical device. It focuses on demonstrating substantial equivalence through bench testing of physical and performance characteristics, rather than clinical efficacy studies or performance metrics for an AI/ML diagnostic tool. Therefore, most of the detailed information requested regarding acceptance criteria and study designs typically associated with AI/ML or extensive clinical trials is not present in this type of regulatory submission document.
§ 874.4710 Esophagoscope (flexible or rigid) and accessories.
(a)
Identification. An esophagoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the esophagoscope and is intended to examine or treat esophageal malfunction symptoms, esophageal or mediastinal disease, or to remove foreign bodies from the esophagus. When inserted, the device extends from the area of the hypopharynx to the stomach. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.