(308 days)
The Strome-Blitzer Cytology Balloon device is indicated for use in the 4-quadrant collection and retrieval of surface cells from the esophagus in adults (22 years of age or older). The device may be delivered transorally under direct endoscopic visualization.
The Strome-Blitzer Cytology Balloon is an inflatable biopsy platform. It consists of a catheter with a silicone balloon at its distal end. The balloon has 6 collection pleats on its surface. Inside each pleat are 2 cytology collection strips for specimen collection. While the balloon is uninflated, the strips are covered by the balloon pleats. When inflated, the strips are exposed. The balloon inflates and deflates with the use of a syringe and attached catheter, and is a sterile, single-use device. There are 4 location indicator dots on the proximal balloon surface for orientation during esophagoscopy.
The provided text describes a medical device, the "Strome-Blitzer Cytology Balloon," and its 510(k) premarket notification to the FDA. The information focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria in the context of an AI/ML algorithm. Therefore, many of the requested details, such as the effect size of human reader improvement with AI assistance, sample sizes for training sets of AI, or ground truth for AI model development, are not present in this document.
However, I can extract the acceptance criteria and study details related to the device's performance as described in the provided text.
Acceptance Criteria and Reported Device Performance (Device-Specific, not AI/ML):
| Acceptance Criteria (Strome-Blitzer Cytology Balloon) | Reported Device Performance |
|---|---|
| Cytologic examination of esophageal smears prepared with the device results in diagnostically useful cytology samples. | Met: Resulted in diagnostically useful cytology samples. |
| Cytology samples demonstrate high cellularity. | Met: Samples showed high cellularity. |
| Cytology samples are morphologically comparable to those generated with the reference cytology brush (U.S. Endoscopy Cytology Brush). | Met: Samples were morphologically comparable to the reference cytology brush. |
| Cytology collection procedures are well tolerated by the animals (no adverse events or significant tissue response). | Met: Procedures were well tolerated by the animals, with no inflammatory response or edema in the tissue of the distal esophagus in control or test areas. |
Study Details:
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: 6 swine.
- Data Provenance: Not explicitly stated (e.g., country of origin), but the study was an "Animal Study," implying prospective data collection specifically for this evaluation.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document implies that "cytologic examination" was performed to evaluate the samples. However, it does not state the number of experts used, nor their specific qualifications, for establishing the ground truth of "diagnostically useful cytology samples of high cellularity" or "morphologically comparable."
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not describe any adjudication method for the evaluation of cytology samples from the animal study.
-
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. This was a study comparing a new medical device (a cytology balloon) to a reference device (a cytology brush) in an animal model, not an AI/ML algorithm requiring human reader performance improvement metrics.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth appear to be based on cytologic examination of the collected samples, which implies expert evaluation (likely by pathologists or cytotechnologists). The document states "cytologic examination... resulted in diagnostically useful cytology samples of high cellularity that were morphologically comparable..." This suggests an expert assessment of the cellular quality and morphology.
-
The sample size for the training set:
- Not applicable. This is a physical device, not an AI/ML algorithm requiring a training set.
-
How the ground truth for the training set was established:
- Not applicable. As above, this is a physical device, not an AI/ML algorithm.
§ 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.