(99 days)
The Sensititre® Vizion® is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The "Sensititre® Vizion® is an instrument that takes a digital image of a Sensitities susceptibility plate and magnifies it through the use of a dedicated software and a monitor. The Sensititre® Vizion® is an alternate manual reading method for the Sensititre® MIC plates for nonfastidious Gram positive, Gram negative and fastidious organisms comprising of Haemophilus influenzae, Streptococci pneumoniae and Streptococci other than S. pneumoniae and Candida spp.
NOTE: Please refer to the Sensititre® 18-24 hour MIC or Breakpoint Susceptibility System package insert and the YeastOne package insert for additional instructions, limitations, and references.
This 510(k) is for the addition of: "Vizion® for reading Sensititre YeastOne Plates" The Vizione captures an image of a Sensitite 96 well micro-titre susceptibility plate and projects it onto a touch screen monitor. The user determines the MIC by visually looking for the color change as indicated in the YeastOne technical insert.
The "Vizion" can be used as an alternate method where the user manually reads the MIC result on the Sensititre System.
The Sensititre® Vizion® is an instrument that takes a digital image of a Sensitities susceptibility plate and magnifies it through the use of a dedicated software and a monitor. The Vizione captures an image of a Sensitite 96 well micro-titre susceptibility plate and projects it onto a touch screen monitor.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Sensititre® Vizion® device:
The provided document is a 510(k) clearance letter from the FDA for the Sensititre® Vizion®. It indicates that the device has been reviewed and found substantially equivalent to legally marketed predicate devices. However, the document itself DOES NOT contain the detailed acceptance criteria or the specific study data proving the device meets those criteria.
This type of FDA letter is a summary of the FDA's decision, not the full submission with all the study details. The study data and acceptance criteria would have been part of the original 510(k) submission (K112276) made by TREK Diagnostic Systems.
Therefore, I cannot populate the table or answer most of your detailed questions directly from the provided text. I can only infer some high-level information.
Here's what can be extracted and what cannot:
What can be inferred from the document:
- Device Performance: The device's primary function is to capture a digital image of a Sensititre susceptibility plate, magnify it, and project it onto a monitor to assist a user in manually reading MIC results by visually detecting color changes. The performance described is its use as an "alternate manual reading method."
- Device Use Case: It's intended for use with Sensititre MIC or BP Susceptibility Test Systems for nonfastidious Gram positive, Gram negative, and fastidious organisms (Haemophilus influenzae, Streptococci pneumoniae, Streptococci other than S. pneumoniae), and Candida spp. Specifically, this 510(k) addition is for reading "Sensititre YeastOne Plates."
- Ground Truth (for device function): The user determines the MIC by visually looking for the color change as indicated in the YeastOne technical insert. This implies the "ground truth" for the device's function is the visually determined color change criterion set by the existing Sensititre/YeastOne methods itself, as interpreted by a human user.
What CANNOT be determined from the provided text:
- Specific Acceptance Criteria: The document does not list any quantitative or qualitative acceptance criteria (e.g., accuracy percentages, concordance rates, error rates) that the device had to meet.
- Reported Device Performance against specific criteria: Since criteria aren't listed, the specific reported performance in relation to those criteria is absent.
- Sample size for the test set: Not mentioned.
- Data provenance (country of origin, retrospective/prospective): Not mentioned.
- Number of experts and qualifications for ground truth: Not mentioned.
- Adjudication method: Not mentioned.
- MRMC comparative effectiveness study and effect size: No mention of such a study or human-in-the-loop performance improvement. The device explicitly states it's an "alternate manual reading method," suggesting it's an aid, but not comparing its impact on a human reader's improvement.
- Standalone (algorithm only) performance: The device requires a "user" to determine the MIC by "visually looking for the color change." This clearly indicates it's not a standalone algorithm, but a tool to assist human interpretation.
- Type of ground truth used: While the method of determining the MIC (visual color change) is described, the specific nature of the "ground truth experts" or "reference method" used for validation of the Vizion's assistance is not elaborated upon. It relies on the established protocol of the Sensititre system.
- Sample size for the training set: Not mentioned (and likely not applicable in the AI sense, as this is an image magnification and display tool, not a machine learning algorithm detecting MICs autonomously).
- How the ground truth for the training set was established: Not mentioned.
Summary Table (based on what can be inferred, with significant gaps):
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Primary Function | Not explicitly stated in the provided document. Likely implicit criteria related to clear image capture, magnification, and accurate display of color changes on Sensititre plates for manual interpretation. | The Vizione captures an image of a Sensitite 96 well micro-titre susceptibility plate and projects it onto a touch screen monitor. The user determines the MIC by visually looking for the color change as indicated in the YeastOne technical insert. It is described as an "alternate manual reading method." |
| Clinical Use | Not explicitly stated in the provided document. Likely implicit criteria related to supporting accurate manual MIC reading for the specified organisms and plate types. | "Intended for use with the Sensititre® MIC or BP Susceptibility Test System... an alternate manual reading method for the Sensititre® MIC plates for nonfastidious Gram positive, Gram negative and fastidious organisms comprising of Haemophilus influenzae, Streptococci pneumoniae and Streptococci other than S. pneumoniae and Candida spp." Also, specifically for "reading Sensititre YeastOne Plates." |
| Safety and Effectiveness | Not explicitly stated in the provided document. FDA's clearance implies that the device was found substantially equivalent to predicate devices, meaning it is considered as safe and effective as those existing devices for its intended use as an aid for manual interpretation. | Substantially equivalent to legally marketed predicate devices. |
Other Study Information (mostly "Cannot be determined"):
- Sample size used for the test set and the data provenance: Cannot be determined from the document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Cannot be determined from the document.
- Adjudication method: Cannot be determined from the document.
- 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: Not mentioned. The device is described as an aid for manual reading, not an AI for autonomous interpretation or a tool explicitly studying reader improvement with assistance in the way a diagnostic AI would.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, the device explicitly requires a user ("The user determines the MIC by visually looking for the color change"). It is a human-in-the-loop device.
- The type of ground truth used: The "ground truth" for the interpretation itself is the visual color change according to the existing Sensititre/YeastOne technical inserts, as interpreted by a human user. For validating the performance of the Vizion as an aid, it would likely involve concordance studies against direct visual reading or a reference method, but the details are not present.
- The sample size for the training set: Not applicable and not mentioned, as this is not an AI/machine learning algorithm in terms of training on large datasets to make diagnostic decisions. It's an imaging and display tool.
- How the ground truth for the training set was established: Not applicable for the reasons above.
To get the detailed information you are requesting, you would need to access the full 510(k) submission (K112276) documents from the FDA, which are typically much more extensive than the clearance letter.
§ 866.1640 Antimicrobial susceptibility test powder.
(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).