(213 days)
The TD 100® disinfector is designed to provide high-level disinfection of Transesophageal (TEE) ultrasound probes. The system can use TD-50 or TD-80 disinfectants, which are designed to be used only with the TD 100® disinfector. The disinfectant bottles cannot be reused in the system.
TD-50 disinfectant is intended for use as single use high-level disinfectant to be used exclusively in the TD 100@ disinfector for high-level disinfection of TEE ultrasound probes.
TD-50 high level disinfectant and TD 1000 disinfector system are intended for use by qualified individuals trained in its use.
TD-50 disinfectant should be used with the following contact conditions in TD 1008 disinfector:
High-Level Disinfectant: TD-5®
Time: 5 minutes
Temperature: 38°C - 40°C
Minimum Recommended Concentration: 1.7% glutaraldehyde
TD-80 disinfectant is intended for use as single use high-level disinfectant to be used exclusively in the TD 1000 disinfector for high-level disinfection of TEE ultrasound probes.
TD-8@ high level disinfectant and TD 1000 disinfector system are intended for use by qualified individuals trained in its usc.
TD-80 disinfectant should be used with the following contact conditions in TD 1008 disinfector:
High-Level Disinfectant: TD-8®
Time: 5 minutes
Temperature: 38°C - 40°C
Minimum Recommended Concentration: 0.3% ortho-phthalaldehyde
The TD 100® disinfector provides high level disinfection of transesophageal (TEE) ultrasound probes when used according to the operating instructions, and when used with TD-50 or TD-80 disinfectants. The TD 1000 disinfector is for use only with TD-50 or TD-8® disinfectants. The TD-5º and TD-8º disinfectants are for use only in the TD 100 disinfector. Thus, the TD 100® disinfector with TD-50 and TD-80 disinfectants represents a dedicated system. Each soiled TEE probe is bedside cleaned and manually cleaned according to the TEE probe manufacturer's instructions before insertion into the TD 100 disinfector. A fresh, unopened bottle of TD-50 or TD-80 disinfectant is loaded into the TD 100% disinfector. The TD 100% disinfector heats the TD-5% or TD-8% disinfectant to 38°-40°C, soaks the TEE probe for at least five minutes, and then thoroughly rinses the disinfectant off the TEE probe before the cycle is complete. The TD 100 disinfector prints a verification report indicating a successful disinfection cycle and the time and average temperature during the disinfection. The TEE probe is then removed from the TD 100® disinfector and dried according to the TEE probe manufacturer's instructions. The TD 100® disinfector is ready for a new cycle immediately after the preceding cycle is completed. Because a fresh bottle of TD-5 or TD-8 disinfectant is used with each cycle, no monitoring of the disinfectant's potency is required, nor is there any requirement for daily testing of the disinfectant solution.
The provided text is a 510(k) Summary for a medical device (TD-100 Disinfector with TD-5 and TD-88 High Level Disinfectants). It describes the device, its indications for use, and makes comparisons to predicate devices. However, the document does not contain the specific information requested in the prompt regarding an AI device, acceptance criteria tables with performance, sample sizes for test/training sets, expert ground truth, adjudication methods, or MRMC studies.
Instead, the document focuses on the disinfector's ability to achieve high-level disinfection, material compatibility, and stability in comparison to other disinfectants. The "acceptance criteria" presented are related to the effectiveness of the disinfectants against various microorganisms and operational parameters of the disinfection process (time, temperature, concentration).
Here's a breakdown of what is and is not in the provided text, in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
- What is present: The document includes a table (Table C.1c) comparing the TD-8 and TD-5 disinfectants' performance against various organisms (Sporicidal, Tuberculocidal, Bactericidal, Fungicidal, Virucidal, Simulated Use, Clinical In-Use) with predicate devices. The "performance" here is typically the contact time and temperature required to achieve the desired effect (e.g., kill the organism). It does not present a typical "acceptance criteria" table with a defined threshold and then the device's reported achievement against that threshold in the way an AI performance summary would.
- Missing: Specific quantitative acceptance criteria (e.g., "sensitivity must be >X%"). The table shows what the disinfectants achieve in terms of kill time/temperature.
2. Sample Size Used for the Test Set and Data Provenance:
- Missing from the text: No sample sizes are provided for any of the microbial efficacy tests (e.g., number of replicates, number of devices tested).
- Missing from the text: No data provenance (country of origin, retrospective/prospective) is mentioned for the microbial efficacy studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not Applicable / Missing: This concept (experts establishing ground truth for a test set) is relevant for AI/diagnostic devices that interpret data (e.g., images). For a disinfectant device, the "ground truth" is established through laboratory microbiological testing (e.g., demonstrating reduction in colony-forming units). The document does not describe the laboratory personnel or their qualifications.
4. Adjudication Method for the Test Set:
- Not Applicable / Missing: Adjudication methods (like 2+1, 3+1) are for human review of data, typically in diagnostic studies. This is not mentioned for the disinfectant efficacy testing.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
- Not Applicable: This type of study is for evaluating the impact of AI on human reader performance in diagnostic tasks. It is not relevant for a high-level disinfectant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable: This pertains to AI algorithm performance. The device is a disinfector, not an algorithm. The "standalone" performance here would be the device's ability to disinfect, which is what the microbial efficacy tests address.
7. The Type of Ground Truth Used:
- What is present: The "ground truth" for this device's performance is microbiological efficacy (kill of specified microorganisms) demonstrated through laboratory testing (Sporicidal, Tuberculocidal, Bactericidal, Fungicidal, Virucidal, Simulated Use, Clinical In-Use). The "Clinical In-Use" section mentions "measurably complete kill of microorganisms" from "Wild-type from patients."
- Missing details: The specific methodologies for measuring kill (e.g., log reduction) are not detailed in this summary.
8. The Sample Size for the Training Set:
- Not Applicable / Missing: This concept is for AI/machine learning models. The device is a physical disinfector with chemical agents. There is no "training set" in this context. The development of the disinfectant formulation and system design would involve R&D and testing, but not a "training set" in the AI sense.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable / Missing: As above, there is no "training set" for this type of device.
Summary of what can be extracted, interpreted, and what is missing based on the prompt's requirements:
1. A table of acceptance criteria and the reported device performance
| Test | Organism | Acceptance Criteria (Inferred from Predicates & General HLD Standards) | Reported Device Performance (TD-8) |
|---|---|---|---|
| Sporicidal | Bacillus subtilis | Achieve kill/inactivation | 32.0 hrs at 37°C |
| Sporicidal | Clostridium sporogenes | Achieve kill/inactivation | 32.0 hrs at 37°C |
| Tuberculocidal | Mycobacterium terrae | Achieve kill/inactivation (typically 5-10 min) | 5.0 min at 37°C |
| Bactericidal | Staphylococcus aureus | Achieve kill/inactivation (typically 5 min) | 5.0 min at 37°C |
| Bactericidal | Salmonella enterica | Achieve kill/inactivation (typically 5 min) | 5.0 min at 37°C |
| Bactericidal | Pseudomonas aeruginosa | Achieve kill/inactivation (typically 5 min) | 5.0 min at 37°C |
| Fungicidal | Trichophyton mentagrophytes | Achieve kill/inactivation (typically 5 min) | 5.0 min at 37°C |
| Virucidal | Poliovirus Type 1 | Achieve kill/inactivation (typically 5 min) | 5.0 min at 37°C |
| Virucidal | Herpes Simplex Virus Type 1 | Achieve kill/inactivation (typically 5 min) | 5.0 min at 25°C |
| Virucidal | Human Influenza Virus A | Achieve kill/inactivation (typically 5 min) | 5.0 min at 25°C |
| Virucidal | Adenovirus Type 1 | Achieve kill/inactivation (typically 5 min) | 5.0 min at 25°C |
| Simulated Use | Mycobacterium terrae | Achieve kill/inactivation | 5.0 min at 37°C |
| Clinical In-Use | Wild-type from patients | Complete kill of microorganisms | Measurably complete kill |
- Note: The "Acceptance Criteria" column is inferred from the common requirements for high-level disinfectants and the performance of the predicate devices. The document explicitly states the "Minimum Recommended Concentration" (MRC) for TD-5 (1.7% glutaraldehyde) and TD-8 (0.3% ortho-phthalaldehyde) and the contact conditions (Time: 5 min, Temperature: 38°C - 40°C) as part of its claim.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
* Sample Size: Not specified in the provided text.
* Data Provenance: Not specified in the provided text. The studies appear to be laboratory-based efficacy tests ("Simulated Use," "Clinical In-Use").
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)
* Not applicable as this is a disinfectant device, not an AI/diagnostic device involving expert interpretation. The "ground truth" is derived from direct microbial efficacy testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
* Not applicable for this type of device and study.
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
* Not applicable for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
* Not applicable in the AI sense. The microbial efficacy tests (Table C.1c) demonstrate the standalone performance of the disinfectant system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
* Microbiological efficacy (kill/inactivation of various microorganisms) determined through laboratory testing and "Clinical In-Use" studies showing "measurably complete kill of microorganisms" from probes after routine clinical use.
8. The sample size for the training set
* Not applicable for this type of device.
9. How the ground truth for the training set was established
* Not applicable for this type of device.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.