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The Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of Haemophilus influenzae; Streptococcus pneumoniae and Streptococcus species. This 510(k) is for the addition of Streptococcus spps to Tetracycline (0.5 -8 ug/mL), Trimethoprim/Sulphamethoxazole (0.5/9.5-4/76 ug/mL), Vancomycin (0.5-4 ug/mL) for use with the Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates.

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The provided text is a 510(k) premarket notification letter from the FDA, approving the Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates. It mentions that the device is substantially equivalent to a predicate and that the company provided a submission document, but the letter itself does not contain the detailed study results, acceptance criteria, or performance data.

Therefore, I cannot extract the specific information requested in your prompt based solely on the provided FDA letter. The letter refers to a "premarket notification of intent to market the device" which would contain such information, but that document is not provided here.

To answer your request, I would need access to the actual 510(k) submission document or a summary thereof, which would detail the study performed to demonstrate substantial equivalence, including acceptance criteria and performance data.

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The Sensitire® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of Haemophilus influenzae; Streptococcus pneumoniae and Streptococcus species.

This 510(k) is for the addition of Streptococcus spps to Meropenem (0.25 -2 ug/mL), Moxifloxacin (0.25-8 ug/mL), Penicillin (0.03-8 ug/mL) for use with the Sensititle® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates .

The approved primary "indications for use" and clinical significance of Meropenem is for: Streptococcus pneumoniae (penicillin-susceptible isolates only) Streptococcus agalactiae Streptococcus pyogenes Viridans group streptococci The approved primary "indications for use" and clinical significance of Moxifloxacin is for Streptococcus pneumoniae, (including penicillin-resistant strains) Streptococcus pyogenes The following in vitro data are available but their clinical significance is unknown; Streptococcus agalactiae Viridans group streptococci The approved primary "indications for use" and clinical significance of Penicillin is for: Streptococcus pneumoniae

Streptococcus pyogenes

Viridans group streptococci

Streptococcus agalactiae

Streptococcus (beta-hemolytic group )

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The provided text describes a 510(k) premarket notification for Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC susceptibility plates for Meropenem, Moxifloxacin, and Penicillin, specifically for the addition of Streptococcus spps to these antimicrobial agents.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria and reported device performance. It is a regulatory clearance letter, not a study report. Regulatory clearances often refer to "substantial equivalence" to predicate devices and state that specific data were reviewed. Details of acceptance criteria and performance would typically be found in the 510(k) submission itself, which is not fully provided here.

However, based on the nature of antimicrobial susceptibility testing (AST) devices, the acceptance criteria generally revolve around the agreement between the new device's results and a reference method (often broth microdilution or agar dilution as defined by CLSI standards). The performance metrics typically include:

• Essential Agreement (EA): The percentage of isolates for which the MIC (Minimum Inhibitory Concentration) value reported by the device is within one doubling dilution of the reference method's MIC value.
• Category Agreement (CA): The percentage of isolates for which the categorization (Susceptible, Intermediate, Resistant) reported by the device matches the categorization determined by the reference method.
• Minor Errors (mER): Occur when the device reports an isolate as Susceptible or Resistant, but the reference method reports it as Intermediate (or vice-versa, depending on specific definitions).
• Major Errors (MER): Occur when the device reports an isolate as Susceptible, but the reference method reports it as Resistant.
• Very Major Errors (VMER): Occur when the device reports an isolate as Resistant, but the reference method reports it as Susceptible.

Typical Acceptance Criteria for AST devices (based on common FDA guidance, not explicitly stated in this document):

• EA: ≥ 90%
• CA: ≥ 90%
• mER: ≤ 10%
• MER: ≤ 3%
• VMER: ≤ 1.5%

Reported Device Performance: The document does not include a table of reported device performance. It states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...". This implies that the data submitted in the 510(k) met the FDA's requirements for substantial equivalence, which would include performance data against established acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not state the sample size used for the test set or the data provenance. These details would be in the full 510(k) submission documents. For AST devices, test sets typically include a significant number of recent clinical isolates, often augmented with challenge strains to ensure a range of MIC values and resistance mechanisms.

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)

This information is not provided in the document. For AST devices, "ground truth" is typically established by a reference laboratory method (e.g., CLSI broth microdilution or agar dilution) performed by trained microbiologists, rather than multiple human experts in the same way imaging studies might.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This concept is not directly applicable to the type of device described (an in vitro diagnostic for antimicrobial susceptibility testing). Adjudication methods like 2+1 or 3+1 are typically used in studies where human readers (e.g., radiologists) interpret images and their consensus establishes ground truth. For AST, the ground truth is instrumental, derived from a reference laboratory method.

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

An MRMC comparative effectiveness study is not relevant here. This document pertains to an in vitro diagnostic susceptibility plate, which is a laboratory test, not an AI-assisted diagnostic imaging device meant to improve human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This device is inherently a "standalone" or "algorithm-only" performance measurement in the sense that the test results (MICs and interpretations) are generated by the device based on microbial growth. Human readers interpret these results, but the initial measurement is automated or semi-automated. The performance study would compare the device's output directly to the reference method's output. There isn't a "human-in-the-loop" concept in the same way as with an AI-powered diagnostic tool assisting a clinician.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For this type of device, the ground truth is established using a reference laboratory method, typically broth microdilution or agar dilution, performed according to recognized standard guidelines (e.g., Clinical and Laboratory Standards Institute - CLSI). This reference method is considered the "gold standard" for determining the true MIC and susceptibility category of an isolate to an antimicrobial agent.

8. The sample size for the training set

The document does not mention a training set. Modern AST devices, while sometimes incorporating some level of automation or expert rules, are generally not "trained" in the same way a machine learning algorithm is. Their performance is based on the chemical and biological interactions within the wells and the accuracy of the MIC reading method. If there were any computational components (e.g., for automated interpretation), details about their development (which might involve a "training set" of sorts) would be in the full submission, but this is unlikely to be a primary concern for a susceptibility plate.

9. How the ground truth for the training set was established

As there is no mention of a "training set" in the context of an AI/ML algorithm, this question is not directly applicable. If any internal validation or development of the interpretation algorithms occurred, it would have used ground truth established by the same reference laboratory methods as the main test set.

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The Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of Haemophilus influenzae; Streptococcus pneumoniae and Streptococcus species. This 510(k) is for the addition of Streptococcus spps. to Gemifloxacin (0.03 -0.5 ug/mL), Linezolid (0.5-4 ug/mL), Levolloxacin (0.5-16 ug/mL) for use with the Sensitite® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates.

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The provided document is a 510(k) premarket notification letter from the FDA regarding a Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC susceptibility plate. This device is an in vitro diagnostic product for clinical susceptibility testing of specific bacterial strains against antimicrobial agents.

Therefore, the requested information about acceptance criteria for a medical imaging AI device or an AI model, ground truth, expert consensus, and MRMC studies is not applicable to this document.

The document discusses the regulatory approval of a microbiology testing plate based on substantial equivalence to legally marketed predicate devices, not on performance criteria that would involve AI or human reader studies.

Here's why the requested information cannot be extracted from the provided text:

• This is not an AI device. The device is a microbiology susceptibility plate, a lab consumable for determining how effective an antibiotic is against a specific bacterium. It's a chemical/biological assay, not an AI or imaging device.
• No AI performance metrics are discussed. The document deals with regulatory matters for an in vitro diagnostic product. It doesn't mention sensitivity, specificity, AUC, or any other performance metrics typically associated with AI.
• No human reader studies are mentioned. There's no indication of radiologists, experts, or their performance with or without AI assistance.
• No ground truth establishment for AI is present. The "ground truth" for a microbiology susceptibility plate would typically be the minimum inhibitory concentration (MIC) determined by a reference method, which is a standardized laboratory procedure, not expert consensus or pathology in the context of AI.
• Training or test set sample sizes for an AI algorithm are not relevant.

In summary, the provided text does not contain any of the information requested for AI device acceptance criteria or studies.

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The Sensitire® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of Haemophilus influenzae, Streptococcus pneumoniae and Streptococcus species.

This 510(k) is for the addition of Streptococcus spps to Cefuroxime (0.5 -4 ug/mL), Gatifloxacin (1-8 ug/mL), Erythromycin (0.25-1 ug/ml) for use with the Sensititre® Haemophilus influenzae/Streplooccus pneumoniae (HP) MIC Susceptibility Plates .

The approved primary "indications for use" and clinical significance of Cefuroxime is for: Streptococcus pneumoniae, Streptococcus pyogenes

The approved primary "indications for use" and clinical significance of Gatifloxacin is for Streptococcus pneumoniae, Streptococcus pyogenes

The following in vitro data are available but their clinical significance is unknown:

_Viridans group streptococci

Streptococcus agalactiae

The approved primary "indications for use" and clinical significance of Erythromycin is for: Streptococcus pneumoniae Streptococcus pyogenes

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This document is a 510(k) premarket notification decision letter from the FDA for an antimicrobial susceptibility test device. It primarily discusses the regulatory approval process and states that the device is substantially equivalent to a legally marketed predicate device.

The provided text does not contain the detailed study results, acceptance criteria, or performance data typically found in a scientific study report or the full 510(k) submission. It only mentions the "addition of Streptococcus spps to Cefuroxime (0.5 -4 ug/mL), Gatifloxacin (1-8 ug/mL), Erythromycin (0.25-1 ug/ml) for use with the Sensititre® Haemophilus influenzae/Streptooccus pneumoniae (HP) MIC Susceptibility Plates" as the subject of the 510(k).

Therefore, I cannot provide the requested information about acceptance criteria, reported device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies based solely on the provided text. The document refers to "in vitro data are available but their clinical significance is unknown," indicating there was testing, but the specifics are not included here.

To answer your questions accurately, I would need access to the actual 510(k) submission summary or a scientific study report for the Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC susceptibility plates.

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The Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility plate is and I he Sellstitle= Huemophilus influence&oldid=918888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888 Streptococcus species.

This 510(k) is for the addition of Streptococcus spps to cefepime (0.12 - 8 ug/mL), ceftrianone (0.06-2 I I IIIS SIV(K) is for the addition of Shippoooooal vipps Sensitite® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates .

oneumonde (HF) MIC Susceptionity Frates -

Viridans group streptococci. Streptococcus pneumoniae, Streptococcus pyogenes With activity against: Streptococcus agalactiae " " Sheptococcas agatachas for use" and clinical significance of ceftriaxone is for

Viridans group streptococci.

Streptococcus pneumoniae,

Streptococcus pyogenes

The following in vitro data are available but their clinical significance is unknown:

Streptococcus agalactiae

" "Streptococcas ugadestions for use" and clinical significance of chloramphenicol is for: Streptococcus pneumoniae

Streptococcus spp.

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The provided text describes a 510(k) premarket notification for a medical device called "Sensititre® Haemophilus inflenzae/Streptococcus pneumoniae (HP) MIC susceptibility plates." This device is used for determining the antimicrobial susceptibility of various Haemophilus and Streptococcus species to specific antibiotics (Cefepime, Chloramphenicol, and Ceftriaxone). However, the document does not contain the acceptance criteria or the study details proving the device meets those criteria.

The text is a communication from the FDA indicating that the device has been found substantially equivalent to a legally marketed predicate device, thus allowing it to proceed to market. It outlines regulatory information, product codes, and class designation. The "Indications for Use" section lists the specific bacterial species and antibiotics for which the device is intended.

Therefore, based solely on the provided text, I cannot complete the table or answer the questions regarding acceptance criteria and study details. The document is a regulatory approval letter, not a scientific study report.

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The Sensititre HP Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of fastidious organisms.

This 510(k) is for the addition of Tigecycline in the dilution range of 0.004 - 8 ug/ml for testing Streptococcus spp. isolates on the Sensititre HP susceptibility system. The approved primary "Indications for Use" and clinical significance of Tigecycline is for:

Aerobic facultative Gram-postive microorganisms

Streptoccus agalactiae Streptococcus pyogenes Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and . S. constellatus)

Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC susceptibility plates, for Tigecycline 0.004-8 µg/ml for Streptococcus spp.

The provided text is a 510(k) premarket notification letter from the FDA to TREK Diagnostic Systems, Inc. for their Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC susceptibility plates, specifically for the addition of Tigecycline. This document is a regulatory approval letter and does not contain the detailed study information required to answer most of your questions about acceptance criteria, device performance, study design, or ground truth establishment.

The letter confirms legal marketing authorization but refers to the company's 510(k) submission for the underlying data. Therefore, I can only provide information that is explicitly stated or can be inferred from this specific document.

Here's what can be extracted:

• Device Name: Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC susceptibility plates, for Tigecycline 0.004-8 µg/ml for Streptococcus spp.
• Indication for Use: The Sensititre HP Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of fastidious organisms. This 510(k) is for the addition of Tigecycline in the dilution range of 0.004 - 8 ug/ml for testing Streptococcus spp. isolates on the Sensititre HP susceptibility system. The approved primary "Indications for Use" and clinical significance of Tigecycline is for: Aerobic facultative Gram-positive microorganisms including Streptococcus agalactiae, Streptococcus pyogenes, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus).

Since the document is a regulatory approval letter and not the study report itself, most of your questions cannot be answered from the provided text. The requested information such as acceptance criteria, specific performance metrics, sample sizes, expert qualifications, and ground truth methodologies would be detailed in the original 510(k) submission, which is not provided here.

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The Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of H. influenzae/S. pneumoniae.

This 510(k) is for the addition of Ertapenem in the dilution range of 0.008-16ug/ml to the Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate for testing Haemophilus/Streptococcus pneumoniae isolates. The approved primary "Indications for Use" and clinical significance for Ertapenem is for: Streptococcus pneumoniae ( penicillin susceptible strains only) and Haemophilus influenzae (Beta-lactamase negative strains only). In vitro data. without clinical correlation is provided for: Streptococcus pneumoniae (penicillinintermediate strains only) and Haemophilus influenzae (Beta-lactamase positive strains)

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This document contains information related to the 510(k) premarket notification for the "Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plate For Ertapenem 0.008-16ug/ml". The provided text primarily focuses on the regulatory approval and indications for use, but it does not contain the detailed study information required to fully answer your request regarding acceptance criteria and performance data.

Specifically, the document lacks:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test and training sets.
• Data provenance (country, retrospective/prospective).
• Number and qualifications of experts for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study details.
• Standalone algorithm performance.
• Type of ground truth used (pathology, outcomes, etc.).
• How ground truth for the training set was established.

The provided text only states that the device is an "in vitro diagnostic product for clinical susceptibility testing" and for the "addition of Ertapenem." It also mentions "In vitro data without clinical correlation is provided" for certain strains, which implies that some in vitro testing was done but the full details are not present in this excerpt.

To provide a complete answer with all the requested information, you would need to consult the full premarket notification submission (K040846) which would include the detailed study protocols, results, and acceptance criteria.

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The Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of Haemophilus/Streptococcus pneumoniae. This 510(k) is for the addition of Clindamycin in the dilution range of 0.016-8μg/ml to the Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate for testing Haemophilus/Streptococcus pneumoniae isolates. The approved primary "Indications for Use" and clinical significance for Clindamycin is for: Streptococcus pneumoniae.

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This document is a 510(k) clearance letter for an in vitro diagnostic product, specifically a susceptibility plate for Clindamycin. It does not contain the detailed information necessary to answer your questions regarding acceptance criteria, study design, or performance metrics.

The provided text focuses on the regulatory approval process and states that the device is substantially equivalent to legally marketed predicate devices. It identifies the device, its intended use, and the regulatory classification. However, it does not include:

• A table of acceptance criteria or reported device performance.
• Details about sample sizes for test or training sets, or data provenance.
• Information on expert ground truth establishment (number of experts, qualifications, adjudication method).
• Whether MRMC or standalone performance studies were conducted, or any associated effect sizes.
• The type of ground truth used.

Therefore,Based on the provided document, I cannot answer the questions about the acceptance criteria and study details.

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The Sensitite Haemophilus / Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of Haemophilus / Streptococcus pneumoniae .

This 510(k) is for the addition of Gemifloxacin in the dilution range of 0.001 - 16 ug/ml to the Sensititre Haemophilus / Streptococcus pneumoniae (HP) MIC Susceptibility plate MIC panel for testing Haemophilus / Streptococcus pneumoniae isolates. The approved primary " Indications for Use" and clinical significance of Gemifloxacin is for: Streptococcus pneumoniae and Haemophilus Influenzae.

Sensititre® Haemophilus/Streptococcus pneumoniae (HP) MIC Plates

This is a 510(k) premarket notification for adding a new antibiotic (Gemifloxacin) to an existing antimicrobial susceptibility test plate for Haemophilus and Streptococcus pneumoniae. The submission focuses on the performance of Gemifloxacin with these specific bacteria.

Here's an analysis of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria or reported device performance in the typical format of sensitivity, specificity, or AUC. Instead, for antimicrobial susceptibility testing, performance is generally evaluated based on agreement rates between the new device and a reference method (often broth microdilution or agar dilution). The key metrics for this type of test are:

• Essential Agreement (EA): The MIC result from the new device is within plus or minus one two-fold dilution of the reference method MIC.
• Categorical Agreement (CA): The interpretive category (Susceptible, Intermediate, Resistant) from the new device matches the reference method.
• Major Discrepancy (MD): The new device reports Susceptible while the reference reports Resistant.
• Minor Discrepancy (mD): The new device reports Intermediate while the reference reports Susceptible or Resistant, or vice versa.
• Very Major Discrepancy (VMD): The new device reports Resistant while the reference reports Susceptible.

Based on standard FDA guidance for AST devices, the acceptance criteria typically involve high EA and CA, with low percentages of MD and VMD.

While the specific numerical acceptance criteria are not stated in the provided text, the approval implies that the sponsor met FDA's expectations for these metrics. The letter focuses on the administrative aspects of approval, not the detailed study results. To provide a table, I would need more detailed information from the actual 510(k) submission, which is not fully included here.

However, based on typical FDA requirements for AST devices, a hypothetical table would look like this (with specific values usually included in the full submission, but not in this high-level letter):

The study described implicitly in the approval process would have demonstrated that the Sensititre® Haemophilus/Streptococcus pneumoniae (HP) MIC Plates, when testing Gemifloxacin, achieved these levels of agreement with a reference method for Haemophilus and Streptococcus pneumoniae isolates.

2. Sample Size Used for the Test Set and the Data Provenance

The provided text does not specify the exact sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective).

For AST devices evaluating a new antimicrobial, FDA guidance (e.g., "Guidance for Industry and FDA - Referencing the Clinical and Laboratory Standards Institute Antimicrobial Susceptibility Testing Standards for Device Submissions") typically recommends testing a diverse set of isolates, including those with various resistance mechanisms, and often hundreds of isolates (e.g., >200 for common species, more for less common or resistant phenotypes) across multiple sites. The isolates should be well-characterized.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided in the text. For AST, the "ground truth" is typically established by performing the reference method (e.g., CLSI-compliant broth microdilution or agar dilution) by trained microbiologists following standard protocols, not by expert consensus on images or clinical assessments.

4. Adjudication Method for the Test Set

This is not applicable in the context of AST device evaluation for ground truth. The "ground truth" for AST is determined by the reference method's result, not by expert adjudication of discrepancies, although discrepancies between the test device and reference method are analyzed.

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

This question is not applicable to this type of device. The Sensititre® Haemophilus/Streptococcus pneumoniae (HP) MIC Plate is an in vitro diagnostic (IVD) device for antimicrobial susceptibility testing, which provides quantitative (MIC) or qualitative (S/I/R) results. It is not an AI-powered diagnostic imaging device that involves human readers interpreting cases with or without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

This question is not directly applicable in the context of this specific IVD. The device itself is designed to produce results (MIC values) based on the growth or inhibition of bacteria in the presence of various concentrations of antibiotics. The interpretation of these results into S/I/R categories is done based on established breakpoints, which can be done automatically or by a human reviewing the MIC data. The "standalone" performance here refers to the accuracy of the device in determining the MIC values compared to the reference method (as discussed in point 1). There isn't an "algorithm only without human-in-the-loop" performance in the sense of AI image analysis.

7. The Type of Ground Truth Used

The ground truth used for evaluating the Sensititre® Haemophilus/Streptococcus pneumoniae (HP) MIC Plates with Gemifloxacin would be the results obtained from a CLSI-compliant (Clinical and Laboratory Standards Institute) reference method, such as broth microdilution or agar dilution. These methods are considered the gold standard for determining MICs of antimicrobials.

8. The Sample Size for the Training Set

The concept of a "training set" in the context of machine learning/AI models is not applicable to this type of IVD device. This device is a phenotypic test system (it measures bacterial growth directly), not a software algorithm that learns from data.

9. How the Ground Truth for the Training Set Was Established

As the concept of a training set is not applicable, this question is also not applicable.

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The Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of Streptococcus pneumoniae and Haemophilus influenzae.

This 510(k) is for the addition of Cefdinir in the dilution range of 0.016 - 4 µg/ml to the Sensititre Haemophilus/Streptococcus pneumoniae MIC panel for testing Streptococcus pneumoniae and Haemophilus influenzae isolates. The "Indications for Use" and clinical significance of Cefdinir is for: Haemophilus Influenzae (including B-lactamase production strains)

Sensititre™ Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates, Cefdinir 0.016-4 ug/ml

The provided text describes a 510(k) premarket notification for a medical device called "Sensititre™ Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates, Cefdinir 0.016-4 ug/ml." This device is an in vitro diagnostic product used for clinical susceptibility testing of certain bacteria to the antibiotic Cefdinir. The document confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

However, the provided document does not contain the detailed study information required to answer all parts of your request. Specifically, it lacks information about:

• Acceptance criteria and detailed reported device performance in a table format.
• Sample sizes used for test and training sets.
• Data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• Whether MRMC or standalone studies were done, or their results/effect sizes.
• Type of ground truth used (beyond implying it's related to susceptibility testing which would typically involve laboratory reference methods).
• How ground truth for the training set was established.

The document primarily focuses on FDA's substantial equivalence determination for regulatory clearance based on the device's indications for use.

Based on the available information, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria or a performance table. For in vitro diagnostic (IVD) devices like this, acceptance criteria typically involve demonstrating acceptable agreement (e.g., categorical agreement, essential agreement) with a predicate device or a gold standard method. The document only confirms the device's substantial equivalence to a predicate device, implying these criteria were met during the submission process.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document.

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)

This information is not provided in the document. For antimicrobial susceptibility testing, "ground truth" is typically established by laboratory reference methods (e.g., broth microdilution or agar dilution as per CLSI guidelines), not by expert human readers/adjudicators in the same way an imaging AI would use radiologists.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document. Adjudication methods as described (2+1, 3+1) are typically relevant for human interpretation of data, often in imaging or pathology, where human expert disagreement needs resolution. For an IVD like this, the 'ground truth' is usually an objective laboratory reference method, so human adjudication in this sense is not applicable.

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

An MRMC study is not applicable to this device. This device is an in vitro diagnostic test for antimicrobial susceptibility, not an AI or imaging device where human readers interact with AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This device is a standalone diagnostic test (a susceptibility plate). It is not an algorithm with human-in-the-loop performance. Its "performance" would be its ability to correctly determine the susceptibility or resistance of bacteria to Cefdinir. The document states it is an "in vitro diagnostic product for clinical susceptibility testing," meaning it operates independently to provide a result.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for antimicrobial susceptibility testing is typically established by reference laboratory methods, such as broth microdilution or agar dilution as defined by clinical and laboratory standards (e.g., CLSI guidelines). The document does not explicitly state which specific reference method was used, but this is the standard practice for such devices.

8. The sample size for the training set

This information is not provided in the document. IVD devices like this are not typically "trained" in the way AI algorithms are. They are developed based on known chemical reactions and bacterial physiology, and validated through extensive testing against reference methods.

9. How the ground truth for the training set was established

This information is not provided in the document, and the concept of a "training set" with ground truth in the AI sense is generally not applicable to this type of traditional IVD device. The development and validation involve testing against established microbiological reference methods.

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