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The TORAYGuide guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the heart and peripheral vasculature. The device is not intended for use in the coronary arteries.

The TORAYGUIDE™ Guidewire is manufactured of 304 stainless steel, which is consistent with guidewires presently in commercial distribution and with the same intended use. The device diameter is 0.65 mm, and is supplied in lengths ranging from 175 to 230 cm. The guidewire has a spring core at the distal end, also of stainless steel. The device is ethylene oxide sterilized and intended for single use only.

The provided text describes the 510(k) summary for the TORAYGUIDE™ Guidewire and its substantial equivalence to a predicate device. However, it does not contain specific details about acceptance criteria, detailed performance results, sample sizes for test or training sets, ground truth establishment, expert qualifications, or comparative effectiveness studies.

The document makes a general statement: "Applicable testing was conducted on the TORAYGUIDE guidewire in accordance with the FDA guidance. All samples met the acceptance criteria. The test results establish that the TORAYGUIDE Guidewire possesses performance characteristics that make it acceptable for its intended use." This indicates that some testing was done and passed, but the specifics are not provided in the summary.

Therefore, most of the information requested cannot be extracted directly from the given text.

Here is a summary of what can be inferred or directly stated from the provided text, along with what cannot be found:

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

• Acceptance Criteria: Not specified in the provided text. The document generically states "All samples met the acceptance criteria."
• Reported Device Performance: No specific performance metrics or results are reported in this summary. It only states that the guidewire "possesses performance characteristics that make it acceptable for its intended use."

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 for Test Set: Not specified. The document only mentions "All samples met the acceptance criteria."
• Data Provenance (country of origin, retrospective/prospective): Not specified.

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 medical device (guidewire) and not an AI/diagnostic software. Ground truth in this context would likely refer to engineering specifications and physical performance tests, not expert interpretation of data.

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

• Not applicable for this type of medical device's performance testing.

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. This is a physical medical device (guidewire), not an AI-assisted diagnostic tool.

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

• Not applicable. This is a physical medical device.

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

• The "ground truth" would likely be engineering specifications and physical testing standards for guidewires (e.g., tensile strength, torqueability, flexibility, kink resistance). These specific standards or methods are not detailed in the summary.

8. The sample size for the training set

• Not applicable. This is a medical device, not an AI model requiring a training set.

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

• Not applicable. This is a medical device, not an AI model.

In summary, the provided 510(k) summary is for a guidewire and primarily focuses on demonstrating substantial equivalence to a predicate device through physical and performance testing that met general FDA guidance. The detailed information typically requested for AI/diagnostic software performance studies (like sample sizes, expert qualifications, ground truth methodology) is not relevant or available in this type of device submission summary.

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The Toraysulfone™ Dialyzer, BS-L Series, is indicated for use in hemodialysis treatment of patients with acute or chronic renal failure.

The Toraysulfone Dialyzer, BS-L Series consists of highly permeable polysulfone hollow fibers housed in a polystyrene casing and secured at each end with polystyrene headers. High permeability dialyzers must be used only in conjunction with dialysis machines equipped with an ultrafiltration controller. The Toraysulfone Dialyzer, BS-L Series is provided in a range of three sizes based on the surface area of the hollow fiber membrane. The device is gammaray sterilized and intended for single use only.

The provided text describes the "Toraysulfone Dialyzer, BS-L Series," a medical device used for hemodialysis. The information details the device's technical characteristics, its intended use, and its equivalence to predicate devices, but it does not provide explicit acceptance criteria with specific numerical targets.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance Study for Toraysulfone™ Dialyzer, BS-L Series

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states that "All samples met the acceptance criteria" for bench testing and that the device characteristics are "identical" or "similar" to predicate devices, implying that specific, pre-defined acceptance criteria were met. However, the exact numerical or qualitative targets for these criteria are not detailed in this 510(k) summary.

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

• Sample Size: Not specified. The document states "All samples met the acceptance criteria" for bench testing, but the number of samples is not given.
• Data Provenance: Not explicitly stated as retrospective or prospective. Bench testing data is typically generated in a lab setting. The document also mentions "published materials included in this 510(k) Notification" for some performance characteristics, but their provenance (e.g., country of origin) is not detailed.

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

Not applicable. This type of information is typically relevant for studies involving subjective assessments, such as image interpretation or clinical diagnosis. The Toraysulfone Dialyzer, BS-L Series is a physical medical device, and its performance is evaluated through objective bench testing and comparison to predicate devices, rather than expert-established ground truth on a test set in the same manner as an AI algorithm.

4. Adjudication Method for the Test Set

Not applicable for a physical device undergoing bench testing. Adjudication methods like "2+1" or "3+1" are used in studies where multiple human readers or algorithms assess discrete outcomes and discrepancies need to be resolved. Performance for this device is based on objective measurements from bench testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or screening tools where reader performance is a key outcome. The Toraysulfone Dialyzer, BS-L Series is a treatment device, and its evaluation focuses on its physical and functional performance, not on human reader interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a physical hemodialyzer, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation largely consists of:

• Objective Measurements: Results from bench testing (e.g., flow and clearance data).
• Predicate Device Performance: Performance data from already legally marketed devices (Toraysulfone Dialyzer K002512 and Fresenius Optiflux 200NR Hemodialyzer K002277), which serve as the standard for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI algorithms. The device design and manufacturing processes are developed and refined, but not through a "training set" of data in the same way an AI model is.

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

Not applicable, as there is no training set in this context.

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The Hemofeel™-CH hemofilter is indicated for use in the prevention or treatment of fluid overload, electrolyte and acid/base imbalances in cases of acute renal failure or toxemia with oliguria or anuria. It may also be used when removal of excess fluid is indicated, such as patients in pulmonary edema or congestive heart failure refractory to diuretic therapy.

The Hemofeel-CH Hemofilter consists of highly permeable polymethylmethacrylate (PMMA) hollow fibers housed in a polystyrene casing and secured at each end with polystyrene headers. Blood enters the device through the arterial inlet port, passes through the hollow fibers and exits at the opposite end through the venous outlet port. The Hemofeel-CH hemofilter is provided in a range of sizes based on the surface area of the hollow fiber membrane. Hemofilter size should be selected by the physician according to the patient's body weight and medical condition. The device is gamma-ray sterilized and intended for single use only.

Toray Industries (America), Inc.'s Hemofeel™-CH Hemofilter study:

1. Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

• Test Set (Clinical Study): 8 anuric critically ill patients.
• Data Provenance: The document does not specify the country of origin, but the clinical study was "in the clinical setting", suggesting a prospective clinical trial.

3. Number of Experts and Qualifications:

• Not Applicable. The document describes a medical device's performance, not an AI or diagnostic system requiring expert interpretation for ground truth. The "experts" involve the physicians overseeing the clinical study.

4. Adjudication Method:

• Not Applicable. This is a performance study for a medical device, not a diagnostic system requiring adjudication of interpretations. Outcomes were assessed in the clinical setting.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This is not an MRMC comparative effectiveness study. It's a study evaluating the performance of a medical device (hemofilter).

6. Standalone (Algorithm Only) Performance:

• No. The device is a physical medical device (hemofilter) and does not involve an algorithm with standalone performance.

7. Type of Ground Truth Used:

• Clinical Outcomes/Observations and In-Vitro Measurements:
  • For the clinical study, the ground truth was based on patient outcomes and observations regarding fluid and electrolyte management, and the occurrence of complications.
  • For in-vitro testing, the ground truth was based on laboratory measurements of various performance parameters (ultrafiltration coefficient, water permeability, pressure drop, hemolysis) against established scientific or engineering benchmarks.

8. Sample Size for the Training Set:

• Not Applicable. This is a medical device, not an AI or machine learning algorithm requiring a training set in that context. The device's design and manufacturing process would involve internal testing and development data, but not a "training set" as understood in AI studies.

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

• Not Applicable. As explained above, there is no "training set" in the context of an AI algorithm for this device. The design and validation of the hemofilter would have involved engineering specifications, material science data, and pre-clinical testing, which serve a similar function to inform product development.

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