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The specific intended use of the St. Leger total knee implant is for patients suffering from pain and/or deformity of the knee joint. The pathological conditions include, but are not parted to severe degenerative arthritis, traumatic arthritis, inflammatory arthritis, and rheumatoid arthritis. The symptomatic problems include pain, decreased ambulation, inability to work, perform activities of daily living. The resulting physical deformities include loss of knee extension, knee flexion, genu valgum and genu varus. The implant may be used in revision knee surgery due to loosening, infection, or prior implant failure if the proper accompanying conditions are present and the surgeon is able to make the necessary anatomical conditions for acceptable alignment and fixation.

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I apologize, but the provided text is a 510(k) premarket notification letter from the FDA regarding a St. Leger Total Knee Implant. This document does not describe a study that uses acceptance criteria to prove the performance of a device in the context of AI/ML or diagnostic accuracy.

The letter pertains to the substantial equivalence determination for a medical device (a knee implant), focusing on its classification, intended use, and limitations (e.g., cemented use only, minimum polyethylene thickness). It does not contain information about:

• Acceptance criteria for performance metrics (like sensitivity, specificity, accuracy)
• Results of a performance study
• Sample sizes for test sets or training sets
• Data provenance
• Expert qualifications or ground truth establishment
• Multi-reader multi-case studies or standalone algorithm performance

Therefore, I cannot fulfill your request for information about acceptance criteria and a study proving device performance based on the provided text.

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Ask a specific question about this device

The Disposable Apron will be used in indications which are the same for that of other aprons. Specifically, the Disposable Apron is intended to be used the hospital environment to protect the healtheare worker from the transfer of micro-organisms. blood, body fluids and particulate material between the worker and the patient. The Disposable Apron is a disposable product intended for single use only.

The Disposable Apron is manufactured from 6 gauge Poly Vinyl and is available in a "onc size fits most" size The apron is secured by heing slipped over the head and tied in back

The provided text describes the acceptance criteria and the study for a Disposable Apron manufactured by Instrument Makar, Inc. The study focuses on viral penetration testing.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for Viral Penetration (ASTM Method F1671-95) based on the K955835 Fluid Barrier Boot study:

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

• Sample Size for the Test Set: 32 samples (referred to as "Fluid Barrier Boot" samples, which are made from the same material as the apron).
• Data Provenance: The document does not specify the country of origin of the data. It appears to be an internal study conducted to support a 510(k) submission, suggesting it's retrospective as per common regulatory processes where testing precedes submission.

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

N/A. This study involves non-clinical testing (viral penetration testing) of a material, not human interpretation or diagnosis. Therefore, there are no "experts" establishing a ground truth in the traditional sense of clinical studies. The "ground truth" is determined by laboratory assay results (presence/absence of bacteriophage).

4. Adjudication Method for the Test Set

N/A. As stated above, this is laboratory testing, not a clinical study involving human interpretation. The outcome (presence/absence of bacteriophage) is determined by objective laboratory assays.

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

No. This is a non-clinical, material-level performance study, not a clinical MRMC study involving human readers or comparative effectiveness with or without AI.

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

N/A. This is a non-clinical material test, not an algorithm performance study.

7. The Type of Ground Truth Used

The ground truth used is objective laboratory assay results for the presence or absence of the oX174 bacteriophage following a controlled challenge. This is a direct measurement of viral penetration through the material.

8. The Sample Size for the Training Set

N/A. This is a non-clinical performance test for a physical product (apron material), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

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

N/A. As there is no training set for an AI algorithm, this question is not applicable.

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The Fluid Barrier Boot is intended to be used in the hospital environment to provide protection from all types of fluids in the Operating Room, Central Sterile and in the Emergency Room.

The Fluid Barrier Boot is manufactured from 6 gauge Poly Vinyl and is available in both knee-high or ankle high boots is small, medium or large sizes. The boots are secured with straps both at the ankle and over the call on the knee-high boot. The ankle-high boot secures only at the ankle.

Here's a breakdown of the acceptance criteria and the study details for the Fluid Barrier Knee-High Boots:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 35 samples were initially prepared, with 32 samples used for the passing/failing assessment.
• Data Provenance: Not explicitly stated, but the test (ASTM Method F1671-95) is a standardized laboratory test; it's retrospective in the sense that the test was conducted on manufactured samples.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• This device is a physical barrier product, and its performance is assessed through a standardized laboratory test (ASTM Method F1671-95). Therefore, there is no "expert" involvement in establishing ground truth in the traditional sense of clinical interpretation. The ground truth is determined by the objective results of the viral penetration assay.

4. Adjudication Method for the Test Set

• No adjudication method (e.g., 2+1, 3+1) was used. The test results are objective and based on the presence or absence of ΦX174 on assay plates following the ASTM F1671-95 methodology.

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

• No MRMC comparative effectiveness study was done. This is not applicable for a physical barrier product being tested for viral penetration.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

• This is not applicable as the device is a physical product, not an algorithm. The performance described is inherently "standalone" in the sense that it's the product's performance under specific test conditions, without human interpretation influencing the result.

7. Type of Ground Truth Used

• The ground truth used is based on objective laboratory test results from the "Viral Penetration Test" ASTM Method F1671-95, which measures the passage of a surrogate virus (ΦX174) through the material.

8. Sample Size for the Training Set

• This information is not applicable. The device is a manufactured physical product, not a machine learning model, so there is no "training set."

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

• This information is not applicable, as there is no training set for this type of device.

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Ask a specific question about this device