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The PP CARE Nitrile Examination Gloves is a disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

PP CARE Nitrile Examination Gloves are Class I patient examination gloves bearing the product code LZA (21CFR880.6250). The gloves are made from acrylonitrile butadiene rubber. These gloves are blue in color and are powder free.

The document provided focuses on the substantial equivalence determination for PP CARE Nitrile Examination Gloves (K212629) based on non-clinical testing. It does not describe a clinical study or AI/algorithm performance. Therefore, many of the requested points are not applicable.

Here's the information that can be extracted from the provided text regarding the non-clinical testing:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Water Tightness Test: 200 samples were tested.
• Data Provenance: The tests described are non-clinical (laboratory/materials testing) and were performed by EG Group Product and Service Co., Ltd. in Thailand. The data is thus prospective for the purpose of this submission and originates from Thailand.
• For other tests like Dimensions, Physical Properties, Powder Residue, the sample sizes are not explicitly stated but are implied to be sufficient for demonstrating compliance with the respective ASTM standards.
• For biocompatibility tests (Skin Irritation, Sensitization, Cytotoxicity, Systemic Toxicity), specific animal models are mentioned (New Zealand White Rabbits, Guinea Pigs, Swiss Albino Mice), indicating laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This document describes non-clinical performance and biocompatibility testing of medical gloves, not a study requiring expert clinical judgment for ground truth. The "ground truth" here is compliance with established international standards (ASTM, ISO, EN).

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

• Not applicable. This is not a study requiring adjudication of expert interpretations.

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 not a study involving human readers or AI.

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

• Not applicable. This document is about medical gloves, not an algorithm or AI device.

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

• The "ground truth" for the device's performance against its acceptance criteria is defined by compliance with established international standards (ASTM D6319-19, EN 455-1:2000) and ISO 10993 series for biocompatibility. These standards set the benchmarks for physical properties, barrier integrity, and biological safety.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning study.

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

• Not applicable. This is not an AI/machine learning study.

Summary of the Study that Proves Device Meets Acceptance Criteria:

The device's compliance with acceptance criteria is demonstrated through a series of non-clinical tests performed in accordance with recognized international standards. These tests assessed:

• Dimensional properties: Length, width, and thickness as per ASTM D6319-19.
• Physical properties: Tensile strength and ultimate elongation (before and after aging) as per ASTM D6319-19.
• Powder Residue: Measurement of powder content as per ASTM D6319-19.
• Water Tightness: To detect holes, conducted in accordance with EN 455-1:2000.
• Biocompatibility:
  • Skin Irritation (ISO 10993-10:2010(E) using New Zealand White Rabbits)
  • Skin Sensitization (ISO 10993-10:2010(e) using Guinea Pigs)
  • In Vitro Cytotoxicity (ISO 10993-5:2009(E) by elution method)
  • Acute Systemic Toxicity (ISO 10993-11:2017 using Swiss Albino Mice)

The results show that the PP CARE Nitrile Examination Gloves meet or exceed all specified acceptance criteria derived from these standards for physical and barrier properties, and demonstrate acceptable biocompatibility (despite an "100% cytotoxic" in vitro result, which was mitigated by a successful acute systemic toxicity test, deeming the device non-toxic under study conditions). These non-clinical tests collectively provide the evidence that the device meets its performance requirements and is substantially equivalent to the predicate device.

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This kit is intended for the quantitative determination of thyrotropin in blood specimens dried on filter paper as an aid in screening newborns for congenital (neonatal) hypothyroidism, using the 1235 AutoDELFIA™ automatic immunoassay system.

The AutoDELFIA™ Neonatal hTSH L assay is a solid phase, two-site fluoroimmunometric assay based on the direct sandwich technique in which two monoclonal antibodies are directed against separate antigenic determinants on the hTSH molecule. Standards, controls and test specimen containing hTSH are reacted simultaneously with immobilised monoclonal antibodies in assay buffer. The assay buffer elutes hTSH from the dried blood spots on the filter paper discs. The complete assay requires only one incubation step. Enhancement solution dissociates europium ions from the labelled antibody into solution where they form highly fluorescent chelates with components of the enhancement solution. The fluorescence in each well is then measured. The fluorescence of each sample is proportional to the concentration of hTSH in the sample.

The provided text describes the 510(k) summary for the AutoDELFIA™ Neonatal hTSH L Kit, which is intended for screening newborns for congenital hypothyroidism. The study that proves the device meets acceptance criteria is primarily a comparison to a predicate device.

Here's an analysis based on the information provided:

Acceptance Criteria and Device Performance

The document describes a comparison study against a predicate device, the AutoDELFIA™ Neonatal hTSH kit, to demonstrate substantial equivalence. The key performance metrics are the reference ranges and mean values of hTSH concentrations.

The qualitative acceptance criteria is "substantially equivalent" to the predicate device. The performance data presented (reference ranges and mean values) are used to support this claim of substantial equivalence. The frequency distributions are also presented to visually demonstrate the similarity.

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: 860 newborns.
   • Data Provenance: Not explicitly stated, but given the context of U.S. regulatory submission by a U.S.-based company, it's highly likely the data is from the U.S. The study is retrospective, as the hTSH concentrations were "measured in 860 newborns" using both kits.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This study does not involve expert interpretation to establish ground truth in the typical sense of diagnostic imaging or clinical assessment. It's a quantitative assay where the "ground truth" for the comparison is the measurement obtained by the predicate device and the new device. Therefore, no experts were explicitly used to establish a ground truth for the test set as would be the case in subjective diagnostic tasks. The ground truth for hTSH levels is assumed to be the quantitative measurement itself.

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

   • There was no adjudication method described. This is a quantitative assay comparison, not a subjective diagnostic task requiring expert consensus.

4. 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:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This is an in vitro diagnostic device (IVD) for laboratory analysis, not a device that involves human readers interpreting outputs or AI assistance.

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

   • Yes, this study represents a standalone performance evaluation of the AutoDELFIA™ Neonatal hTSH L kit in comparison to a predicate device. Both devices are automated immunoassays, meaning they function independently to produce a quantitative result without direct human interpretation in each measurement step.

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

   • The "ground truth" used for this comparative study is the quantitative hTSH concentration measured by the predicate device (AutoDELFIA™ Neonatal hTSH kit). The new device's performance is gauged against this established method to demonstrate substantial equivalence.

7. The sample size for the training set:

   • The document does not provide information about a "training set." This type of in vitro diagnostic device study typically focuses on validation and comparison to a predicate, rather than an AI/ML development pipeline with distinct training and test sets.

8. How the ground truth for the training set was established:

   • As there's no mention of a training set, the establishment of ground truth for it is not applicable based on the provided text.

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