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510(k) Data Aggregation
(268 days)
The ExCellerator Cervical Collection Device is a cervical spatula intended for collecting ectocervical specimens for the ThinPrep Pap test. The device is also intended to be used to aid in a more complete transfer of the specimen material from the endocervical brush (cytobrush) to the PreservCyt solution for ThinPrep testing. The ExCellerator device must be used with an IVD labeled endocervical brush.
The ExCellerator™ Cervical Collection Device is a non-sterile, single use, disposable cervical sampling device (spatula), comprised of inert food grade polypropylene plastic, intended for sampling the ectocervix during the cervical sample collection procedure. Additionally, it aids in more complete transfer of the cytological sample collected with an IVD labeled endocervical brush (cytobrush) into the PreservCyt vial for the preparation of ThinPrep Pap test slides.
Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:
Device: ExCellerator Cervical Collection Device
Purpose: Cervical spatula for collecting ectocervical specimens for ThinPrep Pap test and aiding transfer of endocervical brush specimens.
1. Table of Acceptance Criteria and Reported Device Performance
The document describes several types of testing with acceptance criteria.
Biocompatibility Assessments:
| Assessment | Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Cytotoxicity | MEM Elution Cytotoxicity Assay (ISO) | Non-Cytotoxic | Passed (Non-Cytotoxic) |
| Irritation | Vaginal Mucosal Irritation Test (ISO) | Non-Irritant | Passed (Non-Irritant) |
| Sensitivity | Guinea Pig Maximization Test (ISO) | Non-sensitizer | Passed (Non-sensitizer) |
Structural Assessments:
| Assessment | Test Performed | Acceptance Criteria | Control Mode | Group | Reported Device Performance |
|---|---|---|---|---|---|
| Static Bend | Static Cantilever Bend | < 2-3mm Displacement (Bend) | Displacement (Bend) | A (2017 Production Lot) | Passed |
| Static Bend | Static Cantilever Bend | < 2-3mm Displacement (Bend) | Displacement (Bend) | B (2009 Production Lot) | Passed |
| Static Tension | Static Tension | < 1mm Deformation | Deformation | A (2017 Production Lot) | Passed |
| Static Tension | Static Tension | < 1mm Deformation | Deformation | B (2009 Production Lot) | Passed |
| Static Torsion | Static Torsion | < 45° Angular Displacement | Angular Displacement | A (2017 Production Lot) | Passed |
| Static Torsion | Static Torsion | < 45° Angular Displacement | Angular Displacement | B (2009 Production Lot) | Passed |
| Shelf Life | Not explicitly stated | > 7 years | Not explicitly stated | Not explicitly stated | Successfully Assessed |
Dimensional Assessments:
| Measurement (inches) | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Length | < .0050 Std Dev | Compliant |
| Width - Rail | < .0050 Std Dev | Compliant |
| Width - Paddle End | < .0050 Std Dev | Compliant |
| Width - Head End | < .0050 Std Dev | Compliant |
| Height - Rail | < .0050 Std Dev | Compliant |
| Height - Paddle End | < .0050 Std Dev | Compliant |
| Height – Head End | < .0050 Std Dev | Compliant |
| Hole Length | < .0050 Std Dev | Compliant |
| Hole Width | < .0050 Std Dev | Compliant |
| Hole to Proximal End | < .0050 Std Dev | Compliant |
| Hole to Distal End | < .0050 Std Dev | Compliant |
Performance Data - Bench:
| Assessment | Test Description | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| RWE Data | Real-World Evidence (RWE) data presented, comparing the ExCellerator spatula (primary & complementary/secondary device) to the standard spatula for collecting and transferring cervical samples into ThinPrep vial. | Comparably equivalent or improved adequacy and diagnostics. | Demonstrated comparably equivalent or improved adequacy and diagnostics when using the ExCellerator spatula as both primary and complementary (secondary) device to collect and transfer cervical samples into the ThinPrep vial when compared with the standard spatula. |
| Validation Data | Validation data presented for safety and effectiveness when used as a collecting device and as an aid in transferring sample from IVD labeled cytobrush into ThinPrep PreservCyt Vial. | Safety and effectiveness demonstrated (implied for substantial equivalence). | Demonstrated safety and effectiveness of the ExCellerator device when used as collecting device and as an aid in transferring sample from the IVD labeled cytobrush into ThinPrep PreservCyt Vial. |
Study Details:
The provided text focuses on demonstrating substantial equivalence to a predicate device (Pap Perfect Plastic Spatula, K861389) through various bench tests and real-world evidence, rather than a clinical study involving human readers or a standalone AI algorithm. Therefore, many of the requested details related to human reader studies are not applicable.
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Sample size used for the test set and the data provenance:
- Biocompatibility Tests: The sample sizes for these tests are not specified but are typically standard for ISO-compliant tests on material samples in a lab setting. The provenance is not explicitly mentioned but implied to be laboratory testing of the device material.
- Structural Assessments: Two production lots were used (Group A - 2017, Group B - 2009). The sample size within these groups (number of devices tested) is not specified. Provenance is from manufacturing lots.
- Dimensional Assessments: The sample size is not specified but measurement data was collected. Provenance is from manufacturing.
- Performance Data - Bench (RWE & Validation Data): The specific sample sizes for "RWE Data" and "Validation Data" are not provided. The document only states that "RWE data was presented" and "Validation data was presented." The provenance for RWE would logically be retrospective real-world clinical use data, but details (country, retrospective/prospective) are not given.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable to the types of tests described (biocompatibility, structural, dimensional, and bench performance for a collection device). No pathology or diagnostic ground truth establishment by experts is mentioned. The RWE data refers to "adequacy and diagnostics" but doesn't detail how this was assessed or by whom to establish a ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no expert adjudication for diagnostic ground truth is described.
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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 MRMC study was conducted or described, as this is a physical cervical collection device, not an AI diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For biocompatibility, structural, and dimensional tests, the ground truth is based on predefined engineering and ISO standards.
- For the "Performance Data - Bench" (RWE and Validation), the "adequacy and diagnostics" results from the RWE data would imply clinical outcomes or pathology reports served as a form of ground truth for sample quality, but the specifics are not detailed.
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The sample size for the training set:
- Not applicable. This device is not an AI algorithm requiring a training set. If "training set" refers to samples used for initial development or optimization, those details are not provided.
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How the ground truth for the training set was established:
- Not applicable.
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