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510(k) Data Aggregation
(140 days)
The surgical glove is intended to be worn by operating room personnel to protect a surgical wound from contamination.
Tactyl's powder free surgical gloves are manufactured using TACTYLON™ TACTYLON™ gloves are made of a synthetic material that mimics latex but contain no natural rubber latex. It is also powder free for those users who will benefit from such requirements. The glove meets the physical property requirements of ASTM 3577-91 Rubber Surgical Gloves, Type II, compounded from a rubber cement or from synthetic rubber latex.
Here's an analysis of the provided text regarding the acceptance criteria and supporting "study" for the Powder Free Sterile Surgical Glove. It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence rather than a full-scale clinical trial report. Therefore, some of the requested information (especially around "AI" and "MRMC studies") is not applicable to a traditional medical device like a surgical glove. I will interpret the questions in the context of what's provided.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical Properties | |
| Meets ASTM D3577-91 Rubber Surgical Gloves, Type II | "The glove meets the physical property requirements of ASTM 3577-91 Rubber Surgical Gloves, Type II, compounded from a rubber cement or from synthetic rubber latex." |
| "The physical properties of the glove remain well within the requirements established by ASTM 3577 and remain comparable to TACTYLON™ surgical gloves." | |
| Water Tightness (Freedom from Holes) | |
| FDA test for water tightness (21 CFR 800) | "The product is tested to and has passed the FDA test for water tightness using 1000 ml of water as called for in 21 CFR 800." |
| Acceptance Quality Level (AQL) of 2.5% (21 CFR 800) | "Gloves must pass an Acceptable Quality Level (AQL) of 2.5% as defined in 21 CFR 800." (The document states this is required and implies conformance, but doesn't explicitly state the measured AQL value, only that it "passed" the water tightness test which is governed by this AQL). |
| Biocompatibility | |
| No evidence of delayed dermal sensitization (Guinea Pig) | "Delayed Contact Sensitization Study (Repeated Patch Method) was performed in the Guinea Pig and showed no evidence of causing delayed dermal sensitization in the quinea pig." |
| Not a primary skin irritant (New Zealand white albino rabbit) | "Another test conducted was the Primary Skin Irritation Test (FHSA) in the New Zealand white albino rabbit. The test demonstrated the glove not to be a primary skin irritant." |
| Powder Level | |
| Dramatically reduced powder levels (compared to equivalent) | "The powder free glove has dramatically reduced powder levels from its equivalent, TACTYLON™ surgical glove." (This is a comparative statement rather than a specific numerical acceptance criterion). |
2. Sample Size Used for the Test Set and Data Provenance
- Physical Properties (ASTM D3577-91): The document does not specify the sample size used for testing against ASTM D3577-91. This would typically be defined by the standard itself or internal quality procedures.
- Water Tightness (21 CFR 800): The sample size for the water tightness test is not explicitly stated. However, the AQL of 2.5% specified in 21 CFR 800 implies a statistically based sampling plan, where sample size is determined by the lot size in accordance with ANSI/ASQ Z1.4 (or equivalent) tables. The document only mentions "Gloves must pass an Acceptable Quality Level (AQL) of 2.5%."
- Biocompatibility Studies: Specific sample sizes for the Guinea Pig and Rabbit studies are not mentioned. These are standard animal tests, so recognized sample sizes for such studies would have been used.
- Data Provenance: The device is manufactured by Tactyl Technologies, Inc. in Vista, CA, USA. The testing would have been conducted by or for this company. The studies referenced are non-clinical (laboratory/animal) and therefore, do not have "country of origin of the data" in the human sense. All data is retrospective to the submission date.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This question is not applicable in the context of this device and report. Surgical glove testing (physical properties, biocompatibility, water tightness) does not typically involve human "experts" establishing a "ground truth" in the way clinical studies for AI algorithms do. The "ground truth" here is objective measurement against established standards (ASTM, FDA regulations) and results from animal models.
4. Adjudication Method for the Test Set
- This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials, especially with human readers or subjective assessments, to resolve discrepancies. The tests described for the surgical glove are objective and measured against predefined criteria.
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 for this device. This document describes a traditional medical device (surgical glove), not an AI diagnostic or assistance tool for human readers. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable for this device. This is a physical product, not an algorithm.
7. The Type of Ground Truth Used
- Physical Properties: The ground truth is established by objective measurements against the specifications outlined in ASTM D3577-91, which defines material properties like tensile strength, elongation, and dimensions.
- Water Tightness: The ground truth is objective, based on the absence of water leakage after a specific time, according to the methodology defined in 21 CFR 800 and an accompanying AQL sampling plan.
- Biocompatibility: The ground truth is established by the observed biological response (or lack thereof) in specific animal models (guinea pig for sensitization, rabbit for irritation) as per established toxicology testing protocols (e.g., FHSA methods).
8. The Sample Size for the Training Set
- This question is not applicable in the context of this document. "Training set" refers to data used to train machine learning models. This document describes the testing and properties of a physical manufactured product, not an AI system.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable. As explained above, there is no "training set" or AI model involved in the evaluation of this surgical glove.
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