(322 days)
The 3M™ Basic Disposable Surgical Gowns, 3M™ Disposable Surgical Gowns and 3M™ HP Disposable Surgical Gowns are items of surgical apparel intended to be worn by health care professionals to help protect both the patient and health care worker from transfer of microorganisms, body fluids and particulate matter. These gowns meet level 2 of the AAMI Liquid Barrier Classification.
The 3M™ Reinforced Disposable Surgical Gowns and 3M™ HP Reinforced Disposable Surgical Gowns are items of surgical apparel intended to be worn by health care professionals to help protect both the patient and health care worker from transfer of microorganisms, body fluids and particulate matter. The extra reinforced material is non-permeable and therefore provides a 100% barrier to liquids and blood. These gowns meet level 4 of the AAMI Liquid Barrier Classification within the critical areas of the gowns. *
*To fulfill these requirements, extra reinforced material sheets are integrated into parts of the gown on the front panel and in both sleeves from the cuff to the elbow.
These gowns are for single use.
The 3M surgical gowns are sterile, disposable and intended for single use. They come in a variety of sizes (M, L, XL and XXL). Their construction includes a blue nonwoven fabric consisting of either a SMMS or Spunlace. Those gowns that are labeled reinforce include extra reinforced material sheets integrated into parts of the gown within the front panel and on both sleeves from the cuff to the elbow. The gowns include a specific AAMI Liquid Barrier Performance and Classification (i.e. 2 or 4) Level. All gowns are easy to don and include a hook and loop to close the neck and ties for closing the back of the gown. They include functional cuffs constructed of a white knitted material.
This appears to be a 510(k) premarket notification for surgical gowns, which are medical devices, but not an AI or algorithm-driven device. Therefore, many of the requested fields are not applicable.
Here's the information based on the provided text, with explanations for the non-applicable fields:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (Target) | Reported Device Performance |
|---|---|---|
| Intended Use | Same as predicate device (Kimberly Clark, Ultra Film-Reinforced Surgical Gown K080795) | 3M™ Basic Disposable, 3M™ Disposable, 3M™ HP Disposable: Intended to protect patient and healthcare worker from transfer of microorganisms, body fluids and particulate matter. |
| 3M™ Reinforced Disposable, 3M™ HP Reinforced Disposable: Intended to protect patient and healthcare worker from transfer of microorganisms, body fluids and particulate matter; extra reinforced material provides 100% barrier to liquids and blood. | ||
| Sterile | Yes | Yes |
| Single Use | Yes | Yes |
| Disposable | Yes | Yes |
| AAMI Fluid Barrier Protection Level | Predicate: Level 4 (for reinforced areas) | 3M™ Basic Disposable, 3M™ Disposable, 3M™ HP Disposable: Level 2 |
| 3M™ Reinforced Disposable, 3M™ HP Reinforced Disposable: Level 4 (within critical areas of the gowns) | ||
| Flammability Level | Class 1 (Same as predicate) | Class 1 |
| Materials | Comparable to predicate (Nonwoven SMS) | Nonwoven (SMMS or Spunlace) |
| Optional Sizes | Yes (e.g., L) | Yes |
| Hook-and-loop neck closure | Yes | Yes |
| Tie waist closure | Yes | Yes |
| Reinforcement | Yes (for reinforced models) | Yes* (Note: Includes a reinforced panel on the inside of the gown within the front panel and sleeves from the cuff to the elbow for reinforced models) |
| Cuffs | Yes | Yes |
| Gown Color | Blue | Blue |
| Biocompatibility | Met acceptable and/or required criteria | All results met acceptable and/or required criteria. |
| Linting and Cleanliness - Particulate Matter | Met acceptable and/or required criteria | All results met acceptable and/or required criteria. |
| Tensile Strength | Met acceptable and/or required criteria | All results met acceptable and/or required criteria. |
| ANSI/AAMI PB70:2003 Liquid Barrier Performance | Met acceptable and/or required criteria | All results met acceptable and/or required criteria. |
Explanation of Findings: The study demonstrates substantial equivalence to the predicate device by comparing various physical characteristics and performance standards (like AAMI fluid barrier levels, flammability, and materials) as well as specific biocompatibility and material integrity tests. All tested parameters met the "acceptable and/or required criteria."
2. Sample size 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: The document states that "all results of the testing met acceptable and/or required criteria." However, it does not specify the sample sizes for the biocompatibility, linting, tensile strength, flammability, or ANSI/AAMI PB70:2003 liquid barrier performance tests.
- Data Provenance: Not specified in the provided text. It's likely that such testing would be conducted in a laboratory setting by the manufacturer (3M Health Care, St. Paul, MN, USA) or a contract lab. The document does not indicate if the data is retrospective or prospective.
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)
This is not applicable to this type of device. The ground truth for surgical gowns is established through objective, standardized physical and chemical tests (e.g., AAMI standards for fluid barrier, flammability tests), not through expert consensus on qualitative assessments like image interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable to this type of device, as it refers to methods for reconciling differences in qualitative assessments, typically by human readers in areas like medical imaging. The tests performed are objective and yield quantitative results.
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 is not applicable. An MRMC study is relevant for evaluating the performance of AI-assisted diagnostic tools where human readers are interpreting cases. Surgical gowns are not AI-driven devices.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. This question refers to the performance of an AI algorithm operating independently, which is not relevant for a physical medical device like a surgical gown.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is based on established industry standards and objective physical/chemical test methods. Examples include:
- ANSI/AAMI PB70:2003 Liquid Barrier Performance: This is a defined standard for liquid barrier protection levels.
- Flammability Level (Class 1): A standard classification for material flammability.
- Biocompatibility: Likely assessed against ISO standards (e.g., ISO 10993 series) which involve standardized tests for cytotoxicity, sensitization, irritation, etc.
- Tensile Strength, Linting, Cleanliness: Assessed using established material science testing methodologies.
These are not based on expert consensus for diagnosis, pathology, or clinical outcomes data, but rather on meeting predefined physical and performance specifications.
8. The sample size for the training set
This is not applicable. Surgical gowns are physical products, not AI models that require a training set.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for a physical surgical gown.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.