(29 days)
The TotalShieldTM Zippered Surgical Toga and/or TotalShieldTM Surgical Hood is for use with the TotalShieldTM Surgical Helmet and/or TotalShieldTM Advanced Surgical Helmet with LED lighting as the TotalShieldTM Surgical Helmet System that is intended to be worn by surgical personnel to provide a barrier between the operating environment and the surgical personnel in order to protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.
The TotalShield™ Surgical Helmet System is comprised of the TotalShield™ Zippered Surgical Toga, TotalShield™ Surgical Hood, TotalShield™ Surgical Helmet and Advanced Surgical Helmet with LED lighting and various accessories. The TotalShield™ Zippered Surgical Toga and/or TotalShield™ Surgical Hood are used with the TotalShield™ Helmet and/or TotalShield™ Advanced Surgical Helmet with LED lighting as the TotalShield™ Surgical Helmet System to provide a barrier between the operating environment and the surgical personnel in order to protect against contamination and/or exposure of infectious body fluids and harmful microorganisms. The TotalShield™ Surgical Helmet and Advanced Surgical Helmet with LED lighting have a battery powered fan, which provides a continuous flow of air in the TotalShield™ Surgical Hood or Zippered Surgical Toga. The TotalShield™ Surgical Hood is a stand-alone head cover that may be worn with a separate surgical gown, while the TotalShield™ Zippered Surgical Toga is a one-piece head and body cover. The stand-alone TotalShield™ Surgical Hood is identical to the hood that is incorporated into the TotalShield™ Zippered Surgical Toga. The TotalShield™ Surgical Hood or Zippered Surgical Toga must be worn over a TotalShield™ Surgical Helmet or Advanced Surgical Helmet with LED lighting. The TotalShield™ Zippered Surgical Toga has been tested to meet the applicable AAMI PB70 standards for level 4 compliance. The AAMI standard does not cover apparel for the head, face, and eyes. Therefore, the hoods and lens are exempt from classification under the AAMI PB70:2003 standard.
Here's a breakdown of the acceptance criteria and the study information for the TotalShield Surgical Helmet System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes performance criteria primarily through compliance with various industry standards and internal testing metrics. The key change highlighted is the barrier performance level of the Toga.
| Property | Acceptance Criteria (Predicate) | Reported Device Performance (Modified Device) |
|---|---|---|
| TotalShield™ Zippered Surgical Toga and Surgical Hood | ||
| Flammability of Clothing Textiles | Class 1 Compliant (ASTM F2100-07 reference 16 CFR-1610.4) | Class 1 Compliant - pass |
| Biological Evaluation on Skin Contact | Compliant (ISO-10993-10, ISO-10993-5, ISO-10993-10) | Compliant - pass |
| Sterility Method | Compliant (ISO 11607-2, ISO 11135-1, ISO 10993-7) | Compliant - pass |
| Tear Resistance | Compliant (ASTM D5733 MD Trap Tear), AAMI Level 3 | Compliant - pass |
| Tensile Strength | Compliant (ASTM D5034 Grab Tensile Strength) | Compliant - pass |
| Seam Strength | Compliant (ASTM D1683) | Compliant - passed seam test |
| Lint | Compliant (ISO 9073; EN 13795-2) | Compliant - pass |
| Water Vapor Transmission Rate | Compliant (ASTM E96 with Water) | Compliant - pass |
| Water resistance: Impact penetration | Compliant Level 3 (AAMI/ANSI PB70) | Compliant Level 4 (AAMI/ANSI PB70) |
| Hydrostatic pressure | Compliant Level 3 (AAMI/ANSI PB70) | Compliant Level 4 (AAMI/ANSI PB70) |
| Consensus Standards for barrier performance | Level 3 Barrier Performance AAMI/ANSI PB70:2003/(R)2009 | Level 4 Barrier Performance AAMI/ANSI PB70:2003/(R)2009 |
| Sterility Assurance Level | 10^-6 | Same (10^-6) |
| TotalShield Surgical Helmet and Advanced Surgical Helmet with LED Lighting | ||
| Airflow Testing | Pass Acceptance Criteria (Internal Fan Performance Test Method) | Pass Acceptance Criteria |
| Helmet Noise Testing | Pass Acceptance Criteria (Internal Noise Measurement Test Method) | Pass Acceptance Criteria |
| Battery Life Testing | Pass Acceptance Criteria (Internal Battery Performance Test Method) | Pass Acceptance Criteria |
| Electrical safety and Environmental testing | Not explicitly stated as "acceptance criteria", but tests performed to IEC 60601-1 and IEC 60601-1-2 | Completed and passed |
| Device Usability testing | Not explicitly stated as "acceptance criteria", but tests conducted per IEC 60601-1-6 and IEC 62366:2007 | Conducted and passed |
| Sterilization Validation testing | Not explicitly stated as "acceptance criteria", but tests conducted per AAMI/ANSI/ISO 11607-1, 11607-2 and AAMI/ANSI/ISO 11135-1 | Conducted and passed |
| Shipping Validation | Not explicitly stated as "acceptance criteria", but tests conducted per ASTM D4169-09 | Conducted and passed |
| Biocompatibility Testing | Not explicitly stated as "acceptance criteria", but conducted per ISO 10993-1, ISO 10993-10, ISO 10993-5 and ISO 10993-7 | Conducted and passed |
| ASTM F2407-06 specifications | Adherence to specifications for requirements for performance, documentation, and labeling | Adheres to specifications |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes for each test. It refers to various ASTM, ISO, and AAMI standards, implying that the sample sizes were consistent with those standards.
- Sample Size: Not explicitly stated for individual tests. The tests were performed on the device components (Toga, Hood, Helmet).
- Data Provenance: Not specified, but generally, regulatory submissions like this involve data generated by the manufacturer or their contracted testing labs, typically within the country of manufacture or where the company operates (in this case, Zimmer Surgical, Inc. is based in Dover, OH, USA). The study is prospective in the sense that the testing was performed on the new device (modified device) to demonstrate its performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This device is a surgical helmet system, which is a physical barrier device, not an AI/software device that requires human expert review for "ground truth" establishment in the typical sense of medical image analysis or diagnostic AI. The "ground truth" for this device's performance is established by objective engineering and material science testing standards.
- Number of Experts: Not applicable in the context of establishing "ground truth" for a performance study of this type (physical device testing).
- Qualifications of Experts: The "experts" would be the certified testing laboratories and their personnel who conducted the tests according to the specified international standards (e.g., AAMI, ASTM, ISO). Their qualifications are inherent in their accreditation to perform such tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The performance is determined by objective measurements against established standard criteria, not by subjective human interpretation or consensus that would require adjudication.
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 an AI/software device, so MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or AI device. The "standalone" performance refers to the physical device's adherence to performance standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on objective measurements against established performance standards (e.g., AAMI/ANSI PB70 for barrier performance, ISO standards for biocompatibility and sterility, ASTM standards for material strength and flammability). The device either passes or fails these pre-defined criteria.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" as this is not an AI/machine learning device.
§ 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.