(269 days)
Foothills Surgical Drapes are devices made from natural and synthetic materials intended to be used by medical professionals as protective coverings, such as a patient covering to isolate a site for surgical incision from contamination and to cover accessories in the operating room.
These disposable single-use drapes are designed to be repackaged and sterilized before use by the user using a 100% EtO cycle that has been validated to achieve a SAL of 10-6 in accordance with ANSI/AAMI/ISO 11135:1994. Sterilization residual limits should meet the requirements of the ANSI/AAMI/ISO 10993-9:1995.
Foothills Industries disposable surgical drapes and utility covers are devices made from natural and synthetic materials intended to be used by medical professionals as protective coverings.
The provided text describes the submission for a 510(k) premarket notification for "Foothills Surgical Drapes" and confirms their substantial equivalence to existing predicate devices. However, it does not include information about specific acceptance criteria or a study designed to prove the device meets such criteria as would typically be found for AI/ML-driven devices with performance metrics like accuracy, sensitivity, or specificity.
The document focuses on the technological characteristics and intended use of the surgical drapes being substantially equivalent to legally marketed predicate devices. The "study" mentioned relates to the sterilization validation, which is a process validation, not a performance study in the context of an AI/ML device.
Therefore, many of the requested sections (Table of acceptance criteria, sample sizes, expert involvement, MRMC study, standalone performance, ground truth types and establishment, and training set details) are not applicable to this particular document, as it concerns a traditional medical device (surgical drapes) and not an AI/ML-driven device.
Here's the information that can be extracted or inferred from the provided text, acknowledging the limitations for an AI/ML context:
1. Table of Acceptance Criteria and the Reported Device Performance
As this device is a traditional surgical drape, the "acceptance criteria" revolve around its material properties, intended use, and ability to be sterilized, rather than performance metrics common for AI/ML devices (e.g., sensitivity, specificity). The document indicates substantial equivalence based on these characteristics.
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance (Foothills Surgical Drapes) |
|---|---|---|
| Material & Design | Same as currently marketed surgical drapes. | Made from the same materials and designs as other currently marketed surgical drapes. |
| Absorbency | Same as currently marketed surgical drapes. | Provides the same absorbency as other currently marketed surgical drapes. |
| Packaging | Same as currently marketed surgical drapes. | Has the same packaging as other currently marketed surgical drapes. |
| Other Performance Characteristics | Same as currently marketed surgical drapes. | Possesses the same "other performance characteristics" as other currently marketed surgical drapes. |
| Sterilization Process | Designed to be sterilized by the user using a 100% EtO cycle achieving a SAL of 10-6. | Designed for user sterilization via a 100% EtO cycle validated to achieve a SAL of 10-6 in accordance with ANSI/AAMI/ISO 11135:1994. |
| Sterilization Residuals | Residual limits should meet requirements of ANSI/AAMI/ISO 10993-9:1995. | Sterilization residual limits should meet the requirements of ANSI/AAMI/ISO 10993-9:1995. |
| Labeling | Similarly labeled as disposable and non-sterile. | Similarly labeled as disposable and non-sterile. |
| Intended Use | Protective coverings, patient covering, covering accessories in OR. | Intended for the same uses as predicate devices (protective coverings, isolating surgical site, covering accessories). |
The "study" that proves the device meets (or is equivalent to devices meeting) these criteria is the 510(k) premarket notification review process, which determined substantial equivalence to predicate devices (3M Steri Drape (K031287) and Alcon (K830822)). The sterilization aspect relies on the validation of a 100% EtO cycle designed to achieve a specified Sterility Assurance Level (SAL) and meet residual limits.
The following information is not present in the provided text, as it pertains to AI/ML device performance studies, which are not relevant for a traditional surgical drape 510(k) submission:
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Sample size used for the test set and the data provenance: Not applicable. No test set in the context of an AI/ML performance study is described. The "test" here refers to demonstrating manufacturing and material equivalence, and sterilization validation.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No expert ground truth establishment for a diagnostic/interpretive task.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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: Not applicable. This is not an AI-assisted device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Ground truth" in this context would relate to the material specifications, absorbency values, and successful sterilization, not diagnostic outcomes.
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The sample size for the training set: Not applicable. No training set for an AI/ML model.
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How the ground truth for the training set was established: Not applicable.
§ 878.4370 Surgical drape and drape accessories.
(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.