(73 days)
The Surgical Concept Designs Surgical Drape, Model #01001 is used to cover medical equipment in a surgical setting. It is to be used in general surgery.
The Surgical Concept Designs Surgical Drape is a generally tubular sleeve of polyethylene film with an integrated equipment attachment feature at one end made from polycarbonate, with stainless steel pegs and a butyl rubber gasket.
The provided text does not contain detailed information about specific acceptance criteria or an in-depth study that proves the device meets those criteria in a quantitative sense as might be typical for AI/ML-based devices. Instead, it describes a traditional medical device (a surgical drape) and its 510(k) clearance process, which focuses on substantial equivalence to predicate devices.
However, I can extract the information provided and present it in the requested format, acknowledging where specific details (like numerical acceptance criteria, sample sizes for AI models, expert qualifications for ground truth in an AI context, etc.) are not present in the document.
Acceptance Criteria and Device Performance for Surgical Concept Designs Surgical Drape
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly from 510(k) and Predicate Comparison) | Reported Device Performance (from summary) |
|---|---|---|
| Safety | Device does not impact patient safety (e.g., non-toxic materials, no sharp edges, secure attachment) | "Surgical Concept Designs has determined that any differences in the proposed device will not impact the safety... of the surgical drape for its intended use." |
| Effectiveness | Maintains sterile field, covers equipment adequately, durable during use, prevents contamination | "Surgical Concept Designs has determined that any differences in the proposed device will not impact the ...effectiveness of the surgical drape for its intended use." |
| Material Compatibility | Material (polyethylene film) is suitable for surgical environment | Device is "generally tubular sleeve of polyethylene film" which is consistent with predicate devices also using "polymer film." |
| Functional Design | Integrated equipment attachment feature (polycarbonate, stainless steel pegs, butyl rubber gasket) allows proper function | Device has "an integrated equipment attachment feature at one end made from polycarbonate, with stainless steel pegs and a butyl rubber gasket." |
| Equivalence to Predicates | Device design and materials are substantially equivalent to legally marketed predicate devices | "The device is equivalent to the Microtek Medical Equipment Drape and Advance Medical Designs Slush Drapes which are also surgical drapes manufactured from polymer film cut and configured to a specification." |
| Meeting Applicable Standards | Device meets relevant standards for surgical drapes | "Testing has shown that the proposed device meets the applicable requirements of the standards for surgical drapes." (Specific standards not enumerated in the provided text). |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a "test set" in the context of an AI/ML model. For this physical medical device, evaluation typically involves bench testing, material testing, and potentially simulated use, rather than a data-driven test set.
- Sample Size: Not specified. Testing likely involved a representative number of manufactured drapes to ensure consistency and adherence to standards.
- Data Provenance: Not applicable in the context of data for an AI model. For a physical device, testing is typically performed in a laboratory setting by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. The concept of "ground truth" established by experts for a test set is relevant to AI/ML models, not directly to the 510(k) clearance of a physical surgical drape. The acceptance is based on compliance with existing standards and substantial equivalence to predicate devices, which is evaluated by the FDA.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used in studies involving expert review of cases to establish ground truth for AI models. This is not mentioned or relevant to the 510(k) clearance process for this physical device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study is used to evaluate the diagnostic performance of AI-assisted systems versus human readers alone. This type of study is not relevant to the 510(k) clearance of a physical surgical drape.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This refers to the performance of an AI algorithm in isolation. This is not relevant to the 510(k) clearance of a physical surgical drape.
7. The Type of Ground Truth Used
The "ground truth" for this device's substantial equivalence and safety/effectiveness claims is based on:
- Compliance with recognized standards: The device is stated to meet "applicable requirements of the standards for surgical drapes."
- Performance of predicate devices: The predicate devices (Advance Medical Designs Slush Drapes - K053594, Microtek Medical, Inc. Equipment Drapes - K050322) are established as safe and effective, and the new device is shown to be substantially equivalent.
- Bench testing: Though not detailed, "Testing has shown..." implies bench testing to verify material properties, strength, secure attachment, and other functional aspects.
8. The Sample Size for the Training Set
Not applicable. There is no training set mentioned, as this device is not an AI/ML model.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set mentioned, as this device is not an AI/ML model.
§ 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.