(51 days)
The HAL Scope Holder System is intended for use during medical procedure where sterile barrier is required on manipulating/ movable arms. It is for single use only.
The HAL Scope Holder System is used to provide a sterile barrier for re-usable manipulating arm. The disposable cover includes a sterile quick release scope adapter and sterile drape assembly. The device will be installed to an existing re-usable manipulating arm before a medical procedure to act as a barrier between the sterile field and the non-sterile re-usable manipulating arm. The device is single use only and can be used with Noved Medical Universal Arm.
The provided document describes the HAL Scope Holder System, a surgical drape, and its 510(k) submission for substantial equivalence to a predicate device. The information focuses on the physical and technical comparison of the device and does not involve AI or machine learning. Therefore, many of the requested fields related to AI model evaluation, ground truth, and expert studies are not applicable.
Here's an analysis of the available information:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Technological Equivalence to Predicate Device: | Met: |
| Similarity of Materials (polyethylene film) | Noved Medical drapes are constructed primarily of polyethylene film heat-sealed to a tip attachment. |
| Construction (heat-sealed polyethylene film) | The predicate device and the HAL Scope Holder System are constructed using heat-sealed polyethylene film. |
| Packaging (form, peel and seal pouches, Gamma sterilization, 10^-6 SAL) | The HAL Scope Holder System is packaged in form, peel and seal pouches and is sterilized through Gamma sterilization. Both the new device and the predicate device maintain a sterilization assurance level of 10^-6 SAL. |
| Material Properties: | Met: |
| Strength of polyethylene film | Determined to be acceptable. (Specific quantitative data not provided, but deemed acceptable for the application). |
| Elongation of polyethylene film | Determined to be acceptable. (Specific quantitative data not provided, but deemed acceptable for the application). |
| Appearance and Handling: | Met: |
| Similar to predicate device | Based on appearance and handling evaluations, the HAL Scope Holder System is similar to the predicate device. |
| Barrier Testing: | Not Applicable: |
| Determined not applicable based on Biocompatibility Flow Chart (ISO-10993 guidelines memo dated May 1, 1995). |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The evaluations are described qualitatively (e.g., "based on strength and elongation," "based on appearance and handling evaluations"). These likely refer to mechanical and material tests rather than a "test set" in the context of an AI model.
- Data Provenance: Not explicitly stated, however, the assessments are internal evaluations conducted by Noved Medical, Inc. (the manufacturer).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a surgical drape, and its evaluation does not involve ground truth established by medical experts in the way an AI diagnostic tool would. The "truth" is based on material properties and functional equivalence.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No adjudication method described for this type of device evaluation.
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 device is a physical surgical drape, not an AI-powered tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical surgical drape, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the context of typical AI model evaluation. For this device, the "ground truth" or basis for acceptance is derived from:
- Material specifications and established standards: Polyethylene film properties, sterilization assurance levels (SAL).
- Functional equivalence: Comparison of physical attributes and handling characteristics to a legally marketed predicate device.
- Regulatory guidelines: Adherence to ISO-10993 for biocompatibility assessment.
8. The sample size for the training set:
- Not applicable. There is no AI model involved, thus no training set.
9. How the ground truth for the training set was established:
- Not applicable. There is no AI model involved, thus no training set or ground truth for it.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study proving the HAL Scope Holder System meets its acceptance criteria is a non-clinical evaluation focused on demonstrating substantial equivalence to an existing predicate device (Hydromed Product's Universal Drape) and confirming acceptable material properties.
The key aspects of this study include:
- Technological Comparison: The device was compared to the predicate based on:
- Similarity of Materials: Both use polyethylene film.
- Construction: Both use heat-sealed polyethylene film.
- Packaging and Sterilization: Both use form, peel and seal pouches and Gamma sterilization, maintaining a Sterilization Assurance Level (SAL) of 10^-6.
- Performance Data (Non-Clinical Evaluations):
- Appearance and Handling: The HAL Scope Holder System was evaluated to be "similar to the predicate device" based on these subjective assessments.
- Material Strength and Elongation: The polyethylene film's strength and elongation were "determined to be acceptable." While specific quantitative data for the HAL system is mentioned, it is noted that predicate data was not available, implying this was an internal standard assessment.
- Barrier Testing: This was deemed "not applicable" after reviewing the Biocompatibility Flow Chart (matrix) included in ISO-10993 guidelines memo dated May 1, 1995. This indicates a regulatory-driven decision based on established international standards, not a lack of performance.
Conclusion of the Study:
The study concluded that, "Based on all physical performance comparisons, the HAL Scope Holder System will function effectively and comparable to the Universal Camera Drape marketed by Hydromed Products." This conclusion was sufficient for the FDA to determine substantial equivalence and allow the device to be marketed.
§ 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.