FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Topical Oxygen Oxygen chambers / Topical Oxygen Chambers for Extremities. The chamber provides intermittent pressure up to 50 mmHg, cycling / ramping from 0 mmHg to 50 mmHg of pressure over a 15 to 20 second cycle, then venting back to 0mmHg of pressure within 5 seconds.

AI/ML Overview

The provided text does not describe a study involving detailed acceptance criteria and performance data for a device in the manner typical for AI/ML medical devices. Instead, it is a 510(k) premarket notification summary for a "Topical Oxygen Chamber for Extremities" (HEC 1000). The document discusses safety concerns related to pressure levels and how the device's intermittent pressure design (cycling from 0 mmHg to 50 mmHg) addresses these concerns, differentiating it from devices with continuous pressure exceeding 22 mmHg.

Therefore, many of the requested points from the prompt (e.g., sample size for test set, number of experts for ground truth, MRMC study, sample size for training set) are not applicable as this isn't an AI/ML device where such studies are typically performed.

However, I can extract information related to the device's operational characteristics and the rationale for its safety, which serves as a form of "acceptance criteria" for its safe operation in the context of the 510(k) submission.

Here's the information derived from the provided text, adapted to the prompt's structure where possible:

Acceptance Criteria and Device Performance for Topical Oxygen Chamber (HEC 1000)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance (from document)
Safety - Pressure	Address concern of occluding arterial circulation due to continuous pressure > 22 mmHg:

Avoid prolonged, continuous pressure above 22 mmHg.
Allow for capillary refill time. | The HEC 1000 provides intermittent pressure up to 50 mmHg.
Cycles from 0 mmHg to 50 mmHg with an average fill time of less than 25 seconds.
Applies pressures above 22 mmHg for no longer than 15 seconds before venting to nearly 0 mmHg for 3-4 seconds.
Pressures less than 22 mmHg are applied for approximately 15 seconds.
Safety risk of capillary occlusion is minimized by limiting time above 22 mmHg to ~15 seconds and allowing ~15 seconds for capillary refill.
Worst-case scenario (if failing to reach 50mmHg within 60s): Pressures > 22 mmHg for no greater than 45 seconds, then vents and holds at nearly 0 mmHg. |
| Safety - Pressure Relief | Prevent prolonged constant pressures above 22 mmHg even in case of malfunction. | - Software design: If the set pressure (50 mmHg) is not achieved within 60 seconds (implying the unit would reach 22 mmHg in ~15s, thus being above for ~45s), the software automatically vents the chamber and remains on hold.
Hardware design: Unit is designed with a pressure relief valve to vent automatically upon reaching 50 mmHg of pressure.
These built-in redundancies address safety concerns of exceeding prolonged constant pressures above 22 mmHg. |
| Safety - Infection | Device material/construction should not prevent proper disinfection. | (Not explicitly detailed in the provided text beyond stating the concern) |
| Safety - Fire | Mitigate hazards of pure oxygen when an open flame is present. | (Not explicitly detailed in the provided text beyond stating the concern) |
| Effectiveness (Limitations) | Device has diminished/no effectiveness for ulcers/wounds associated with:
Severe ischemic disease.
Raynaud's Disease.
Acute/chronic ischemic disease secondary to thrombosis, embolism.
Avascularity (absent blood supply).
Osteomyelitis.
Wounds not adequately debrided of necrotic tissue.
Wounds not irrigated clean of topical ointments (required removal of dressings). | Implicitly, the device is effective for conditions outside of these stated limitations when used with proper wound preparation (debridement, irrigation, dressing removal). The submission cites various studies (see point 3) supporting the effectiveness of topical oxygen therapy generally, rather than providing specific performance data for the HEC 1000 against a defined effectiveness metric. |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable (N/A). This is a 510(k) submission for a physical medical device (Topical Oxygen Chamber), not an AI/ML device that typically involves a "test set" in this context. The safety assessment relies on device design considerations ("chamber performance qualification testing" with "actual data in section G" which is not provided in the extract) and a review of existing medical literature and adverse event databases, not a specific clinical "test set" for performance evaluation in the AI/ML sense.

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)

Not applicable (N/A). "Ground truth" in the AI/ML sense, requiring expert consensus on a test set, is not relevant here. The "ground truth" for the device's safety and effectiveness relies on established medical understanding of oxygen therapy, circulatory physiology, and clinical experience, as evidenced by citations and letters from medical professionals like "Dr. Benjamin" and "Dr. Hess" (see point 9 for more detail on their input).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable (N/A). No "test set" or adjudication in the AI/ML context.

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 (N/A). This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable (N/A). This is not an algorithm. The device operates independently of human interpretation of its outputs, but requires human intervention for application and patient monitoring.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the safety claims (specifically regarding pressure and circulation) is based on physiological principles (capillary occlusion pressure of 22 mmHg) and clinical experience (Dr. Benjamin's letter on over 400 patients using intermittent chambers).
For effectiveness, the "ground truth" is derived from published medical literature/clinical studies (cited in section 3 of the document) and general understanding of wound healing and oxygen therapy.

8. The sample size for the training set

Not applicable (N/A). There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable (N/A). As there is no training set, this point is not relevant. However, the basis for the safety assertions includes:
- "Chamber performance qualification testing" (data in section G, not provided) for the HEC 1000's operational parameters (fill time, venting).
- Clinical experience and expert opinion: A "letter from Dr. Benjamin" (cited in section F and 3.12) regarding his experiences using intermittent chambers on "over 400 patients" is referenced to support the safety profile of intermittent pressure. Another letter from "R. Hess" (cited in section 3.13) is also mentioned.
- Review of adverse event databases: Searches of MDR (Manufacturer and User Facility Device Experience) and MAUDE (Manufacturer and User Facility Device Experience) databases to confirm no reported adverse reactions specifically to topical oxygen chambers.

Summary

Regulation Number and Section

§ 878.5650 Topical oxygen chamber for extremities.

(a)
Identification. A topical oxygen chamber for extremities is a device that is intended to surround a patient's limb and apply humidified oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers such as bedsores.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Topical Oxygen Chamber for Extremities.” See § 878.1(e) for the availability of this guidance document.