(75 days)
The LTM Wound Dressing is intended for the management of wounds including:
- Partial and full thickness wounds; -
- Pressure ulcers; -
- Venous ulcers: -
- Diabetic ulcers; -
- Chronic vascular ulcers; -
- Tunneled/undermined wounds; -
- Surgical wounds (donor sites/grafts, post-Moh's surgery, post laser surgery, podiatric, wound dehiscence);
- Trauma wounds (abrasions, lacerations, second-degree burns and skin tears); +
- Draining wounds -
- And other bleeding surface wounds.
The LTM Wound Dressing provides an environment that supports wound healing and control of minor bleeding.
The device is intended for single patient, one time use only.
The LTM Wound Dressing device is identical in materials and construction to the Company's rno DTM Wound Droomigical Mesh (K070560). Like the LTM Surgical Mesh, LTM Wound Dressing consists of a terminally sterilized sheet of the processed porcine dermal matrix provided in prescribed geometric configurations and thickness, and packaged in a double pouch configuration.
The provided 510(k) summary for the LTM Wound Dressing does not describe a study that uses acceptance criteria in the way typically seen for AI/ML device performance. Instead, it relies on a Substantial Equivalence argument based on a predicate device.
Here's an analysis of the provided information in the context of your request:
1. Table of Acceptance Criteria and the Reported Device Performance
Not applicable in the traditional sense for this submission. The "acceptance criteria" for this 510(k) is demonstrating substantial equivalence to a legally marketed predicate device. The performance is deemed acceptable if it is comparable to the predicate.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (LTM Wound Dressing) |
|---|---|
| Safe and effective for intended uses. | "as safe and as effective as the legally marketed predicate devices" |
| Same or similar indications for use. | Has "the same intended uses and the same or similar indications" as predicate devices. |
| Same or similar technological characteristics. | "identical in materials and construction" to LTM Surgical Mesh (K070560); "same or similar technological characteristics" as predicate devices. |
| Same or similar principles of operation. | Has "the same or similar... principles of operation as its predicate devices." |
| Biocompatible. | Based on LTM Surgical Mesh testing, device is "biocompatible." |
| Manufacturing process capable of inactivating viral components. | Based on LTM Surgical Mesh testing, manufacturing process is "capable of inactivating any viral components." |
| Functions as intended. | Based on LTM Surgical Mesh testing, "functioned as intended and the performance observed was as expected." |
2. Sample Size Used for the Test Set and the Data Provenance
Not applicable. There was no specific "test set" for the LTM Wound Dressing itself. The submission leverages data from the LTM Surgical Mesh (K070560), which previously underwent testing. The document does not specify the sample sizes or data provenance for that historical testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. No ground truth establishment by experts for a test set is described. The assessment is based on the previously established safety and effectiveness of the predicate device (LTM Surgical Mesh) and the new device being technologically identical.
4. Adjudication Method for the Test Set
Not applicable. No test set or associated adjudication method is described.
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 a medical device submission for a physical wound dressing, not an AI/ML-driven diagnostic or assistive device. Therefore, no MRMC study or AI assistance is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not explicitly stated for the LTM Wound Dressing as it relies on substantial equivalence. For the predicate LTM Surgical Mesh, the "performance data" included "biocompatibility testing, animal implantation testing, and biomechanical testing." These types of tests likely relied on:
- Biocompatibility: Standardized assay results.
- Animal Implantation: Histopathological analysis, clinical observation, and potentially outcomes data from animal models.
- Biomechanical Testing: Quantitative measurements of physical properties.
8. The Sample Size for the Training Set
Not applicable. 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. There is no training set or associated ground truth establishment.
Summary of the Study that Proves the Device Meets the Acceptance Criteria:
The "study" that proves the LTM Wound Dressing meets the acceptance criteria is a demonstration of technological identity and substantial equivalence to a previously cleared device, the LTM Surgical Mesh (K070560).
The key arguments are:
- Technological Identity: The LTM Wound Dressing is "identical in materials and construction" to the LTM Surgical Mesh.
- Leveraging Prior Data: The LTM Surgical Mesh "has undergone extensive biocompatibility testing, animal implantation testing, and biomechanical testing."
- Equivalence of Data: Because the devices are technologically identical, the "testing conducted on the LTM Surgical Mesh is equally applicable to the LTM Wound Dressing."
- Conclusion: This similarity allows the conclusion that the LTM Wound Dressing is "as safe and as effective" as its predicate devices.
Therefore, the "proof" is based on the direct transferability of established safety and performance data from a predicate device due to their identical nature. There was no new clinical or performance study specifically for the LTM Wound Dressing described in this 510(k) submission.
N/A