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510(k) Data Aggregation
(210 days)
The Harbor MedTech Architect™ Px Extracellular Collagen Matrix is indicated for the local management of moderately to heavy exuding wounds, including:
· Partial and full thickness wounds,
- · Draining wounds,
· Pressure sores/ulcers,
· Venous ulcers,
· Chronic vascular ulcers,
· Diabetic ulcers,
· Trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin tears),
· Surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Mohs surgery, podiatric wounds, dehisced surgical incisions)
The Harbor MedTech Architect™ Px Extracellular Collagen Matrix (ECM) is a decellularized equine pericardial device The Architect™ Px ECM is provided sterile for single use only. The device must be rehydrated and rinsed prior to use following the procedure described in the Instructions for Use.
The Architect™ Px ECM is available in multiple sizes. The Architect™ Px ECM is available as a standard dressing and in a fenestrated model with pre-cut slits in the collagen matrix.
This document is a 510(k) summary for the Harbor MedTech Architect™ Px Extracellular Collagen Matrix. It does not describe an AI/ML device or a study involving human readers or ground truth established by experts.
Therefore, many of the requested categories are not applicable to the provided text.
Here's a breakdown of the relevant information from the document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of acceptance criteria with specific numerical targets. Instead, it describes performance testing results in a narrative way, stating that the device "conforms to the performance specifications established" for its predicate and that "the Architect™ Px ECM tissue has the mechanical strength and integrity to perform as intended."
| Criteria Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Physical Attributes | Conformance to performance specifications of predicate device. | "Results of this testing confirmed that the minor changes to the manufacturing process yielded a device that conforms to the performance specifications established for the Architect™ ECM cleared under premarket 510(k) notification K122502." |
| Mechanical Strength/Integrity | Sufficient mechanical strength and integrity to perform as intended. | "Results of the tensile, suture pull-out, staple pull-out and flexibility testing show that the Architect™ Px ECM tissue has the mechanical strength and integrity to perform as intended." |
| Biocompatibility | Acceptable. | "Extensive biocompatibility testing... was completed and found to be acceptable." (Note: these studies were not repeated for this submission as materials, processing, packaging, and sterilization had not changed, and the decreased BDDGE concentration did not warrant repeating them.) |
| Viral Inactivation | Acceptable. | "Extensive... viral inactivation testing was completed and found to be acceptable." (Note: these studies were not repeated for this submission as materials, processing, packaging, and sterilization had not changed, and the decreased BDDGE concentration did not warrant repeating them.) |
| Equivalence to Predicate | Substantially equivalent in indications, materials, manufacturing, and design principles. | "Harbor MedTech, Inc., demonstrated that... the Architect™ Px Extracellular Collagen Matrix (ECM) is substantially equivalent in indications, materials, manufacturing and design principles to the predicate device... The Architect™ Px Extracellular Collagen Matrix has the following similarities to the predicate devices: has the same intended use, uses the same operating principle, incorporates the same basic design, incorporates the same materials and manufacturing processes, uses the same species of animal tissue." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes "verification and validation studies" and "performance bench testing." It does not specify sample sizes for these tests, nor does it provide information on data provenance (country of origin, retrospective/prospective). These appear to be laboratory bench tests on material samples, not clinical data sets from patients.
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. This is a medical device (collagen matrix), and the testing described is bench testing, not an AI/ML algorithm requiring expert ground truth for image interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This pertains to expert review for diagnostic algorithms, which is not relevant here.
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 document is for a medical device (collagen matrix) and does not involve AI or human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document is for a medical device (collagen matrix), not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable in the context of diagnostic AI. For this device, the "ground truth" or reference for performance is the established specifications and performance of the predicate device, as confirmed through physical and mechanical testing.
8. The sample size for the training set
Not applicable. This is a medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a medical device, not an AI model.
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