Search Results

The MiMedx HydroFix™ Surgical Sheet is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The surgical sheet minimizes tissue attachment to the device in case of direct contact with the tissues.

The HydroFix™ Surgical Sheet is a flexible sheet of 30 Wt.% polyvinyl alcohol (PVA) material with dimensions 60 ±6 mm X 50 ±5 mm and 60 ±6 mm X 100 ±10 mm with a thickness of 1.0 ±0.2 mm. The comers of the sheet are rounded. There are no holes or perforations. There are no markings on either side of the sheet, raised (embossed) or printed. The sheet is provided sterile and hydrated in saline solution.

The HydroFix™ Surgical Sheet will be provided in other shapes and sizes as needed for particular surgical procedures.

This document describes the 510(k) submission for the HydroFix™ Surgical Sheet, which aims to demonstrate its substantial equivalence to previously cleared devices. It primarily focuses on comparing the new device's performance and characteristics to those of predicate devices rather than establishing specific acceptance criteria for standalone performance.

Here's an analysis of the provided information based on your requested points:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria with pass/fail thresholds for the HydroFix™ Surgical Sheet. Instead, it states that the device's performance was judged as "comparable to the predicate devices."

2. Sample size used for the test set and the data provenance

• Sample size for test set: Not specified for in vitro tests. For in vivo tests, it mentions studies conducted in "both sheep and rabbit models," implying a sample size of at least two different animal types, but the number of individual animals within each model is not provided.
• Data provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, in vivo studies typically imply prospective animal studies conducted in a controlled environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The document refers to "in vitro" and "in vivo" testing, implying laboratory and animal model evaluations, not expert-based ground truth for interpretation as might be found in diagnostic imaging studies.

4. Adjudication method for the test set

This information is not provided, as the evaluation type doesn't involve human interpretation that would require an adjudication method.

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

No, an MRMC comparative effectiveness study was not done. This device is a surgical sheet, not an AI-assisted diagnostic tool, so such a study would not be applicable.

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

This concept is not applicable. The device is a surgical sheet, not an algorithm. The testing performed was to evaluate the physical and biological characteristics of the sheet.

7. The type of ground truth used

• For In Vitro Testing: The ground truth is inherent in the physical properties and mechanical measurements themselves (e.g., actual tensile strength, burst strength, etc., measured according to established material testing standards).
• For In Vivo Testing: The ground truth is the observed biological response and mechanical performance within the animal models as assessed by researchers (e.g., visual assessment of tissue attachment, successful suturing, etc.). This would likely involve histological examination and gross observations post-sacrifice.

8. The sample size for the training set

This concept is not applicable. The device is a physical product (surgical sheet), not a machine learning algorithm that requires a training set.

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

This concept is not applicable, as there is no training set for a physical surgical sheet.

Ask a specific question about this device

The MiMedx HydroFix™ Vaso Shield is indicated as a cover for vessels during anterior vertebral surgery.
Fusion surgery, Adjacent level surgery, Artificial Disc Implantation, Implant or Hardware Removal, Trauma, Vascular Surgery in the Spine.

The MiMedx HydroFix™ Vaso Shield is a flexible sheet of polyvinyl alcohol (PVA) material provided in various dimensions. It is slippery, clear, pliable, conformable, nanoporous permanent vessel cover that minimizes tissue contact between the vessels and the spine. There are no holes or perforations. There are no markings on either side of the sheet, raised (embossed) or printed. The sheet is provided sterile and hydrated.

The provided text does not describe acceptance criteria for a device, nor does it detail a study proving the device meets acceptance criteria.

This document is a 510(k) summary for the HydroFix™ Vaso Shield, which is a regulatory submission to the FDA (Food and Drug Administration) for market clearance based on substantial equivalence to existing devices. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria and performance studies in the context of AI/software devices.

Here's why the prompt's requested information is not present and what this document does describe:

• Acceptance Criteria & Device Performance (Table): This document does not establish performance criteria for an AI/software device. Instead, it compares the HydroFix™ Vaso Shield to predicate devices based on "technological characteristics and performance criterion" evaluated through in vitro testing. There's no table presenting acceptance criteria for an AI solution nor reported device performance in terms of metrics like accuracy, sensitivity, or specificity.
• Sample Size, Ground Truth, Adjudication, MRMC, Standalone Performance, Training Set: These are all concepts relevant to studies evaluating AI/software devices, often involving medical imaging, diagnosis, or risk prediction. This 510(k) pertains to a physical medical device (a vessel cover), not an AI algorithm. Therefore, such information is entirely absent.
• "Study that proves the device meets the acceptance criteria": The "study" mentioned here is in vitro testing (Simulated Use and Environmental conditioning testing) to demonstrate substantial equivalence to predicate devices, not a clinical or performance study of an AI system.

Information that is present in the document:

• Proprietary Name: HydroFix™ Vaso Shield
• Common Name: Vessel Guard or Cover
• Indications for Use: As a cover for vessels during anterior vertebral surgery.
• Device Description: Flexible sheet of polyvinyl alcohol (PVA) material, slippery, clear, pliable, conformable, nanoporous, permanent vessel cover that minimizes tissue contact between vessels and the spine. Provided sterile and hydrated.
• Substantially Equivalent Devices (Predicates): K090022 Paradis Vaso Shield™, K100905 HydroFix™ Vaso Shield, K101826 HydroFix™ Vaso Shield, K101805 HydroFix™ Vaso Shield.
• Performance Evaluation (used for substantial equivalence):
  • In Vitro Testing: Simulated Use and Environmental conditioning testing for 49℃ to 54℃ high temperature exposure limit.
• Limitations/Warnings included in the FDA Letter:
  • "The safety and effectiveness of this device for reducing the incidence, severity, and extent of post-operative adhesion formation have not been established."
  • The indication for use "as a cover for vessels during anterior vertebral surgery" must be prominently displayed in all labeling.

In conclusion, this document describes a physical medical device and its clearance process through the FDA's 510(k) pathway, which is based on demonstrating substantial equivalence to existing devices, rather than a performance study of an AI system against specific acceptance criteria.

Ask a specific question about this device

The HydroFix Vaso Shield™ is indicated for use as a cover for vessels following anterior vertebral surgery.

The MiMedx HydroFix™ Vaso Shield is a flexible sheet of polyvinyl alcohol (PVA) material provided in various dimensions. It is a slippery, clear pliable, conformable, nanoporous provided in valled over that minimizes tissue contact between the vessels and the spine. There are no holes or perforations. There are no markings on either side of the sheet, raised (embossed) or printed. The sheet is provided sterile and hydrated.

Acceptance Criteria and Study for HydroFix™ Vaso Shield (K101805)

The provided document describes the 510(k) premarket notification for the HydroFix™ Vaso Shield. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness criteria through a new study with predefined acceptance criteria. Instead, the "acceptance criteria" are implied by the demonstration of comparable performance to existing, legally marketed devices.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document mentions a "Large Animal Implantation A sheep model (animal study)." It does not specify the exact number of sheep used in the study.
• Data Provenance: The study was an in vivo animal study conducted on sheep. The country of origin for the data is not specified. It is a prospective study as an experiment was conducted to generate the data for the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not provide details on the number or qualifications of experts used to establish ground truth for the animal study. Veterinary surgeons or researchers would likely have been involved in the implantation and assessment of the devices in the sheep model.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the animal study data. The results would likely have been analyzed and interpreted by the research team involved.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC comparative effectiveness study was not performed. This type of study is typically used for diagnostic devices involving human interpretation of images or other data, which is not applicable to this physical implantable device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This is not
applicable. The HydroFix™ Vaso Shield is a physical implantable device, not an algorithm or software. Its performance is assessed through its physical interaction with tissues in vivo.

7. Type of Ground Truth Used

The ground truth for the in vivo testing was established through direct observation and assessment of the implanted devices in the animal model. This would likely involve:

• Direct observation/histology: Assessing the physical separation of soft tissue, the presence or absence of vessel damage, and tissue responses at the implant site.
• Pathology: Likely the most definitive ground truth, involving histological examination of tissues around the implant to confirm device presence, tissue separation, and absence of adverse reactions or damage.

8. Sample Size for the Training Set

No training set is mentioned or applicable. This device's performance was evaluated through an in vivo study, not through a machine learning or algorithm-based approach that requires training data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set was used.

Ask a specific question about this device

Ask a specific question about this device

The MiMedx Group, Inc. HydroFix™ Vaso Shield is indicated as a cover for vessels during anterior vertebral surgery.

The MiMedx HydroFix™ Vaso Shield is a flexible sheet of polyvinyl alcohol (PVA) material provided in various dimensions. There are no holes or perforations. There are no markings on either side of the sheet, raised (embossed) or printed. The sheet is provided sterile and hydrated.

The provided text describes a 510(k) summary for the MiMedx HydroFix™ Vaso Shield, focusing on demonstrating its substantial equivalence to predicate devices rather than establishing novel acceptance criteria for device performance as an AI device. Therefore, a direct table of "acceptance criteria" and "reported device performance" in the context of an AI device's metrics (like sensitivity, specificity, etc.) is not applicable here.

However, I can extract the performance criteria that were evaluated to show substantial equivalence and explain the study conducted.

Here's a breakdown of the requested information based on the provided text, interpreted for a medical device (not an AI device):

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative "acceptance criteria" with numerical thresholds for performance metrics. Instead, it describes comparative performance against predicate devices to demonstrate "comparable" or "equivalent" performance.

2. Sample size used for the test set and the data provenance

• Sample size for in vitro testing: Not specified.
• Sample size for in vivo testing: Not specified, only mentions "a porcine model," implying one or more animals were used.
• Data provenance: The in vivo study was conducted in a "porcine model," indicating animal data. The location or specific details of where the in vitro testing occurred are not provided. Both types of studies appear to be prospective, as they were conducted to demonstrate substantial equivalence for this specific 510(k) application.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided in the document. The studies conducted (in vitro and in vivo animal studies) do not involve human expert interpretation for "ground truth" in the way an AI device study would. The performance was likely assessed by researchers and possibly veterinary professionals in the case of the porcine model.

4. Adjudication method for the test set

Not applicable and not provided. This concept is typically relevant for human-interpreted diagnostic findings, not for the physical performance testing of a medical device described 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 is a medical device, not an AI device. No MRMC study involving human readers or AI assistance was conducted or mentioned.

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

Not applicable. This is a physical medical device, not an algorithm or AI.

7. The type of ground truth used

For the in vitro and in vivo studies, the "ground truth" would be objective measurements and observations of the device's physical and functional characteristics (e.g., how well it holds a suture, its light reflectivity) under controlled experimental conditions. It is not based on expert consensus, pathology, or outcomes data in the typical sense of diagnostic ground truth.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model that requires a training set.

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

Not applicable. As above, this is a physical medical device, not an AI model.

Ask a specific question about this device