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The HydroMARK™ Plus Breast Biopsy Site Marker is indicated to mark tissue during a percutaneous breast biopsy procedure, including axillary lymph nodes, be visible under ultrasound for at least six (6) weeks, and be permanently visible by x-ray and MRI.

The HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly and Hummingbird shapes) is a two-component marker that provides permanent marking of a breast biopsy or axillary lymph node biopsy site following a breast biopsy procedure. The implantable marker is made of a highly expandable solid cylinder of polymerized and desiccated hydrogel that has the permanent titanium marker embedded. Upon fluid contact (e.g., water, blood, etc.), the hydrogel material expands to an equilibrium point. Once the material hydrates, it is visible under ultrasound. Over time, the hydrogel is resorbed by the patient's body. The titanium wire is permanently visible under x-ray and MRI even after the hydrogel is resorbed.
The HydroMARK™ Plus Breast Biopsy Site Marker is a permanent implant and is not intended to be removed unless the marked tissue requires surgical removal. The marker is supplied pre-loaded in a sterile, disposable applicator that is designed to fit into specified commercially available breast biopsy devices. During a breast biopsy procedure, the marker is deployed through a compatible introducer into the biopsy cavity created by the breast biopsy device.
The focus of this submission is a modification to the applicator of the marker, which has been modified to enhance compatibility of use in the MR Environment. The markers themselves remain unchanged from the predicate device.

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The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. The MOLLI Marker can be implanted for greater than 30 days. Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance (MOLLI Systems (MOLLI System and MOLLI 2 System)), the MOLLI Marker is located and surgically removed with the target tissue.

The MOLLI Systems (MOLLI System and MOLLI 2 System) are intended only for the non-imaging detection and localization of the MOLLI Marker that has been implanted in a site intended for surgical removal.

The MOLLI Systems (MOLLI System and MOLLI 2 System) are precision surgical marking and guidance systems for locating non-palpable lesions during surgery. The system consists of a temporary marker (MOLLI Marker), a marker delivery system (MOLLI Introducer), a detection wand (MOLLI Wand/MOLLI 2 Wands), and a visualization tablet (MOLLI Tablet/MOLLI Tablet 2). The MOLLI Wand/MOLLI 2 Wand Family and MOLLI Tablet/MOLLI 2 Tablet constitute the system. The MOLLI System is intended for the non-imaging detection and localization of the MOLLI Marker that has been implanted in a site intended for surgical removal.

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InnoClip™ Clip Applier is indicated for patients undergoing laparoscopic surgical procedures involving occlusion of blood vessel, ducts and other tubular structures, and for radiographic marking.

The InnoClip™ Clip Applier is a disposable clip cartridge contains 10, 16 or 20 implantable titanium clips, and should be used with "Taiwan Surgical" Reusable Clip Applier Handle. The product line includes two shaft diameters, 10 mm and 5 mm. Titanium clip sizes are 5.5 × 9.0 mm and 5.5 × 11 mm for the 10 mm applier, and 4.6 × 9.1 mm for the 5 mm applier. The applier is designed to be introduced through applicable trocar sleeves, or larger sleeves with a fitted converter.

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InnoClip™ Disposable Clip Applier is indicated for patients undergoing laparoscopic surgical procedures involving occlusion of blood vessel, ducts and other tubular structures, and for radiographic marking.

The InnoClip™ Disposable Clip Applier consists of a handle piece and 10, 16 or 20 implantable titanium clips. The product line includes two shaft diameters, 10 mm and 5 mm. Titanium clip sizes are 5.5 × 9.0 mm and 5.5 × 11 mm for the 10 mm applier, and 4.6 × 9.1 mm for the 5 mm applier. The applier is designed to be introduced through applicable trocar sleeves, or larger sleeve with a fitted converter.

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The SCOUT MD Reflector is intended to be placed percutaneously in soft tissue (>30 days) to mark a biopsy site or a soft tissue site intended for surgical removal. Using imaging guidance (such as ultrasound, MRI, or radiography) or aided by non-imaging guidance (SCOUT MD System) the SCOUT MD Reflector is located and surgically removed with the target tissue. The SCOUT MD System is intended only for the non-imaging detection and localization of the SCOUT MD Reflector that has been implanted in a soft tissue biopsy site or a soft tissue site intended for surgical removal.

The SCOUT MD Surgical Guidance System consists of the following components:

• SCOUT MD Delivery System, which includes two components:
  • SCOUT MD Reflector
  • SCOUT MD Delivery Device
• SCOUT MD Guide
• SCOUT MD Single-Use Handpiece
• SCOUT MD Console

The SCOUT MD Delivery System is used to implant the preassembled SCOUT MD Reflector. The needle of the Delivery System is percutaneously advanced into tissue to the site to be marked for biopsy or surgical removal. Needle placement is confirmed under imaging technique (radiographic, ultrasound). The Reflector (tissue marker) is deployed at the target site and the Delivery Device is removed from the patient and discarded. The Reflector, a passive implant, remains in situ and, if surgical removal of the target tissue is necessary, the Reflector is located at the time of surgery (intraoperatively) by the SCOUT MD Surgical Guidance System. The SCOUT MD Guide/Handpiece connected to the SCOUT MD Console is used to detect the SCOUT MD Reflector but it does not contact tissue. SCOUT MD Guides are used with sterile SCOUT Guide Sheath and/or sterilized per the instructions in the IFU. When the SCOUT MD System detects the Reflector, the Console emits audible feedback that increases in cadence as the Guide/Handpiece is placed closer to the Reflector. The distance between the distal end of the Guide/Handpiece and the detected Reflector, in millimeters, is displayed on the Console. If necessary, the Reflector is removed from the patient during a subsequent surgical procedure along with the tissue of interest or the Reflector can be left in-situ.

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The VizMark Preloaded Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

The VizMark Tissue Marker is a sterile, nonpyrogenic, single use tissue marker consisting of a gadolinium filled polymeric tube that is visible on standard radiographs (x-ray, mammography) as well as ultrasound and Magnetic Resonance Imaging (MRI). The tissue marker is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location. VizMark Preloaded Tissue Markers are supplied pre-loaded in a sterile, single patient use delivery device.

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The Disposable Polymer Ligation Clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.

The Disposable polymer ligation clips includes Polymer Clips and Multiple polymer clips. The devices are sterilized by EO, single-use, non-absorbable, non-active implantable devices designed for use in general surgical procedures that require vessel or tissue ligation. The Disposable polymer ligation clips are compatible with the reusable, non-sterile Clip appliers which are made by Kangji. The clips are placed around the tissue and closed with the grip of a clip applier. These clips are made of medical grade acetyl homopolymer and supplied in different sizes and packaged in different clip quantity.

Polymer Clips are housed in a colored cartridge which is consist of base and platen. The clips shall be placed and fired in clip applier one by one. Polymer Clips are available in four sizes: M, ML, L, XL.

Multiple polymer clips (model: KJ-JZJDML, KJ-JZJDL, KJ-JZJDXL) are available in 3 sizes (ML, L, XL), housed in a colored cartridge and has 3 clips which can be placed in clip applier in one time and fired constantly totally 3 times.

Multiple polymer clips (except model: KJ-JZJDML, KJ-JZJDL, KJ-JZJDXL) are available in ML and L size, housed in a striped cartridge. The cartridge which contains 5-15 clips will be placed in clip applier. The clips will be delivered individually advance after each firing.

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The GI Windows Flexagon Plus OTOLoc System is intended for use in the creation of side-to-side jejunum-jejunum and ileum-ileum anastomoses in minimally invasive and laparoscopic surgery. Once wound strength is sufficient to maintain the anastomosis, the device is passed from the body. The effects of this device on weight loss were not studied. The GI Windows Flexagon SFM Plus OTOLoc is intended for use in adult patients > 21 years.

The Flexagon SFM Plus OTOLoc device is a magnetic compression anastomosis system, which is a surgical device used for the creation of anastomoses in minimally invasive surgery in the gastrointestinal tract. The system is comprised of self-forming magnets and includes the delivery system. The OTOLoc component provides enterotomy preservation for immediate fluidic flow upon implant, while the alternating dipoles of the Flexagon magnet drives magnetic self-alignment to prevent apposition. The anastomosis formation occurs over time once the remodeling of the targeted tissues is complete. The Flexagon magnets compress the opposing tissues which allows the body to dictate the time required for re-epithelialization. Compression and necrosis of tissue is achieved between magnet devices and is created by the polar attraction of the magnet devices with subsequent healing of tissue around the devices. Once the anastomosis is formed, the magnet device is expelled naturally in approximately 3-6 weeks.

The provided text does not contain acceptance criteria or study details for an AI/software device. The document is an FDA 510(k) clearance letter for a physical medical device, the "Flexagon Plus OTOLoc System," which is a magnetic compression anastomosis system.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study proving an AI device meets them, as the input document is not about an AI device.

The document discusses:

• Acceptance criteria (implicitly met through "Pass" results) for various non-clinical performance tests (biocompatibility, sterilization, packaging, shelf-life, magnetic properties, etc.) and animal studies.
• Clinical performance data for the physical device based on patient outcomes, but not related to an AI's diagnostic or assistive capabilities.

To answer your request, I would need a document detailing the clearance of an AI-powered medical device.

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MammoSTAR Biopsy Site Identifier is indicated for use to radiographically mark soft tissue at the surgical site during a surgical procedure or for future surgical procedures.

MammoSTAR Biopsy Site Identifier is a sterile, single use tissue marker consisting of pyrolytic carbon coated zirconium oxide discrete marker e that is visible on standard radiographs (x-ray, mammography, fluoroscopy, kV, and CT) as well as ultrasound and Magnetic Resonance Imaging (MRI) incorporated into lyophilized BiomarC Delivery Gel. MammoSTAR is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location.

Based on the provided FDA 510(k) clearance letter, the "MammoSTAR Biopsy Site Identifier" is cleared without new device performance data. The clearance is based on the device being identical to its predicate device (K100994) with only one difference being an added contraindication and an extended shelf life, which was verified through testing. Therefore, there is no specific performance data from a new study presented in this document to describe or prove the device meets acceptance criteria.

The document indicates that no new performance data was required because the device is deemed identical to the predicate device, and thus, already meets the established criteria for safety and effectiveness based on the predicate's clearance.

Here's an attempt to answer your request based on the information provided and inferred within the document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this 510(k) is a "Change Being Effected (CBE) determination" where the device is considered identical to its predicate except for an added contraindication and an extended shelf-life, explicit "acceptance criteria" and "reported device performance" from a new study are not provided for the claims of equivalency in the typical sense. Instead, the acceptance criteria are implicitly met by being identical to the predicate device, which was previously deemed safe and effective.

The only "performance" mentioned that might resemble a test is the shelf-life verification.

Regarding the study proving the device meets acceptance criteria:

The document explicitly states: "No new performance data is required to support this Change Being Effected (CBE) determination." and "no clinical study is deemed necessary to support this Change Being Effected (CBE) determination since substantial equivalence has been sufficiently demonstrated."

Therefore, there is no new study described in this document that proves the device meets (newly established) acceptance criteria. The clearance is based on the device being substantially equivalent to a legally marketed predicate device (K100994) which has already met these criteria. The only change mentioned that involved verification was the extended shelf-life from 6 months to 60 months, which "has been verified." The details of this verification study (e.g., methodology, results) are not provided in this document.

Given this, the following points cannot be answered from the provided text as they relate to a new study that doesn't exist for this 510(k) submission:

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

• Not applicable / Not provided. No new test set or data provenance is mentioned for device performance.

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 / Not provided. No new ground truth establishment is described.

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

• Not applicable / Not provided. No test set or 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

• No. This device is an "Implantable Clip" and a "Biopsy Site Identifier," not an AI diagnostic/imaging device. Therefore, an MRMC study with AI assistance is not relevant to this product.

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

• No. This is a physical implantable device, not an algorithm.

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

• Not applicable / Not provided. No new ground truth is described.

8. The sample size for the training set

• Not applicable / Not provided. As this is not an AI/machine learning device, there is no training set mentioned.

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

• Not applicable / Not provided. As this is not an AI/machine learning device, there is no training set mentioned.

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The Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips are intended for use in procedures involving the ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.

Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips are single-use, non-active implantable devices designed for use in general surgical procedures that require vessel or tissue ligation. The clips are manufactured from a non-absorbable acetal polymer and are provided prepackaged in color-coded cartridges, which are provided as single-use, sterile devices.

The provided FDA 510(k) clearance letter pertains to a new version of a physical medical device (surgical clips), not an AI/Software as a Medical Device (SaMD).

Therefore, the document does not contain any of the information requested in points 2-9, as these points are specific to the evaluation and validation of AI/SaMD products, which involve concepts like:

• Acceptance criteria for AI performance (e.g., sensitivity, specificity, AUC): This is relevant for diagnostic or predictive AI systems.
• Sample sizes for test sets, data provenance, ground truth establishment, expert adjudication, MRMC studies, standalone performance, and training set details: These are critical components of validating AI model performance to ensure its accuracy, robustness, and generalizability.

Since the Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips are physical devices, their acceptance criteria and proof of efficacy are based on benchtop non-clinical performance testing and biocompatibility assessments, which are detailed in the "Performance Data" section (Section J) of the 510(k) summary.

Here's how to interpret the provided document in the context of your request:

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

The document lists the following non-clinical performance tests and biocompatibility assessments that were conducted. While explicit "acceptance criteria" are not numerically stated in this summary for each test (as they typically would be in a full test report), the statement "in order to ensure the device performed equivalently to the predicate" implies that the new device's performance in these tests met established safety and efficacy standards, likely mirroring or demonstrating similar performance to the predicate device.

For the remaining points (2-9), the information is not applicable to a physical device like surgical clips.

• 2. Sample sized used for the test set and the data provenance: Not applicable to physical clips. Testing involves benchtop models or animal studies for implantation, not human data sets.
• 3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for physical clips is established through engineering and biological testing standards, not expert annotation of data.
• 4. Adjudication method: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. MRMC studies are for AI/SaMD to compare human performance with and without AI assistance.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This concept applies to AI algorithms.
• 7. The type of ground truth used: For physical devices, ground truth for efficacy and safety is established through validated test methods (e.g., mechanical strength testing, leak resistance, biocompatibility standards, often with reference to predicate devices).
• 8. The sample size for the training set: Not applicable. This relates to AI model development.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document details the testing performed for a physical medical device (surgical clips) to demonstrate its substantial equivalence to a predicate device, focusing on non-clinical performance and biocompatibility rather than AI/software performance metrics.

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