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The SimpleStitch Suturing System is intended for endoscopic placement of suture(s) and approximation of soft tissue (e.g., closure and healing of ESD/EMR sites, and closing of fistula, perforation or leaks).

The SimpleStitch Suturing System ("SimpleStitch SS") is a sterile, single patient-use device that enables endoscopic placement of sutures and approximation of soft tissue within the gastrointestinal tract using a flexible endoscope. The system includes the following components: SimpleStitch Suture Device, SimpleStitch Suture Cartridge, and SimpleStitch Suture Cinch. The SimpleStitch SS is designed for compatibility with single-channel endoscopes (gastroscopes and colonoscopes) with a minimum working channel inner diameter of 2.8mm. During use, the suturing device/suture cartridge is mounted to the endoscope's exterior; the cinching device goes through the endoscope's working channel. The SimpleStitch SS is available with a USP 2-0 and USP 0 nonabsorbable polyester suture. Tissue is secured using a cinch anchor once tissue approximation is complete.

This FDA 510(k) clearance letter and summary is for a physical medical device (SimpleStitch Suturing System), not an AI/Software as a Medical Device (SaMD). Therefore, the information typically requested for AI/SaMD performance studies (such as acceptance criteria for algorithm performance, sample size for test sets with ground truth, number of experts for ground truth, MRMC studies, standalone performance, training set details, etc.) is not applicable here.

The document focuses on demonstrating substantial equivalence to a predicate device (OverStitch Endoscopic Suturing System) through:

• Comparison of Technological Characteristics: Showing similarities in intended use, indications for use, principle of operation, materials, and design.
• Performance Data: Primarily bench testing (dimensional verification, functionality, destructive testing, side-by-side comparison with predicate, usability, packaging, shelf-life), biocompatibility, MRI safety, and an animal (swine) survival study.

There is no mention of an algorithm or AI model, nor any associated acceptance criteria, ground truth establishment, or statistical performance metrics typically associated with AI/SaMD.

Therefore, I cannot provide the requested information regarding acceptance criteria and study proof in the context of an AI/SaMD for this document.

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The device is indicated for use in fixation of prosthetic material to soft tissue in minimally invasive ventral and minimally invasive groin hernia repair procedures.

The MaxTack™ Motorized Fixation Device is a single-use, sterile device that contains 30 absorbable tacks, preloaded into a standard shaft. The device is designed for introduction and use through a 5 mm or larger cannula. The device's tacks are constructed of an absorbable synthetic polyester copolymer derived from lactic and glycolic acid. The first 25 tacks are dyed with D&C Violet No. 2. The last 5 tacks are dyed with D&C Green No. 6. to serve as an indicator of low tack count to the user. The distal end of the shaft has a mesh manipulation/grip feature that may be used to facilitate positioning of the mesh.

The device is intended for use in a sterile operating room environment in surgical procedures where fixation of prosthetic material, such as mesh, to soft tissues is indicated. This device is designed, tested, and manufactured for single patient use only. Intended users are healthcare professionals who have been trained in applicable surgical procedures and approaches involving fixation devices prior to employing this device.

The MaxTack™ Motorized Fixation Device is a medical device for fixing prosthetic material to soft tissue in minimally invasive hernia repair. The FDA's 510(k) summary provides details on non-clinical performance data to demonstrate substantial equivalence to a predicate device.

1. Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary for the MaxTack™ Motorized Fixation Device does not explicitly list quantitative acceptance criteria with specific thresholds alongside reported device performance. Instead, it indicates that "applicable design verification and validation activities... showed conformance to applicable technical design specifications and performance" and that the design differences from the predicate device "were found to have no impact on safety or effectiveness."

The "Summary of Studies" section outlines various performance tests conducted. While specific quantitative results are not provided in this summary document, the implication is that the device met the internal specifications and standards set for these tests to demonstrate substantial equivalence.

To illustrate, based on the document, here's a conceptual table of what acceptance criteria might have been inferred, along with the reported high-level outcome:

2. Sample Size and Data Provenance for Test Set

The document does not specify the exact sample sizes for each of the non-clinical tests (benchtop, ex-vivo, reliability, in-vivo, in-vitro studies, usability testing). It also does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. However:

• Non-clinical (benchtop, ex-vivo, in-vitro) studies: These are typically conducted in a controlled laboratory setting (prospective by nature of setting up experiments). The document mentions a "Rat Model" for the in-vivo strength study, which is a controlled animal study.
• Usability study: These are prospective studies involving human users in a simulated or actual use environment.
• Reliability study: Typically prospective testing under defined conditions.

3. Number of Experts used to establish Ground Truth and Qualifications:

The document does not describe the use of human experts to establish ground truth for this device in the way it would for an AI/CADe device. The MaxTack™ Motorized Fixation Device is a mechanical fixation device, not an image analysis or diagnostic AI device. Therefore, the "ground truth" is established through physical, chemical, and mechanical performance testing, as well as biological response studies (e.g., biocompatibility) against established engineering specifications and regulatory standards, rather than expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set:

Not applicable, as this is primarily a hardware/mechanical device with software control, not an AI diagnostic system requiring adjudication of interpretations. Performance is measured against physical and engineering metrics, not expert interpretations.

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

No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for AI-powered diagnostic or assistive devices, where the performance of human readers with and without AI assistance is evaluated. The MaxTack™ Motorized Fixation Device is a surgical tool, not an AI diagnostic assistant.

6. Standalone (Algorithm Only) Performance:

Not applicable. This device is a motorized surgical tool, not a standalone algorithm. Its "performance" is inherently tied to its mechanical and software functions as a complete system.

7. Type of Ground Truth Used:

The "ground truth" for this device's performance is established through empirical data from various non-clinical tests, including:

• Pre-defined Engineering Specifications: Performance metrics (e.g., force required for tack deployment, fixation strength, battery life, dimensional tolerances) are compared against predetermined design and functional requirements.
• Biocompatibility Standards: Adherence to ISO 10993 series and FDA guidance for biological safety.
• Usability Metrics: Compliance with IEC 62366-1 regarding safety and effectiveness of use.
• Electrical Safety and EMC Standards: Adherence to IEC 60601-1 and IEC 60601-1-2.
• Sterilization and Packaging Standards: Compliance with SAL of 10-6 and packaging integrity standards (ASTM D4169, EN ISO 11607-1).
• Benchtop and In-Vitro Measurements: Direct measurements of physical properties and performance in controlled environments.
• In-Vivo (Animal Model) Outcomes: Biological responses and material degradation in a living system (rat model).

8. Sample Size for the Training Set:

Not applicable. This device is a mechanical/software system, not a machine learning model that requires a "training set" in the context of AI. The software within the device controls the motor and tack deployment, and its "training" or development would involve traditional software engineering and validation, not machine learning model training.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no "training set" in the machine learning sense for this device. The software's truth is established by its design specifications and validated through software verification and validation activities (e.g., unit testing, integration testing, system testing, compliance with IEC 62304) to ensure it correctly executes the intended functions (e.g., motor control for tack deployment, low tack count indication).

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The Mediclose™ System is a single-use indicated for approximation of tissues and percutaneous suturing of port-site fascia wounds following laparoscopic surgery.

The Mediclose™ System is an Automatic Trocar Closure (ATC) device supplied with one or more Mediclose™ Adaptors, supplied sterile for single use. The combination of the Mediclose™ Device and one Mediclose™ Adaptor results in a minimally invasive surgical system which aids surgeons in closing trocar wounds following a laparoscopic procedure. In laparoscopic surgery, trocars are used to gain access to the body in a minimally invasive way. This means that these procedures are performed through incisions of approximately 12 mm, compared to traditional open surgery which needs a large wound across the abdomen. The Mediclose™ Device is available in one size and configuration, designed for single-handed use, to which each of three Mediclose™ Adaptors can be fitted, at the user's option, depending on the make/model of trocar being used. The Mediclose™ System is intended to pass a suture through the soft-tissue laver (fascia) of a trocar wound after laparoscopic surgery. This is done with the end-goal of closing the trocar-induced wound by pulling needles through the fascia and subsequently closing the wound. The Mediclose™ System has two items: The Mediclose™ Device, which incorporates the suture and needle set; The Mediclose™ Adaptor, three color-coded models are available separately from the Mediclose™ . Device which are compatible with a specific brand/model of 12 mm trocar sleeves that are legally cleared for marketing in the USA, viz: Ethicon EndoPath Covidien VersaOne Applied Medical Kii The Mediclose™ Device also contains a needle-suture set manufactured by Assut Europe composed of two straight cylindrical needles attached to Glicofil Lac, a braided, coated, violet PGLA absorbable suture. The suture and needles are mounted into the device at the time of manufacture, making it ready to use upon opening the packaging.

The provided FDA 510(k) summary for the Mediclose™ System focuses on non-clinical testing for substantial equivalence, rather than a study proving performance against clinical acceptance criteria. The device is a suturing device, and the evaluation is primarily based on mechanical and biocompatibility tests.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents extensive non-clinical testing with acceptance criteria. No clinical performance acceptance criteria are mentioned as no clinical studies were submitted. The table below summarizes the non-clinical acceptance criteria and reported results.

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The OverStitch NXT Endoscopic Suturing System is intended for endoscopic placement of suture(s) and approximation of soft tissue.

The OverStitch NXT Endoscopic Suturing System (ESS) and accessories are intended for endoscopic placement of sutures and approximation of soft tissue within the gastrointestinal tract utilizing a single-channel endoscope. The system is comprised of the Needle Driver Assembly and Anchor Exchange Device (collectively referred to as ESS), and accessories such as the Tissue Helix or NXT Tissue Helix Pro, Suture Cinch and Suture-Anchor Assembly devices. All devices are sterile packaged and designed for single use and are manufactured from various thermoplastic, silicone, stainless steel and other medical grade materials.

The OverStitch NXT ESS is designed for compatibility with single channel endoscopes. The ESS is mounted onto the endoscope using polyester medical tape for the endcap assembly. The external catheter sheath has two working channels through which the Anchor Exchange and OverStitch accessories can operate, independent of the endoscope channel.

The handle of the Needle Driver Assembly is squeezed to actuate the needle body and exchange the proprietary Suture-Anchor Assembly with the Anchor Exchange to perform stitching operations.

The document is a 510(k) summary for the OverStitch NXT Endoscopic Suturing System, indicating that clinical performance data was not required to demonstrate substantial equivalence. Therefore, there is no study described in this document that proves the device meets specific acceptance criteria based on clinical performance or AI algorithm output. The acceptance criteria and performance data mentioned in section {5} refer to non-clinical bench testing, functional testing on an ex vivo model, and packaging integrity, as well as biocompatibility.

Here's the information derived from the document regarding the non-clinical performance:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

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

This document describes non-clinical testing. It does not provide specific sample sizes for the bench tests, ex vivo model, or packaging integrity tests. The provenance of the data is from Apollo Endosurgery Inc./Boston Scientific's own testing procedures. The tests are prospective in the sense that they were conducted specifically for this submission.

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

This information is not applicable to the non-clinical and ex vivo testing described. There were no human expert evaluations in the context of clinical "ground truth" establishment for this submission as clinical data was not required.

4. Adjudication Method for the Test Set

Not applicable as it was non-clinical and ex vivo testing, not human expert adjudication.

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 MRMC study was conducted. This device is not an AI-assisted diagnostic or therapeutic device that would involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a medical device (endoscopic suturing system), not an AI algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" was established by engineering specifications, validated test methods (e.g., ASTM standards), and comparison to the predicate device's established performance parameters. For the ex vivo model, the ground truth was the expected device function and intended use observed in the model.

8. The Sample Size for the Training Set

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

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

Not applicable for the same reason as point 8.

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The endomina® system, composed of a triangulation (endomina® platform) and an instrument for tissue piercing and approximation (TAPES), is intended for endoscopic placement of suture(s) and approximation of soft tissue in the gastrointestinal tract. The system is to be used on an adult population.

The endomina® system is intended for endoscopic placement of suture(s) and approximation of soft tissue in the gastrointestinal tract utilizing an endoscope. The system is comprised of a triangulation platform (endomina® platform) and an instrument for tissue piercing and approximation (TAPES). The endomina® system is sterile packaged and designed for single use and is manufactured from various thermoplastic, silicone, stainless steel materials, biocompatible 3D printing materials and other medical grade materials.

endomina® platform:
The endomina® platform can be assembled on a regular flexible endoscope inside the stomach. It includes a bendable therapeutic channel meant for the endoscopic tool TAPES. This channel can be deployed perpendicular to the axis of the endoscope, thereby ensuring the triangulation, leaving the channel of the endoscope free for other instruments.

TAPES:
TAPES is an instrument intended to be used with the endomina® platform and a flexible endoscope for tissue approximation in the gastrointestinal tract. TAPES is inserted in the bendable arm of endomina®'s platform. TAPES enables piercing and approximation of two, internal tissues with a needle which are then linked by releasing anchors connected with suture. These anchors create a stitch that can then be tightened, generating interrupted stitches in the gastrointestinal tract.

The provided document describes the 510(k) premarket notification for the endomina® system, an endoscopic tissue approximation device. It details the device's characteristics, intended use, and the non-clinical performance data used to demonstrate its substantial equivalence to a predicate device.

However, the document does not contain the kind of information typically found in an FDA submission for an AI/ML-driven device, which would include specific acceptance criteria like precision, recall, or AUC, or details about the study design (e.g., sample size, expert consensus, MRMC study, ground truth establishment) for validating such an algorithm.

The endomina® system is a mechanical device for endoscopic suturing. Its performance evaluation focuses on physical attributes (dimensions, material properties, mechanical integrity, sterility, shelf-life, biocompatibility) and functional aspects like "suture delivery accuracy," "pull-off force," "force needed to approximate tissue," and "needle piercing force." The "Non-clinical Performance Data" section confirms "Appropriate product testing was performed on endomina® system to evaluate conformance with standard requirements and substantial equivalence to the predicate device."

Therefore, I cannot extract the specific information requested in the prompt (acceptance criteria for an AI/ML device, details of an AI/ML study, MRMC study, standalone performance, training set details) because the provided text pertains to a medical device, not an AI/ML algorithm.

The closest equivalent information regarding "acceptance criteria" and "proof" in this document is found under "Non-clinical Performance Data," which lists various bench tests and animal testing:

Relevant Information from the Document:

• Acceptance Criteria (implicit for a mechanical device): Conformance with standard requirements and substantial equivalence to the predicate device. This implies meeting pre-defined mechanical and functional specifications.
• Reported Device Performance (as described in the "Non-clinical Performance Data"):
  • Bench testing included:
    • Suture delivery accuracy
    • Needle attachment
    • Pull-off force to remove the distal tip from the endoscope
    • Size of approximated tissue fold
    • Force needed to approximate the tissue
    • Ease of insertion into a patient gastrointestinal tract
    • Suture strength
    • Force needed to separate anchors and suture
    • Needle piercing force
  • Sterility: SAL 10-6 confirmed by sterilization validation according to EN ISO 11135:2014 /A1:2019.
  • Packaging and Shelf-life: Packaging integrity confirmed by ASTM F1929-15 and ASTM F1886-16. Shelf-life claims confirmed by functional testing on aged products.
  • Biocompatibility: Testing performed on all components per ISO 10993-1: 2018, including chemical characterization (ISO 10993-18: 2020), cytotoxicity (ISO 10993-5: 2009), sensitization (ISO 10993-10: 2010), irritation (ISO 10993-10: 2010), acute systemic toxicity (ISO 10993-11: 2017), material mediated pyrogenicity (USP ), and implantation (ISO 10993-6: 2016).
  • Animal Testing: Performed to demonstrate substantial equivalence regarding ease of use, efficacy, and safety during endoscopic tissue approximation for suturing in a minipigs' stomach.

Regarding the specific questions in the prompt, based on the provided text, the answers are:

1. A table of acceptance criteria and the reported device performance: This is not presented as a formal table with precise numerical criteria and outcomes, as one would expect for an AI/ML device's performance metrics. Instead, the "Non-clinical Performance Data" section lists the types of tests performed and the successful validation of these tests to establish conformance and substantial equivalence.

   Acceptance Criteria (Implicit for non-AI device)	Reported Device Performance (from "Non-clinical Performance Data")
   Conformance to standard requirements	Bench testing (suture delivery accuracy, forces, etc.) performed
   Substantial equivalence to predicate	Animal testing demonstrated substantial equivalence
   Sterility (SAL 10-6)	Confirmed by EN ISO 11135:2014 /A1:2019
   Packaging Integrity	Confirmed by ASTM F1929-15 and ASTM F1886-16
   Shelf-life	Confirmed by functional testing on aged products
   Biocompatibility	Performed as per ISO 10993 standards

2. Sample size used for the test set and the data provenance: Not applicable in the context of an AI/ML test set. The document mentions "minipigs" for animal testing, which is a "sample" but not an AI test set. No country of origin for generic "data" is mentioned, and the nature is pre-market testing, not retrospective/prospective clinical data for an algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a mechanical device's function is typically established through engineering specifications, physical measurements, and animal/cadaveric studies, not expert consensus on image interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This refers to AI/ML ground truth adjudication.

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, as this is a mechanical device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as there is no algorithm described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this mechanical device, ground truth would be based on engineering specifications, physical measurements, and histological/observational results from animal studies concerning tissue approximation, rather than expert interpretation of a dataset.

8. The sample size for the training set: Not applicable, as there is no AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable, as there is no AI/ML algorithm requiring a training set.

In summary, the provided document describes the regulatory clearance of a mechanical medical device, not an AI/ML device. Therefore, the questions related to AI/ML specific acceptance criteria, study design, ground truth, and training data cannot be answered from the given text.

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The Su2ura® Approximation Device is indicated in endoscopic surgery for the placement of interrupted or running stitches in soft tissue.

The Anchora Su2ura® Approximation Device is a sterile single use device is indicated in endoscopic surgery for the placement of interrupted or running stitches in soft tissue. The device is a 5mm single-use endoscopic suturing device loaded with threaded anchors. It is designed to deploy up to 19 anchors by a trigger action of the handle of the delivery system. After deployment, each anchor is anchored within the tissue in which it was deployed. After deployment of 2 or more anchors, the suture that passes between the anchors can be tightened to pull the anchors toward each other and approximate the tissue. The delivery system consists of a plastic handle and a 36-cm stainless steel shaft. The handle includes a Trigger, a Knob, and a Toggle Button. A Cap can be added at the distal edge of the Shaft to advance extracorporeal suture knots. The anchors can be deployed in single-stitch or running- stitch configuration. The device deploys the anchors through a needle with an outer diameter of 2.1 mm, available in two lengths: 5 mm and 9 mm protrusion. The Anchor is advanced outside of the needle by a Pushrod. Each anchor, made of stainless steel, is threaded with an off-the-shelf UHMWPE suture manufactured by Teleflex Medical. The device provides the anchors already threaded on this suture. The device is sterile packaged and designed for single use only. The device is manufactured from medical grade materials (mainly plastics and stainless steels).

The Su2ura Approximation Device is a sterile, single-use endoscopic suturing device with the following acceptance criteria and reported performances:

1. Acceptance Criteria and Device Performance

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

• Biocompatibility: Not explicitly stated as a test set with a specific sample size of biological samples, but rather a set of material characterization studies (extractables and leachables) and toxicological risk assessments. The input does not provide information on the number of samples for these tests.
• Human Factors: 18 representative users. The provenance of the users (e.g., country of origin, whether they were clinicians or laypersons, etc.) is not specified. The study appears to be prospective.
• Pre-Clinical Performance (Animal Study): 8 pigs (5 for test items, 3 for control items). The provenance of the data is a GLP animal study. It is a prospective study.
• Mechanical Performance, MRI Safety, Packaging Integrity: These involved various bench tests. The sample sizes for each specific test (e.g., number of devices tested for tensile strength or deployment reliability) are not explicitly stated in the provided text. The data provenance is from laboratory/bench testing.

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

• Biocompatibility: No explicit external experts are mentioned for establishing ground truth. Compliance was based on ISO standards.
• Human Factors: The "representative users" assessed usability. It's not stated whether these were "experts" in the sense of clinicians or if their feedback constituted a "ground truth" to be adjudicated. Their feedback was used to confirm usability.
• Pre-Clinical Performance (Animal Study): Not explicitly stated how many experts were involved in evaluating the histopathological data, but it would typically involve veterinary pathologists. Their specific qualifications are not detailed.
• Mechanical Performance, MRI Safety, Packaging Integrity: Ground truth for these studies relies on recognized ASTM and USP standards and internal engineering measurements. No external "experts" were mentioned for ground truth establishment beyond standard scientific and engineering practices.

4. Adjudication Method for the Test Set

The document does not specify any formal adjudication method (like 2+1 or 3+1) for the various studies conducted as part of the regulatory submission.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a surgical tool, and its effectiveness is not assessed through human reader interpretation of images, but rather through direct use in surgery, performance in bench tests, and pre-clinical animal studies. Clinical testing was expressly stated as "not required to demonstrate substantial equivalence."

6. Standalone Performance Study

The studies described (bench testing, animal study, human factors) are essentially "standalone" in the sense that they evaluate the device itself. However, the term "standalone performance" often refers to the algorithm-only performance of AI devices without human-in-the-loop. This device is a mechanical surgical tool, not an AI or imaging diagnostic device, so this concept does not directly apply.

7. Type of Ground Truth Used

• Biocompatibility: Compliance with ISO 10993 standards (e.g., acceptable levels of extractables/leachables, lack of toxicological risk).
• Human Factors: User feedback and observed usability were used to confirm clarity of training and IFU, and the overall usability of the device. This is a form of self-reported or observed performance against predetermined usability goals.
• Pre-Clinical Performance (Animal Study): Histopathological data (from tissue analysis) and clinical monitoring of animals provided the ground truth for safety and performance (e.g., successful closure, similar long-term safety profile to controls).
• Mechanical Performance, MRI Safety, Packaging Integrity: These rely on objective measurements and adherence to established industry standards (ASTM, USP) and predefined product specifications.

8. Sample Size for the Training Set

This question is not applicable. The Su2ura® Approximation Device is a mechanical surgical device, not a machine learning or AI model, so there is no "training set" in the context of algorithm development.

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

This question is not applicable, as there is no training set for this type of device.

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The OverStitch Sx Endoscopic Suturing System is intended for endoscopic placement of suture(s) and approximation of soft tissue.

OverStitch™ Sx Endoscopic Suturing System and The accessories are intended for endoscopic placement of sutures and approximation of soft tissue within the gastrointestinal tract utilizing a single-channel endoscope. The system is comprised of the Needle Driver Assembly and Anchor Exchange Device (collectively referred to as ESS), and accessories such as the Tissue Helix, Suture Cinch and Suture-Anchor Assembly devices. All devices are sterile packaged and designed for single use and are manufactured from various thermoplastic, silicone, stainless steel and other medical grade materials.

The OverStitch Sx ESS is designed for compatibility with single channel endoscopes. The ESS is mounted onto the endoscope using thermoplastic polyurethane straps for the endcap assembly. The external catheter sheath has two working channels through which the Anchor Exchange and OverStitch accessories can operate, independent of the endoscope channel.

The handle of the Needle Driver Assembly is squeezed to actuate the needle body and exchange the proprietary Suture-Anchor Assembly with the Anchor Exchange to perform stitching operations.

The provided text is a 510(k) summary for the Apollo Endosurgery OverStitch™ Sx Endoscopic Suturing System. It describes the device, its indications for use, and a comparison to a predicate device. However, it does not contain specific acceptance criteria, detailed study results, sample sizes for test or training sets, ground truth establishment methods, or information about human expert involvement or MRMC studies for AI performance. The document explicitly states "Clinical testing was not required to demonstrate substantial equivalence."

Therefore, I cannot provide a table of acceptance criteria, detailed study results proving acceptance, or information about AI-related aspects (sample sizes, ground truth, experts, MRMC, standalone AI performance) based on the provided text.

The closest information available regarding "acceptance criteria" is a general statement about non-clinical performance data:

"Acceptance criteria were met in each of the studies listed above. The results confirmed equivalency between the subject and predicate devices, and that no new issues of safety or efficacy were raised."

The studies mentioned are:

• Non-Clinical Performance Data:
  • Bench testing: suture drag testing, tensile testing, endoscope compatibility, reliability, and bond strength.
  • Functional Testing: an ex vivo model utilized under the same test methods as the predicate.
  • Packaging Integrity: testing in accordance with ASTM F2096-11, ASTM F1980-16, ASTM D4169-16 and ASTM F88/F88M-15.
• Biocompatibility: Testing and toxicological assessments performed in accordance with ISO 10933-1, including cytotoxicity, irritation and skin sensitization, systemic toxicity, and material mediated pyrogenicity.

Without specific numerical values or targets for these tests, a table of acceptance criteria and reported performance cannot be generated. Moreover, the device described is a physical medical device (suturing system), not an AI/ML powered device, which explains the absence of information related to AI models, ground truth, expert reviews, and MRMC studies.

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The AbClose - Port Site Closure Device has application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.

The AbClose™ - Port Site Closure Device is a sterile, single-use device including 2 major components, Suture Guide and Suture Passer. The device is used with a commercially cleared suture, and is used as a manual instrument to pass needles with suture through soft tissues for suturing. The device is designed with a suture retrieval system for unassisted fascial closures, facilitating standard suture closure techniques.

The Suture Guide is structured by a Handle and a Suture Catcher. The pyramid-shape Suture Catcher is controlled by a Push Button to fold the Suture Catcher into cylinder shape for insertion into the trocar wound. Once the Suture Guide is in position, Suture Catcher is expanded back to a pyramid shape to stabilize the device on the trocar wound site. The Suture Passer is a handheld suture grasping device designed to pass sutures through soft tissue. It features a Handle and a stainless steel Needle assembled with a Suture Shaft that grasps a suture. The Suture Passer is designed to work with the Suture Guide to penetrate through soft tissues and deploy suture ends into the Suture Catcher. Withdraw Suture Guide by folding the Suture Catcher into cylinder shape, the two suture ends are securely captured and are ready for user to type knots to close the trocar wound site.

This document describes the AbClose - Port Site Closure Device, which is a sterile, single-use device used in laparoscopic procedures for tissue approximation and percutaneous suturing to close incision sites.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define "acceptance criteria" for performance in a quantitative table. Instead, it states that various tests were performed and "all the results were passed," indicating that the device met the internal design specifications and requirements. The core acceptance is framed around demonstrating substantial equivalence to the predicate device (K160117).

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

• The document does not specify the sample sizes used for each of the mechanical tests or the animal study. It only states that the tests were "successfully performed" with "all the results were passed."
• Data Provenance: The animal study was mentioned, implying prospective data collection for the functional testing. The biocompatibility and mechanical tests are typically lab-based studies. The country of origin for the data is implied to be related to the manufacturer, Medeon Biodesign, Inc., which is based in Taipei, Taiwan.

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

• This information is not provided in the document. The studies described are primarily engineering/laboratory tests and an animal model, not studies requiring human expert adjudication for ground truth (e.g., image interpretation).

4. Adjudication Method for the Test Set:

• This information is not applicable/provided as the studies described do not involve human expert adjudication in the context of diagnostic accuracy or similar tasks.

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:

• An MRMC study was not performed. The device described is a surgical instrument (port site closure device), not an AI-assisted diagnostic or interpretive tool.

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

• A standalone performance study in the context of an algorithm or AI was not performed, as the device is a physical surgical tool. The functional animal study could be considered a "standalone" performance test of the device itself.

7. The Type of Ground Truth Used:

• Biocompatibility: Ground truth is established by the well-defined scientific standards and recognized guidance (ISO 10993 series, USP Chapter ) which describe the expected biological responses to materials.
• Mechanical Testing: Ground truth is established by the engineering design specifications and predefined pass/fail criteria for each test (e.g., minimum force, number of cycles, dimensional tolerances).
• Functional Testing (Animal Model): Ground truth is established by the successful execution of the intended surgical function (approximating tissues, closing incision sites) in the animal model, as defined by appropriate veterinary/surgical endpoints. This typically involves observation of successful closure, absence of complications related to the device, and potentially histological examination of the tissue if relevant.

8. The Sample Size for the Training Set:

• This is not applicable as the device is a mechanical surgical instrument, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established:

• This is not applicable for the reason stated in point 8.

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The OverStitch Endoscopic Suturing System is intended for endoscopic placement of suture(s) and approximation of soft tissue.

The OverStitch™ Endoscopic Suturing System and accessories are intended for endoscopic placement of sutures and approximation of soft tissue within the gastrointestinal tract utilizing either a dual channel or single-channel endoscope. The system is comprised of the Needle Driver Assembly and Anchor Exchange Device (collectively referred to as ESS), and accessories such as the Tissue Helix, Suture Cinch and Suture Anchor Assembly devices. All devices are sterile packaged and designed for single use and are manufactured from various thermoplastic, silicone, stainless steel and other medical grade materials.

This document is a 510(k) summary for a medical device (OverStitch Endoscopic Suturing System) and thus does not contain the detailed study data, acceptance criteria, or ground truth establishment typically found in a full clinical study report or a premarket approval (PMA) application. A 510(k) submission primarily demonstrates substantial equivalence to a legally marketed predicate device, often relying on bench testing and comparisons of technological characteristics rather than extensive clinical trials for new functionality.

Based on the provided text, here's what can be extracted and what cannot:

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

The document states: "Appropriate product testing was performed to evaluate conformance to USP requirements, product specifications, and equivalence to the predicate design. The device was evaluated against individual functional and reliability requirements, as well as OverStitch Endoscopic Suturing System compatibility."

Specific quantitative acceptance criteria are not explicitly listed in this summary. Instead, it refers to conformance with USP requirements and product specifications.

The performance reported is qualitative: "The results of all studies confirmed substantial equivalence between the subject and predicate designs, and that no new issues of safety or efficacy were raised."

Performance Testing Mentioned:

• Bench testing included:
  • Needle passing reliability
  • Suture Cinch deployment and pull-off strength
  • Tensile strength per USP
  • Needle pull off strength per USP
  • Suture diameter measurements per USP
• Packaging Integrity: Confirmed by repeating testing in accordance with ASTM F1929-15, ASTM DI69-16, and ASTM F1886/F1886M-16.
• Biocompatibility: Performed in accordance with ISO 10933-1, including extractable and leachable studies (ISO 10993-18: 2005) and toxicological risk assessment (ISO 10993-17: 2002).

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

• Sample Size: Not specified in the provided summary.
• Data Provenance: The tests are "bench testing" and "packaging integrity" studies, which implies laboratory-based, non-clinical data. No specific country of origin is mentioned, but the FDA approval implies compliance with US standards. This is retrospective in the sense that the testing was completed prior to submission.

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 as the evaluation relies on a comparison to a predicate device and bench testing against established standards (USP, ASTM, ISO), rather than a clinical study requiring expert assessment of patient outcomes or images for ground truth.

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

• Not applicable. As this is primarily bench testing and comparison to a predicate device, there is no need for an adjudication method as would be used in a clinical study with human readers or assessments where consensus is required.

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 MRMC study was done. This device is a mechanical endosurgical suturing system, not an AI or imaging-based diagnostic tool. The concept of "human readers improving with AI assistance" is not relevant to this device. The document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence."

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

• Not applicable. This is a mechanical device, not an algorithm. Its performance is assessed through bench testing of its mechanical properties and functionality.

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

• The "ground truth" for this submission is established through conformance to recognized standards (USP, ASTM, ISO) and comparison to the performance characteristics of the legally marketed predicate device (K181141 - OverStitch™ Endoscopic Suturing System). It is not based on clinical "outcomes data" or "expert consensus" in the traditional sense of a diagnostic or therapeutic clinical trial. The phrase "no new issues of safety or efficacy were raised" implies the performance is deemed equivalent to the previously cleared device, which serves as a benchmark.

8. The sample size for the training set:

• Not applicable. This refers to a mechanical device, not a machine learning algorithm that requires a "training set."

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

• Not applicable. See point 8.

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The OverStitch Endoscopic Suturing System is intended for endoscopic placement of suture(s) and approximation of soft tissue.

The OverStitch™ Endoscopic Suturing System and accessories are intended for endoscopic placement of sutures and approximation of soft tissue within the gastrointestinal tract utilizing either a dual channel or single-channel endoscope. The system is comprised of the Needle Driver Assembly and Anchor Exchange Device (collectively referred to as ESS), and accessories such as the Tissue Helix, Suture Cinch and Suture-Anchor Assembly devices. All devices are sterile packaged and designed for single use and are manufactured from various thermoplastic, silicone, stainless steel and other medical grade materials.

The provided text is a 510(k) summary for the OverStitch™ Endoscopic Suturing System and Accessories. It outlines the device's technical specifications and the non-clinical performance data used to demonstrate substantial equivalence to a predicate device. However, it explicitly states that clinical performance data was not required for this submission.

Therefore, I cannot provide information on acceptance criteria and a study proving the device meets those criteria from this document, as the document focuses on non-clinical testing for substantial equivalence, not on establishing device performance against clinical acceptance criteria through a clinical study.

Here's a breakdown of what can be and cannot be extracted from the provided text based on your request:

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

• Cannot be provided. The document details non-clinical performance testing (e.g., needle passing reliability, pull-off strength) to show equivalence to a predicate device, but it does not specify explicit "acceptance criteria" for these performance metrics or report quantitative results against such criteria in a manner suitable for a table. It only states that the testing "confirmed conformance to product specifications" and "equivalency between the subject and predicate devices."

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

• Cannot be provided. The document mentions "product testing" and "bench testing" but does not detail the sample sizes used for these tests. Data provenance (country of origin, retrospective/prospective) is also not mentioned for the non-clinical tests.

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 document describes non-clinical bench testing and verification/validation activities for a physical medical device. The concept of "ground truth" established by experts, as would be relevant for diagnostic AI/imaging devices, does not apply to the type of testing described here.

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

• Not applicable. As above, the testing described is non-clinical performance testing of a physical device, not an interpretation-based study where adjudication would be relevant.

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. The document explicitly states: "Clinical Performance Data: Clinical testing was not required to demonstrate substantial equivalence." An MRMC study is a type of clinical study, typically for diagnostic devices or AI applications, which was not performed or submitted here.

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

• No. This device is a mechanical endoscopic suturing system; it is not an algorithm or AI system.

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

• Not applicable. "Ground truth" in the context of expert consensus, pathology, or outcomes data is relevant for clinical studies, particularly for diagnostic devices or AI. The testing described here is non-clinical performance testing against product specifications.

8. The sample size for the training set

• Not applicable. This device is a physical medical instrument, not a machine learning model, so there is no "training set."

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

• Not applicable. As above, this is not a machine learning model.

In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence for a physical medical device through non-clinical performance, materials, and sterilization testing, rather than presenting clinical study data with acceptance criteria for device performance.

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