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Regeneten Bioinductive Implant is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

Regeneten Bioinductive Implant is a resorbable type I bovine Achilles-derived collagen implant that provides a layer of collagen over injured tendons. The device is designed to provide a layer between the tendon and the surrounding tissue during healing. The device features a large porosity design with a low tensile modulus to allow for recipient tissue ingrowth into the implant at the repair site for natural remodeling and the passive formation of collagen over injured tendons. The physical structure and placement of Regeneten Bioinductive Implant provides and supports an environment for healing. When hydrated, Regeneten Bioinductive Implant is an easy-to-use, soft, pliable, nonfriable, porous implant. Regeneten Bioinductive Implant is provided as a sterile, single-use device in a variety of sizes. The arthroscopic configuration of the Bioinductive implant is preloaded in a cartridge and packaged in a sterile, dual seal tray-in-tray configuration.

The provided text does not describe a study involving an AI/ML powered medical device, an imaging device, or any study that would require acceptance criteria as typically understood for such devices (e.g., accuracy, sensitivity, specificity).

The document is an FDA 510(k) premarket notification for a medical device called the "Regeneten Bioinductive Implant," which is a surgical mesh for managing and protecting tendon injuries. The core of the submission argues for substantial equivalence to a predicate device (Rotation Medical Collagen Tendon Sheet-DDI).

Therefore, I cannot extract the requested information regarding acceptance criteria, study design, expert involvement, ground truth establishment, or sample sizes related to an AI/ML or imaging study from this document. The document explicitly states:

• "No clinical study was conducted for the predicate device and a clinical study was not required to substantiate new performance claims for the subject device."
• "Published clinical literature from investigator-initiated post-market clinical studies was reviewed in this submission in support of new performance claims for the subject device."
• "This submission does not include any performance or preclinical testing and therefore, is not claiming compliance to any new FDA recognized consensus standards."

The additional performance claims for the Regeneten Bioinductive Implant (bioinduction, formation of tendon-like tissue, and change the course of tear progression) are supported by:

• Review of an animal study (from section 19, not provided here).
• Review of published clinical literature from investigator-initiated post-market clinical studies (from section 20, not provided here).

Since the original request specifically asks for details related to acceptance criteria and a study proving a device meets these criteria in the context of AI/ML or imaging, and this document pertains to a resorbable collagen implant and lacks the mentioned study types, I must state that the information requested is not present in the provided text.

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The Smith+Nephew INTELLIO 4K CCU is intended for use in diagnostic, and operative endoscopic surgical procedures, including but not limited to, for example: orthopedic procedures, laparoscopic procedures, and otolaryngology (sinuscopic) procedures when used with an appropriately indicated endoscope.

The Smith & Nephew INTELLIO 4K CCU is a part of the Smith & Nephew visualization system. It is an all-in-one 4K imaging console and LED light source designed for endoscopic surgical procedures. The CCU is compatible with the LENS 4K Camera Head. The functional system level architecture of this device demonstrates multiple functions, that includes the illumination of surgical space and capturing of raw imaging data from the camera sensors. It also processes the imaging data and transfers it to the attached monitor for display. Apart from capturing still images and video during the procedure, the device also adjusts the visualization settings (brightness, line enhancement, color saturation/hue and image zoom) and allows optional communication to a medical tablet to facilitate centralized control of all tower devices from the tablet. The device contains of a Wi-Fi board that supports communication frequency of 2.4 GHz and 5.0 GHz. The device uses a LED light engine to illuminate the surgical space. The User Interface (UI) consists of buttons and LEDs that can be accessed on the front panel, which also contain the ports for camera head connector and USB slots for medical tablet and flash drive.

The provided text is a 510(k) summary for the Smith & Nephew Intellio 4K Camera Control Unit. It outlines the device description, indications for use, comparison to a predicate device, and non-clinical performance data.

However, the document does not contain any information regarding acceptance criteria, study details, or performance metrics in the context of device performance meeting acceptance criteria as typically seen for AI/ML device clearances. The "Non-Clinical Performance Data" section lists various engineering tests (Shock and Vibration, EMI/EMC, Safety, Packaging Design Verification) that were performed and states they "passed all acceptance criteria." However, it does not provide the specific numerical acceptance criteria or the reported performance data for these tests.

Furthermore, it explicitly states: "Clinical Performance Data: Clinical testing was not necessary for the determination of substantial equivalence." This indicates that no human-in-the-loop or standalone performance study, as described in your request (e.g., MRMC study, ground truth establishment, expert adjudication), was performed or provided for this 510(k) submission.

Therefore,Based on the provided text, I cannot fulfill your request for the following reasons:

• No Acceptance Criteria or Performance Data for "Device Performance" (as in clinical/diagnostic performance): The document refers to acceptance criteria for engineering tests (e.g., shock, vibration, safety), stating they passed, but it does not provide specific acceptance criteria or performance results for these tests. Crucially, it does not describe any clinical or diagnostic performance criteria or studies that would involve AI/ML components or human-in-the-loop performance.
• No Clinical Study Data: The document explicitly states "Clinical testing was not necessary for the determination of substantial equivalence." This means there is no data on:
  • Sample size for test sets
  • Data provenance
  • Number or qualifications of experts for ground truth
  • Adjudication methods
  • MRMC studies or effect sizes
  • Standalone algorithm performance
  • Type of ground truth used (clinical, pathology, outcomes)
  • Training set sample size or ground truth establishment for a training set (as no AI/ML component seeking performance clearance is mentioned).

This 510(k) focuses on substantial equivalence to a predicate device for a camera control unit and its accessories, primarily based on technological similarities and non-clinical engineering performance, not on a device that utilizes AI/ML requiring clinical performance validation as implied by your detailed request.

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The LENS 4K Camera Control Unit and LENS 4K Camera Head are used in diagnostic and operative procedures for arthroscopic and endoscopic procedures to provide illumination, visualization and capture of surgical sites within articular cavities, body cavites, hollow organs and canals. Additionally, the LENS 4K Camera Control Unit and LENS 4K Camera Head are indicated for use in endoscopic surgical procedures in the thoracic cavity when used with an appropriately indicated thoracoscope.

The Smith & Nephew LENS 4K System ( 4K Camera Control Unit (CCU) and LENS 4K Camera Head), is an integrated camera/ LED light source/ image management device that provides visualization, illumination and image/video capture combined in a single console. The LENS 4K CCU works in conjunction with a camera head, appropriate light guides, couplers and endoscopes. The LENS 4K CCU will be offered in two versions, one with Wi-Fi and one without Wi-Fi. The non-Wi-Fi version does not have the ability to communicate to a tablet but captures the data to an attached USB storage device or to the Smith & Nephew 660HD-E Image Management System, which is a Class 1 device per LMB for display and sharing for display and sharing. Additionally, the LENS 4K System will also work with an optional Tablet Application, which was cleared in K190367. The Tablet application, when downloaded to a mobile device, acts as a tool to remotely capture video recordings and image files wirelessly from the LENS 4K System. The application provides the ability to view and annotate by voice or graphics or to text. Sharing of patient data from the Tablet is provided via the ability to archive to a USB storage device on the CCU, email, printing, or export to the local tablet camera roll.

This FDA 510(k) summary for the Smith & Nephew LENS 4K System (K191177) describes a device that provides illumination, visualization, and image/video capture for arthroscopic and endoscopic procedures. The information provided heavily focuses on demonstrating substantial equivalence to a predicate device (Smith & Nephew LENS Integrated System, K153606), rather than presenting a detailed study proving the LENS 4K System meets specific performance acceptance criteria found in a typical clinical trial.

However, based on the provided text, we can extract details related to performance testing and acceptance criteria to the extent possible.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" against which "device performance" is reported in a numerical table format, as would be common for a medical imaging AI product. Instead, it lists categories of testing performed to demonstrate that the device "met the established performance specifications." Therefore, the table below reflects the types of testing done and the general conclusion drawn, rather than specific numerical criteria and results.

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

This information is not provided in the document. The filing focuses on demonstrating substantial equivalence based on engineering and performance testing rather than clinical study data. There is no mention of a "test set" in the context of patient data or images.

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

This information is not provided in the document. As there is no mention of a test set involving patient data/images for which ground truth would be established by experts, this section is not applicable.

4. Adjudication Method for the Test Set

This information is not provided in the document. Not applicable given the absence of a clinical test set.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or performed based on the provided document. The device is a camera system, not an AI-assisted diagnostic tool designed to improve human reader performance.

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

A standalone performance study in the context of an algorithm's diagnostic accuracy was not performed or mentioned. This device is a camera system for visualization during surgery, not an AI algorithm performing a diagnostic task. The "performance data" mentioned (video output, temperature, software V&V, etc.) refers to the engineering and functional performance of the hardware and associated software.

7. Type of Ground Truth Used

The concept of "ground truth" as typically applied to diagnostic AI algorithms (e.g., pathology, expert consensus) is not applicable here. The performance testing described (Video Output, Camera Head Surface Temperature, Software V&V, Emissions, Electrical Safety) would rely on objective engineering measurements and verification against design specifications and relevant standards, rather than clinical ground truth derived from patient outcomes or expert interpretations.

8. Sample Size for the Training Set

This information is not provided in the document. The device is a hardware system with associated software, not a machine learning model that requires a training set in the AI sense.

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

This information is not provided in the document. Not applicable as there is no mention of a training set for an AI model.

Summary of Study Type:

The provided document describes a 510(k) premarket notification for a medical device (a 4K camera system for endoscopy). The 'study' referred to is a series of engineering and functional performance tests conducted on the device itself to ensure it meets established design specifications and relevant regulatory standards (e.g., electrical safety, emissions). The primary goal of the submission is to demonstrate substantial equivalence to an existing predicate device (Smith & Nephew LENS Integrated System, K153606) based on similar intended use, fundamental scientific technology, basic design, and comparable performance. It is not a clinical study evaluating diagnostic accuracy or physician performance, nor is it related to AI/ML software performance studies that would typically involve test sets, ground truth, and expert readers.

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The Double ENDOBUTTON Fixation Device is intended for the treatment of anterior glenoid bone loss using the Latarjet or bone block procedure (allograft or autograft).

The subject of this Traditional 510(k) is the Double ENDOBUTTON Fixation Device. The Smith & Nephew Double ENDOBUTTON Fixation Device is used during the healing period of osteotomies for orthopedic reconstruction and to assist in the management of fracture fixation. The device consists of three components: two stainless steel fixation devices and a UHMW polyethylene suture. This device is provided sterile, for single use only.

The provided document is an FDA 510(k) clearance letter and associated summary for a medical device (Double ENDOBUTTON Fixation Device). It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain the information requested in points 1-9 regarding acceptance criteria and a study proving a digital health device or AI/ML device meets those criteria.

Specifically, the document discusses a mechanical fixation device used in orthopedic surgery, not a software device or an AI/ML algorithm. Therefore, the concepts of "acceptance criteria" for an AI/ML model, "sample size for test set," "ground truth establishment," "MRMC study," or "standalone performance" are not applicable to the content of this document.

The performance data mentioned in the document refers to:

• Mechanical testing: Interface pressure, suture construct tests.
• Bacterial endotoxin testing.
• Clinical literature review: Comparing complication rates and clinical outcome scores (ROWE, Walch-Duplay, ASES) between the device's usage and predicate screws.

Since the document provided does not describe an AI/ML device or its validation, I cannot fill in the requested table and information.

To answer your request, I would need a document describing the validation of an AI/ML or digital health device.

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The Smith & Nephew MICRORAPTOR Knotless Suture Anchor is intended for use only for the reattachment of soft tissue to bone for the following indications:

Hip
• Acetabular labrum repair/reconstruction

Shoulder

• Capsular stabilization
• Bankart repair
• Anterior shoulder instability
• SLAP lesion repairs
• Capsular shift or capsulolabral reconstructions
• Biceps tenodesis
• · Rotator cuff tear repairs

The MICRORAPTOR Knotless Suture Anchor consists of an anchor on an inserter fitted with a suture passer, and two accessory drills. The anchor consists of the following components: a proximal anchor body (REGENESORB or PEEK), and a non-absorbable PEEK distal anchor tip. The anchor is preloaded on a stainless steel inserter. This device is provided sterile, for single use only.

The provided text is a 510(k) Summary for the MICRORAPTOR Knotless Suture Anchor, a medical device. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a clinical or AI-based study.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

The "Summary Performance Data" section mentions that the device met "performance specifications for insertion strength and pullout strength" and "met performance specifications for cyclic loading based on the predicate." However, it does not explicitly state what those specifications (acceptance criteria) were or provide numeric results of the testing. It implies that these were mechanical engineering tests, not studies involving human readers or AI.

This document is for a physical medical device (suture anchor), not software or an AI device. The questions in the prompt are more relevant to AI/software device submissions, particularly those involving image analysis or diagnostic support.

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The Smith & Nephew MICRORAPTOR Suture Anchor is intended for the reattachment of soft tissue to the following indications:

Hip
Acetabular labrum repair/reconstruction

Shoulder

• Capsular stabilization
• Bankart repair
• Anterior shoulder instability
• SLAP lesion repairs
• Capsular shift or capsulolabral reconstructions
• Biceps tenodesis

The Smith & Nephew MICRORAPTOR Suture Anchor consists of an anchor on a flexible and/or straight inserter, flexible and/or straight drill, and curved and/or straight insertion accessory instruments. The implant will be offered in an absorbable material (REGENESORB), single loaded #1 ULTRABRAID suture with multiple suture color offerings. This device is provided sterile, for single use only.

This document is a 510(k) Pre-Market Notification for a medical device called the "MICRORAPTOR REGENESORB Suture Anchor". It describes the device's intended use and demonstrates its substantial equivalence to previously cleared predicate devices, rather than a clinical study evaluating the performance of an AI/ML powered device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, expert involvement, and comparative effectiveness studies for an AI device is not applicable to this document.

This document describes the following for the MICRORAPTOR REGENESORB Suture Anchor:

1. Acceptance Criteria and Reported Device Performance (Summary):

The performance of the MICRORAPTOR REGENESORB Suture Anchor was evaluated against performance specifications derived from its predicate devices.

Study Description (Summary per the provided text):

The submission refers to "Performance data" to demonstrate that the MICRORAPTOR REGENESORB Suture Anchor met the specified criteria. These appear to be benchtop or laboratory tests, not clinical studies involving human subjects or AI algorithms.

• Bacterial Endotoxin Testing: Was completed and met acceptable endotoxin limits per ANSI/AAMI ST72:2011.
• Insertion Strength Testing: Performance data demonstrates the device met specifications based on the predicate Pivot NANOTACK Suture Anchor, 1.4mm (K131769).
• Cyclic Loading Testing: Performance data demonstrates the device met specifications based on the predicate OSTEORAPTOR Suture Anchor (K082215).

Given that this document describes a traditional medical device (suture anchor) and not an AI/ML powered device, the following points are not applicable and are therefore marked as "N/A":

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): N/A (This is for an AI/ML powered device, not a suture anchor)
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): N/A
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A
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: N/A
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A (The "ground truth" here is the performance of specified predicate devices and standard endotoxin limits for a physical device)
8. The sample size for the training set: N/A
9. How the ground truth for the training set was established: N/A

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The Smith & Nephew SUTUREFIX Curved Suture Anchors are intended for the secure fixation of soft tissue to bone for the following indications:

Hip
• Acetabular labrum repair/reconstruction

Shoulder

• · Capsular stabilization
• Bankart repair
• Anterior shoulder instability
• SLAP lesion repairs
• Capsular shift or capsulolabral reconstructions
• Rotator cuff tear repairs
• Bicepts tenodesis

The Smith & Nephew SUTUREFIX Curved suture anchor system consists of an all suture based implant, hole preparation, and curved insertion accessory instruments. The implant will be offered in multiple suture configurations including single and double loaded suture options. The instruments will include sterile flexible drills and reusable curved drill guides and obturators.

This document is a 510(k) premarket notification for a medical device, specifically the Smith & Nephew SUTUREFIX Curved Suture Anchor. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study of the device's performance against specific acceptance criteria.

Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not present in this type of regulatory submission. The document states that performance data exists, but does not provide the specifics of those studies.

Here's a breakdown of the available information based on your request:

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

Note: The specific numerical acceptance criteria and reported values for insertion and pull-out strength are not provided in this summary.

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

Not provided in this document. The document mentions "Performance data demonstrates," but does not specify the sample sizes or the provenance (e.g., country of origin, retrospective/prospective nature) of the data.

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

Not applicable/Not provided. This is a physical device, and the "ground truth" would relate to its physical and mechanical properties, not an assessment by human experts in the way an AI or diagnostic device would require.

4. Adjudication method for the test set

Not applicable/Not provided. See point 3.

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 surgical implant, not an AI or diagnostic device that involves human readers/interpreters.

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

Not applicable. This is a surgical implant, not an algorithm.

7. The type of ground truth used

For the physical performance tests (insertion strength, pull-out strength, bacterial endotoxin), the "ground truth" would be established by objective laboratory measurements following validated test methods.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI model 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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