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The SPEEDTRAP suture construct is indicated for use in soft tissue approximation in orthopedic procedures.

The SPEEDTRAP graft preparation system consists of a suture construct provided on a disposable delivery device. The SPEEDTRAP Graft Preparation system is offered in long and short configurations with white (undyed) and green/white (undyed) color options, including single and multi-pack (Qty. 4) offerings.

This document is a 510(k) summary for the SPEEDTRAP Graft Preparation System, a medical device for soft tissue approximation. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study demonstrating the device meets those criteria, as typically found in an AI/software medical device submission.

However, it does describe the types of tests performed to establish equivalence.

Here's an analysis based on the provided text, highlighting the absence of the requested information for AI/software devices and interpreting the available data in the context of a traditional medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a formal table of acceptance criteria with corresponding performance data in the way one would expect for an AI/software medical device. Instead, it states that "Performance data equivalence was established using non-clinical testing, including suture diameter and suture tensile strength testing." It also mentions "bacterial endotoxin testing."

While not explicitly called "acceptance criteria," the regulatory standards and testing performed for substantial equivalence imply certain thresholds must have been met for these non-clinical tests.

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

• Test Set Sample Size: Not specified. The document states "non-clinical testing" was performed, but the number of sutures or tests conducted for diameter, tensile strength, or endotoxin is not provided.
• Data Provenance: Not applicable in the context of human data. These are non-clinical (laboratory/bench) tests on the physical device itself.

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

Not applicable. Ground truth, in the context of AI/software devices, refers to expert labeling or pathology. For this physical medical device, "ground truth" would be established by standardized measurement techniques and laboratory protocols for the non-clinical tests. No human experts are mentioned for establishing ground truth for these device performance metrics.

4. Adjudication Method for the Test Set:

Not applicable. This concept is for human expert review of cases, typically for AI/software validation. The performance tests described (suture diameter, tensile strength, bacterial endotoxin) are objective laboratory measurements, not subjective expert assessments requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, usually in diagnostic imaging. The SPEEDTRAP Graft Preparation System is a physical surgical suture system, not an AI/software diagnostic tool.

6. If a Standalone Performance Study (Algorithm Only) was done:

No, a standalone (algorithm only) performance study was not done. This is specific to AI/software devices operating without human intervention. The SPEEDTRAP system is a manually implanted surgical device.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" would be the objective, measured values obtained through standardized laboratory testing methods. For instance, for suture diameter, the ground truth would be the measurement obtained using a calibrated micrometer; for tensile strength, it would be the force at break measured by a tensile testing machine according to a standard. It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set:

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI.

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

Not applicable, as there is no training set for this type of device.

In summary: The provided document is a 510(k) summary for a physical medical device (suture system). It details regulatory information and establishes substantial equivalence based on material, design, and non-clinical performance (suture diameter, tensile strength, bacterial endotoxin). The questions provided are primarily geared towards the validation of Artificial Intelligence/Software as a Medical Device (AI/SaMD), and thus, most of them are not directly applicable to the content presented in this document.

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The GRYPHON PEEK Anchor is intended for: Shoulder: Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Elbow: Ulnar or Radial Collateral Ligament Reconstruction; Hip: Capsular repair, acetabular labral repair.

The Gryphon PEEK Anchors are non-absorbable threaded suture anchors manufactured of PEEK material. The barbed anchor comes preloaded on a disposable inserter assembly and is intended for fixation of #2 suture to bone. The Gryphon PEEK Anchor is provided as size 3.0mm. The Gryphon PEEK Anchors will be offered with partially absorbable Orthocord suture options, similar to the Gryphon P BR Anchor. Technologies characteristics including design and packaging are the same as the predicate cleared devices.

The provided text is a 510(k) summary for a medical device called the "Gryphon PEEK Anchor." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a standalone study with detailed performance metrics.

Therefore, the information you've requested regarding acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, and ground truth establishment methods for a new study is not present in this document.

The study described here is primarily a comparative assessment to existing, legally marketed devices (predicates) to establish substantial equivalence.

Here's what can be extracted from the document in relation to your questions, and what cannot:

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

• Not explicitly provided as a table with specific quantitative acceptance criteria or a detailed breakdown of reported performance values.
• The document states: "Non clinical Testing Verification activities were performed on the implant or its predicates. Testing assessments include pull out testing, shelf-life, sterilization and biocompatibility. Safety and Performance Results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices."
• This indicates that mechanical performance (pull-out strength) and other safety aspects were tested, and the results were found to be comparable to existing devices, satisfying the "substantial equivalence" criteria for regulatory approval. However, no numerical values or specific thresholds are given.

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

• Not specified. The document mentions "pull out testing" but does not give sample sizes, origin of data, or details on whether the testing was conducted on clinical samples or benchtop models.

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 specified. This scenario is for a mechanical device; "ground truth" as typically understood in AI/imaging studies (e.g., expert consensus on image interpretation) is not relevant here. Device performance is determined by engineering tests (e.g., measuring pull-out force).

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

• Not applicable/Not specified. 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 device is a surgical anchor, not an AI or imaging diagnostic tool. An MRMC study would not be relevant.

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

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

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

• Mechanical testing results. The "ground truth" for a device like this would be derived from objective engineering measurements (e.g., the force at which the anchor pulls out of bone substitute).

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device. There is no concept of a "training set."

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

• Not applicable. See point 8.

In summary:

The document describes a 510(k) submission for a non-absorbable threaded suture anchor. The "study" mentioned is focused on "Non clinical Testing Verification activities... includ[ing] pull out testing, shelf-life, sterilization and biocompatibility." The primary conclusion drawn from these activities is that the device is "substantially equivalent to predicate devices." This type of regulatory submission does not typically involve the detailed breakdown of performance metrics, sample sizes, and ground truth establishment methods that would be seen in an AI or diagnostic study.

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The MINI QuickAnchor Plus is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows:
Shoulder: Bankart Repair
Wrist: Scapholunate ligament reconstruction.
Hand: Thumb ulnar or radial collateral ligament.
Foot: Hallux valgus reconstruction.
Ankle: Midfoot reconstruction.

The MINILOK QuickAnchor Plus is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows:
Wrist: Scapholunate ligament reconstruction.
Hand: Thumb ulnar or radial collateral ligament.
Foot: Hallux valgus reconstruction.
Ankle: Midfoot reconstruction.

The MiniQuick Anchor Plus w/ Orthocord, and MINILOK QuickAnchor w/ Orthocord, are preloaded disposable anchor/inserter assemblies designed to facilitate the delivery and installation of the anchor into bone.

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of performance metrics like accuracy, sensitivity, or specificity. Instead, the document is a 510(k) summary for a medical device (MINILOK QuickAnchor Plus and Mini QuickAnchor Plus with Orthocord sutures), which primarily focuses on demonstrating substantial equivalence to pre-existing legally marketed devices.

The information provided includes:

• Device Description: Explains the nature of the anchors and sutures.
• Proposed Indications for Use: Specifies the medical conditions and anatomical locations for which the devices are intended.
• Safety Information: Mentions biocompatibility studies demonstrating non-toxicity, non-irritation, non-sensitization, and non-cytotoxicity.
• Substantial Equivalence: Lists predicate devices to which the current device is deemed substantially equivalent.

There is no mention of:

• A table of acceptance criteria and reported device performance in terms of clinical or technical metrics.
• Sample sizes for test sets, data provenance, or details about training sets.
• The number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
• Standalone algorithm performance.
• Types of ground truth used (e.g., pathology, outcomes data).

Therefore, based on the input document, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them, as this type of information is not present in the provided 510(k) summary. These summaries historically focus on demonstrating equivalence through design, materials, and intended use to predicate devices, rather than presenting detailed prospective clinical trial data with specific performance metrics and acceptance thresholds.

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The RC Loop Anchor with Dual Orthocord Suture is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows: Rotator cuff repair

RC Loop with Dual Suture is a preloaded, absorbable disposable suture anchor/ inserter assembly for rotator cuff repair. The absorbable polylactic acid (PLA) anchor is an identical anchor as that of the Panalok RC Loop Anchor in design and configuration. The absorbable anchor is a one piece suture anchor constructed of molded Poly (L-lactide) polymer. The anchor system may be sold with Ethibond Suture (NDA 17-804 and 17-809), Panacryl Suture (K964345), or Orthocord Suture (K040004 and K043298).

The information provided describes a 510(k) premarket notification for a medical device and not a study assessing device performance against acceptance criteria in the context of AI/ML or diagnostic accuracy. Therefore, most of the requested information regarding acceptance criteria, study design, expert ground truth, and reader studies is not present in the provided text.

However, I can extract the relevant information regarding the type of assessment performed for this medical device:

Device: RC Loop Anchor with Dual Orthocord Suture

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified.
• Data Provenance: Not applicable. The "test set" in this context refers to physical bench testing, not a dataset of medical images or patient records. This was a bench test, and not a clinical study.

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

• Number of Experts: Not applicable. Ground truth for bench testing is established by technical specifications and validated testing methodologies, not expert consensus in a clinical diagnostic sense.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable. Bench testing results are typically evaluated against predefined engineering and material standards.

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:

• MRMC Study: No. This is a physical medical device (suture anchor), not an AI/ML diagnostic tool.

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

• Standalone Performance: Not applicable. This is a physical medical device.

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

• Type of Ground Truth: Engineering specifications, material standards (e.g., USP monograph), and predefined technical criteria for suture compatibility and deployment.

8. The sample size for the training set:

• Sample Size: Not applicable. This refers to a physical medical device, not an AI/ML algorithm.

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

• How Ground Truth Was Established: Not applicable.

Summary of the Study:

The provided text describes a 510(k) Premarket Notification for a medical device. The "study" mentioned is a series of bench tests conducted to demonstrate that the RC Loop Anchor with Dual Orthocord Suture is "substantially equivalent" to a predicate device.

• Study Type: Bench testing (not a clinical trial, diagnostic accuracy study, or AI/ML performance study).
• Purpose: To demonstrate conformance to consensus and voluntary standards, and that the device performs as intended in terms of material properties (suture conformance to USP monograph) and functional aspects (suture compatibility and deployment).
• Conclusion: Based on the bench testing, device description, and comparison to predicate devices, the manufacturer concluded that the device is substantially equivalent to predicate devices.

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The Mitek Super QUICKANCHOR Anchor Plus is intended for fixation of USP size #2 through #5 suture to bone for the indications listed below.

Shoulder: Rotator cuff repair; capsular repair; biceps repair; deltoid repair.

Ankle: Achilles tendon repair/reconstruction.

Knee: Extra capsular repairs; Reattachment of: medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions.

Super Quickanchor Plus (with ORTHOCORD) is a preloaded, metallic disposable suture anchor/ inserter assembly designed to allow soft tissue repair to bone. The metal anchor is an identical anchor as that of the Super Quickanchor Plus in design, configuration and dimensions. The anchor system may be sold with Ethibond Suture (NDA 17-804 and 17-809), Panacryl Suture (K964345), or Orthocord Suture (K040004 and K043298).

The provided text describes the "Super Quickanchor Plus" device and its 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. This document is a premarket notification for a medical device and therefore does not contain the kind of detailed study information (e.g., acceptance criteria, test set sample sizes, expert qualifications, HR/AI performance improvement, training set details) associated with demonstrating the performance of a device against specific acceptance criteria.

The document primarily states that the determination of substantial equivalence was based on:

• Detailed device description
• Conformance to consensus and voluntary standards
• Bench testing: This bench testing "demonstrated that the ORTHOCORD suture conformed to the USP monograph for absorbable sutures, and the suture compatibility and deployment met predetermined acceptance criteria."

Therefore, it's impossible to fill out most of the requested table and answer the study-specific questions based on the provided text. The text confirms that some acceptance criteria related to suture conformity, compatibility, and deployment were met through bench testing, but it does not specify what those criteria were or the details of the study.

Here's what can be extracted and what cannot:

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

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

• Sample Size: Not specified.
• Data Provenance: Not specified, but generally, bench testing for 510(k) submissions would be laboratory-based rather than patient data.

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 was bench testing, not a clinical study involving expert interpretations of data.

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

• Not applicable. This was bench testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is a medical device (surgical anchor), not an AI diagnostic or interpretive tool.

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

• Not applicable. This is a medical device (surgical anchor).

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

• For the bench testing described, the "ground truth" would be objective measurements and adherence to technical specifications and standards (e.g., USP monograph specifications, engineering performance metrics for deployment forces, mechanical integrity).

8. The sample size for the training set

• Not applicable. This is a medical device, not an AI/machine learning model that undergoes "training."

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

• Not applicable.

Summary of what the document does communicate regarding device performance:

The document states that the Super Quickanchor Plus (with ORTHOCORD) was found to be substantially equivalent to its predicate device (Super Quickanchor Plus, K041116). This determination was supported by bench testing that confirmed:

• The ORTHOCORD suture conformed to the USP monograph for absorbable sutures.
• The suture compatibility and deployment met predetermined acceptance criteria.

These statements confirm that certain performance standards were met, but the specific numerical values of the acceptance criteria and the detailed results of the bench testing are not included in this 510(k) summary.

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Output:
The Mitek Rotator Cuff QuickAnchor® Plus is indicated for Rotator cuff repair.

Rotator Cuff Quickanchor Plus (with ORTHOCORD) is a preloaded metallic disposable suture anchor/ inserter assembly designed to allow soft tissue repair to bone. The metal anchor is an identical anchor as that of the Rotator Cuff Quickanchor Plus in design, configuration and dimensions. The anchor system may be sold with Ethibond Suture dimensions. (NDA 17-804 and 17-809), Panacryl Suture (K964345), or Orthocord Suture (K040004 and K043298).

The provided text is a 510(k) summary for the "Rotator Cuff Quickanchor Plus" device. It describes a suture anchor system used for rotator cuff repair. However, it does not include a study that proves the device meets specific acceptance criteria in the way described in your request (i.e., with reported device performance alongside acceptance criteria, detailed sample sizes, expert involvement, etc.).

Instead, the document states:

"The determination of substantial equivalence for this device was based on a detailed device description, and conformance to consensus and voluntary standards. Bench testing was performed demonstrating that the ORTHOCORD suture conformed to the USP monograph for absorbable sutures, and the suture compatibility and deployment met predetermined acceptance criteria."

This indicates that some bench testing was done against "predetermined acceptance criteria" for suture compatibility and deployment, and that the ORTHOCORD suture conformed to a USP monograph. However, the document does not provide the specific acceptance criteria themselves, nor does it detail the results of this bench testing beyond a general statement of conformance.

Therefore, I cannot fulfill your request to create a table of acceptance criteria and reported device performance, or provide details about sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone performance, as this information is not present in the provided text.

The document primarily focuses on establishing substantial equivalence to a predicate device (Rotator Cuff Quickanchor Plus, K992611) manufactured by the same company, based on design, configuration, and intended use, rather than presenting a performance study with detailed acceptance criteria and results.

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The Mitek GII Anchor (QUICKANCHOR) is intended for fixation of USP size #2 suture to bone for the indications listed below.

Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsulo-labral reconstruction, biceps tenodesis, deltoid repair.

Ankle: Lateral instability, medial instability, achilles tendon repair/reconstruction, midfoot reconstruction.

Foot: Hallux valgus reconstruction.

Wrist: Scapholunate ligament.

Hand: Ulnar or lateral collateral ligament reconstruction.

Elbow: Tennis elbow repair, biceps tendon reattachment.

Knee: Extra capsular repairs; Reattachment of: medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions.

GII Quickanchor Plus (with ORTHOCORD) is a preloaded, metallic disposable suture anchor/ inserter assembly designed to allow soft tissue repair to bone. The metal anchor is an identical anchor as that of the GII Quickanchor Plus in design, configuration and dimensions. The anchor system may be sold with Ethibond Suture (NDA 17-804 and 17-809), Panacryl Suture (K964345), or Orthocord Suture (K040004 and K043298).

The GII Quickanchor Plus is a medical device designed for soft tissue repair to bone using a preloaded, metallic disposable suture anchor/inserter assembly. The following details the acceptance criteria and the study that demonstrates the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not specify a distinct "test set" for the GII Quickanchor Plus separate from the general bench testing. The evaluation was based on conformance to consensus and voluntary standards and bench testing. Therefore, details regarding sample size for a specific test set, country of origin, or retrospective/prospective nature of the data are not provided.

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

This information is not provided in the document. The evaluation relies on "conformance to consensus and voluntary standards" and "bench testing" rather than expert-established ground truth on case data.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the testing described (bench testing for material conformance and system deployment), an adjudication method as typically applied to clinical or imaging datasets is not applicable or described.

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

No MRMC comparative effectiveness study is mentioned. The submission is for a medical device (suture anchor), not an AI diagnostic tool that would typically involve human reader performance evaluation.

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

This is not applicable as the GII Quickanchor Plus is a physical medical device, not an algorithm or AI system. The "standalone" performance refers to the device's ability to meet its functional specifications during bench testing. The bench testing demonstrated that the Orthocord suture, suture compatibility, and deployment met predetermined acceptance criteria.

7. Type of Ground Truth Used

The ground truth used was based on:

• USP monograph for absorbable sutures: This serves as a standardized, objective benchmark for material properties.
• Predetermined acceptance criteria for suture compatibility and deployment: These are internal engineering specifications established to ensure the device functions as intended.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical medical implant, not an AI model that requires a training set of data.

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

This information is not applicable, as there is no training set mentioned for this device.

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The Lupine Loop Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows:

OPEN PROCEDURES SHOULDER

1. Bankart repair
2. SLAP lesion repair
3. Rotator cuff repair
   4a. Capsule shift/capsulo-labral reconstruction, at the anterior glenoid rim site
   4b. Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus
4. Biceps tenodesis
5. Acromio-clavicular separation
6. Deltoid repair

ELBOW

1. Biceps tendon reattachment
2. Tennis elbow repair

ANKLE

1. Achilles tendon repair/reconstruction
2. Lateral stabilization
3. Medial stabilization at the medial talus site
   Foot: Hallux Valgus reconstruction
4. Midfoot reconstruction

KNEE

1. Medial collateral ligament repair
2. Lateral collateral ligament repair
3. Joint capsule closure to anterior proximal tibia
4. Posterior oblique ligament or joint capsule to tibia repair
5. Extra capsular reconstruction / ITB tenodesis
6. Patellar ligament and tendon avulsion repairs.

ARTHROSCOPIC PROCEDURES SHOULDER

1. Bankart repair
2. SLAP lesion repair
3. Rotator cuff repair
4. Capsule shift repair (glenoid rim)

Lupine Loop System is a preloaded, absorbable disposable suture anchor/ inserter assembly designed to allow soft tissue repair to bone. The absorbable polylactic acid (PLA) anchor is an identical anchor as that of the Panalok Loop Anchor in design, configuration and dimensions. The absorbable anchor is a one piece suture anchor constructed of molded Poly (L-lactide) polymer. The anchor system may be sold with Ethibond Suture (NDA 17-804 and 17-809), Panacryl may be sold with bor Orthocord Suture (K040004 and K043298).

This document, K050771, is a 510(k) Premarket Notification for the Lupine Loop Anchor system. It focuses on establishing substantial equivalence to a predicate device rather than presenting a standalone study with detailed performance metrics and acceptance criteria for the new device as a medical AI submission would. Therefore, much of the requested information regarding acceptance criteria and a study proving those criteria are met is not present in this type of submission.

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

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: The document states that the Lupine Loop Anchor was evaluated for "suture compatibility and deployment met predetermined acceptance criteria." However, the specific numerical or descriptive acceptance criteria themselves are not provided.
• Reported Device Performance: The document states that the device "met predetermined acceptance criteria" for suture compatibility and deployment. However, the actual reported performance data (e.g., tensile strength, deployment force, success rate) is not provided.

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

• Sample Size: The document does not specify a sample size used for any testing.
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given the nature of a 510(k) for a physical medical device (a suture anchor), pre-clinical testing would typically be laboratory-based mechanical or biocompatibility testing rather than clinical data in the sense of a medical AI product.

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

• This information is not applicable to this type of submission. "Ground truth" in the context of expert consensus is relevant for diagnostic or image-based AI devices. For a physical device like a suture anchor, ground truth would typically be established through engineering specifications, material properties, and mechanical testing standards.

4. Adjudication Method for the Test Set

• This information is not applicable to this type of submission. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among human readers in diagnostic studies, which is not the type of study described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This type of study assesses how AI assistance impacts human reader performance, which is not relevant for a standalone physical device like a suture anchor.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

• Yes, in spirit, a "standalone" assessment of the device's physical properties was done. The document indicates "suture compatibility and deployment met predetermined acceptance criteria." This implies testing the device itself, independent of a human operator's skill, to ensure it functions as intended. However, this is not an "algorithm-only" standalone study as understood in AI.

7. The Type of Ground Truth Used

• The document states that the determination of substantial equivalence was based on "conformance to consensus and on a detailed device descriptions) ... ... ... Voluntary standards" and that the "ORTHOCORD suture compatibility and deployment met predetermined acceptance criteria."
• Therefore, the ground truth relies on engineering specifications, material science standards (e.g., USP monograph for sutures), and performance criteria established through mechanical and functional testing. It is not based on expert consensus, pathology, or outcomes data in the sense of a diagnostic or therapeutic AI.

8. The Sample Size for the Training Set

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

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

• This information is not applicable as there is no AI model or training set described.

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