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510(k) Data Aggregation
(86 days)
The Smith & Nephew HEALICOIL Knotless Suture Anchor is intended for use only for the reattachment of soft tissue to bone for the following indications:
Shoulder
• Biceps tenodesis
· Rotator cuff tear repair
The HEALICOIL Knotless Suture Anchor consists of an anchor on an inserter fitted with a suture passer. The anchor consists of the following components: a proximal implant (REGENESORB or PEEK), a non-absorbable distal implant (PEEK or Titanium), and a nonabsorbable PEEK plug. The anchor is preloaded on a stainless steel inserter. This device is to be used with Smith & Nephew ULTRABRAID, ULTRATAPE, and MINITAPE Sutures. This device is provided sterile, for single use only.
The provided text describes the 510(k) premarket notification for the "HEALICOIL Knotless Suture Anchor" device. It outlines the device's characteristics, intended use, and substantial equivalence to predicate devices, but it does not contain detailed information about acceptance criteria or specific study results that would typically be found in a comprehensive clinical or performance study report.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth
- Adjudication method
- Multi reader multi case (MRMC) comparative effectiveness study information
- Standalone (algorithm only) performance information
- Type of ground truth used
- Sample size for the training set
- How the ground truth for the training set was established
The document focuses on demonstrating substantial equivalence to already cleared predicate devices by comparing their intended use, technological characteristics, and performance data from bench testing (insertion strength, pull-out strength, cyclic loading, sterilization, shelf-life, biocompatibility, bacterial endotoxin testing).
Here's what the document does provide regarding performance data:
Summary Performance Data (as reported in the document):
| Performance Aspect | Reported Outcome |
|---|---|
| Sterilization | Compared to predicate HEALICOIL REGENESORB Suture Anchor (K123393). (Implies comparability, not specific acceptance criteria or quantitative results are provided). |
| Shelf-life | Based on configurations of predicate HEALICOIL REGENESORB Suture Anchor (K123393) and reference devices MICRORAPTOR Knotless Suture Anchor (K181746) and BIORAPTOR 2.3 PK Suture Anchor (K071586). (Implies comparability, not specific acceptance criteria or quantitative results are provided). |
| Bacterial Endotoxin | Testing completed and met acceptable endotoxin limits per ANSI/AAMI ST72:2011. (Specific acceptance criteria not provided, but compliance to a standard is stated). |
| Biocompatibility | Evaluated against requirements per ISO 10993-1:2018. All acceptance criteria were met. (Specific acceptance criteria not provided, but compliance to a standard is stated). |
| Insertion Strength | HEALICOIL Knotless Suture Anchor had met performance specifications. (Specific specifications not provided). |
| Pull-out Strength | HEALICOIL Knotless Suture Anchor had met performance specifications. (Specific specifications not provided). |
| Cyclic Loading | HEALICOIL Knotless Suture Anchor met performance specifications based on the primary predicate FOOTPRINT PK Suture Anchor (K073509). (Specific specifications not provided, but reliance on predicate's performance is stated). |
Study Information (based on the provided text):
The document describes bench testing rather than a "study" in the traditional sense of a clinical trial or a study involving human readers or algorithms. The performance data summarized relates to the physical and biological characteristics of the device and its components, primarily to establish substantial equivalence with existing devices.
- Data Provenance: The studies are described as "performance data" and "bench testing." The specific location or retrospective/prospective nature of the data collection is not detailed, but it's implied to be laboratory-based testing conducted by the manufacturer or a contracted lab.
- Ground Truth / Experts / Adjudication / MRMC / Standalone / Training Set: These concepts are typically associated with studies evaluating diagnostic or AI-driven devices, neither of which applies to this submission for a surgical suture anchor. Therefore, the document does not contain information on these aspects. The "ground truth" for this type of device is usually established by objective engineering specifications, materials science standards (e.g., ISO for biocompatibility), and mechanical testing protocols.
In summary, the provided document is a 510(k) summary focused on demonstrating substantial equivalence through comparison of the device's design, materials, and bench-level performance data against predicate devices, rather than a clinical study report with detailed acceptance criteria for diagnostic performance or AI effectiveness.
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(70 days)
The A.I.M.™ Suture Anchor is intended for use in arthroscopic, mini-open or open surgical procedures for fixation of soft tissue to bone.
The A.I.M. ™ Suture Anchor is intended for use in the following applications:
Ankle: Mid-foot Reconstruction
Foot: Hallux valgus reconstruction
Hand: Ulnar or lateral collateral ligament reconstruction
Wrist: Scapholunate ligament reconstruction
The implant system includes a 1.7mm diameter PEEK (polyether-etherketone) anchor. pre-mounted on a disposable inserter. The anchor is preloaded with USP size 0 Ultra High Molecular Weight Polyethylene suture. The device is designed to be inserted into a pre-formed hole using a single use disposable awl
The provided text includes a 510(k) summary for the A.I.M.™ Suture Anchor, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices. The study mentioned specifically details "anchor pull-out forces are equivalent or superior to a referenced predicate device", but it does not specify acceptance criteria or the full details of this study to meet your requested information.
Therefore, I cannot provide the requested table and study details. The document is primarily a regulatory submission for substantial equivalence.
Here's a breakdown of why I cannot fulfill your request based on the provided text:
- Acceptance Criteria and Reported Performance: The document states, "Data have been provided in the submission that demonstrates that the anchor pull-out forces are equivalent or superior to a referenced predicate device." This indicates a performance metric (pull-out force) was evaluated and compared to a predicate, but neither specific numerical acceptance criteria nor the precise "reported device performance" values are provided.
- Study Details (Sample size, data provenance, experts, adjudication, MRMC, standalone, ground truth, training set): The document mentions "anchor pull-out forces" were tested, but it does not offer any details about the study design, such as:
- Sample size for test set
- Data provenance (country, retrospective/prospective)
- Number or qualifications of experts
- Adjudication method
- MRMC comparative effectiveness study or effect size
- Standalone algorithm performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
The submission's focus is on declaring substantial equivalence based on material history and general performance comparison to predicates, rather than presenting a detailed performance study with explicit acceptance criteria for a new type of device or an AI/software component, which is what your questions suggest.
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(189 days)
The Micro/Mini N-PK Bone Anchor is intended for the reattachment of soft tissue to bone for the following indications: Elbow, Hand and Wrist - Biceps tendon reattachment - Ulnar or lateral collateral ligament reconstruction . - ◆ Scapholunate ligament reconstruction - . Lateral epicondylitis repair
The Micro/Mini N-PK(H) Bone Anchor consists of an adjustable loop of non-absorbable suture (Sizes 2, 0 and 2- 0) with one (1) or two (2) attached anchors. The bone anchor is a two part system, one part nickel-titanium (nitinol) and the second part polyetheretherketone (PEEK). The PEEK part resides within the nitinol sleeve and retains the suture. The nitinol part expands upon delivery providing resistance to pullout. The construct is provided sterile and preloaded on a disposable delivery instrument.
This 510(k) summary describes the Micro/Mini N-PK(H) Bone Anchor, a device intended for the reattachment of soft tissue to bone. The study focuses on demonstrating substantial equivalence to predicate devices through functional and safety testing.
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| Functional and Safety Testing | |
| Biocompatibility | Conducted in accordance with ISO 10993-1 standards. |
| Corrosion testing | Conducted in accordance with ASTM F2129. |
| Tensile testing | Performed to verify compliance with USP suture requirements. |
| Fixation/Static disassembly strength | Comparison testing performed. |
| Cyclic fatigue performance | Comparison testing performed. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes used for each specific test (biocompatibility, corrosion, tensile, fixation/static disassembly, cyclic fatigue). The data provenance is not specified either (e.g., country of origin, retrospective or prospective). These tests are typically performed in a laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The study involves laboratory-based functional and safety testing of a medical device, not a diagnostic or prognostic assessment requiring expert interpretation of results. Therefore, there is no "ground truth" in the clinical sense established by experts.
4. Adjudication method for the test set
Not applicable, as this is laboratory 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 510(k) submission for a bone anchor, not an AI-based diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not 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
For the functional and safety testing, the "ground truth" is defined by the established industry standards and requirements against which the device's performance is measured:
- Biocompatibility: ISO 10993-1 standards.
- Corrosion: ASTM F2129 standards.
- Tensile testing: USP suture requirements.
- Fixation/Static disassembly strength and Cyclic fatigue performance: Comparison testing to predicate devices, implying that the performance of the predicate devices serves as the benchmark or "ground truth" for acceptable performance.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for this type of medical device testing. The device's design and materials are tested against established performance standards and predicate device performance.
9. How the ground truth for the training set was established
Not applicable, as there is no training set involved. The ground truth for the device's performance is established by recognized international and industry standards (ISO, ASTM, USP) and the performance characteristics of legally marketed predicate devices.
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(79 days)
The Smith & Nephew Suture Anchors are intended for the reattachment of soft tissue to bone for the following indications: Hip: Hip capsule repair - Acetabular labrum reattachment/reconstruction Shoulder: Capsular stabilization - Bankart repair - Anterior shoulder instability - SLAP lesion repairs - Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator Cuff repairs Biceps Tenodesis Foot and Ankle: Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy Knee: Extra-capsular repairs - Medial collateral ligament - Lateral collateral ligament - Posterior oblique ligament Patellar realignment and tendon repairs - Vastus medialis obliquous advancement Iliotibial band tenodesis Elbow, Wrist, and Hand: Lateral epicondylitis repair Biceps tendon reattachment Ulnar or radial collateral ligament reconstructions
Subject of this Traditional 510(k) premarket notification is an addition to the indications for use for the Smith & Nephew, Inc. BIORAPTOR® 2.9, BIORAPTOR® 2.3 PK, OSTEORAPTOR®, and BIORAPTOR Knotless Suture Anchors. These suture anchors were cleared via premarket notifications K053344, K071586, K082215, and K093428, respectively, and have identical indications for use. Smith & Nephew, Inc. seeks to expand the existing indications for use for the subject devices to include acetabular labrum reconstruction.
The provided document is a 510(k) summary for Smith & Nephew suture anchors, seeking to expand their indications for use. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving a device meets specific acceptance criteria through a new study with performance metrics.
Therefore, many of the requested sections related to acceptance criteria, device performance from a test set, expert involvement, and ground truth are not explicitly available in the provided text. The submission relies on the prior clearances and the inherent characteristics of the device.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present specific quantitative acceptance criteria or reported device performance in the manner requested (e.g., sensitivity, specificity, accuracy for a diagnostic device). Instead, it states that "Smith & Nephew is relying on the mechanical testing (insertion strength, pull-out strength, and suture sliding) provided for the predicate devices as a measure of substantial equivalence." This implies that the acceptance criteria for these mechanical properties were met in the original clearances of the predicate devices, and because there have been no changes to the design or materials, they are still considered met.
| Acceptance Criteria (Implied from Predicate Devices) | Reported Device Performance (Implied from Predicate Devices) |
|---|---|
| Sufficient insertion strength | Met (based on prior clearances of predicate devices) |
| Sufficient pull-out strength | Met (based on prior clearances of predicate devices) |
| Acceptable suture sliding characteristics | Met (based on prior clearances of predicate devices) |
| No significant changes in design or materials compared to predicate devices | Confirmed: "There have been no major changes in design or materials..." |
| No additional risk introduced by expanded indication (acetabular labrum reconstruction) | Confirmed: "...the expansion of indications for use to include labral reconstruction introduces no additional risk..." |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This submission doesn't describe a new study with a "test set" for performance evaluation in the context of diagnostic accuracy or a similar measurable outcome. The "test set" implicitly refers to the mechanical testing performed for the original clearances of the predicate devices. The document does not provide details on the sample sizes or data provenance (country of origin, retrospective/prospective nature) of these original mechanical tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not applicable. There is no mention of experts establishing a "ground truth" for a test set in this 510(k) submission. The evaluation is based on mechanical properties and substantial equivalence to previously cleared devices.
4. Adjudication Method for the Test Set
Not applicable. No adjudication method is described for a test set in this submission.
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 for surgical procedures (suture anchors), not an AI-assisted diagnostic tool. An MRMC study is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical surgical implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this type of device (suture anchors) is established through mechanical testing (e.g., measuring forces required for insertion, pull-out, and suture sliding) against engineering specifications and industry standards, and ultimately, through clinical outcomes data from the use of the device and its predicates. The submission references reliance on "mechanical testing" for the predicate devices and "published articles supporting the additional indication," suggesting that the clinical effectiveness and safety of such devices are established in the medical literature.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI/machine learning device.
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(89 days)
The 2.0 PK Suture Anchor T and 2.0 PK Suture Anchor S is intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder: Capsular stabilization- Bankart repair, Anterior shoulder instability, Slap lesion repair, Capsular shift or capsulolabral reconstruction, Acromilavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs and Biceps tenodesis.
Foot/Ankle: Hallux valgus repairs, Medial or lateral instability repairs/reconstruction. Achilles tendon repairs/reconstruction, Mid-foot reconstruction, Metatarsal ligament/tendon repairs/recontructions and Bunionectomy.
Elbow, Wrist, and Hand: Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, and Scapholunate ligament reconstruction,
Knee: Extra-capular repairs -Medial collateral ligament, Lateral ligament, Posterior oblique ligament, Patellar realignment and tendon repairs - Vastus medialis obliquous advancement and Illoiotibial band tenodesis.
The 2.0 PK Suture Anchor T and the 2.0 PK Suture Anchor S consist of a non-absorbable suture anchor with attached non-absorbable suture(s) preassembled to a stainless steel insertion device, and is provided sterile, for single use only. Both anchor models achieve fixation via ribbed/threaded design characteristics that are consistent with the repair of soft tissue to bone.
The provided text describes a 510(k) submission for a medical device, specifically the "2.0 PK Suture Anchor T and 2.0 PK Suture Anchor S." This is a premarket notification for a traditional medical device, not an AI/ML powered device. Therefore, many of the requested criteria such as "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only) performance," "ground truth establishment," and "training set sample size" are not applicable.
The document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices through performance testing. This means the acceptance criteria are largely based on showing comparable performance in defined mechanical tests rather than clinical accuracy studies.
Here's an interpretation of the available information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table format, nor does it provide detailed raw performance data. Instead, it makes a general statement of equivalency to predicate devices. The "acceptance criteria" are implicitly met if the device's performance in the Summary Performance Data demonstrates substantial equivalence to the predicate devices.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Insertion Properties | Substantially equivalent to Smith & Nephew 2.3 BIORAPTOR and Arthrex Mini BioSuture Tak™ anchors. |
| Fixation Properties | Substantially equivalent to Smith & Nephew 2.3 BIORAPTOR and Arthrex Mini BioSuture Tak™ anchors. |
| Safety and Efficacy | Differences from predicate devices do not raise new issues of safety and efficacy. |
| Clinical Indications | Intended for the same range of soft tissue to bone reattachment indications as predicate devices (Shoulder, Foot/Ankle, Elbow/Wrist/Hand, Knee). |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample size for the performance tests. It refers to "performance testing conducted" for insertion and fixation properties. The data provenance is not specified beyond being "conducted" by Smith & Nephew. It is certainly prospective testing, as it's performed to validate the new device. It is not clinical data but rather bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is a mechanical device, and "ground truth" for the test set would be objective measurements from engineering tests rather than expert consensus on medical images or diagnoses.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is not a diagnostic device involving expert review.
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 implant/fastener, not an AI-powered diagnostic or assistive technology.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is a medical implant/fastener, not an AI-powered algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device would be established by objective engineering measurements (e.g., pull-out strength, insertion force, material properties) during performance testing in a lab setting, compared against established standards or the performance of predicate devices. It is not pathology, outcomes data, or expert consensus in a clinical sense.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, there is no training set for this type of device.
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