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510(k) Data Aggregation
(56 days)
The Litho EVO laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectory, Gynaecology, ENT and General Surgery.
Urology
Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis) including:
· Urethral Strictures
· Bladder Neck Incisions (BNI)
· Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral Tumors,
· Ablation of Benign Prostatic Hypertrophy (BPH).
· Transurethral incision of the prostate (TUIP)
· Holmium Laser Resection of the Prostrate (HoLRP)
· Holmium Laser Enucleation of the Prostate (HoLEP)
· Holmium laser Ablation of the Prostate (HoLAP)
· Condylomas
· Lesions of external genitalia
Lithotripsy and Percutaneous Urinary Lithotripsy
· Endoscopic fragmentation of ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones.
· Endoscopic fragmentation of kidney calculi
· Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed.
Gastroenterology
Open and endoscopic Gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis) including:
· Appendectomy
Polyps
· Biopsy
· Gall Bladder calculi
Biliary/Bile duct calculi
· Ulcers
· Gastric ulcers
· Duodenal ulcers
· Non Bleeding Ulcers
Pancreatitas
Haemorrhoids
· Cholecystectomy
Benign and Malignant Neoplasm
Angiodysplasia
Colorectal cancer
· Telangiectasias
· Telangiectasias of the Osler-Weber-Renu disease
Vascular Malformation
· Gastritis
· Esophagitis
Esophageal ulcers
Varices
· Colitis
· Mallory-Weiss tear
· Gastric Erosions
Arthroscopy
Arthroscopy/Orthopaedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) in small and large joints of the body, excluding the spine but including:
· Ligament and tendon Release
· Contouring and sculpting of articular surfaces
· Capsulectomy in the Knee
· Chondreplasty in the Knee
Debridement of inflamed synovial tissue
Chondromalacia Ablation
Chondromalacia and tears
· Plica Removal
· Meniscectomy
Loose Body Debridement
· Lateral retinecular release
Ablation of soft, cartilaginous and bony tissue in Minimal Invasive Spinal Surgery including
· Percutaneous Laser Disc Decompression/Discectomy of the L4-5 and L5-SI lumbar discs, including Foraminoplasty Percutaneous Cervical Disc Decompression/Discectomy
Percutaneous Thoracic Disc Decompression/Discectomy
Gynaecology
Open and laparoscopic gynaecological surgery (incision, excision, ablation, vaporization, coagulation and haemostasis) of soft tissue
ENT
Endoscopic endonasal surgery (incision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue and cartilage) including:
· Endonasal/sinus Surgery
· Partial turbinectomy
· Polypectomy
Dacryocystorhinostomy
Frontal Sinusotomy
Ethmoidectomy
· Maxillary antrostomy
· Functional endoscopic sinus surgery
General Surgery
Open, laparoscopic and endoscopic surgery (incision, resection, ablation, vaporization, coagulation and haemostasis) including:
· Appendectomy
Skin incision
· Excision of external and internal lesions
· Complete of partial resection of internal organs, tumors and lesions
Biopsv
Litho Evo is based on Holmium laser cavity emitting at 2100nm. Laser emission is triggered by mean of a footswitch and is delivered to the tissue through fiber optics. The main parts (subsystems) of the subject device are the Holmium laser source, the optical delivery system, the power electronics, the control electronics and the cooling system. Moreover, a specific software controls the device functions and allows the user selections through the touchscreen display.
The provided text describes a 510(k) premarket notification for a medical device called Litho Evo, a Holmium laser system. This submission is a "Special 510(k)" due to modifications of an already cleared device, Olympus Empower H35 (K180426). The document states that performance testing and software verification and validation were conducted according to relevant standards. However, it does not provide a detailed study that proves the device meets specific acceptance criteria in terms of clinical performance or effectiveness.
Here's a breakdown of the requested information based only on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria for device performance in a clinical or measurable outcomes sense, nor does it report specific performance metrics (e.g., success rates, fragmentation efficiency, treatment times) for the Litho Evo device. Instead, it focuses on compliance with general safety and performance standards for medical electrical equipment and laser products.
| Acceptance Criteria (Stated as Compliance with Standards) | Reported Device Performance (Stated as Compliance) |
|---|---|
| IEC 60601-1:2012, ed 3.1 (Basic Safety & Essential Performance) | Passed all required testing and is in compliance |
| IEC 60601-1-2 Ed 4: 2014 (EMC Requirements) | Passed all required testing and is in compliance |
| IEC 60601-2-22: 2012-10 ed 3.1 (Surgical Laser Equipment) | Passed all required testing and is in compliance |
| IEC 60825-1 Ed. 3.0 (2014) (Safety of Laser Products) | Passed all required testing and is in compliance |
| Software Verification and Validation Testing | Conducted and documentation provided as recommended by FDA guidance. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe any specific human-subject or clinical "test set" for evaluating the performance of the Litho Evo device against acceptance criteria. The performance testing mentioned refers to technical compliance with engineering and safety standards, not clinical 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. The performance testing described is related to engineering and safety standards, not medical interpretation or clinical ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of a test set requiring adjudication in the context of clinical performance.
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. The Litho Evo is a laser surgical instrument, not an AI-assisted diagnostic or interpretive device. Therefore, MRMC studies and AI effect sizes are not relevant 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 laser surgical instrument requiring human operation, not an autonomous algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for the performance testing mentioned appears to be defined by the technical specifications and requirements outlined in the cited IEC and FDA standards for safety, electromagnetic compatibility, and laser product safety.
8. The sample size for the training set
Not applicable. This device does not use machine learning or AI that would require a "training set" in the conventional sense. Software verification and validation were conducted, but this doesn't equate to an AI training set.
9. How the ground truth for the training set was established
Not applicable. (See #8)
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(219 days)
The Straumann® Variobase™ Abutment is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase" Abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations.
The Straumann® Variobase " Abutments are pre-manufactured (stock) abutments, sometimes referred to as "Ti-bases". Straumann® Variobase" Abutments are available to fit Straumann® dental implant platforms NNC (Narrow Neck CrossFit®), RN (Regular Neck), WN (Wide Neck), NC (Narrow CrossFit®), and RC (Regular CrossFit®). A dental laboratory technician would design the corresponding coping and/or crown (the second component of the Variobase two-piece abutment) and/or prosthetic restoration in the dental laboratory using either a burnout coping or STL model for open CAD software. The coping and/or crown would be manufactured via validated Straumann milling.
The provided text describes a 510(k) submission for Straumann® Variobase™ Abutments, detailing the device, its intended use, and performance testing. However, it does not include the specific acceptance criteria or the full study details needed to populate all sections of your request comprehensively. The text primarily focuses on bench testing for fatigue limits and establishing substantial equivalence to predicate devices, rather than a clinical study evaluating diagnostic performance against defined acceptance criteria.
Based on the provided document, here's what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Explicitly Stated for diagnostic metrics. The document mentions "requirements of ISO 5832-11" for material and evaluation of "fatigue load limits" in accordance with "FDA guidance document 'Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments'". These are performance standards for mechanical properties, not diagnostic accuracy. | Not Explicitly Stated for diagnostic metrics. The study focused on evaluating "fatigue load limits" of the abutments and confirming the material meets ISO 5832-11. The document concludes "the Straumann® Variobase" Abutments are substantially equivalent to the predicate devices and do not pose new issues of safety and effectiveness when used as labeled." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the context of diagnostic performance as described. The testing involved mechanical bench testing of components (Polycon® ae and Zerion®) rather than a test set of patient data.
- Data Provenance: Not applicable. The tests were bench tests conducted on device components, not on 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 a mechanical performance study, not a study requiring expert-established ground truth for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This was a mechanical performance study.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is a traditional 510(k) for a dental abutment, focusing on material and mechanical properties, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. Not an AI diagnostic device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable in the context of diagnostic performance. For the mechanical testing, the "ground truth" would be established by the engineering standards and test methodology (e.g., ISO 5832-11 and FDA guidance for fatigue testing), rather than clinical ground truth.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device.
Summary of what is described in the 510(k):
The submission describes the Straumann® Variobase™ Abutments as pre-manufactured (stock) abutments made from a titanium-aluminum-niobium alloy (meeting ISO 5832-11). Performance testing involved bench testing to evaluate the fatigue load limits in accordance with FDA guidance for Class II dental implants and abutments. This testing was to demonstrate substantial equivalence to predicate devices (K120822 and K111935) and confirm that the device does not pose new safety or effectiveness issues. The materials for the coping/crown component were also identical to predicate devices. The focus is on the mechanical and material properties of the abutment to support prosthetic restorations.
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