(30 days)
The Bausch & Lomb Hansatome Excellus Microkeratome is a precision-manufactured instrument indicated for use in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
The Hansatome® Excellus™ Microkeratome is a precision-manufactured instrument indicated for use in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea. It functions identically to the existing Hansatome Microkeratome in that the cutting head rotates about a piyot pin. Propulsion is via a rolling gear within the head which engages with an arcuate gear rack affixed to the suction ring. In addition, the Hasatome Excellus Power/Suction Supply Unit includes 1) a vacuum regulator to allow the physician to set vacuum prior to surgery, 2) a vacuum tank that provides reserve vacuum in the event the vacuum pump fails or power is interrupted during the course of surgery, and 3) a battery pack back-up power supply to the microkeratome motor in the event power is interrupted during the course of surgery. The microkeratome's LCD also contains a back-lit display so the User can read the LCD display in low/no light conditions.
The provided text describes a 510(k) submission for the Hansatome Excellus Microkeratome, seeking to establish substantial equivalence to a predicate device. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive new clinical studies with detailed acceptance criteria and performance metrics against such criteria.
Therefore, the document does not contain the kind of detailed acceptance criteria and a study design with performance metrics that would be typical for a new device requiring efficacy or diagnostic accuracy studies. Instead, the "study" is a comparison to a predicate device, focusing on similarities and differences in design and function.
I will, however, extract what can be inferred about "acceptance criteria" and "device performance" in the context of a 510(k) for a device like a microkeratome, and explain why other details (like sample sizes for test/training sets, expert qualifications, MRMC studies, etc.) are not present.
1. A table of acceptance criteria and the reported device performance
In a 510(k) for a microkeratome, "acceptance criteria" primarily relate to demonstrating that the new device performs its intended function similarly to the predicate device and meets relevant safety standards. The "reported device performance" is essentially the detailed description of the new device's features and how they align with or improve upon the predicate, without introducing new questions of safety or effectiveness.
| Acceptance Criteria (Inferred from 510(k) submission type) | Reported Device Performance (Hansatome Excellus) |
|---|---|
| Intended Use: Device performs lamellar resection of the cornea preceding LASIK surgery or other treatment requiring initial lamellar resection of the cornea, identically to the predicate device. | Performs "Lamellar resection of the cornea preceding LASIK surgery or other treatment requiring initial lamellar resection of the cornea" – Identical to Current Hansatome. |
| Operating Principle: Device uses an electrically driven oscillating blade housed in a head which guides the blade across the cornea within controlled parameters, identically to the predicate device. | Uses "Electrically driven oscillating blade housed in a head which guides the blade across the cornea within controlled parameters" – Identical to Current Hansatome. |
| Patient Contact Portions: Device's patient contact portions (Suction Ring, Microkeratome Head, Blade) are made of materials identical to the predicate device. | Patient contact portions (Suction Ring, Microkeratome Head, Blade) are made of "Stainless Steel, Stainless Steel, Low Carbon Stainless Steel" respectively – Identical to Current Hansatome. |
| Keratome Mechanism: Device's mechanism (single arcuate gear rack, temporal pivot, interchangeable heads, DC power, footswitch blade oscillation) is identical to the predicate device's mechanism. | Mechanism is "Single arcuate gear rack with temporal pivot pin, 3 interchangeable heads with fixed thickness, DC powered 6-9 volts, Footswitch Blade oscillation" – Identical to Current Hansatome. |
| Safety and Functionality Features (Improvements): The new device incorporates enhancements (vacuum regulator, vacuum tank, battery pack, backlit LCD) that improve safety and user experience without altering the fundamental cutting mechanism or therapeutic effect, or that meet recognized safety standards (e.g., UL Listing). | - Vacuum Regulator: Allows physician to set vacuum prior to surgery. |
- Vacuum Tank: Provides reserve vacuum if pump fails or power is interrupted.
- Battery Pack: Back-up power for microkeratome motor if power is interrupted.
- Back-lit LCD: User can read display in low/no light conditions.
- More efficient vacuum pump: Can operate at elevations up to 7000 feet (vs. 6500 for predicate).
- Power/Suction Supply Unit: UL Listed (vs. Not UL Listed for predicate). |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. This 510(k) submission is for a medical device (microkeratome) and relies on demonstrating substantial equivalence to a predicate device through engineering and design comparisons, and potentially bench testing, rather than a clinical "test set" for performance evaluation in a diagnostic or efficacy study. No human or animal subject data from a "test set" is described for the purpose of validating performance against specific clinical acceptance criteria.
- Data Provenance: Not applicable. The "data" are primarily engineering specifications, design comparisons, and functional descriptions of the device and its predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts & Qualifications: Not applicable. Ground truth, in the sense of expert consensus on diagnostic outcomes or pathology, is not relevant for this type of device submission. The "ground truth" here is the established safety and effectiveness of the predicate device, as demonstrated through its prior marketing and regulatory clearance, and the assumption that the new device, being substantially equivalent, shares that history.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. As there is no clinical "test set" requiring adjudication of outcomes, this information is not relevant to 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
- MRMC Study: Not applicable. This device is a surgical instrument, not an AI-assisted diagnostic tool or an imaging device requiring interpretation by human readers. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a mechanical surgical instrument; it does not involve algorithms or AI operating in a standalone capacity. Its performance is intrinsically tied to its mechanical function and human use in surgery.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: The "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate device (Hansatome® Microkeratome). The argument for the new device's safety and effectiveness relies on its substantial equivalence in intended use, operating principle, materials, and fundamental mechanism, with noted improvements in safety and user convenience features (e.g., UL listing, vacuum tank, battery backup) that do not alter the core function in a way that would introduce new risks or questions of effectiveness.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is a medical device clearance based on substantial equivalence, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no training set for a machine learning model.
§ 886.4370 Keratome.
(a)
Identification. A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.(b)
Classification. Class I.